article 14 of directive (eu) 2016/798 and commission

Guide for the application of Article 14 of Directive (EU) 2016/798 and Commission Implementing Regulation (EU) No 2019/779 on a system of certification of entities in charge of maintenance for vehicles

In accordance with Article 19(3) of Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016

Guidance on ECM certification process

Released by European Union Agency for Railways

This guide does not contain any legally binding advice. It may serve as a clarification tool without however dictating in any manner compulsory procedures to be followed and without establishing any legally binding practice. The guide provides explanations on the provisions contained in the TSIs and should be helpful for understanding the approaches and rules described therein. However, it does not substitute for them.

The guide is publicly available and it will be regularly updated to reflect progress with European standards and changes to the TSIs.

The reader should refer to the website of the European Union Agency for Railways for information about its latest available edition.

Manuscript completed in June 2021

Neither the European Union Agency for Railways nor any person acting on behalf of the European Union Agency for Railways is responsible for the use that might be made of the following information.

Luxembourg: Publications Office of the European Union, 2021

© European Union Agency for Railways, 2021

Reproduction is authorised provided the source is acknowledged.For any use or reproduction of photos or other material that is not under the ERA copyright, permission must be sought directly from the copyright holders.

Print ISBN 978-92-9477-302-9 doi:10.2821/423550 TR-04-20-455-EN-CPDF ISBN 978-92-9477-303-6 doi:10.2821/731954 TR-04-20-455-EN-N

Document History

Version Date Comments

Version 1.0 20/08/2013 New structure – new presentation

Version 2.0 08/07/2015 New § 9.7 supervision NSA – article 9 regulation 445/2011

Version 3.0 18/06/2020 Draft Revision for enter of application regulation 779/20219

Version 4.0 01/07/2020 Draft Revision of the guide after meeting on 30/06/2020





Version 9.0 01/03/2021 Final version of the guide after comments received on 01/12/2020

Guide for the application of Article 14 of Directive (EU) 2016/798 and Commission Implementing Regulation (EU) No 2019/779 on a system of certification of entities in charge of maintenance for vehicles

In accordance with Article 19(3) of Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016

Guidance on ECM certification process

Contents

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

1.1. Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.2. Principle for this guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.3. Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2. DOCUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

2.1. What legislative documents are related to ECM certification? . . . . . . . . . . . . . . . . . . . . . 8

2.2. What documents do you need to have in mind? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2.3. Do you know the Wagon and LOC&PAS TSIs? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

3. DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.1. Common acronyms in the day – to – day life in the ECM certification. . . . . . . . . . . . . 13

4. VEHICLE AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

4.1. What vehicles fall under regulation 2019/779? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

4.2. What are the exclusion of vehicles from the application of Commission Implementing Regulation 2019/779 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

4.3. What is an ECM? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

4.4. Who can be an ECM? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

4.5. How many ECMs can a vehicle have? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

4.6. What is a maintenance workshop? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

4.7. What does “maintenance” mean? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

4.8. What is a maintenance system? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

4.9. What is the ECM-F1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

4.10. What is the ECM-F2? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

4.11. What is the ECM-F3? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

4.12. What is the ECM-F4? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

4.13. What is release to service and return to operation? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284.13.1. Proposal of a minimum set of information to be exchanged during the

“Release to Service” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304.13.2. Proposal of a minimum set of information to be exchanged during the

“Return to operation” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

5. CERTIFICATION OF ECM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

5.1. What does Certification mean? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

5.2. What is an ECM certificate? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

5.3. Which ECMs have to be certified . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

5.4. What are the steps to follow to obtain an ECM certificate? . . . . . . . . . . . . . . . . . . . . . . 37

5.5. What does the schema “Schema chosen to award ECM certificates in each member state” in ERADIS mean? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

5.6. Can a NSA of a Member State A give an ECM certificate in a Member State B? . . . . 38

6. RESERVED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

7. RESERVED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

8. IMPLEMENTATION OF THE REGULATION 2019/779 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

8.1. What does the transitional period mean? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

8.2. What are the deadlines you need to have in mind? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 418.2.1. Deadlines for certification bodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 418.2.2. Deadlines for ECM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

9. ORGANISATION OF THE RAILWAY SECTOR IN EUROPE AND RESPONSABILITIES OF ACTORS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

9.1. Who are the different “Stakeholders” participating in the maintenance of vehicles? . . . 43

9.2. You are a Keeper, what are your responsibilities? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

9.3. You are a RU/IM, what are your responsibilities? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

9.4. You are a manufacturer, what are your responsibilities? . . . . . . . . . . . . . . . . . . . . . . . . . 48

9.5. Is there a harmonised framework for the pre departure inspection? . . . . . . . . . . . . . 49

9.6. You are an ECM, what are your responsibilities? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

9.7. Application of Article 4(6) - Use of Safe Alert IT tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

9.8. You are an accredited or recognized ECM certification body or a NSA designated as ECM certification body. What are your responsibilities? . . . . . . . . . . . . . . . . . . . . . . . . . 51

9.9. You are an NSA supervising RUs and IMs. When supervision shows a non compliance of an ECM with the requirements, what are your responsibilities in connection with Article 11 of the ECM regulation? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

9.10. What other legal information do you need to have in mind when managing contracts? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

9.11. When a new authorisation for placing on the market is necessary? . . . . . . . . . . . . . . 54

9.12. How to understand the article 3(2)b (Assessment of RUs and IMs maintaining vehicles, other freight wagons, exclusively for their own operation)? . . . . . . . . . . . . 55

9.13. What are the steps for the assessment of the ECM requirements during the process of safety certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

10. WHAT IS THE MAINTENANCE FILE? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

11. EXCHANGE OF INFORMATION BETWEEN RAILWAY ACTORS . . . . . . . . . . . . . . . . . . . . . 65

11.1. What is the information that stakeholders have to exchange according to the maintenance of vehicles? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

11.2. How to find an ECM certification body, how to publish your ECM certificate, how to find an ECM certified? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

12. MANAGEMENT OF CHANGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

12.1. I would like to change the ECM of my fleet, how to proceed? . . . . . . . . . . . . . . . . . . . . 68

13. HOW TO MANAGE SAFETY CRITICAL COMPONENTS? . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

13.1. What is a safety critical component. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

13.2. For which type of vehicle? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

13.3. What is the SCC management process? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

13.4. What are the possible methods for the identification of SCC? . . . . . . . . . . . . . . . . . . . . 74

14. COMPETENCES OF MAINTENANCE STAFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

14.1. Develop a matrix of the qualifications according to the ECM functions and relevant key functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

14.2. Competences of maintenance workers (ECM-F4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

15. WAGONS FOR DANGEROUS GOODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

16. ECM ANNUAL REPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Annex I Mapping Table IM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Annex II Mapping Table RU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Annex III REGULATION 2019/779 Art.15 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

GUIDANCE ON ECM CERTIFICATION PROCESS

6 Version 9.0 (01/03/2021). Uncontrolled when printed. Download the latest version at era.europa.eu.© 2021 EU Agency for Railways. All rights reserved.

1. INTRODUCTION

1.1. Scope

This guide provides information on the application of the “Commission Implementing Regulation (EU) 2019/779 of 16 May 2019 laying down detailed provisions on a system of certification of entities in charge of maintenance of vehicles1 pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 445/2011 [1]” as referred to in Article 14(6) and (8) of the Safety Directive. That regulation will be referred to in the present document as the “ECM Regulation”.

This guide aims at a correct and common understanding of the concepts of ECM developed in the ECM Regulation but does not contain any legally binding advice. It contains explanatory information of potential use to all actors2 whose activities may have an impact on the safety of railway systems and who directly or indirectly need to apply the ECM Regulation. It may serve as a clarification tool without however dictating in any manner compulsory procedures to be followed and without establishing any legally binding practice. The guide provides explanations on the provisions contained in the ECM Regulation and should aid understanding of the approaches and rules described therein.

This guide has been prepared by the European Union Agency for Railways (ERA) with the support of Recognised Bodies and National Safety Authority experts. It represents a developed collection of information gathered by the Agency during internal meetings and meetings with ACBs (Accredited Certification Bodies), RCBs (Recognised Certification Bodies) and NSAs.

ERA will organise other workshops during 2021/2022, and when necessary, ERA will review and update the guide to reflect the progress with the return on experience on the implementation of the ECM Regulation received during these workshops. As it is not possible to give a timetable for this revision process at the time of writing, the reader should refer to the Agency for information about the latest available edition of the guide or consult the Agency website (http://www.era.europa.eu).

The ECM Regulation provides a framework for the harmonisation of requirements and methods to assess the ability of entities in charge of maintenance for vehicles.

1.2. Principle for this guide

Although the guide may appear to be a stand-alone document for reading purposes, it is not a substitute for the ECM Regulation. For ease of reference, when relevant, the related article of the ECM Regulation or the safety directive is copied or referred to in the guide. Guidance

1 OJ L139/360 27/05/20192 The concerned actors are the contracting entities as defined in Article 5 of ECM Regulation including their suppliers

and service providers, or the certification bodies as defined in Article 6 of ECM Regulation.

1. INTRODUCTION

7Version 9.0 (01/03/2021). Uncontrolled when printed. Download the latest version at era.europa.eu.© 2021 EU Agency for Railways. All rights reserved.

is then provided in the following paragraphs to help provide understanding where this is considered necessary.

A first main structure of the present guide was proposed, discussed and approved during the “Task Force on the ECM Guidelines”.

1.3. Structure

The guide is divided into the following parts:

▶ Part 1 “Introduction” contains the scope and explains the structure of the guide;

▶ Part 2 “Documents” defines the documents useful for the guide;

▶ Part 3 “Definitions” contains a list of questions/answers relative to definitions, terms and abbreviations used throughout the guide;

▶ Part 4 “Vehicle and maintenance” explains the maintenance process;

▶ Part 5 “Certification of ECM” describes the different steps of the ECM certification;

▶ Part 6 “Where does the ECM certification apply ?” explains the geographical scope of ECM certificate;

▶ Part 7 “Accreditation – Recognition of certification bodies” contains a list of questions/answers relevant to better understand the environment of accreditation and recognition;

▶ Part 8 “Implementation of article 3 of the regulation 2019/779” System of certification.

▶ Part 9 “Organisation of the railway transport in Europe and responsibilities of actors”

▶ Part 10 “Maintenance file and technical file” contains a list of questions/answers to explain how to follow the requirements of the regulation 2019/779 to build the essential documents relative to the maintenance functions.

▶ Part 11 “Exchange of information between railway actors”

▶ Part 12 “Management of changes” It explains how to meet the different changes inherent to ECMs.

▶ Part 13 “Safety-critical components”

▶ Part 14 “Competences of maintenance workers”

▶ Part 15 “Wagons for Dangerous goods”

▶ Part 16 “ECM annual report”

▶ Part 17 “Annexes”



2. DOCUMENTS

2.1. What legislative documents are related to ECM certification?

[Ref. N°] Title Reference Version

[1] Commission Implementing Regulation (EU) 2019/779 of 16 May 2019 laying down detailed provisions on a system of certification of entities in charge of maintenance of vehicles pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 445/2011Current consolidated version:(Hereafter called “ECM Regulation”)

(EU) 2019/779 27/05/201916/06/2020

[2] Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety (Railway Safety Directive)(Hereafter called “Safety Directive”)

(EU) 2016/798 11/05/2016

[3] Directive (EU) 2016/797 of the European Parliament and of the Council of 17 June 2008 on the Interoperability of the rail system within the Community(Hereafter called “Interoperability Directive”)

(EU) 2016/797 11/05/2016

[4] Commission Implementing Regulation (EU) N°402/2013 of 30 April 2013 on the common safety method on risk evaluation and assessment and repealing Regulation (EC) n° 352/2009 amended by Commission Implementing Regulation (EU) 2015/1136 of 13 July 2015.(Hereafter called “CSM-RA Regulation”)

402/2013/EC(EU) 2015/1136

30/04/201313/07/2015

[5] COMMISSION REGULATION (EU) No 1302/2014 of 18 November 2014 concerning a technical specification for interoperability relating to the ‘rolling stock — locomotives and passenger rolling stock’ subsystem of the rail system in the European Union.(Hereafter called “Loc&Pas TSI”)Amended by:Commission Regulation (EU) 2016/919 of 27 May 2016Commission Implementing Regulation (EU) 2018/868 of 13 June 2018Commission Implementing Regulation (EU) 2019/776 of 16 May 2019Commission Implementing Regulation (EU) 2020/387 of 9 March 2020

(EU) 1302/2014 18/11/2014

2. DOCUMENTS



[6] COMMISSION REGULATION (EU) No 321/2013 of 13 March 2013 concerning the technical specification for interoperability relating to the subsystem ‘rolling stock — freight wagons’ of the rail system in the European Union and repealing Decision 2006/861/EC.(Hereafter called “Wagon TSI”)Amended by:Commission Regulation (EU) No 1236/2013 of 2 December 2013Commission Regulation (EU) 2015/924 of 8 June 2015Commission Implementing Regulation (EU) 2019/776 of 16 May 2019Commission Implementing Regulation (EU) 2020/387 of 9 March 2020

(EU) 321/2013 09/03/2020

[7] COMMISSION REGULATION (EU) 2016/919 of 27 May 2016on the technical specification for interoperability relating to the ‘control-command and signalling’ subsystems of the rail system in the European Union(Hereafter called “CCS TSI”)Amended by:Commission Implementing Regulation (EU) 2019/776 of 16 May 2019Commission Implementing Regulation (EU) 2020/387 of 9 March 2020

(EU) 2016/919 09/03/2020

[8] COMMISSION IMPLEMENTING REGULATION (EU) 2019/773 of 16 May 2019 on the technical specification for interoperability relating to the operation and traffic management subsystem of the rail system within the European Union and repealing Decision 2012/757/E(Hereafter called “OPE TSI”)

(EU) 2019/773 16/05/2019

[9] COMMISSION REGULATION (EU) No 1304/2014 of 26 November 2014 on the technical specification for interoperability relating to the subsystem ‘rolling stock — noise’ amending Decision 2008/232/EC and repealing Decision 2011/229/EU(Hereafter called “NOISE TSI”)Amended by:Commission Implementing Regulation (EU) 2019/774 of 16 May 2019

(EU) 1304/2014 16/05/2019

[10] Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.

765/2008/EC 09/07/2008

[11] COMMISSION IMPLEMENTING REGULATION (EU) 2018/545 of 4 April 2018 establishing practical arrangements for the railway vehicle authorisation and railway vehicle type authorisation process pursuant to Directive (EU) 2016/797 of the European Parliament and of the Council

(EU) 2018/545 04/04/2018

[12] COMMISSION IMPLEMENTING DECISION (EU) 2018/1614 of 25 October 2018 laying down specifications for the vehicle registers referred to in Article 47 of Directive (EU) 2016/797 of the European Parliament and of the Council and amending and repealing Commission Decision 2007/756/EC

(EU) 2018/1614 25/10/2018

[13] Commission Regulation (EU) No 1078/2012 of 16 November 2012 on a common safety method for monitoring to be applied by railway undertakings, infrastructure managers after receiving a safety certificate or safety authorisation and by entities in charge of maintenance(Hereafter called “CSM Monitoring”)

1078/2012/EC 16/11/2012

[14] Commission Delegated Regulation (EU) 2018/761 of 16 February 2018 establishing common safety methods for supervision by national safety authorities after the issue of a single safety certificate or a safety authorisation pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 1077/2012(Hereafter called “CSM Supervision”)

(EU) 2018/761 16/02/2018

[15] RID – 2019 The Regulation concerning the International Carriage of Dangerous Goods by Rail (RID) forms Appendix C to COTIF, and has an annex. This Regulation applies to international traffic.

RID 2019 01/01/2019




[16] DIRECTIVE 2008/68/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 September 2008 on the inland transport of dangerous goods

2008/68/EC 30/09/2008

[17] ECM certification scheme ERA-1172-003 V1.1

15/06/2020

[18] ECM accreditation scheme ERA -1172-002 V3.1

15/06/2020

[19] EN 17095 Railway applications – Rolling stock maintenance- Maintenance records

DS/EN 17095/2019

03/2019

[20] EN 17023 Railway applications-Railway vehicle maintenance- Creation and modification of maintenance plan

DS/EN 17023: 2018

12/2018

[21] ISO 9712 “Non-destructive testing — Qualification and certification of NDT personnel” ISO 9712 Edition 4

2012/06

[22] Series of standards EN 15085 “Railway applications — Welding of railway vehicles and components” Series EN 15085 Last versions

[23] EN ISO/IEC 17021 “Conformity assessment — Requirements for bodies providing audit and certification of management systems”

EN ISO/IEC 17021 2015/08

[24] EN ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”

EN ISO/IEC 17025 2018/01

[25] EN ISO/IEC 17065 Conformity assessment- Requirements for bodies certifying products, processes or services

EN ISO/IEC 17065 2012/09

[26] EN ISO/IEC 17000 Conformity assessment – Vocabulary and general principles

EN ISO/IEC 17000 2020/05

2. DOCUMENTS


2.2. What documents do you need to have in mind?

Here you can find the diagram describing the different regulations and the schemes associated:

The different standards supporting the accreditation and recognition process of ECM certification bodies and ECM certification are:

▶ EN ISO/IEC 17065:2012 Conformity assessment- Requirements for bodies certifying products, processes or services

▶ EN ISO/IEC 17021-1:2015 Conformity assessment- Requirements for bodies providing audit and certification of management systems -- Part 1: Requirements

▶ EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories

▶ EN 17095 Railway applications – Rolling stock maintenance- Maintenance records

▶ EN 17023 Railway applications-Railway vehicle maintenance- Creation and modification of maintenance plan

▶ EN ISO/IEC 17000:2020 Conformity assessment – Vocabulary and general principles

▶ IAF MD 1:2018 Audit and certification of a Management System Operated by a Multiple-Site Organization

Guidance for vehicle authorisation

ISBN 978‐92‐9205‐437‐3

Vehicle authorisation (EU) 2018/545

InteroperabilityDirective

(EU) 2016/797

TSI OPE (EU) 2019/773

TSI NOISE(EU) 1304/2014

TSI CCS(EU) 2016/919

TSI WAGON(EU) 321/2013

TSI LOC & PAS(EU) 1302/2014

ECM guidelinesERA – VERSION 09

ISBN 978‐92‐9477‐302‐9

ECM Regulation (EU) 2019/779

CSM on monitoring (EU) 1078/2012

CSM guide on monitoring ERA/GUI/05‐2012/SAF

Safety Directive(EU) 2016/798

Safety Certificate(EU) 2018/763

Guidance for safety certificateand supervision

ISBN 978‐92‐9205‐427‐4

ECM ACCREDITATION SCHEME

ECM‐1172‐002‐V3.1

ECM CERTIFICATION SCHEME

ECM‐1172‐003‐V1.1

CSM on risk (EU) 402/2013

NVRSpecifications for

vehicle register (EU) 2018/1614

CSM guide on risk ERA/GUI/01‐2008/SAF

ERADIS – ECMRECORDS

ERADISECM RFU

Active Regulation

Guidance material

Register



▶ IAF MD 2:2017 Transfer of Accredited Certification of Management Systems

▶ IAF MD 5:2015 Determination of Audit Time of Quality and Environmental Management Systems.

The accreditation and recognition scheme [18] precises in the part 3.1.3 c the knowledge and skills addressing assessment principles, practices and techniques and knowledge of the specific standards related to them.

The above documents should be understood as the latest valid version of each document – in case of modifications, the latest version applies.

2.3. Do you know the Wagon and LOC&PAS TSIs?

The Technical Specifications for Interoperability (TSIs) define the technical and operational standards which must be met by each subsystem or part of subsystem in order to meet the essential requirements and ensure the interoperability of the railway system of the European Union.

The LOC&PAS TSI concerns the rolling stock subsystem and applies to the following types of rolling stock:

▶ Self-propelling thermal or electric trains;

▶ Thermal or electric traction units;

▶ Passenger carriages;

▶ Mobile railway infrastructure construction and maintenance equipment.

The Wagon TSI concerns the rolling stock subsystem and applies to freight wagons including vehicles designed to carry lorries.

More information on these TSIs can be found at

https://www.era.europa.eu/activities/technical-specifications-interoperability_en

https://www.era.europa.eu/activities/technical-specifications-interoperability_en

3. DEFINITIONS


3. DEFINITIONS

3.1. Common acronyms in the day – to – day life in the ECM certification.

Acronym Meaning

AB Accreditation Body

ACB Accredited Certification Body

APOM/APIS Authorisation for the Placing on the Market / Placing in Service (of structural subsystems and vehicles)

CA Conformity Assessment

CAB Conformity Assessment Body

CSM Common Safety Methods

CUV

EA European co-operation for Accreditation (http://www.european-accreditation.org)

EA (MLA) EA Multi-Lateral Agreement

EC European Commission (http://ec.europa.eu/index_en)

ECCM European Common Criteria for Maintenance

ECM Entity in Charge of Maintenance

ECM - F1 Management function

ECM - F2 Maintenance Development function

ECM - F3 Fleet Maintenance Management function

ECM - F4 Maintenance Delivery function

EEA European Economic Area

EFTA European Free Trade Association (http://www.efta.int)

EN European Norm

ERA European Railway Agency (http://www.era.europa.eu)

ERATV European register of authorised types of vehicles referred to in Article 34 of Interoperability Directive (Commission Implementing Decision 2011/665/EU)

ERADIS European Railway Agency Database of Interoperability and Safety

EVN European vehicle Number

EU European Union

ERA European Union Agency for Railways

EVIC European Visual Inspection Catalogue

EWT European Wheelset traceability catalogue

GCU General Contract of Use (http://www.gcubureau.org)

IAF International Accreditation Forum (http://www.iaf.nu/)

(IAF) MD Mandatory document of IAF

IM Infrastructure Manager

http://www.european-accreditation.org/

http://www.european-accreditation.org/

http://ec.europa.eu/index_en

http://www.efta.int/

http://www.era.europa.eu/

http://www.gcubureau.org/

http://www.iaf.nu/



ISA Independent Safety Assessment Body

ISO International Organization for standardization

IT Information Technology

LNG Liquefied Natural Gas

MLA Multilateral Agreements

MoU Memorandum of Understanding

MRA Mutual Recognition Agreements

MS Member State

NAB National Accreditation Body

NDT Non-Destructive Test

NoBo Notified Body

NSA National Safety Authority

NVR National Vehicle Register

OTIF Organisation intergouvernementale pour les Transports Internationaux Ferroviaires - Intergovernmental Organisation for International Carriage by Rail (http://www.otif.org)

OTM On–Track Machine

RID Regulations concerning the International Carriage of DangerousGoods by Rail, as adopted under Directive 2008/68/EC.

RFU Recommendations for use (https://eradis.era.europa.eu/safety_docs/ecm/recommendationsForUse/default.aspx)

RS Rolling Stock

RSD Railway Safety Directive

RU Railway Undertaking

SAIT Safety Alert IT-Tool

SCC Safety-critical components

SMS Safety Management System

VTA Vehicle Type Authorisation

RTS Release to Service

http://www.otif.org/

https://eradis.era.europa.eu/safety_docs/ecm/recommendationsForUse/default.aspx

https://eradis.era.europa.eu/safety_docs/ecm/recommendationsForUse/default.aspx


4. VEHICLE AND MAINTENANCE


4.1. What vehicles fall under regulation 2019/779?

▶ Freight wagon

A non-self-propelled vehicle designed for the purpose of transporting freight or other materials to be used for activities such as construction or infrastructure maintenance.

Each freight wagon must have been assigned a unique EVN and one ECM in charge for this wagon in the NVR. As it is permissible in certain circumstances to assign a single EVN to a fixed formation of two or more wagon units (defined as multiple wagons in [6] and [12]), it is in turn possible that a “wagon” from the perspective of the ECM can consist of more than one element. In each case the EVN and the associated entry in the NVR will be the binding definition on what constitutes an individual “wagon”.

Picture 1: Example of a unit consisting of a (freight) wagon that can be operated separately, featuring

an individual frame mounted on its own set of wheels



Picture 2: Example of a unit consisting of a rake of permanently connected two elements (blue and

orange), those elements cannot be operated separately (articulated wagon)

Picture 3: Example of a unit consisting of a rake of permanently connected two elements, those

elements cannot be operated separately

▶ Locomotives (thermal or electric traction units)

Locomotives (mentioned in TSI Loc§Pas 2.3.1) consists in the engine of a train designed for pulling or, sometimes, pushing a train or individual railway cars or freight wagons. These traction vehicles are not capable of carrying a payload. They are intended for freight and/ or passenger transport. Power sources can be one, or a combination, of the following: diesel engine, steam, electricity, LNG, battery or hydrogen (non-exhaustive list).



Picture 4: Example of a French freight locomotive that is powered by electricity.

▶ Multiple units/Trainset

Multiple units or trainset (mentioned in TSI Loc§Pas 2.3.1) consist of several vehicles formed into a fixed formation or set, with their own means of propulsion and do not require a locomotive. Depending on the power source these multiple units are sometimes known as Electric Multiple Units (EMUs), Diesel Multiple Units (DMUs) and Battery Electric Multiple Unit (BEMU). Other power sources and hybrids also exist e.g. battery and Hydrogen or LNG.

Picture 5 : Example of an Electric Multiple unit in Germany.

▶ Passenger coaches

Passenger coaches (mentioned in TSI Loc§Pas 2.3.1) are vehicles that contain no traction power and thus rely on locomotives to push or pull them. Their primary purpose is for the transportation of passengers.



Picture 6: Example of passenger coaches being pulled by an electric locomotive in Switzerland.

▶ On Track Machines (OTM)

An OTM (mentioned in TSI Loc§Pas 2.3.1) is a vehicle used for performing works on or around the tracks, running on its own rail wheels, designed and intended to be detected by a track-based train detection system for traffic management. When in transport (running) mode they are self-propelled or hauled.

Picture 8: Example of an On-Track Machine, often painted bright yellow.

4.2. What are the exclusion of vehicles from the application of Commission Implementing Regulation 2019/779

It must be noted that some vehicles are excluded from the application of Commission Implementing Regulation 2019/779:

▶ The vehicles corresponding to cases stated in the article 2(2) of Directive 2016/798. Example: Metros. The reason is that the art 2(2) states the cases for which the Directive 2016/798 does not apply.

▶ Upon decision of the MS when transposing the Directive 2016/798, the vehicles corresponding to cases stated in the article 2(3) of Directive 2016/798. Example: Vehicles reserved for strictly local, historical or tourist use. This reflects a choice by MS when transposing the Directive 2016/798.



▶ Upon derogation identified and justified in NSA annual report according to article 19 of directive 2016/798, the vehicles corresponding to the cases stated in the art 15(1) of Directive 2016/798. Examples: Freight wagons operated under international agreement with third countries on 1520 mm system. This reflects a choice by MS.

As these vehicles are excluded from the scope of the ECM regulation and these categories are not foreseen on the certificate forms of annex IV of the regulation, no certificates may be granted to Entities in Charge of Maintenance of these vehicles only, nor should there be any reference to them on certificates covering other vehicles well on the scope.

Nevertheless, the services of voluntary assessment of Maintenance Management Systems according to the requirements of annex II of the regulation may be provided by certification bodies under the same conditions as foreseen in the certification scheme.

In this case however, the attestations possibly granted after the assessments shall not be called “certificates” and will not be registered in the ERADIS database.

4.3. What is an ECM?

After a vehicle is placed in service, an Entity in Charge of its Maintenance has to be designated and to be identified in the National Vehicle Register.

The ECM shall ensure the vehicles for the maintenance of which it is in charge are in a safe state of running by means of the establishment of a maintenance system.

The maintenance system shall be composed of four functions (see section 4.8).

In accordance with article 3(1) of the regulation 2019/779 any ECM shall satisfy the requirements of Annex II, in respect of all vehicles subject to Directive (EU) 2016/798.

4.4. Who can be an ECM?

The ECM is the body registered as such in the NVRs. There are no conditions of nationality to become an ECM. An ECM established outside the EU or outside the contracting countries of OTIF can provide maintenance to vehicles used on the railway system of the EU or of the contracting countries of OTIF. In that case the ECM has to be certified against the ECM Regulation or its equivalent in OTIF rules ATMF annex A.

4.5. How many ECMs can a vehicle have?

Article 47 of Directive (EU) 2016/797 provides that the NVR is to contain, among other compulsory information, the identification of the owner, the keeper and the entity in charge of maintenance of the vehicle.

Commission Implementing Decision (EU) 2018/1614 establishes the requirements for the information to be contained in the NVR and, for each vehicle, the data relative to the ECM (and not several ECM) has to be compulsorily fulfilled. Therefore a vehicle can only have one ECM assigned in the NVR at any given time.



4.6. What is a maintenance workshop?

A Maintenance workshop is a mobile or fixed entity composed of staff, including those with management responsibility, tools and facilities organised to deliver maintenance on vehicles, parts, components or sub-assemblies of vehicles.

A Maintenance workshop is an entity having a management, staff, tools and facilities necessary to carry out maintenance operations on the vehicle itself or on parts and components of the vehicle. Mobile teams, depending on a fixed structure where maintenance works are performed or being self-supporting, and fulfilling the requirements of the definition of a maintenance workshop as defined hereinbefore, are assimilated to maintenance workshops.

A maintenance Workshop may be in charge, of the whole maintenance delivery function (ECM-F4) or parts of it as described in the Art. 14(3)d of the Directive (EU) 2016/798.



4.7. What does “maintenance” mean?

The design operating state:

(Definition in the TSI wagon [7] )The ‘design operating state’ covers all conditions under which the unit is intended to operate and its technical boundaries. This design operating state may go beyond the specifications of the TSI in order that units may be used together in a train on the network under the safety management system of a railway undertaking.

It means a state when a vehicle, subsystem or part of subsystem is performing a required function for which it has been designed, manufactured and tested. It includes at least the nominal operating mode, it may include degraded operating modes, provided theses modes have been designed, implemented and tested so that the essential requirements are met.

When the vehicle is used, it will be subject to wear and tear or may get damaged more or less and therefore will not remain fully conform to its design operating state. The goal of maintenance is to restore this vehicle in its design operating state.

4.8. What is a maintenance system?

MAINTENANCE Restore the vehicle in its conditions of use (design operating state)

DESIGN OPERATING STATE

Described in the technical file

USE

The vehicle is operated

DEGRADATION OF PERFORMANCE

Vehicle no more in a design operating state

Establish the maintenance file

ECM‐F2

MANAGEMENT

Remove from operation and

return to operation ECM‐F3

MANAGEMENT

Deliver the technical

maintenance tasks ECM‐F4

MANAGEMENT

MANAGEMENT PROCESS‐



According to article 1(1) of the regulation 2019/779, the maintenance system shall be composed of the following functions:

(a) the ECM-F1, which supervises and coordinates the maintenance functions referred to in points (b) to (d) and ensures the safe state of the vehicle in the railway system;

(b) the ECM-F2, which is responsible for the management of the maintenance documentation, including the configuration management, based on design and operational data as well as on performance and return on experience;

(c) the ECM-F3, which manages the vehicle’s removal for maintenance and its return to operation after maintenance; and

(d) the ECM-F4, which delivers the required technical maintenance of a vehicle or parts of it, including the release to service documentation

These 3 last functions are coordinated in the maintenance system through a MANAGEMENT PROCESS

It should not be understood as a strictly mandatory organisational structure for ECMs. Nevertheless the structure put in place by the ECM has to reflect on this functional maintenance breakdown. The ECM has to attach all elements (internal services, subdivisions and contractors) of its organisational structure to one or more maintenance functions.

MAINTENANCE DEVELOPMENT

FLEET MAINTENANCEMANAGEMENT

MAINTENANCE DELIVERY

Performancetargets

Initial technicaldocumentation

Technological survey Legislation

Information on operationsfrom RUs, IMs, keepers Records on

maintenance performed

Return on experience

Information on SCC

Maintenance file

Return to operationto RUs, IMs, keepers

Records on maintenance performed

Release to service Return on

experience

Maintenance orders

Vehicle to maintain

Vehicle maintained

ECM

MAN

AGEM

ENT



4.9. What is the ECM-F1

The Management Function ECM-F1 shall supervise and coordinate the functions ECM-F2, ECM-F3 and ECM-F4 of the ECM and ensure the safe state of vehicle.

The ECM-F1 has two main tasks:

▶ Coordination of the functions ECM-F2, ECM-F3 and ECM-F4, as defined in the article 14(3) of Directive (EU) 2016/798, allowing the organization to achieve the maintenance targets defined in the Maintenance System (e.g. in the Maintenance Policy);

▶ Monitoring of the functions ECM-F2, ECM-F3 and ECM-F4 as defined in the article 14(3) of Directive (EU) 2016/798, granting the conformity against legislation and standards and allowing the organization to improve its Maintenance System.

The safe state of vehicles can be ensured through the design, the implementation and the improvement of the Maintenance System.

The coordination activities shall be performed according to processes and procedures defined within the Maintenance System, those provisions shall take into account the use of contractors to implement the functions, the allocation of responsibilities, the management and exchange of information, the management of documents and their traceability, the management of competence of the staff, the definition of strategies and plans to define and to achieve the maintenance targets, etc..

The ECM-F1 checks the implementation of the Maintenance System defining a systematic monitoring process, based on the CSM for Monitoring (Commission Regulation 1078/2012) to check the performances of the ECM in the field of maintenance (and safety, as consequence). When needed, the ECM-F1 creates the conditions to correct or to improve the Maintenance performances, defining and implementing changes in the Maintenance System. The impact of those changes on the maintenance processes shall be evaluated according to the CSM for Risk Assessment[4]. Monitoring can be performed through checks of results of processes if a maintenance function is certified (point 9.5)

A decision making process should be managed by the ECM-F1 on the basis of the results of the assessments of shared and owned risks. An initial process-based risk assessment, or equivalent, shall be used to identify such risks, whereas the CSM-RA regulation [4] shall be used for all changes and the CSM monitoring [13] shall be used for monitoring during the O&M phase.

4.10. What is the ECM-F2?

The maintenance development function (ECM-F2) covers the management of the maintenance documentation, including the configuration management, based on design and operational data as well as on required performance and return on experience.

It also covers the compliance with interoperability rules and the establishment and continuous update of the maintenance file.



The maintenance development process can be described as follows:

At the moment when operation starts

The initial development of the maintenance file depends on the initial technical documentation (see chapter 10) and the pattern of operations planned.

The process may be described as following:

When operation starts it is necessary to check if the initial technical documentation supplied by the manufacturer is relevant in comparison with the operations performed or planned to be performed and the performance targets of the users of the vehicles (keepers, RUs, IMs).

During the lifecycle of the vehicle

INPUT

Initial technical documentation (in particular interoperability limit values)

Information on operation planned to be performed

Performance targets Information on Safety critical

components

OUTPUT

(First) Maintenance file

Maintenance development

INPUT

Maintenance file Interoperability limit values Information on operation Records on maintenance

performed and return on experience

Technological survey Legislation (changes) Performance targets Information on Safety critical

components

OUTPUT

Maintenance file updated

Maintenance development



In accordance with the Annex II(II)(5) of the ECM Regulation, the update of the maintenance file depends on:

▶ The limit values that have to be maintained to assure the interoperability of the vehicle according to its authorisation of placing on the market/placing in service. They are stated in the initial technical documentation and every update of this documentation justified by a change in the design of the vehicle.

▶ Information on operation such as but not limited to:

⚬ Behaviour of the vehicle during operation;

⚬ type and extent of operations (passenger or freight, high speed or conventional, long straight lines or lots of curves, direct trains or lots of stop-start,…);

⚬ empty or loaded journeys;

⚬ mileage / journey time;

⚬ detected failures on components

⚬ incidents, accidents or defects occurred during operation;

⚬ content of daily inspection performed by the RUs (maintenance level 1);

⚬ environmental conditions (mountains, climatic, dust conditions, sand along ,coast,…)

⚬ behaviour and skills of drivers.

▶ Records on maintenance already performed, on inspections performed by RUs/IMs, keepers, ECM, owners and on studies related to return of experience. The ECM-F4 are often requested to take part to return on experience studies.

▶ Technological survey. The lifecycle of rolling stock extends to 40-50 years. Technology evolves a lot during this long lifecycle. The technological survey may include:

⚬ Condition based monitoring. This monitoring considers the behaviour of the different components.

⚬ Technological progress that includes the continuous progress of:

• materials,

• equipment,

• spare parts,

• tools and industrial equipment,

• IT systems,

• working and management methods.

⚬ Availability of materials, equipment and spare parts. Spare parts or materials may become obsolete or be unavailable. Generally the manufacturers give 10 years assurance regarding availability of electrical / electronic devices. So at certain time equivalent spare parts or materials have to be found.



▶ Evolution of applicable legislation:

⚬ Railway,

⚬ Environment,

⚬ Health and safety,

⚬ Safety of components,

⚬ Etc.

▶ Performance targets imposed by users (RU, IM, keeper):

⚬ reliability and availability of vehicles,

⚬ safety.

After taking into account all information, the ECM-F2 covers the update or not of the maintenance file and the dissemination of the updates of documentation to interested parties.


The Fleet Maintenance Management (ECM-F3) covers the removal from/return to operation before/after maintenance and the management of relations with ECM internal/external entities delivering maintenance (ECMs-F4).

Return to operation is only possible when maintenance operations are completed and the vehicles are back in a safe state of running. With regard to the exchange of information, the information on the completeness of maintenance activities performed on the vehicle must be received from ECM-F4, this is done through the releases to service that are the confirmation of the maintenance delivery that the maintenance activities ordered have been completed.

ECM-F3 may be defined as the management of a company’s vehicle fleet. The fleet maintenance management is then the part of the fleet management dedicated to maintenance of vehicles.

This function means in particular the responsibility for:

▶ applying the maintenance file to the vehicles through maintenance orders addressed to maintenance delivery.

▶ collecting and transferring, to maintenance development, information on maintenance performed and operations performed, including at least defects, incidents, accidents, mileage.

The inputs for the ECM-F3 are:

▶ the maintenance file;

▶ the performance targets imposed by users (RU, IM, keeper), such as the reliability and availability of vehicles.



The ECM-F3 must check the availability of the maintenance delivery.

The ECM-F3 will have the duty to ensure that maintenance orders are addressed only to duly qualified entities performing maintenance delivery.

The outputs of the ECM-F3 processes are:

▶ The maintenance orders addressed to the maintenance delivery. The maintenance orders are addressed by applying internal procedures when ECM-F3 and ECM-F4 are both internal to the ECM and by contracts in other cases. The maintenance orders contain the complete information issued from the maintenance file that is necessary to perform the maintenance tasks required from the maintenance delivery.

▶ The organisation for the return to operation of the vehicle in due time (including any delays occurred in the maintenance work resulting in the implementation of additional provisions for ensuring a safe state of running to the vehicle.

The ECM-F3 is responsible for declaring the vehicle fit for purpose and fit for its return to operation after the maintenance work has been completed by the ECM-F4. This return to operation is finally addressed to RUs generally through the keeper.

Further the ECM-F3 has to give to RUs, directly or through the keepers, all the information obtained from the ECM-F4 about maintenance limitations due to maintenance activities affecting the operating state of the vehicle, in order to able the RUs in stating operation limitations/restrictions for use to ensure a safe operation.


The Maintenance Delivery (ECM–F4) is the technical execution of the ordered technical maintenance tasks. The ECM-F4 task may be done in Maintenance Workshops. The ECM-F4 covers the management of maintenance orders issued by the ECM-F3, the management of the supply chain, the management of facilities, industrial equipment and tools and the management of maintenance technical works.

This function means the technical execution of tasks/works defined in the maintenance file and ordered by the fleet maintenance management. The ECM-F4 must be competent to perform the maintenance works/tasks requested in the orders.

Generally after completion of a maintenance order coming from the ECM-F4, the ECM-F3 addresses a report including a summary of the activities performed, information about limitation affecting the operating state of the vehicle and release to service. This report may also be addressed directly to the ECM-F2.



There is a huge need to request not only delivery but also information on return of experience between the ECM-F1 and the ECM-F4. The requirements addressing the return on experience are based on the requests from the ECM-F2 and should be part of the maintenance orders

4.13. What is release to service and return to operation?

Release to service

The “Release to Service” (RTS) is the confirmation by the ECM-F4 to the ECM-F3, that all maintenance work ordered has been performed according to the maintenance documentation. This confirmation can be noticed as documented information in paper or a defined electronic information channel. It must be traceable.

The ECM-F3 defines what maintenance records are needed for the completion of the task. It delivers these documents together with its maintenance order as a basis for establishing an “RTS notice”. The ECM-F4 executes the ordered work, completes the maintenance records and reports discovered but unresolved safety related deficiencies.

In addition to the formal RTS notice, the following information may possibly be needed by the ECM-F3:

▶ Records on work performed incl. any findings, (extra-)time for execution, etc.

▶ Records of unplanned work performed due to findings and incl. the release by the ECM-F3

▶ Records on final vehicle testing

▶ Records on main component testing (incl. used testing devices)

▶ Lists of exchanged parts (incl. their exact identification)

▶ List of deficiencies related to safety

▶ List of deficiencies related to reliability, if requested

▶ Any information on vehicle or component condition, as requested by the ECM-F3 (in case of condition-based maintenance)

INPUT

Maintenance orders Rolling stock that has to be

maintained

OUTPUT Records on maintenance

performed including the release to service

Return on experience if requested

Rolling stock maintained

SCC: exceptional maintenance findings beyond wear and tear if necessary

Maintenance delivery



The ECM-F4 delivers the document set via the agreed channel to the ECM-F3.

The report shall include all the information related to maintenance limitations due to maintenance activities affecting the operating state of the vehicle, in order to able the RUs in deciding stating operation limitations/restrictions for use to ensure a safe operation.

When this is completed, the vehicle is ready to leave the workshop and physically go back to commercial operation, however for this the “notice of return to operation” is requested by the ECM-F3 (see next chapter).

Return to operation

The “Return to Operation” is considered as a sensitive topic. It is formally the confirmation of the ECM that the vehicle is in a safe state for operation. The RU may operate the vehicle on the network only with a valid “Return to Operation Notice”.

A formal approach would suggest that the vehicle is transferred by the ECM to the Keeper. Further the vehicle is transferred from the keeper to the RU, which is responsible to use correctly the vehicle. In reality, the vehicle is brought to an agreed transfer point, where from it is taken into commercial use after establishing the “return to operation notice”.

The ECM-F 3 establishes the Return to Operation Notice based on the Release to Service documentation from the ECM-F4. The duty is to check the documentation for completeness and to clarify whether safety-relevant defects are listed which might cause a restriction of use. The Return to Operation Notice can be noticed as documented information in paper or a defined electronic information channel. It must be traceable.

The definition of the return to operation (article 2(d) of the regulation 2019/779) states that it possible to send the return to operation to the RU or to the keeper. Especially when a restriction of use be necessary it is the duty of the ECM-F3 to make this available to the responsible RU or via keeper upon contractual agreement.

It is a duty of RUs to consider the information included in the Return to Operation in order to establish and ensure the operation of the vehicle in a safe state.

ECM – F4Release to Service

documentation

According to the Maintenance System

ECM – F3



In the reality the keeper is not practically involved in this process, so there is a functional direct contact between the ECMs and RUs. To avoid confusion in the distribution of responsibilities, normally no information other than that reported about the vehicle should be given to the RU.

The minimum information that the keeper should receive is reported in 4.12.2.

4.13.1. Proposal of a minimum set of information to be exchanged during the “Release to Service”

Minimum set of information to be addressed to the Fleet Management function:

Workshop (Name of the workshop)

12 Digits vehicle N. (EVN)

Check in date (Date of the check in of the vehicle in the workshop)

Check out date (Date of the check out of the vehicle (workshop))

Maintenance File (Reference to the adopted maintenance file)

Derogation against the technical instructions?: YES / NO

Description of the derogation

list of safety related deficiencies as base for ECM-F3 for restrictions

This field contains the Safety related deficiencies that the ECM-F4 shall report to the ECM-F3 for restrictions.

ECM – F3 Return to operations

According to the Maintenance system and contractual arrangements

Keeper

RU/IM



4.13.2. Proposal of a minimum set of information to be exchanged during the “Return to operation”

Minimum set of information to be addressed to the keeper:

The keeper (and the RU) needs the information that the vehicle is in a safe state for operation. No need to transfer all the details to the keeper (or to the RU). The traceability of maintenance record is the ECM’s responsibility. ECM is releasing a vehicle to operation with or without restriction for use. This is the information the keeper (RU) needs for operation.

Note concerning the use of the vehicle

Notes concerning the use of the vehicle, this field contains the limitations that the keeper shall report to the RU. These limitations shall be related to the parameters used by the staff to compose trains.

Formal transmission of information between the ECM and RU may be possible. The Return to Operation document accompanying the vehicle contains all the necessary information for the RU, in case of technical restrictions affecting operations, the keeper has the responsibility to inform the RU.

RU sets the restriction for use and communicates them on the agreed channel to keeper. (Normally it is the responsibility RU to take the operation restriction to ensure the safe state based on its Safety Management System)

It is a duty of RUs to consider the information included in the Return to Operation in order to establish and ensure the operation of the vehicle in a safe state.



5. CERTIFICATION OF ECM

5.1. What does Certification mean?

It means: “Third party attestation related to products, processes, systems or persons (ISO/IEC 17000:2004).”

In the application of the ECM Regulation, the certification is the process to be applied by the tandem:

▶ The accredited or recognised certification body or the NSA (acting as certification body) and

▶ The applicant for the certificate: the ECM or the outsourced maintenance function

The requirements to be fulfilled by the applicant during the certification process are described in the Annex II of the ECM Regulation and the certification scheme ERA-1172/003 V1.1

5.2. What is an ECM certificate?

The certificate provided by the accredited or recognised certification body or by the NSA (acting as certification body) according to the ECM Regulation, provides the assurance that the applicant fulfills the requirements established in Annex II of the ECM Regulation and the certification scheme.

The format of this certificate is defined in the Annex IV of the ECM Regulation and available in the ERA database ERADIS. This database is accessible in the following link:

http://eradis.era.europa.eu/safety_docs/ecm/default.aspx

http://eradis.era.europa.eu/safety_docs/ecm/default.aspx



5.3. Which ECMs have to be certified

As mentioned in the diagram below, for case (1) and case (2), the certificate is mandatory.

Case 3 is an exemption for RU’s and IM’s who maintain vehicles exclusively for their own operation (the RU exclusively operates the vehicles, no other RU operates the vehicles) from mandatory ECM certification. When the RU/IM operate vehicles in partnership with others RUs, the article 3(4) cannot be applied. If an RU or IM maintains vehicles exclusively for its own operations, the RU or IM has to be the registered ECM of the vehicles it operates, and keeper too, in the relevant NVR.

The operation of a vehicle does not only cover the transport of freight or passengers. Operation covers any authorized use of the vehicle like the transport of freight or passengers, pulling/pushing other vehicles, movements for disposition, running of locomotives without a train, movement of empty wagons, running of an OTM from one construction site to the next (self-propelled or pulled by other traction / in a train).

Article 3.1All ECMs shall satisfy the requirements of Annex II, in respect of all vehicles subject to Safety Directive

2016/798

Case(1)

Entity applies for becoming ECM for freight wagons

Case(2)

All the other cases/scenarios not covered nor in Case (1)

neither in Case (3)

Case(3)

Entity applies for becoming ECM for vehicles (xx):

Vehicles (xx) are not freight wagons

Entity has the role of RU/IM too

Entity maintains vehicles exclusively for their own operation

Art. 3.2 (a)Mandatory certificate

Art. 3.2 (b)Mandatory certificate

Art. 3.3 or 3.4Entity may choose 2 possibilities for Annex II

requirements checks

Art. 3.4Compliance with Annex II to be checked via ECM certification process Art. 3.4

Compliance with Annex II to be checked via ECM certification process

Art. 3.3Voluntary certificate Art. 3.4

Compliance with Annex II to be checked via safety certification/authorisation

process

Regulation (EU) 2019/779 and system of ECM certification

ECM Certificate by CertBody

Art. 3.5If ECM is RU/IM too, the ECM certificate is deemed evidence for compilance with CSM SMS 5.2.4, 5.2.5

Compliance registered by NSA/ERA in the Safety Certification/

Authorisation



RU’s/IMs cannot apply for an article 3(4) assessment for vehicles that they operate in partnership with other RU’s/IMs.

RUs/IMs cannot use compliance with the Annex II of ECM Regulation assessed during safety certification/authorization process to operate nor be the ECM for other vehicles not included in art. 3(2)b of ECM Regulation nor operate as an outsourced maintenance function.

This RU/IM cannot use compliance with Annex II to act as ECM for freight wagons. To do so, it needs a valid ECM certificate for freight wagons (ECM Regulation see article 3(2) a).

Possible exceptions are:

▶ Movements following an accident or incident to clean the track or as part of technical assistance if the vehicle used aren’t registered in the NVR and they don’t run as a train to arrive in the area affected by the accident or incident;

▶ Activities or shunting operations carried out by contractors (i.e. entities other than the railway undertaking or the infrastructure manager being ECM of the concerned vehicles) excluding any other railway undertakings or infrastructure managers operating these vehicles for their own railway activities.

When the RU/IM wants to become, or continue as, an ECM maintaining vehicles exclusively for its own operations according to Article 3(2)b of Regulation 2019/779, they must notify their NSA or Safety Certification Body (NSA/ERA) thereof. The RU/IM must analyse the risks related to the changes according to their SMS and take proper risk mitigation measures. The requirements in Annex II of the ECM Regulation 2019/779 must be fulfilled from 16th of June 2022, at the latest.

If the changes to the SMS are deemed as substantial changes by the RU/IM, they have to apply for an update of their SSC or SA. An NSA/ERA can also initiate the need for an updated SSC, or NSA in cases of an updated SA, if the changes to the SMS for a specific RU/IM are considered as substantial changes.

a) NSAs will assess fulfilment of the obligations of the ECM Regulation during NSAs supervision activities.

b) The mapping table in Annex I for the IM and Annex II for the RU to this guide presents a cross-reference between SMS (2018/762) and Annex II (2019/779) requirements, the template can be used by the RU/IM to easily understand the link between SMS and Annex II and provide necessary evidence where the corresponding requirement of Regulation EU 2019/779 is allocated and accomplished by means of the company´s SMS documentation.

c) The RU/IM need to at least fulfil requirements for the management function ECM-F1, in their own SMS and their own operation. Remaining functions as the maintenance development function ECM-F2, the fleet maintenance management function ECM-F3, and the maintenance delivery function ECM-F4 may be outsourced under the responsibility and monitoring of the management function ECM-F1.



If an RU/IM wants to demonstrate compliance with Annex II of Regulation 2019/779 during the process of safety certification/authorisation, it has to apply for the assessment to the safety certification body (ERA or NSA) /safety authorisation (NSA) in the case of an application for the granting or renewal or update of a safety certificate/authorisation. The request for a safety certificate from the RU is made in the One Stop Shop, the request for the safety authorisation is made by the IM directly to the NSA involved following the national rules. It is necessary, when the RUs submit the application through the OSS for a new safety certificate or renewal/change update of safety certificate or IMs submit the application to the NSAs of new safety authorisation or renewal/update of safety authorisation, to make explicit if they intend to be checked as an ECM in the safety certification process/safety authorisation process. If not they should attach the ECM certificate issued by a certification body in the part 5.2.4 and 5.2.5 of the mapping table. According to article 3(5) of the ECM Regulation, the ECM certificate granted to a railway undertaking or an infrastructure manager shall be deemed evidence of compliance with points 5.2.4 and 5.2.5 both of Annex I and Annex II to Commission Delegated Regulation (EU) 2018/762 as regards vehicle maintenance of vehicles.



The following diagram describes the different options.

Note 1: Based on the knowledge of the safety performance of the RU/IM that the NSA has got from previous supervision activities, the NSA identifies the requirements of annex II of Regulation 2019/779 that it judges pertinent to be assessed. However it is not required to the NSA to assess the conformity to all the requirements of the annex II of Regulation 2019/779 during supervision’

To be ECM certified by certification body< 16/06/2022

maintaining vehicles exclusively for its own

operations ?

Notified as ECM in NVR?

Change to comply with Annex IIconsidered significant

when applying CSM RA?

Existing Safety Certificate valid > 16/06/2022 ?

RU/IM (not freight)

performing ECM functions

Compliance with Annex II to be demonstrated

through safety certification/

authorisation process by using the mapping table provided in ECM

guideline (Art. 3.4) < 16/06/

2022‐ and notification in NVR

Update NVR

SSC issued, including ECM activities

SSC is issued and a Certified ECM is

needed for maintenace activities > 16/06/2022

Application checked against ECM Annex II

Intermediate check against ECM Annex II (NSA supervision)

*see note 1

NO

YES

YES

NO

YES

NO

YES

NO

YES

NO



5.4. What are the steps to follow to obtain an ECM certificate?

For further information see also the Certification scheme ERA-1172/003 V1.1

5.5. What does the schema “Schema chosen to award ECM certificates in each member state” in ERADIS mean?

According to the Article 6(1) of the ECM regulation, the Member States shall provide the Agency information concerning the ECM certification bodies.

Therefore there are different schemas to be chosen by each Member State:

▶ “Accreditation”: it means accredited certification bodies will be able to perform the ECM certification.

▶ “Recognition”: certification bodies recognised by the member state will be able to perform the ECM certification.

▶ NSA as certification body: the NSA designated by the member state as certification body will be able to perform the ECM certification

The sectoral scheme for accreditation and recognition ERA1172/002 V3.1 contains requirements to be used by National Accreditation Bodies or by recognition bodies when assessing certification bodies performing ECM certification. It shall be also used by Members States when designating the NSAs to act as ECM certification body (according to article 14 of Directive (EU) 2016/798).

Review of the application collected to ensure that: Information is

sufficient Certification

activities can be prepared

Initial application review

Assessment of maintenance documentation

Evaluate presence of necessary processes (requirements)

Document review

Evaluate implementation of maintenance system

Interview of ECM personnel

On‐site audits

Evaluate appropriateness of competences in place

Coherence in application of processes(b,c,d) and sampling

Activities affecting safety annex II

On‐site inspections

Regular monitoring of representative areas and functions covered by the scope of maintenance system

Minimum one audit every 12 months

Surveillance activities

Stage 1 Stage 2

Starting of certification process

Granting of ECM Certificate

DECISION4 months



The applicant ECM is free to choose its certification body (Article 7(1) of ECM Regulation). The ECM can contract body:

▶ with a certification accredited or recognised in any Member state;

▶ With the NSA of the Member State where the ECM is established only if the NSA has been designated by its Member state to perform ECM certification.

5.6. Can a NSA of a Member State A give an ECM certificate in a Member State B?

An accredited or recognized ECM certification body can certify any ECM on the whole territory of the EU.

But if those ECM certification bodies are NATIONAL (public) authorities/agencies, they are limited to the national territory for matters associated to national sovereignty.

When an NSA acts as ECM certification body, as an NSA is a national (public) authority, it is also limited to its national territory.

NSA of a member state A may certify ECMs with legal address in the member state A only. Nevertheless, the certificate granted by a NSA is valid on the whole territory of EU.

European cooperation accreditation

National Accreditation Body

Certification body

Designation by Member State

Cooperation of

Certification bodies (ERA)

ISO 17011 Regulation 765/2008/EC

Accreditation scheme (13)

Certification scheme (14)

Recognition by Member State

NSA as Certification body

Supervises, monitors (cross auditing)

ECM Certificate

6. RESERVED


6. RESERVED



7. RESERVED

8. IMPLEMENTATION OF THE REGULATION 2019/779


8. IMPLEMENTATION OF THE REGULATION 2019/779

8.1. What does the transitional period mean?

Starting from 16.06.2020, any ECM certificate shall be issued in accordance with the ECM Regulation to entities in charge of maintenance, without prejudice to Article 15(1) of Directive 2016/798/EU.

Nevertheless, as defined in the Article 15 of the ECM Regulation 2019/779/EU, there are different transitional periods related to special cases in the implementation of the ECM Regulation.

8.2. What are the deadlines you need to have in mind?

8.2.1. Deadlines for certification bodies

Between 16 June 2020 and 15 June 2021, under Article 6(3) of Commission Implementing Regulation (EU) 2019/779, certification bodies may comply with either the previous or the new accreditation scheme, details can be found in the ERA clarification note ERA1172/001 .

That means that the certification bodies accredited or recognised or NSAs acting as ECM certification bodies in accordance with the sectoral accreditation scheme for Regulation (EU) No 445/2011, should be deemed accredited or recognised to perform the activity of certification also for the scope of other categories of vehicles until 16 June 2021.

The scope of activities of ECM certification bodies compliant with the sectoral accreditation scheme for Regulation (EU) No 445/2011 should be automatically extended to all vehicle categories but with a time limited validity (until 15 June 2021).

As of 16 June 2021, certification bodies shall be accredited or recognised in accordance with the new sectoral accreditation scheme in order to be able to perform the activity of certification also for the scope of other categories of vehicles.

In accordance with Article 15(1), certification bodies remain accredited or recognised under the conditions for which those certification bodies have been accredited or recognised. They are not affected by the 16 June 2021 deadline as regards performing the activity of certification for freight wagons.

For more information see the clarification ERA 1172/001 V2.0

https://www.era.europa.eu/sites/default/files/activities/docs/era_1172-001_clarification_ecm_accreditation_scheme_v1-0_en.pdf



8.2.2. Deadlines for ECM

The following figures show the details of the transitional period as foreseen by ECM Regulation EU 2019/779 and Regulation 2020/780.

For new RUs/IMs that intend to cover the role of ECM for vehicles other than wagons in accordance of application of article 3(4) of Regulation 2019/779 from 16 June 2020 they can do so by demonstrating compliance with the requirements of Annex II of Reg. 2019/779 during the SSC process from the 16th June 2020 on.

When you are an RU/IM and declared as an ECM in the NVR and maintaining vehicles exclusively for your own operations, you have a safety certificate or a safety authorisation, you can continue to be ECM and maintaining vehicles exclusively for your own operations until the end of validity of the existing safety certificate and at the moment of the renewal of certificate, the assessment done by the authorizing entity will cover all the requirements of annex II of Regulation 2019/779.

“When you are an RU/IM and not declared as an ECM in the NVR and you would like to become an ECM and maintaining vehicles exclusively for its own operations, either you need to have an ECM certificate (voluntary) or it will be done via notification to NSA/ERA as the Safety Certification Body for Safety Certificate or NSA for Safety Authorisation, and be “assessed” according point 5.3. It shall be done at latest 16 June 2022.

ECM certificates for freight wagons delivered before 16 June 2020 under the regulation 445/2011 keep the date of end validity (maximum until 06/2025). All the surveillance activities and amendments made during this time will be under the regulation 445/2011. It is recommended to the ECM certification bodies to prepare the ECM to the new requirements of the regulation 2019/779 during this phase of transition. (See different scenarios in Annex III)

9. ORGANISATION OF THE RAILWAY SECTOR IN EUROPE AND RESPONSABILITIES OF ACTORS



9.1. Who are the different “Stakeholders” participating in the maintenance of vehicles?

The different roles (ECM, RU/IM, keeper, maintenance workshop) can be encompassed by one or several entities provided that they fulfil their intended responsibilities.

The responsibilities of railway parties are stated in the Safety Directive 2016/798, in Articles 4(14)a and 16 (for NSAs) and the RID, chapter 1.4 (for the transport of dangerous goods). Regarding the maintenance of vehicles, responsibilities are also stated in the ECM regulation.

For example, a railway undertaking encompassing the role of ECM of vehicles shall comply in addition to its duties and responsibilities of railway undertaking with the requirements of Annex II of the ECM Regulation 2019/779.It is not regulated who should appoint the ECM. This is left to decisions of the stakeholders. Article 33 of the Interoperability Directive indicates that the registration holder is responsible for providing the information for registration of vehicles to the registering entity. This information includes among others the denomination of the ECM.

Nevertheless it is important to consider that, in practice, the tasks and obligations of RUs and ECMs have to be described in contractual arrangements. These contractual arrangements may also concern intermediaries such as keepers.



9.2. You are a Keeper, what are your responsibilities?

The keeper is defined in the article 3(19) of the Safety Directive and in the article 3(21) of the interoperability directive.

Apart from the obligations of registration holder, the Safety or Interoperability Directive does not define any additional explicit responsibility for the keeper. In practical terms, unless otherwise specified in the registration documents, the keeper of the vehicle is considered to be the “registration holder” in the meaning of Article 47(6) of the Interoperability Directive (See Annex 3.2.3 of the NVR Decision [12]). Based on Article 4(4) of the Safety Directive it can be understood that the responsibilities of the keeper are basically to implement the necessary risk control measures, where appropriate in cooperation with other actors, to assure in contractual way to RUs/IMs that vehicles (and when requested additional services) provided meet consistently safety requirements.

The contract of use established between a keeper and a RU/IM should cover all the relevant requirements, including at least: Obligations and tasks related to safety issues including the obligations related to the exchange of relevant information or the traceability of safety related documents.

Also based on article 4(4) of the Safety Directive it can be understood that responsibilities of the keeper are to assure to RUs/IMs that vehicles provided meet consistently the appropriate legal requirements.

In particular the keeper should assure to RUs/IMs that the vehicles provided have:

▶ a valid authorization for placing on the market;

▶ an ECM registered in the NVR;

▶ all initial documentation of maintenance of vehicles involved was consigned to ECM uncharged.

For freight wagons and for vehicles other than freight wagons, in the case of Art. 3(2)b of the ECM Regulation, the keeper should assure also to RUs/IMs that the ECM certificate is valid.



A keeper may be an ECM but it is not mandatory.

To avoid its vehicles being put out of operation, the keeper should pay attention to the following responsibilities:

▶ The keeper may select an ECM and contracts with it

▶ The keeper may make contractual arrangements with subcontractors (e.g. maintenance workshops), but nevertheless the ECM is responsible to take the decision if the subcontractor is sufficiently competent to be authorised to perform maintenance tasks. To this end an agreement should be achieved between the keeper and the ECM.

▶ The keeper acting as registration holder has to ensure that the data it addresses to the registration entity is correct and has to get assurance that the ECM holds a valid certificate for freight wagons and for vehicles other than freight wagons, in the case of Art. 3(2)b of the ECM Regulation. Nevertheless when the keeper is not the registration holder, as it is the main interlocutor for the RUs, it should assure that the vehicle is compliant with the legislation in force and thus that data stated in the NVR is correct and that the ECM holds a valid certificate (only for freight wagons and for vehicles other than freight wagons, in the case of Art. 3(2)b of the ECM Regulation).

▶ As main interlocutor of the RUs/IMs, the keeper should assure that a vehicle is put, in due time, at disposal of the ECM to perform maintenance tasks in consistency with the decisions of the Fleet Maintenance Management (ECM-F3).

▶ For freight wagons and for vehicles other than freight wagons, in the case of Art. 3(2)b of ECM Regulation: the keeper should take specific actions if ECM certificate is suspended or revoked (e.g. assign another ECM, inform its customers including RUs).

▶ Suspension and revocation of ECM certificates imply that the ECM registered in NVRs is not compliant anymore to the legislation in force and therefore that the registration of the vehicle should be suspended forbidding this latter to be operated.

▶ The keeper should specify to the RUs/IMs the conditions of use of the wagons, especially if there are specific conditions (e.g. type of goods transportable, specific operational limitations).

▶ In any case the keeper should participate actively to the exchange of information between ECMs and RUs/IMs when there is no direct contractual arrangement on exchange of information between ECMs and RUs/IMs.

▶ The keeper has to implement the necessary risk control measures and has to cooperate with other actors.

For international transport the provisions of the OTIF CUV and GCU (General Contract of Use) apply to keepers and RUs as users of freight wagons. The obligations and rights of the keepers of freight wagons are described in chapter II of the GCU.



9.3. You are a RU/IM, what are your responsibilities?

The Railway Safety Directive states in Article 4(3) that RUs shall be made responsible for safe operation and to fulfill this responsibility, it requires that they establish a SMS.

According to the Art 9(2) of the Safety Directive, the RU is responsible to control all the risks related to the supply of maintenance and therefore has to implement control measures to get assurance that vehicles are maintained in such a way that they can be used safely when put in trains.

Controlling the risks associated to the supply of maintenance is not equivalent to being responsible for the maintenance. Controlling the risks means that the RUs has identified hazards to its operations caused by maintenance, evaluated the risks associated with those hazards and define control measures to ensure the safe operation of its trains.

This means in particular that:

▶ The RU must get assurance, that the maintenance provided by the ECM leads to a safe state of running of the vehicles. This may be achieved by getting assurance that the maintenance system put in place by the ECM ensures the safe state of running. In other words the RU must get assurance that the maintenance system makes the ECM capable of providing maintenance keeping the vehicles in a safe state of running. Nevertheless ensuring this safe state of running through a maintenance system remains the unique responsibility of ECMs.

The ECM is responsible for the maintenance and the RU, within its risk control, must get assurance that the ECM is capable to comply with its responsibility and that maintenance is sufficiently effective to make the vehicles in a safe state of running.

▶ The ECM certification is the effective and efficient way to bring this assurance to the RUs. Therefore the RUs should not be required to re-evaluate the maintenance system of ECM already being granted with ECM certificate.

USE


RU/IM








▶ By virtue of point 5.1.3. c) of annex I of Regulation (EU) 2018/762, the RU shall ensure the freight wagons and other vehicles in the case of Art. 3(2)b of the ECM Regulation it operates, before their departure, have a certified ECM. The Certificate has to be delivered by a duly accredited or recognised certification body or by an NSA entitled by its MS as certification body. The certificate has also to be within its validity period. The ERADIS database provide data on certificates.

In addition the RUs check that the scope of the certificate corresponds to the three kinds of wagons (tank wagons for dangerous goods, other wagons for dangerous goods, or other wagons). Those checks could also be facilitated by contractual arrangements with the keeper or through sectorial arrangements in place, e.g. GCU.

▶ The ECM certification, like any certification, doesn’t guarantee to RU that there will never be non-conformities on the wagons due to improper maintenance. In addition, between maintenance interventions a vehicle may also be damaged by users such as loaders.

The RU is therefore responsible for taking additional control measures described here below. The RU should undertake inspections before the departure of a train or on route. Those inspections have to comply with the processes described in its SMS. The RU must assure that each vehicle in its train will be in such a state that doesn’t compromise the safe operations. It does not aim to control that maintenance was appropriate and done correctly but that vehicles are in a sufficient state for safe use.

Some of those inspections are carried out by the RU itself (e.g. drivers and/or operational staff), for some the RU may subcontract to other entities like loaders or maintenance workshops. But even by subcontracting some of the measures to other players the RU keeps the responsibility according to Article 4(3) of the Safety Directive. The RU must decide how to fulfil its obligations and, if necessary, agree with the other players on rules for procedures that the other players take over for the RU.

▶ The pre-departure and on-route inspections can be seen by the ECM as information on the minimum performance level required by the RUs or on the limitations the RUs meet in operating wagons. Therefore this information should be considered as an input by the ECM for updating the maintenance file.

On the other hand, there could be specific information included in the maintenance file that could be seen as an input by the RU to update the content of pre-departure or on- route inspections/monitoring measures.

Consequently exchange of technical information should be developed by railway parties.

▶ By virtue of Article 5(4) of the ECM Regulation, if a contracting party, in particular a RU/IM, has a justified reason to believe that a particular ECM does not comply with the requirements of Article 14 of Directive (EU) 2016/798 or with the certification requirements of this Regulation, it shall without delay inform the certification body and the relevant NSA thereof. The certification body or, where the ECM is not certified (see Art. 3(2)b), the relevant NSA shall take appropriate action to check if the claim of non- compliance is justified and shall inform the parties involved. As a consequence, the certification body has to consider this claim within its surveillance activities (or, where the ECM is not certified (see Art. 3(2)b, the relevant NSA has to consider this claim within its supervision activity) and may take actions such as imposing an improvement plan, limiting the scope of application of the



certificate, suspending the certificate, or revoking the certificate depending on the degree of non–compliance (See Article 8 of ECM Regulation).

▶ By virtue of Article 5(2) of the ECM Regulation, the RU/IM shall provide information on the real operations performed. In particular the mileage and specific operational conditions are requested by the ECM to update the maintenance file. This provision of information should be organised between the RU/IM and the ECM or between the RU/IM and the keeper (the keeper plays the role of intermediate).

▶ By virtue of Article 5(3) of the ECM Regulation, all contracting parties shall exchange information on maintenance of vehicles in accordance with the criteria listed in section I.7 and I.8 of Annex II of ECM Regulation.

▶ The RU shall fulfil its duties about transmission of information with its commercial partners – i.e. other RUs/IMs, keepers and ECMs since there could be direct relations between RU and ECM (e.g. RU assuming also the role of keeper or requesting for direct exchange of information).

▶ The RU/IM shall implement any other additional control measures that it considers necessary to keep the identified risks related to the supply of maintenance under control. Those risks could be highlighted through a structured approach to risks assessment and a systematic analysis of findings related to the routine monitoring put in place by the RU/IM as part of its SMS arrangements.

9.4. You are a manufacturer, what are your responsibilities?

Apart from the obligations in the role of “applicant”, the Interoperability Directive do not define any additional explicit responsibility for the manufacturer.

In the role of “applicant” as is defined in the article 2(22) of the Interoperability Directive, the manufacturer shall provide to the keeper of vehicle:

▶ initial identification of safety-critical components;

▶ the complete technical file with specific maintenance instructions recorded in the technical files of subsystems referred to in Article 15(4) of Directive (EU) 2016/797;

▶ recommendations for maintenance as part of the initial documentation ;

▶ information on safety critical components and appropriate maintenance instructions related to them through reference in the technical file of subsystems referred to in Article 15(4) of Directive (EU) 2016/797 ;

▶ technical and engineering support on SCCs and their safe integration when an ECM/Keeper addresses a request; this can be done by agreement or contractual arrangements.

As previewed in the Article 5 of the ECM Regulation the manufacturer shall exchange of information with the ECM and other actors when they address a request.



9.5. Is there a harmonised framework for the pre departure inspection?

The ECM Regulation doesn’t regulate the pre-departure inspections. They are not part of the maintenance activities of the ECM but they are set up by the Railway Undertaking, as part of their SMS, to verify the vehicle is fit for the journey and the operation: the ECM Certification does not liberate the RU/IM from its responsibilities to manage the risks in operations and maintenance.

The pre-departure inspections are regulated in particular by the TSI OPE [8] and must be managed by Railway Undertakings within their SMS. There are some harmonising tools already in place. The GCU (General Contract of Use) is a harmonised contract between Railway Undertakings and keepers regarding the provision of wagons.

The harmonisation of the pre-departure inspections should be developed by the stakeholders themselves.

It is important for the ECM to know the content of those inspections and their possible differences when establishing and updating the maintenance file. For that purpose, cooperation between RU/IMs and ECMs is crucial.

9.6. You are an ECM, what are your responsibilities?

All ECMs shall satisfy the requirements of Annex II, even if they are not certified.

ECM must set up and keep updated the maintenance file (maintenance development part II.4 b and II.5 annex II)

ECM must ensure that the implementation of the first maintenance file is done correctly (maintenance development part II.4 c annex II)

ECM must coordinate all those activities and supervise its subcontractors

Exchange of information - Article 5(1) of ECM regulation

ECM

USE


RU/IM KEEPER








The ECM has to address return to operation issues to RUs/IMs and keepers.

Regarding the vehicles, responsibilities are also stated in the ECM regulation. The ECM should ensure that it continuously meets the relevant requirements set out in Article 14(3) of the safety directive and in article 4, 5(1), 5(3), 5(5) and Annex II of the ECM Regulation and applies them consistently. This assurance may be provided to other railway parties by means of the ECM certification, when it is mandatory, or by means of the compliance related to the application of Art. 3(4) of ECM Regulation.

The ECM has the responsibility for setting out the maintenance file for each vehicle and to ensure that this maintenance file is correctly applied.

As part of the maintenance management function (ECM-F1), the ECM has to perform itself the necessary coordination and monitoring of all its maintenance activities. These tasks may be partially outsourced but coordination and monitoring as a whole remain one of the main and crucial task of the management function of the ECM in accordance with Article 14(3) of the safety directive. The other maintenance functions may be performed (totally or partially) internally or (totally or partially) outsourced. This includes the call for technical expertise when not available internally, for instance from manufacturers of vehicles or components, and the use of contracted maintenance workshops.

Regardless of the outsourcing arrangements in place, the ECM shall be responsible for the outcome of maintenance activities it manages and shall establish a system to monitor performance of those activities (See Article 9(3) of ECM Regulation). In addition the ECM has to apply the CSM on monitoring.

The ECM has to inform its clients about any change in the status of its certificate (amended, renewed or revoked) that may cause contractual liability issue.

9.7. Application of Article 4(6) - Use of Safe Alert IT tool

Safety Alerts IT tool is a platform, developed by Agency in the frame of Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety. It facilitates the exchange of information among the relevant actors who identify or are informed of a safety risk relating to defects and construction non-conformities or malfunctions of technical equipment, including those of structural subsystems.

SAIT is a secure website which grants registered users the ability to share information quickly about safety risks relating to defects of technical equipment between the European railway actors.

▶ Who shall report?

SAIT is for railway undertakings, infrastructure managers, entities in charge of maintenance and all other actors (not including national or state bodies and authorities), including manufacturers, maintenance suppliers, keepers, service providers, contracting entities, carriers, consignors, consignees, loaders, unloaders, fillers and unfillers.



Only employees or agents of one of the above mentioned categories of organisations, will be granted access to the SAIT (Safety Alerts IT tool). Organisations may request as many user accounts as they require. Organisations should make their own internal arrangements for authorizing staff to publish, comment and receive safety alerts.

▶ What to report?

Users should report information about hazards that, in their own judgement and in accordance with the policies of their own organisation:

Relate to defects and construction non-conformities or malfunctions of technical equipment, including those of structural subsystems

The hazard, event or information is novel or unexpected and therefore the related risk is likely to be poorly controlled

The related risk, if not controlled, has the potential to lead to an accident or incident involving serious injury or 1 or more fatalities

The related risk is relevant for more than 1 actor

▶ Where to report?

When you for the first time use SAIT, you must create an EU Login account for your company. SAIT can be found at the following web address: https://safetyalerts.era.europa.eu/safetyalerts

SAIT is overseen by Agency. SAIT was developed, is hosted and day to day support is provided by Directorate-General for Informatics of the European Commission (DIGIT).

▶ When to report?

As soon as possible after detection of the defect, including out of business hours.

▶ Why to report?

The entity in charge of maintenance shall use the SAIT to inform the rail sector and the rail supply industry about new or unexpected safety relevant findings including exceptional maintenance findings beyond wear and tear (article 4(6) of [1])

9.8. You are an accredited or recognized ECM certification body or a NSA designated as ECM certification body. What are your responsibilities?

The applicant ECM is free to choose its certification body (Article 6(1) of ECM Regulation). The ECM can contract body:

▶ With a certification accredited or recognised in any Member state;

▶ With the NSA of the Member State where the ECM is established only if the NSA has been designated by its Member state to perform ECM certification

https://safetyalerts.era.europa.eu/safetyalerts



The Member State shall be responsible for ensuring the competency of the NSA acting as ECM certification body when it is not accredited or recognised. To this end the Member State should base its control measures on the annex II of the ECM regulation and the ECM accreditation scheme. The Member State should also communicate on those control measures and their results with all interested parties to avoid creating doubts on the competence of NSAs.

For recognition, when applying the article 5(2) of the Regulation 765/2008, the Member State shall provide evidences to the Commission and the other Member States on equivalence between the scheme put in place with the Annex II of the ECM Regulation and the ECM accreditation scheme.

The certification bodies have to examine and treat claims from the NSA (Article 11 of ECM Regulation), RU or any other contracting party (Article 5(7) of ECM Regulation) and take appropriate action to check if the claim of non-compliance is justified and shall inform the parties involved (including the relevant national safety authority) of the results of its investigation (Article 5(4) of ECM Regulation).

The certification body is solely empowered to decide whether to amend, renew, limit the scope of application, suspend or revoke the ECM certificate based upon significant changes in the circumstances applying at the time the original certificate was awarded (Cf. Article 7(8) of ECM Regulation) or if the ECM no longer complies with the certification requirements or any improvement plan (Cf. Article 8(2) of ECM Regulation).

9.9. You are an NSA supervising RUs and IMs. When supervision shows a non compliance of an ECM with the requirements, what are your responsibilities in connection with Article 11 of the ECM regulation?

According to Article 11 of the ECM Regulation, an NSA that has a justified reason to believe that an ECM does not meet the requirements of the ECM Regulation shall at first “take the necessary decision” and then afterwards “inform the national bodies or authorities responsible for the accreditation or recognition, the Agency, the certification body and other interested parties as appropriate. As a general rule, an NSA shall not supervise certified ECMs as this would lead to a duplication of the surveillance regime of the ECM certification bodies, except when the NSA acts as ECM certification body. But, during its regular supervision activities directed towards IMs and RUs, an NSA can detect problems and defects that may put in question the compliance of the ECM’s with the requirements of ECM Regulation.

Which decision shall be taken?

After requesting justification about the supposed lack of compliance with the requirements of ECM Regulation and based on the information received from the RU/IM/keeper (and possibly ECM and ECM certification body), the NSA may take further action or a decision is necessary.

The NSA, in a proportionate way, may take the following action:

▶ NSA decision against RU/IM if measures from RU/IM are not satisfactory as regards technical aspects and timing;



▶ If measures from RU/IM are not satisfactory and the NSA has legal duty regarding ECMs: NSA decision against ECM if measures from ECM are not satisfactory as regards technical aspects and timing.

Who shall be informed?

For informing the sector, it shall be sufficient that an NSA informs the RU/IM/keeper where the lack of compliance with requirements of ECM Regulation occured. According to Article 5(5) of the ECM Regulation, it is the responsibility of the sector to take the necessary activities and spread this information to all parties involved. The NSA asks the RU/IM for confirmation that the RU/IM has fulfilled its duties according to Article 5(3). The RU/IM shall report back to the NSA.

Further information according to Article 11 shall follow a graduated approach depending on the safety criticality of lack of compliance with requirements of ECM Regulation and the corresponding actions of the RU/IM/ECM in response to the defect. To accommodate this, the following matrix shall be applied:

(re)action of the ECM / frequency of occurrence of the defect

ECM acts efficient and competent / isolated case

ECM actions show deficiencies / repeated cases

No or inadequate ECM actions / numerous cases

safety risk of the defect

high 2 3 3

medium 1 2 3

low 1 1 2

▶ “1” means mild case, not safety critical (No further information by NSA necessary)

▶ “2” means medium case, safety critical (NSA informs ECM certification body, NSA checks necessity of recording in ERA Safety Information System)

▶ “3” means severe case, safety critical (NSA informs ECM certification body, NSA records case in ERA Safety Information System (= information to ERA), NSA informs ERA and national bodies or authorities responsible for the accreditation or recognition)

The examples provided here are specific only for wagons and focused only on the maintenance activities performed from ECM-F4:

▶ Low: Wrong/incomplete marking on wagons/vehicles, deadline for overhaul elapsed;

▶ Medium: Wrong tare/load spring installed (Y25 bogies), brake rigging wrongly plugged;

▶ High: Defect on axle or solid wheel repaired by welding, visibly different buffer types in wagon/vehicle ending, bogie frame rubbing against axle, axle box destroyed by loose screws.

9.10. What other legal information do you need to have in mind when managing contracts?

The contractual and non-contractual liability issues, as private law in general, remain within the competence of the Member States, although the EU has intervened in such field where



it appeared necessary to ensure the proper functioning of the internal market. In particular, the EU has adopted two regulations, one dealing with the law applicable to contractual obligations and the other one dealing with the law applicable to non-contractual obligations (See respectively Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I) and Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II)). These two regulations establish a set of binding rules of private international law which determine which (national) law is applicable.

So EU Regulations applicable to ECM are “Without prejudice to civil liability in accordance with the legal requirements of the Member States” (See Article 4(3) of the Safety Directive) or “without prejudice to existing national and international liability rules” (See Article 7(4) of the Safety Directive).

An ECM is liable to its contract partners (RU, IM, keepers, etc.) for breaches of contract (as provided in the contract and in the law governing the contract) whereas it is liable for damages caused to others than its contract partners (or to its contract partners but outside the scope of the contract) under the national laws governing the damage and the resulting liability.

Court jurisdiction

Article 6(4) of the ECM Regulation provides that “Member States shall take the measures necessary to ensure that decisions taken by the certification bodies are subject to judicial review”. Article 7(6) of the same Regulation provides that “The certification body shall set out in detail the reasons on which each of its decisions is based. The certification body shall notify its decision and the reasons to the entity in charge of maintenance, together with an indication of the process, time limit for appeal and the contact details of the appeal body”.

The “appeal body” referred to in the ECM Regulation is not a new body to be established by the Member States but rather an existing judicial (or administrative) body within the Member State where the certification body is established competent to hear appeal cases by applicants ECM against decisions of such certification body.

9.11. When a new authorisation for placing on the market is necessary?

New authorisation for placing on the market of vehicle is not required when substituted parts are compliant with references or specifications in the technical file.

The “new authorisation” is defined in the Art. 14, paragraph 1, letter d) of Regulation (UE) 2018/545 [12] as the vehicle type authorisation and/or vehicle authorisation for placing on the market issued by the authorising entity after a change of an already authorised vehicle and/or vehicle type, pursuant to Articles 21(12) or 24(3) of Directive (EU) 2016/797.

The criteria to apply for the decision when a “new authorisation” for placing on the market is necessary are set out in the Art. 15 of Regulation (UE) 2018/545 [12].



Concerning the change in the framework of maintenance of the vehicle, “new authorisation”

For instance, in the case of the substitution of a wheel by another one complying with the specification of the technical file, it would not be necessary to proceed to a new authorisation for placing on the market/placing in service neither a communication to the NSA. According to the Interoperability Directive this substitution is a “substitution in the framework of maintenance” means any replacement of components by parts of identical function and performance in the framework of preventive or corrective maintenance. It should only be necessary to have this substitution recorded in the configuration file of the vehicle. This information is, of course, available to NSAs upon request.

If the specification of the new parts impairs the design operating state, it is considered as a major change of the technical design and possibly leads to a new authorisation for placing on the market/placing in service according to the Interoperability Directive.

The Interoperability Directive distinguishes between

a) ‘upgrading’ means any major modification work on a subsystem or part of it which results in a change in the technical file accompanying the ‘EC’ declaration of verification, if that technical file exists, and which improves the overall performance of the subsystem and

b) ‘renewal’ means any major substitution work on a subsystem or part of it which does not change the overall performance of the subsystem;

In case of upgrading or renewal, the ECM could be the applicant for this new authorisation. In any case, the ECM should manage it through contractual arrangements with the RU/keeper and taking in consideration:

▶ The existing authorisation for placing in service;

▶ The guarantee of the vehicle by the manufacturer.

Other different question is if the fact, that the specification of the new parts impairs the design operating state, could be considered as a significant change affecting safety. In this case it is necessary to evaluate by the proposer (ECM) of the change if the change is safety relevant and, in this case, to apply the Common safety Method on Risk Assessment and Evaluation[4].

Activities in context of substitution in the framework of maintenance are covered by the ECM Regulation and by ECM-certification. Upgrading and renewal are not covered by the ECM-Regulation.

9.12. How to understand the article 3(2)b (Assessment of RUs and IMs maintaining vehicles, other freight wagons, exclusively for their own operation)?

According to Article 3(2)b an ECM certification is not mandatory for an ECM which is RU or IM maintaining vehicles, other than freight wagons, exclusively for its own operations. However,



these entities have to satisfy the Requirements of Annex II (ECM requirements) according to the methods and times described in paragraph 8.2.2.

They shall demonstrate compliance with Annex II:

a) By a voluntary ECM certification by the relevant certification body. The relevant certification body issues an ECM certificate. The certificate is included in the ECM Certificates Database of ERADIS. The RU/IM is a regular ECM and treated as such. By a voluntary ECM certification by a competent certification body. The competent certification body issues an ECM certificate. The certificate is included in the ECM Certificates Database of ERADIS and it shall be deemed evidence of compliance with points 5.2.4 and 5.2.5 both of Annex I and Annex II to Commission Delegated Regulation (EU) 2018/762 as regards maintenance of vehicles. The RU/IM is a regular ECM and treated as such. The RU/IM in this case shall communicate to the authorising entity the possession of the ECM Certificate as this could lead to the need for an update of the Safety Certificate/Authorisation.

b) Through the process of safety certification/safety authorisation. In this case, the safety certification body will not issue an ECM certificate nor an entry in the ECM Certificates Database of ERADIS. The maintenance activities are limited to vehicles exclusively operated by the applicant for its own operations.

Although it is possible to strictly apply the ECM Certification scheme, while assessing the compliance of the maintenance activities of a RU/IM with the ECM requirements together with the application for a safety certificate (or safety authorisation), the safety certification body may follow a more flexible approach adapted to the safety certification (or authorisation) process.”

If the safety certification body follows the adapted approach, it brings its assessment process for the maintenance activities of the applicant in consistency with its existing processes for safety certification/authorisation (in compliance with the practical arrangements for issuing single safety certificates to railway undertakings, the CSM on safety management system requirements and the CSM for supervision by national safety authorities after the issue of a single safety certificate or a safety authorisation).

The safety certification body will incorporate all maintenance activities described in the ECM certification scheme and in particular will take into account its knowledge of the applicant and those risks related to:

▶ the management system of the RU/IM;

▶ the existing competences;

▶ the assurance that the RU/IM address seriously the establishment and the updates of the maintenance files.

The principles underpinning this flexibility lie on the wide and detailed view the Agency and NSAs have, among stakeholders and interested parties, on the safety of the (European) railway system and in particular, on safety risks. The Agency and NSAs have then sufficient safety maturity and knowledge of the applicants to target the assessment of the maintenance system of the RU/IMs by using a risk based approach.



This picture shows the possible adaptation of the ECM Certification Scheme by safety certification/authorisation bodies assessing together the application for a safety certificate (or safety authorisation) and the ECM requirements.

The Assessment of RU or IM during the process of safety certification

Initial Assessment

CSM SMS / PA SSC CSM Supervision

Supervision activities

Granting of safety certificate or safety authorisation

ECM Certification Scheme‐

Initial Assessment Surveillance activities

Initial audit

On‐site audit


On‐site audit


Granting of ECM certificate

Initial Assessment Supervision activities

CSM SMS CSM

Granting of safety certificate (or safety

autorisation)Targeting of surveillance

activities based on safety risks

ECM certification process adapted to existing processes for safety certification (CSM SMS) and supervision activities (CSM Supervision)



The picture shows, that the process of safety certification is different from the process of ECM certification.

A RU/IM who demonstrates compliance with Annex II during the process of safety certification will not receive an ECM-Certificate.

The ECM activities of this RU/IM are mandatory limited to the vehicles exclusively for its own operations.

This RU/IM cannot act as ECM for freight wagons.

NSAs and the ERA have been established as safety certification bodies. The CSM on SMS requirements and the CSM on supervision consider the implementation of processes for safety certification, which is different from the process of ECM certification.

The management system of an RU/IM that maintains vehicles exclusively for its own operations has to include methods and instruments for complying with both, the safety management system requirements and the requirements of Annex II of ECM Regulation. Although the two management systems are designed for different actors there are overlaps.

The assessment of the ECM requirements should take the overlaps into account. It should be seen as an “add on” to the SMS assessment according to Regulation (EU) 2018/763.

According Safety directive, for RUs/IMs there are 2 different phases:

▶ safety assessment for the issuing the safety certification / safety authorization; in this phase audits / inspections are possible but not mandatory; the assessment is made by the certification body / NSA for the safety authorization;

Compliance with Annex II

RU maintaining vehicles exclusively for its own operation

Voluntary ECM certification Process of safety certification

+initial certification audit ‐stage 1: documents ‐stage 2: on side‐ 2019/779 inc. Annex II‐ SZS

+Issuing the ECM certificate

+ surveillance‐ 2019/779, Art. 8‐ every 12 M‐ geographical and functional balance‐ audit time for surveillance audits should be proportional to the audit time spent on the initial audit ensuring overall continuing compilance

ECM‐Certification Bo

dy

Internal excha

nge

or

ERA NSA + Safety assessment‐ 2018/763 practical arrangements‐ 2018/762 SMS requirements ‐ Annex II of 2019/779+ Issuing the safety certificate

+ Supervision‐ 2018/761, article 3 supervision process‐ identify risk areas‐ develop the supervision strategy ‐ coordination with other NSA if necessary‐ supervision plan(s)‐ allocated resources affect priorities

Internal excha

nge

Information gathered during

assessment

Information gathered during

supervision

Safety certification bo

dyNSA



▶ supervision process after the issuing the safety certification / safety authorization, made by NSAs; in this phase audits and inspections are suitable techniques for assessing that RU / IM continues to duly apply their SMS.”

During supervision activities, after issuing a safety certification / authorization NSAs monitor the SMS effectiveness and the application of CSMs.

Before issuing a safety certificate, the safety certification body has to check,

▶ if the RU is aware of the requirements of annex II of the ECM Regulation

▶ if the RU established procedures to supervise and coordinate its maintenance activities (management function)

▶ If the RU has procedures to identify safety critical components.

Before issuing the safety authorization, the national safety authority has to check.

▶ if the IM is aware of the requirements of annex II of the ECM Regulation

▶ if the IM established procedures to supervise and coordinate its maintenance activities (management function)

▶ If the IM has procedures to identify safety critical components.

9.13. What are the steps for the assessment of the ECM requirements during the process of safety certification

1) Initial screen

The safety certification body checks an add-on to the SMS requirements if

a) the provided basic information covers the maintenance of vehicles exclusively for RU/IM operations

b) the application file contains sufficient evidence and is structured and internally cross-referenced so that it can be properly assessed against the requirements of annex II of ECM regulation

c the maintenance report is available

2) Detailed assessment before issuing the safety certificate :

After the completion of the initial screen stage, the safety certification body shall proceed with the detailed assessment of the application file, using the safety management system requirements and as “add on” for maintenance and checking the compliance with ECM Regulation through the Safety Certification/Authorisation mapping table (see Annex I and Annex II).

If the RU/IM is a newcomer ECM, the company presents during Safety Certification/Authorisation process (first issue/renewal by Agency/NSA) the mapping table with the



requirements of Regulation EU 2018/762 (Annex I for RU or Annex II for IM) by adding a column where the corresponding requirement of Regulation EU 2019/779 is allocated and accomplished by means of the company SMS documentation.

If the RU/IM is already registered as ECM, the company presents during Safety Certification/Authorisation process (renewal by Agency/NSA or supervision activity by NSA) the mapping table already presented at the moment of the first issue/renewal of the Safety Certificate/Authorisation by adding a column where the corresponding requirement of Regulation EU 2019/779 is allocated and accomplished by means of the company SMS documentation.

Where correspondence is not found, the RU/IM can present an adjunctive mapping table where the remaining ECM requirements are allocated and accomplished by means of the company specific maintenance system documentation.

The ECM Regulation guide contains appendix 1 and appendix 2 with an example of a complete mapping table for RU/IM where corresponding ECM Regulation requirements are indicated.

Agency/NSA can also use the ECM Certification Scheme (doc. ERA 1172/003) to check in detail the compliance with ECM Regulation requirements and are enabled to arrange on-site visits, where appropriate, to gain evidence of the implementation of such requirements.

3) Supervision after issuing the safety certificate

During the period of validity of the safety certificate, the NSA(s) shall supervise the continued fulfilment of the safety management system requirements and the “add on” for all 4 maintenance functions as shown in the annex II.

The NSA has develop a supervision strategy according to the specifications of the CSM Supervision.

10. WHAT IS THE MAINTENANCE FILE?



Article 14(2) of the Safety Directive introduces the maintenance file as follow:

“…the entity in charge of maintenance shall:

(a) ensure that vehicles are maintained in accordance with the maintenance file of each vehicle;”

According to the sections II.4. and II.5. of annex II of the ECM Regulation [1], the ECM has the duty to develop and maintain (continuously update) the maintenance file. For building this document, the ECM needs to have:

Initial technical documentation

For vehicles compliant with TSIs, the initial development of the maintenance file is based on the technical file (Refer to section 2.4 of annex IV of the Interoperability Directive [3]) and on the APOM. The content of the technical file is described in detail in the relevant TSIs.

As interoperability doesn’t cover all the technical characteristics of a vehicle but only the ones making the vehicle compliant with the essential requirements through the applicable TSIs, there may be additional technical information that has to be provided to the ECM. This additional technical information is requested contractually between the applicant and the manufacturer of the vehicle.

Therefore the initial technical documentation on which the maintenance file will be built is composed of:

Initial technical documentation including initial maintenance documentation

Technical fileAdditional technical documentation

requested contractually including the relevant maintenance documentation

In case the complete technical file has not been provided to the ECM, access should be arranged contractually between the keeper and the ECM. The keeper himself should be aware of its responsibility to provide the appropriate and correct technical information on the vehicle.

For vehicles compliant with TSIs, the documentation described in the relevant TSIs as part of the technical file should be necessarily provided to the ECM, for instance:

▶ Freight vehicles under the revised TSI wagon: There is the chapter 4.5 of annex to TSI Vehicle [6];

▶ Vehicles other than freight wagons under revised TSI Loc&pas: There is the chapters 4.2.12 and 4.5 of annex to TSI Loc&Pas [5];

▶ CCS on board subsystem of vehicles other than freight wagons under revised TSI CCS: There is the chapter 4.5 of annex to TSI CCS [7].



For vehicles not complaint with TSIs (like the majority of existing vehicles) or partially compliant with TSIs, the technical file is replaced by all technical and existing maintenance information that accompany the vehicle.

Initial technical documentation including initial maintenance documentation

Technical and existing maintenance information that accompany the wagon

Additional technical documentation requested contractually including

the relevant maintenance documentation

The initial development of the maintenance file shall take also into account the pattern of operations planned. It includes also the performance targets required by the users: RUs/IMs and keepers.

Content of the maintenance file

The maintenance file has to be created for each vehicle and contains all the information that is necessary to carry out maintenance.

The maintenance file is composed of the following four elements:

1 General Documentation ( extract of chapter 4.5.1 of annex to TSI Wagons [6], chapter 4.2.12.2. of annex to TSI Loc&Pas [5] and chapter 4.5.1 of annex to TSI CCS [7])composed of:

▶ Drawings and description of the vehicle and its components;

▶ Any legal requirement concerning the maintenance of the unit;

▶ Drawing of systems (electrical, pneumatic, hydraulic and control-circuit diagrams);

▶ Additional on-board systems (description of the systems including description of functionality, specification of interfaces and data processing and protocols);

▶ Configuration files for each vehicle (parts list and bill of material) to enable (in particular but not only) traceability during maintenance activities;

▶ the conditions for first line maintenance, i.e. the definition of Line Replaceable Units (LRUs), the definition of approved compatible versions of hardware and software, the procedures for replacing failed LRUs, the conditions for storing LRUs and for repairing failed LRUs.

This documentation may be updated by the ECM.

2 Maintenance Design Justification File (extract of chapter 4.5.2 of annex to TSI Wagons [6], chapter 4.2.12.3.1. of annex to TSI Loc&Pas [5] and chapter 4.5.1 of annex to TSI CCS [7]) explains how maintenance activities are defined, designed and updated in order to ensure that the vehicle characteristics will be kept within permissible limits of use during its lifetime and to ensure that the vehicle is in a safe state of running compliant with the planned pattern of operations. It shall give input data to determine the criteria for maintenance activities. It consists of :

▶ Precedents, principles and methods used to design the maintenance of the unit;

▶ Limits of the normal use of the unit (e.g. km/month, climatic limits, foreseen types of loads etc.) according to the planned pattern of operations;



▶ Relevant data used to design the maintenance and origin of these data (e.g. return of experience);

▶ Tests, investigations and calculations carried out to design the maintenance;

▶ (first/initial) maintenance file (mostly created by the manufacturer): all safety verifications and risk analysis done for defining maintenance activities, intervals etc. shall be covered in the file, because it shall be transparent for the ECM. This is necessary for optimizations of the file by the ECM later on. This is also relevant in case of changing ECM;

▶ all maintenance requirements and procedures (including health monitoring, diagnosis of events, test methods and tools and also the required professional competence) necessary for achieving essential requirements and values quoted in the mandatory requirements of TSI CCS throughout the equipment life-cycle (transport and storage before installation, normal operation, failures, repair work, checking and maintenance, decommissioning, etc.).

This file must be updated by the ECM to enable traceability of changes in maintenance.

3 Maintenance Description File (extract of chapter 4.5.3 of annex to TSI Wagons [6], chapter 4.2.12.3.2. of annex to TSI Loc&Pas [5] and chapter 4.5.1 of annex to TSI CCS [7]) describing how maintenance activities have to be conducted. Maintenance activities include, among others: inspections, monitoring, tests, measurements, replacements, adjustments and repairs. These activities are split into :

▶ Preventive maintenance; scheduled and controlled;

▶ Corrective maintenance;

▶ Light and heavy maintenance

Basically the maintenance description file should contain at least:

▶ Component hierarchy and functional description. The hierarchy sets up the boundaries of the vehicle by listing all the items belonging to the product structure of that vehicle and using an appropriate number of discrete levels. The lowest item of the hierarchy shall be a replaceable component;

▶ Parts list: the parts list shall contain the technical and functional descriptions of the spare parts (replaceable units) and the references from the spare part provider and manufacturer, in order to allow identification and procurement of the correct spare parts. The list shall include all parts specified for changing on condition, or which may require replacement following electrical or mechanical malfunction, or which will foreseeable require replacement after accidental damage. The spare parts list shall also cover component and software modification levels. Interoperability constituent shall be indicated and referenced to their corresponding declaration of conformity;

▶ The limit values for components which are not to be exceeded in service are to be stated; the possibility of specifying operational restrictions in degraded mode (limit value reached) is permitted;

▶ The checks to be carried out when maintaining equipment other than Control-Command and Signaling equipment and which influences the Control-Command and Signaling Subsystems (e.g. changing the wheel diameter);



▶ The checks to be carried out if CCS equipment is subject to exceptional stress (e.g. adverse environmental conditions or abnormal shocks);

▶ List of reference to the European legal obligations to which components or subsystems are subject.

▶ A maintenance plan i.e. the structured set of tasks to perform the maintenance including the activities, procedures and means. The description of this set of tasks includes:

⚬ Disassembly/assembly instructions drawings necessary for correct assembly/disassembly of replaceable parts;

⚬ Maintenance criteria;

⚬ Checks and inspections in particular of safety relevant parts; these include visual inspection and non-destructive tests (where appropriate e.g. to detect deficiencies that may impair safety);

⚬ Welding procedures;

⚬ Tools and materials required to undertake the task;

⚬ Consumables required to undertake the task;

⚬ Personal protective safety provision and equipment;

⚬ Necessary tests and procedures to be undertaken before release to service and return to operation.

4 Configuration File for each vehicle (parts list and bill of material) to enable (in particular but not only) traceability during maintenance activities all along the lifecycle. The configuration files contain the records on maintenance performed. Traceability of maintenance records depends on their impact on safety and has to be compliant with applicable legislation.

11. EXCHANGE OF INFORMATION BETWEEN RAILWAY ACTORS



11.1. What is the information that stakeholders have to exchange according to the maintenance of vehicles?

The exchange of information is critical. Therefore, this is an important requirement in the ECM Regulation obliging RUs, IMs, manufacturers, keepers, ECMs, certification bodies and the relevant national safety authorities to exchange information. As established in the Article 5 of the ECM Regulation:

▶ The entity in charge of the maintenance of the vehicle shall deliver information on the maintenance of a vehicle, and, where applicable on aspects relevant for the operation to the railway undertakings or infrastructure managers at request, either directly or via the keeper;

▶ The railway undertaking or the infrastructure manager shall deliver information on the operation of a vehicle to the entity in charge of maintenance at request, either directly or via the keeper of the vehicle;

▶ All parties involved in the maintenance process such as railway undertakings, infrastructure managers, keepers, entities in charge of maintenance, as well as manufacturers of vehicles, subsystems or components, shall exchange relevant information about maintenance in accordance with the criteria listed in Sections I.7 and I.8 of Annex II;

▶ Where any involved party, in particular a railway undertaking or an infrastructure manager, has evidence that an entity in charge of maintenance does not comply with Article 14 of Directive (EU) 2016/798 or with the requirements of this Regulation, it shall without delay inform the certification body and the relevant national safety authority thereof. The certification body or, where the entity in charge of maintenance is not certified, the relevant national safety authority shall take appropriate action to check whether the claim of non-compliance is justified;

▶ Where there is a change of entity in charge of maintenance, the keeper, in accordance with Article 47(6) of Directive (EU) 2016/797, shall inform without delay the registration entity referred to in Article 4(1) of Commission Decision 2007/756/EC (9) and request the update of the vehicle register. In that situation:

(i) the former entity in charge of maintenance shall without delay deliver the maintenance documentation to the keeper;

(ii) the former entity in charge of maintenance shall be relieved of its obligations when it is removed from the vehicle register;

(iii) in the absence of a new entity in charge of maintenance the registration of the vehicle shall be suspended.



The exchange of information covers specifically Safety Critical Components too. As established in the Article 4(2), 4(3) and 4(6) of the ECM Regulation:

▶ The entity in charge of maintenance shall, either directly or via the keeper provide information to the railway undertakings and infrastructure managers operating the vehicles, keepers, manufacturers, holders of vehicles authorisations and holders of the type authorisation of vehicles, subsystems or components, as most appropriate and shall in particular, inform them of exceptional maintenance findings beyond wear and tear;

▶ Where during the maintenance of a vehicle an entity in charge of maintenance becomes aware of evidence suggesting a component not previously identified as safety critical should be considered as such, it shall inform the manufacturer, the holder of the vehicle type authorisation and the holder of the vehicle authorisation without delay;

▶ The entity in charge of maintenance shall inform the rail sector and the rail supply industry about new or unexpected safety relevant findings including exceptional maintenance findings beyond wear and tear, in relation to vehicles, subsystems or other components, when the related risks are relevant for more actors and are likely to be poorly controlled. The entity in charge of maintenance shall use the Safety Alert IT or another informatics tool provided by the Agency for this purpose.

The exchange of information covers also information between certification body, Member States and authorities as in article 6(1), 6(2), 6(8), 11 and 13:

▶ Member States shall provide the Agency with the following information concerning the certification bodies:

⚬ name

⚬ address

⚬ contact details

⚬ the nature of their empowerment in accordance with Article 14 of Directive (EU) 2016/798 (accreditation, recognition or if they have taken on the task as the national safety authority);

▶ Member States shall inform the Agency about any change in the situation within one month of the occurrence of that change;

▶ A national safety authority, a national investigation body or the Agency may request information from any certification body on the situation concerning an individual ECM certification. The certification body shall reply within 2 weeks at the latest;

▶ If a national safety authority has knowledge that an entity in charge of maintenance does not comply with the requirements of Annex III of Directive (EU) 2016/798 or with the certification requirements of this Regulation, it shall inform the national bodies or authorities responsible for the accreditation or recognition, the Agency, the certification body and other interested parties as appropriate;

▶ The Agency shall collect, record and publish basic information on certification bodies and certified entities in charge of maintenance. The Agency shall create an IT tool for delivering this task.



The exchange of information on changes related to ECM certificate is ruled in Article 7(8):

▶ An ECM certification shall be valid for a maximum period of 5 years. The certified entity in charge of maintenance shall inform the certification body of any changes that might have an impact on the validity of its certification without delay.

The exchange of information between the ECM and other actors may be done in various ways using various methods of communication. The traditional method is paper-based forms (e.g. defined proformas, train books, engineering documents e.g. change request documents, modifications, special checks, safety bulletins etc.). Digital data exchange is now increasingly the norm, this can be a commercial industrial software solution (e.g. SAP, Maximo), or ECM in-house system linked to the Maintenance Management Information System (MMIS) or customer’s system (e.g. Railfleet). Day-to-day information exchange also uses common methods such as E-mail (normal and certified), phone, Text SMS and even verbal. What is important, whichever mixture of methods is chosen, is that the information is correct, complete, comprehensible by both parties and a record is generated to provide traceability.

11.2. How to find an ECM certification body, how to publish your ECM certificate, how to find an ECM certified?

See the ERADIS guide, part 5

http://eradis.era.europa.eu/help/docs/User%20Manual%20-%20ERADIS%20Safety%20Documents.pdf

http://eradis.era.europa.eu/help/docs/User Manual - ERADIS Safety Documents.pdf

http://eradis.era.europa.eu/help/docs/User Manual - ERADIS Safety Documents.pdf



12. MANAGEMENT OF CHANGES

12.1. I would like to change the ECM of my fleet, how to proceed?

The critical aspect when changing of ECM is the proper transfer of information between the former ECM and the new ECM.

▶ (sufficient) information on the maintenance file including records on maintenance performed and safety verifications and risk analysis done for defining maintenance activities, intervals etc.

▶ The technical documentation (technical file is not the property of ECM)

▶ The configuration files of each vehicle

▶ All additional information required by contract between keeper and ‘former’ ECM

Consequently, ERA recommends strongly taking in account these details and issues when negotiating and setting up contractual arrangements between all the involved parts, above all with contracts between the ECM and the client.

13. HOW TO MANAGE SAFETY CRITICAL COMPONENTS?



To deal with Safety Critical Components, a guidance has been prepared by WG48 of CEN/TC256.

The objective of the “guide for identification and management of Safety Critical Component for railway vehicle” (SSCs guide) drafted by the above WG48 is to provide an overview of the requirements captured from the legislation and the actors involved in their fulfilment.

In addition, the document SCCs guide aims to promote a common understanding of those requirements together with practical arrangements to fulfil them in a proper way and giving guidance for the SCC identification and management.

The objective of the SCCs guide is neither to produce an applicable list of SCC components nor to provide for examples of SCC.

This SCCs guide is applicable to vehicles only. The definition of “vehicle” is as in Art. 3(21) Directive 2016/798 (Safety Directive).

13.1. What is a safety critical component

Safety critical components are components for which a single failure has a credible potential to lead directly to a serious accident such as:

▶ any train collision or derailment of trains resulting in the death of at least one person or serious injuries to five or more persons or extensive damage to rolling stock, the infrastructure or the environment, and

▶ any other accident with the same consequences which has an obvious impact on railway safety regulation or the management of safety;

▶ ‘extensive damage’ means damage that can be immediately assessed by the investigating body to cost at least EUR 2 million in total

The SCCs guide collects in a table a list of accidents related to the definition of SCCs applicable for vehicle’s components.

13.2. For which type of vehicle?

To make it clear the applicability of SCC requirements in the field of railway vehicles, it is necessary to distinguish between two categories of vehicles:

▶ new vehicle;

▶ existing vehicle.



For convenience, a new vehicle is intended as a vehicle for which an applicant has requested to the authorizing entity a vehicle authorisation for placing on the market following the new legislation (complying with Regulation 2018/545)

The SCCs requirements for new vehicles also apply to existing vehicles that have a vehicle authorisation for placing in service following engineering change/renewal/upgrading/refurbishment of existing vehicles, which already have a vehicle authorisation for placing on the market, only for the parts of the vehicle related to engineering change/renewal/upgrading/refurbishment.

In that cases, the entity managing the change (holder of the vehicle type authorisation) plays the same role as the Manufacturer.

In addition, the applicant for the vehicle type authorisation is responsible for compiling the technical file that is to accompany the ‘EC’ declaration of verification to be submitted for the application.

Usually, the detailed content of the different documents of the technical file is prepared by the Manufacturer of the vehicle, where the Manufacturer may play the role of “applicant” itself.

The maintenance documentation is a part of the technical file and it is given by the applicant (directly or via the Keeper) to the ECM to make it able to manage and implement the maintenance of the vehicle.

The ECM is responsible for managing the first “maintenance file” by adapting the maintenance documentation to the real operating conditions, performances required and return on experience and to keep updated the maintenance file throughout the lifecycle of the vehicle.

In the case of existing vehicle too, the ECM is responsible for managing the maintenance documentation (see Art. 14(3)b of safety directive) and keeping it updated throughout the lifecycle of the vehicle.

The technical file and the maintenance file play a fundamental role in the accomplishment of the SCC requirements.

13.3. What is the SCC management process?

The identification and management of SCCs starts as part of the design phase under the responsibility of the vehicle Designer/Manufacturer from the concept phase and, when the vehicle is in operation/maintenance phases, through the collaboration and exchange of information with ECM/RU/Keeper (references on the life-cycle phases applicable to a vehicle can be found in EN50126-1-2017).

Generally, to guarantee the safety level in normal and degraded situations, as requested by the relevant TSIs, Designers/Manufacturers are requested to carry out design, construction or assembly for satisfying at least safety requirements.



As regards SCCs, it is expected that Designers/Manufacturers will seek to minimise or eliminate SCCs by means of architectural and functional design choices (see also 5.9 of EN50126-1:2017). However, where it is not practicable to ‘design out’ a SCC, it is crucial that the component is clearly identified, managed and notified. To do so for new vehicles, the Manufacturer is required to:

▶ identify SCCs during the concept/design phase by means of risk-based analysis;

▶ insert a SCCs list in the technical file/maintenance description file/operation documentation together with their specific requirements for:

⚬ operation, servicing, maintenance,

⚬ operational, servicing and maintenance traceability;

▶ specify precedents, principles and methods used to identify SCCs and their specific requirements inside the Maintenance Design Justification File.

These SCCs deliverables, being part of the technical documentation of the vehicle, need to be notified to ECMs/RUs/Keepers to support them during operation/maintenance phases and to update, where necessary, the technical file of the vehicle.

The same process is also valid in the case of engineering change/renewal/upgrading/refurbishment of the vehicle, where in this case the designer/Manufacturer/Entity managing the engineering change/renewal/upgrading/refurbishment is called to provide for the SCCs deliverables.

Neither Manufacturers/Entities managing the change nor ECMs are obliged to identify retrospectively SCCs for existing vehicles except in the case of engineering change/renewal/upgrading/refurbishment, only for the parts of the vehicle related to engineering change/renewal/upgrading/refurbishment.

However, for existing and new vehicles, if during its routine maintenance activities (see Table for details) an ECM becomes aware of evidence suggesting a component not previously identified as safety critical should be considered as such, it must notify the:

▶ Manufacturer,

▶ the holder of the vehicle type authorisation and

▶ the holder of the vehicle authorisation.

After receiving this notification, the Manufacturer, when it can be identified, is required to confirm if the component is safety-critical through risk assessment taking into account use and environment of the component in the context of the vehicle’s operation and maintenance.

In the case of confirmed SCC, the Manufacturer is required to collaborate with the ECM/RU/Keeper to develop specific operational, servicing, maintenance and traceability requirements.

If the Manufacturer cannot be identified, the ECM may confirm the identification of the SCC through a risk assessment procedure as part of its maintenance system and develop specific operational, servicing, maintenance and traceability requirements in collaboration with RU/Keeper.



As a consequence, the outcomes and deliverables of the confirmed SCC need to be notified to, at least:

▶ Keepers/RUs

▶ ECMs

▶ the entity managing the technical file and recorded in the relevant part of the technical file.

In addition, for existing and new vehicles, the Manufacturer is required to provide technical and engineering support on SCCs and their safe integration, when an ECM or a Keeper makes a request.

As detailed above, the ECM is involved to identify new potential SCC during its routine maintenance (reference to in Article 4(3) of ECM Regulation) and, in addition, it may have need, based on REX or other ECM’s activities, to change the SCCs list or their specific requirements (see Annex III.10 of Safety Directive).

In these cases, the ECM is required to use the appropriate “SCCs identification procedure” of its maintenance system through the application of risk-based analysis as required in Annex II of the ECM Regulation.

The following table summarises the high-level activities during which the ECM could:

▶ become aware of evidence that a new SCC is identified as such and notifies it to the Manufacturer for confirmation

▶ change the SCCs list provided by the Manufacturer or their specific requirements

▶ make a request to the Manufacturer for technical and engineering support on SCCs and their safe integration:

ID. ECM Regulation – Annex II, referenced activities Detail of activities

1

Ref. to in: ▶ 2.2, 2.3 part. I, ▶ 2, 4, 5, 6 part II:

when managing changes to the maintenance file of the vehicle as a consequence of:

Non-exhaustive list of examples: ▶ technical/operational change ▶ renewal/upgrading/refurbishment ▶ change of:

⚬ mission profile ⚬ Maintenance plan ⚬ authorization of the vehicle ⚬ vehicle’s configuration ⚬ competence of personnel

▶ legislation’s requirement

2

Ref. to in: ▶ 3, part I:

as an output of monitoring activities on:

▶ collection and analysis of safety relevant data comprising unexpected or exceptional safety and maintenance findings

▶ reporting from accidents, incidents, near misses and other dangerous occurrences

▶ internal audit reporting

3

Ref. to in: ▶ 4, part I:

as an output of continuous improvement on:

▶ collection and analysis of data from: ⚬ regular monitoring ⚬ auditing ⚬ recommendation from national safety authority, national

investigation body, industry, internal investigation, ⚬ report or information from railway undertakings or other sources

to determine measures to be adopted

Table x – ECM activities related to the SCCs list (new component or changes), changes to SCCs requirements and requests for support from Manufacturer



The following flow diagrams show the Manufacturer’s and the ECM’s perspective of the SCCs management process above described.

Vehicleoperation/maintenance

ECM is operating:

Changes to the maintenance file

Monitoring activities

Continuous improvement and finds out:

Need for Manufacturer

support about SCC and its safe integration

Evidence of new potential SCC

Need for changing on SCC list or SCC requirements

Send notification about potential SCC to:

Manufacturer

Holder of the vehicle type

Holder of the vehicle authorisation

Address a request of support, directly or via the Keeper, to

Manufacturer

Is Manufacturer identified?

ECM to Perform Risk‐based analysis

NOManufacturer identified?

Risk‐based analysis

Manufacturer is asked to:

Confirm new SCC

Respond to the request of support

Manufacturer to perform Risk‐based analysis

Manufacturer to consider use and environment of component and

vehicle

SCC Deliverables: Confirmation (Y/N) Requirements Precedents,

principles, methods

Collaboration with RU/Keeper for operational requirements

SCC Deliverables: Confirmation (Y/N) Requirements Precedents,

principles, methods

Collaboration with ECM for servicing/maintenance

requirements

Provide for updating:Technical File Maintenance File Maintenance Design

Justification File Operation documentation

YES



13.4. What are the possible methods for the identification of SCC?

A way to identify safety critical components is to use a bottom-up method which has the characteristic to start from the point of view of the component and, by analysis, going through different levels up to the main effect of the component failure.

Using a bottom-up method implies 2 steps to be carried out:

▶ Step 1 – Identification of vehicle’s components

▶ Step 2 - Analysis and identification of component’s criticality

One of the most common used bottom-up method is FMECA process

Another way to identify critical components is to use a top-down method.

The top-down method does not start from the component’s view as in the bottom-up method, but it starts from the main “top” effect and, by analysis, going through different levels down to the elementary event causing the main one.

One of the most common used top-down method is the Fault Tree Analysis

More explanations on these methods are in the “Railway Applications - Vehicle Maintenance - Guide for identification and management of Safety Critical Components for railway vehicles” drafted by the WG48 of CEN/CENELEC. The document is referenced as FprCEN/TR 17696, and the publication is forecasted for the end of 2021.

(The link when it will be available could be add in this part)

14. COMPETENCES OF MAINTENANCE STAFF



This part is focused on the competence management of maintenance staff as previewed in the Annex II, Section I, Point 6 of Regulation (EU) n. 2019/779.

When designing the competency management system, the ECM and/or maintenance workshop should ensure that there is an alignment between safety responsibility and competency for staff at all levels of the ECM and/or maintenance functions The qualifications and certifications must be aligned with the tasks a person may undertake and the safety responsibilities that person may be designated.

§ 6. Competence management — a structured approach to ensure that employees have the competences required in order to achieve the organisation’s objectives safely, effectively and efficiently in all circumstances

6.1. The organisation must set up a competence management system providing for:

(a) the identification of posts with responsibility…

(b) the identification of posts involving safety tasks;

(c) the allocation of staff with the appropriate competence to relevant tasks.

6.2. Within the organisation’s competence management system, there must be procedures to manage the competence of staff, including at least:

(a) identification of the knowledge, skills and experience required for safety-related tasks as appropriate for the responsibilities;

(b) selection principles, including basic educational level, mental aptitude and physical fitness;

(c) initial training and qualification or certification of acquired competence and skills;

(d) assurance that all staff are aware of the relevance and importance of their activities and how they contribute to the achievement of safety objectives;

(e) ongoing training and periodical updating of existing knowledge and skills;

(f ) periodic checks of competence, mental aptitude and physical fitness where appropriate;

(g) special measures in the case of accidents/incidents or long absences from work, as required.



The organisation to set up a competence management system must to take into account:

▶ Requirements of TSIs about professional competences required for the maintenance (information designer/manufacturer of vehicles or part of vehicles shall to include in the maintenance file).

For example see the extract of chapter 4.5 (5) of annex to TSI Loc&Pas [6] and chapter 4.6 of annex to TSI CCS [8]):

▶ For on-board software, the designer/manufacturer shall specify, for any on-board software modification, all maintenance requirements and procedures (including health monitoring, diagnosis of events, test methods and tools and also the required professional competence) necessary for achieving essential requirements and values quoted in the mandatory requirements of this TSI throughout the life-cycle (Installation, normal operation, failures, repair work, checking and maintenance, decommissioning, etc.);

▶ The manufacturers of the equipment and of the subsystem shall provide information sufficient to define the professional competences required for the installation, final inspection and maintenance of the Control-Command and Signalling Subsystems.

▶ National rules if existing about professional competences required for the maintenance issued exclusively in the national territory.

▶ The risks manufacturers has indicated in the technical file for health and safety that arise from using and maintaining their equipment and subsystems.

14.1. Develop a matrix of the qualifications according to the ECM functions and relevant key functions.

Below some recommendations and examples as evidences for building an efficient competence management system and to respect the above requirements of ECM Regulation.

The following rules could be included in the maintenance system as they are considered as good practice.

If the ECM or Maintenance workshop can demonstrate through experience and risk assessment that it has more effective maintenance rules than the here-below recommended good practices, it should better introduce these in its maintenance system.

The objective of this part is to provide a guideline to define, within the ECM’s competence management system, the procedures to manage the competence of maintenance staff of four functions of ECM with a specific focus concerning the procedures to manage the competence of maintenance staff of ECM-F4.”

Qualification of acquired competence and skills is a mixture of:

▶ Work experience

▶ Basic education (elementary school, university, ...)

▶ Additional training (activity-related)



The matrix below could be used as a guide by ECM to be a part of their competence management system and to monitor and control the qualification of the staff.

Activities work experience rail sector

basic education additional training

1 YE

AR

3 YE

AR

5 YE

AR

x YE

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nts

xxx

ECM-F1 manager

ECM-F2 manager

ECM-F3 manager

ECM-F4 manager

Fleet engineer

Component engineer

Workers / inspectors of safety-critical components

14.2. Competences of maintenance workers (ECM-F4)

The staff deployed in maintenance delivery function (ECM-F4) needs to have personal skills (physical fitness, mental aptitude, basic educational level and, where requested in the member state, a minimum age) and be generally trained to work in railway vehicle maintenance field (competence on maintenance).

The basic educational level also ensures the competence on the language of the country (general knowledge, speaking, speech comprehension, reading, writing), where this competence is required.

In addition, high skill and competence may be required for people working on specific safety components/activities (ref. to in Annex II, IV.8).

The competence on maintenance can be recognized through the CMS of the ECM (internal process of training to issue a qualification) or through external resources (training centre).

The basic requirements of a general training program covering railway vehicle maintenance sector should be at least:

▶ basic knowledge of vehicle’s operation and maintenance,

▶ basic knowledge on vehicle’s main functions/systems,

▶ basic rules to carry out maintenance (repair, inspection, cleaning, lubrication, calibration, measuring, diagnosis, assembly and disassembly activities, testing),



▶ basic knowledge of the most common tools and equipment used in vehicle’s maintenance

▶ general health and safety instructions, ergonomics and health protection, generic earthing provisions, provisions against electric shock, hot surface and other,

▶ organisation of vehicle’s maintenance (maintenance plan, maintenance manuals and reference documents, use/handling of tools and equipment, maintenance orders, spare parts list),

▶ interfaces between the various processes within ECM-F4 and between function ECM-F4 and ECM-F3 (for the creation of the Maintenance orders / for the release to service) and between ECM-F4 and ECM-F2 (for the proposed changes / for applying changes).

Based on the organisation of the ECM, the general training program may be characterized in professional areas and structured/grouped with a technical view as the following non-exhaustive examples:

Group A – ‘Release to service’ skill with the following competence on:

▶ final vehicle testing procedure, methods and results,

▶ specific vehicle’s operation and maintenance profile (scheduled operation profile, scheduled maintenance intervals),

▶ checking maintenance orders performed and restrictions applicable for safe running,

▶ current vehicle documentation applicable (legal requirements, technical specifications),

▶ preparing document accompanying vehicle for its release to service.

Group B – ‘Brake and pneumatic system’ skill with the following competence on:

▶ knowledge on vehicle’s different brake systems, their functioning principles, interfaces, typical malfunctions and fault-finding procedure,

▶ comprehension of technical drawings and functional schemes related to brake and pneumatic system and knowledge on physical location of its components on the vehicle,

▶ knowledge on use, handling and storage of specific tools and equipment for calibration, measuring, testing, diagnostics and IT system devices.

Group C – ‘Electric/electronic main power supply system’ skill with the following competence on:

▶ knowledge on vehicle’s power supply systems, their functioning principles, interfaces, typical malfunctions and fault-finding procedure,

▶ specific health protection measures for a safe maintenance (i.e. earthing provisions),

▶ comprehension of technical drawings and functional schemes related to vehicle’s power supply system and knowledge on physical location of its components on the vehicle,


Group D – ‘Mechanical parts related to movement and traction coupling’ (bogie, wheel, axle, axle-boxes, running-gear, suspensions, shock-absorbers, buffing and draw gear, coupling system…) skills with the following competence on:



▶ knowledge on vehicle’s mechanical components related to movement and traction coupling, their functioning, interfaces, typical malfunctions and fault-finding procedure,

▶ specific health protection measures for a safe maintenance,

▶ comprehension of technical drawings and functional schemes related to vehicle’s movement and traction coupling and knowledge on physical location of its components on the vehicle,


Additional specific training program may be required for particular maintenance activities related to safety (see Annex II, IV.8), where required by law or NSA or established by ECM itself:

(a) joining techniques (including welding and bonding);

(b) non-destructive testing;

(c) final vehicle testing and release to service;

(d) maintenance activities on brake systems, wheel sets and draw gear;

(e) Maintenance activities on firefighting system (such as portable fire extinguishers, fire detection systems, fire containment and control systems for passenger rolling stock, etc.)

(f ) maintenance activities on specific components of freight wagons for the transport of dangerous goods, such as tanks, valves, etc.;

(g) maintenance activities on specific components of OTMs (such as elevating platforms and other work equipment typical of OTMs)

(h) maintenance activities on safety-critical components;

(i) maintenance activities on control-command and signalisation systems;

(l) maintenance activities on door control systems;

(m) other identified specialist areas affecting safety.

ECM should consider existing standards, where appropriate, and indications provided by Manufacturer to identify qualification requirements and issue specific qualification based on defined training process, for instance:

NON-DESTRUCTIVE TESTING

Concerning the activities “non-destructive testing” on all safety-critical components and in general on all components listed above, at least evidence of compliance of maintenance workers competences with the relevant standard should be required:



* “non-destructive testing”: qualification of NDT staff regarding the application of the tests in the industrial sector “railway maintenance”.

In particular, should be necessary to give evidence of the competences in the industrial sector “railway maintenance” in compliance with standard ISO 9712. The criteria for the qualification of NDT staff regarding the application of the tests in “railway maintenance” is in addition to standard ISO 9712.

If there are national rules concerning this field each ECM or Maintenance workshop shall respect them for its staff involved in the application of the NDTs in “railway maintenance”.

In absence of national rules, each ECM or Maintenance workshop should define a specific procedure for the qualification of NDT staff regarding the application of the tests in the industrial sector “railway maintenance” issued by the relevant third part Certification Body.

JOINING TECHNIQUES (INCLUDING WELDING AND BONDING)

Concerning the activities joining techniques in the case of “welding processes”, at least evidence of compliance with the relevant standard is required:

* joining techniques in the case of “welding processes”: certification of staff and maintenance workshop.

In particular, in the case of “welding processes” are applied, at least for staff and maintenance workshop the certification in conformity to the series of standards EN 15085 and EN ISO 14731 is required.

The certification body shall fulfil the requirements of the standard EN 15085-1.

If there are national rules concerning this field each ECM or Maintenance workshop should respect them for its staff and the organisation of workshop.

In absence of national rules, each ECM or Maintenance workshop should define a specific procedure for the certification of staff and maintenance workshop issued by the relevant third part Certification Body.

It is recommended that the above rules are included in the maintenance system as they are considered as good practice.

If the ECM or Maintenance workshop can demonstrate through experience and risk assessment that it has more effective maintenance rules than the here-below recommended good practices, it should better introduce these in its maintenance system.

15. WAGONS FOR DANGEROUS GOODS


15. WAGONS FOR DANGEROUS GOODS

You are an ECM dealing with wagons transporting dangerous goods; some requirements shall be taken into account during the certification process.

Additional requirements for ECM, dealing with wagons transporting dangerous goods

▶ Competence management in Dangerous Goods as required in RID Chapter 1.3

▶ Maintenance system for tanks based on legal requirements (RID, Type approval) and return of experience

▶ Information management with RU and others e.g. customer/operator regarding checks between mandatory RID-inspections as defined in GCU Annex 9 or suggested in RID 1.4.3.3 a

▶ Documentation system regarding tank file as required in RID 4.3.2.1.7

Only for ECM-F4 (Maintenance Delivery)

▶ Competence management system in Dangerous goods (RID Chapter 1.3)

▶ Qualification for welding of tanks acc. RID 6.8.2.1.23

▶ Particular proceedings/equipment related to this substances

▶ Occupational health and safety processes with regard to Dangerous Goods



16. ECM ANNUAL REPORT

Each entity in charge of maintenance shall submit an annual report of its activities.

The requirements for this report are set out in Annex V of the ECM-Regulation.

If compliance with Annex II is demonstrated through an ECM certification, the report shall be submitted to the certification body and to the relevant customers (including keepers). The ECM shall make it available to the national safety authority and to the Agency upon request.

If compliance with Annex II is demonstrated through the process of safety certification or authorisation, the report shall be submitted to the safety certification body in case of application for granting or renewal of a safety certificate and to the NSA that does the surveillance.

The entity in charge of maintenance shall issue a report, which covers usually a period of 12 months, starting 2 months before the last surveillance and ending 2 months before the next planned surveillance. In case of article 3(4) of the ECM-Regulation the NSA can define other periods.

The entity in charge of maintenance shall address the report to the NSA 1 month before the next planned surveillance audit.

In case of a requested renewal or amendment of an issued certificate the application should cover a current maintenance report.

period of report

2 months 1 month2 months

last surveillance send report planed surveillance

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- cor

resp

ondi

ng

requ

irem

ents

31.

CO

NTE

XT

OF

THE

ORG

AN

ISAT

ION

Non

e1.

1. T

he o

rgan

isat

ion

shal

l:(c

) ide

ntify

inte

rest

ed p

artie

s (e

.g. r

egul

ator

y bo

dies

, au

thor

ities

, rai

lway

und

erta

king

s, in

fras

truc

ture

man

ager

s, co

ntra

ctor

s, su

pplie

rs, p

artn

ers)

, in

clud

ing

thos

e pa

rtie

s ex

tern

al

to th

e ra

ilway

sys

tem

, tha

t ar

e re

leva

nt to

the

safe

ty

man

agem

ent s

yste

m;

I.2.1

(par

tially

co

vere

d), I

.9.1

(p

artia

lly c

over

ed)

41.

CO

NTE

XT

OF

THE

ORG

AN

ISAT

ION

Non

e1.

1. T

he o

rgan

isat

ion

shal

l:(d

) ide

ntify

and

mai

ntai

n le

gal

and

othe

r req

uire

men

ts re

late

d to

saf

ety

from

the

inte

rest

ed

part

ies

refe

rred

to in

poi

nt (c

);

I.1.(b

) and

(f),

I.9.3

51.

CO

NTE

XT

OF

THE

ORG

AN

ISAT

ION

Non

e1.

1. T

he o

rgan

isat

ion

shal

l:(e

) ens

ure

that

the

requ

irem

ents

re

ferr

ed to

in p

oint

(d) a

re ta

ken

into

acc

ount

in d

evel

opin

g,

impl

emen

ting

and

mai

ntai

ning

th

e sa

fety

man

agem

ent s

yste

m;

I.1.(d

)

61.

CO

NTE

XT

OF

THE

ORG

AN

ISAT

ION

Non

e1.

1. T

he o

rgan

isat

ion

shal

l:(f

) des

crib

e th

e sc

ope

of th

e sa

fety

man

agem

ent s

yste

m,

indi

catin

g w

hich

par

t of t

he

busi

ness

is in

clud

ed o

r not

in it

s sc

ope

and

taki

ng in

to a

ccou

nt

the

requ

irem

ents

refe

rred

to in

po

int (

d).

I.1.(a

) (pa

rtia

lly

cove

red)

, I.9

.1

(par

tially

cov

ered

)

72.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip

and

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te

lead

ersh

ip a

nd

com

mitm

ent t

o th

e de

velo

pmen

t, im

plem

enta

tion,

m

aint

enan

ce a

nd c

ontin

ual

impr

ovem

ent o

f the

saf

ety

man

agem

ent s

yste

m b

y:

(a) t

akin

g ov

eral

l acc

ount

abili

ty

and

resp

onsi

bilit

y fo

r saf

ety;

I.5.5

and

I.5

(in

gene

ral)

85Ve

rsio

n 9.

0 (0

1/03

/202

1). U

ncon

trol

led

whe

n pr

inte

d. D

ownl

oad

the

late

st v

ersi

on a

t era

.eur

opa.

eu.

© 2

021

EU A

genc

y fo

r Rai

lway

s. A

ll rig

hts

rese

rved

.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

82.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip

and

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te

lead

ersh

ip a

nd

com

mitm

ent t

o th

e de

velo

pmen

t, im

plem

enta

tion,

m

aint

enan

ce a

nd c

ontin

ual

impr

ovem

ent o

f the

saf

ety

man

agem

ent s

yste

m b

y:

(b) e

nsur

ing

com

mitm

ent

to s

afet

y by

man

agem

ent

at d

iffer

ent l

evel

s w

ithin

th

e or

gani

satio

n th

roug

h th

eir a

ctiv

ities

and

in th

eir

rela

tions

hips

with

sta

ff an

d co

ntra

ctor

s;

I.1.(g

) and

(h)

(par

tially

cov

ered

), I.9

.3

92.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip

and

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te

lead

ersh

ip a

nd

com

mitm

ent t

o th

e de

velo

pmen

t, im

plem

enta

tion,

m

aint

enan

ce a

nd c

ontin

ual

impr

ovem

ent o

f the

saf

ety

man

agem

ent s

yste

m b

y:

(c) e

nsur

ing

that

the

safe

ty

polic

y an

d sa

fety

obj

ectiv

es a

re

esta

blis

hed,

und

erst

ood

and

are

com

patib

le w

ith th

e st

rate

gic

dire

ctio

n of

the

orga

nisa

tion;

I.1(a

) and

(b),

I.9.3

102.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip

and

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te

lead

ersh

ip a

nd

com

mitm

ent t

o th

e de

velo

pmen

t, im

plem

enta

tion,

m

aint

enan

ce a

nd c

ontin

ual

impr

ovem

ent o

f the

saf

ety

man

agem

ent s

yste

m b

y:

(d) e

nsur

ing

the

inte

grat

ion

of th

e sa

fety

man

agem

ent

syst

em re

quire

men

ts in

to

the

orga

nisa

tion’

s bu

sine

ss

proc

esse

s;

I.1(d

)

112.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip

and

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te

lead

ersh

ip a

nd

com

mitm

ent t

o th

e de

velo

pmen

t, im

plem

enta

tion,

m

aint

enan

ce a

nd c

ontin

ual

impr

ovem

ent o

f the

saf

ety

man

agem

ent s

yste

m b

y:

(e) e

nsur

ing

that

the

reso

urce

s ne

eded

for t

he s

afet

y m

anag

emen

t sys

tem

are

av

aila

ble;

I.1(e

)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

86

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

122.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip

and

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te

lead

ersh

ip a

nd

com

mitm

ent t

o th

e de

velo

pmen

t, im

plem

enta

tion,

m

aint

enan

ce a

nd c

ontin

ual

impr

ovem

ent o

f the

saf

ety

man

agem

ent s

yste

m b

y:

(f) e

nsur

ing

that

the

safe

ty

man

agem

ent s

yste

m is

effe

ctiv

e in

con

trol

ling

the

safe

ty ri

sks

pose

d by

the

orga

nisa

tion;

I.1.(c

) (pa

rtia

lly

cove

red)

132.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip

and

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te

lead

ersh

ip a

nd

com

mitm

ent t

o th

e de

velo

pmen

t, im

plem

enta

tion,

m

aint

enan

ce a

nd c

ontin

ual

impr

ovem

ent o

f the

saf

ety

man

agem

ent s

yste

m b

y:

(g) e

ncou

ragi

ng s

taff

to

supp

ort c

ompl

ianc

e w

ith th

e sa

fety

man

agem

ent s

yste

m

requ

irem

ents

;

I.1.(g

) and

(h)

(par

tially

cov

ered

)

142.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip

and

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te

lead

ersh

ip a

nd

com

mitm

ent t

o th

e de

velo

pmen

t, im

plem

enta

tion,

m

aint

enan

ce a

nd c

ontin

ual

impr

ovem

ent o

f the

saf

ety

man

agem

ent s

yste

m b

y:

(h) p

rom

otin

g co

ntin

ual

impr

ovem

ent o

f the

saf

ety

man

agem

ent s

yste

m;

I.4 (p

artia

lly c

over

ed)

152.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip

and

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te

lead

ersh

ip a

nd

com

mitm

ent t

o th

e de

velo

pmen

t, im

plem

enta

tion,

m

aint

enan

ce a

nd c

ontin

ual

impr

ovem

ent o

f the

saf

ety

man

agem

ent s

yste

m b

y:

(i) e

nsur

ing

that

saf

ety

is

cons

ider

ed w

hen

iden

tifyi

ng

and

man

agin

g th

e or

gani

satio

n’s

busi

ness

risk

s an

d ex

plai

ning

ho

w c

onfli

ct b

etw

een

safe

ty

and

othe

r bus

ines

s go

als

will

be

reco

gnis

ed a

nd re

solv

ed;

I.2.2

and

I.2.

3 (p

artia

lly c

over

ed),

I.1.(f

), I.9

.1

87Ve

rsio

n 9.

0 (0

1/03

/202

1). U

ncon

trol

led

whe

n pr

inte

d. D

ownl

oad

the

late

st v

ersi

on a

t era

.eur

opa.

eu.

© 2

021

EU A

genc

y fo

r Rai

lway

s. A

ll rig

hts

rese

rved

.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

162.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip

and

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te

lead

ersh

ip a

nd

com

mitm

ent t

o th

e de

velo

pmen

t, im

plem

enta

tion,

m

aint

enan

ce a

nd c

ontin

ual

impr

ovem

ent o

f the

saf

ety

man

agem

ent s

yste

m b

y:

(j) p

rom

otin

g a

posi

tive

safe

ty

cultu

re.

172.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.1.

A

doc

umen

t de

scrib

ing

the

orga

nisa

tion’

s sa

fety

pol

icy

is e

stab

lishe

d by

the

top

man

agem

ent a

nd is

:

(a) a

ppro

pria

te to

the

orga

nisa

tion’

s ch

arac

ter a

nd

exte

nt o

f rai

lway

ope

ratio

ns;

I.1.(a

)

182.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.1.

A

doc

umen

t de

scrib

ing

the

orga

nisa

tion’

s sa

fety

pol

icy

is e

stab

lishe

d by

the

top

man

agem

ent a

nd is

:

(b) a

ppro

ved

by th

e or

gani

satio

n’s

chie

f exe

cutiv

e (o

r a

repr

esen

tativ

e(s)

of t

he to

p-m

anag

emen

t);

I.1.(a

)

192.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.1.

A

doc

umen

t de

scrib

ing

the

orga

nisa

tion’

s sa

fety

pol

icy

is e

stab

lishe

d by

the

top

man

agem

ent a

nd is

:

(c) a

ctiv

ely

impl

emen

ted,

co

mm

unic

ated

and

mad

e av

aila

ble

to a

ll st

aff.

I.1.(a

)

202.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.2.

The

saf

ety

polic

y sh

all:

(a) i

nclu

de a

com

mitm

ent t

o co

nfor

m w

ith a

ll le

gal a

nd o

ther

re

quire

men

ts re

late

d to

saf

ety;

I.1.(b

) (pa

rtia

lly

cove

red)

and

I.1.

(a)

(in g

ener

al)

212.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.2.

The

saf

ety

polic

y sh

all:

(b) p

rovi

de a

fram

ewor

k fo

r se

ttin

g sa

fety

obj

ectiv

es a

nd

eval

uatin

g th

e or

gani

satio

n’s

safe

ty p

erfo

rman

ce a

gain

st th

ese

obje

ctiv

es;

I.1.(b

) and

(c ),

and

I.1

.(a) (

in g

ener

al),

I.9.3

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

88

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

222.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.2.

The

saf

ety

polic

y sh

all:

(c) i

nclu

de a

com

mitm

ent t

o co

ntro

l saf

ety

risks

whi

ch a

rise

both

from

its

own

activ

ities

and

th

ose

caus

ed b

y ot

hers

;

I.1.(f

), an

d I.1

.(a) (

in

gene

ral),

I.9.

4 (in

ge

nera

l), I.

9.5

(in

gene

ral)

232.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.2.

The

saf

ety

polic

y sh

all:

(d) i

nclu

de a

com

mitm

ent t

o co

ntin

ual i

mpr

ovem

ent o

f the

sa

fety

man

agem

ent s

yste

m;

I.4 a

nd I.

1.(a

) (in

ge

nera

l)

242.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.2.

The

saf

ety

polic

y sh

all:

(e) b

e m

aint

aine

d in

acc

orda

nce

with

the

busi

ness

str

ateg

y an

d th

e ev

alua

tion

of th

e sa

fety

pe

rfor

man

ce o

f the

org

anis

atio

n.

I.1.(c

) and

I.1.

(a) (

in

gene

ral)

252.

LE

AD

ERSH

IP2.

3.

Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

2.3.

1. T

he re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

of s

taff

havi

ng

a ro

le th

at a

ffect

s sa

fety

(in

clud

ing

man

agem

ent

and

othe

r sta

ff in

volv

ed in

sa

fety

-rel

ated

task

s) s

hall

be d

efine

d at

all

leve

ls

with

in th

e or

gani

satio

n,

docu

men

ted,

ass

igne

d an

d co

mm

unic

ated

to th

em.

I.5 (i

n ge

nera

l)

262.

LE

AD

ERSH

IP2.

3.

Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

2.3.

2. T

he o

rgan

isat

ion

shal

l ens

ure

that

sta

ff w

ith

dele

gate

d re

spon

sibi

litie

s fo

r saf

ety-

rela

ted

task

s sh

all h

ave

the

auth

ority

, co

mpe

tenc

e an

d ap

prop

riate

reso

urce

s to

pe

rfor

m th

eir t

asks

with

out

bein

g ad

vers

ely

affec

ted

by th

e ac

tiviti

es o

f oth

er

busi

ness

func

tions

.

I.5 (i

n ge

nera

l), I.

6 (in

gen

eral

), II.

6 (in

ge

nera

l), II

I.1, I

II.7,

IV.8

89Ve

rsio

n 9.

0 (0

1/03

/202

1). U

ncon

trol

led

whe

n pr

inte

d. D

ownl

oad

the

late

st v

ersi

on a

t era

.eur

opa.

eu.

© 2

021

EU A

genc

y fo

r Rai

lway

s. A

ll rig

hts

rese

rved

.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

272.

LE

AD

ERSH

IP2.

3.

Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

2.3.

3.

Del

egat

ion

of

resp

onsi

bilit

y fo

r saf

ety-

rela

ted

task

s sh

all

be d

ocum

ente

d an

d co

mm

unic

ated

to th

e re

leva

nt s

taff,

acc

epte

d an

d un

ders

tood

.

I.5 (i

n ge

nera

l)

282.

LE

AD

ERSH

IP2.

3.

Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

2.3.

4. T

he o

rgan

isat

ion

shal

l des

crib

e th

e al

loca

tion

of ro

les

refe

rred

to

in p

arag

raph

2.3

.1. t

o bu

sine

ss fu

nctio

ns w

ithin

an

d w

here

rele

vant

, out

side

th

e or

gani

satio

n (s

ee 5

.3.

Cont

ract

ors,

part

ners

and

su

pplie

rs).

I.5 (i

n ge

nera

l), I.

9.4

and

I.9.6

(in

gene

ral)

292.

LE

AD

ERSH

IP2.

4.

Cons

ulta

tion

of s

taff

and

othe

r pa

rtie

s

2.4.

1.

Staff

, the

ir re

pres

enta

tives

and

ex

tern

al in

tere

sted

par

ties,

as a

ppro

pria

te a

nd w

here

re

leva

nt, s

hall

be c

onsu

lted

in d

evel

opin

g, m

aint

aini

ng

and

impr

ovin

g th

e sa

fety

m

anag

emen

t sys

tem

in

the

rele

vant

par

ts th

ey a

re

resp

onsi

ble

for,

incl

udin

g th

e sa

fety

asp

ects

of

oper

atio

nal p

roce

dure

s.

I.1.(h

)

302.

LE

AD

ERSH

IP2.

4.

Cons

ulta

tion

of s

taff

and

othe

r pa

rtie

s

2.4.

2. T

he o

rgan

isat

ion

shal

l fac

ilita

te th

e co

nsul

tatio

n of

sta

ff by

pr

ovid

ing

the

met

hods

and

m

eans

for i

nvol

ving

sta

ff,

reco

rdin

g st

aff’s

opin

ion

and

prov

idin

g fe

edba

ck o

n st

aff’s

opin

ion.

I.5.4

and

I.1.

(h)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

90

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

313.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

1. T

he o

rgan

isat

ion

shal

l:(a

) ide

ntify

and

ana

lyse

all

oper

atio

nal,

orga

nisa

tiona

l an

d te

chni

cal r

isks

rele

vant

to

the

char

acte

r and

ext

ent o

f op

erat

ions

car

ried

out b

y th

e or

gani

satio

n. S

uch

risks

sha

ll in

clud

e th

ose

aris

ing

from

hum

an

and

orga

nisa

tiona

l fac

tors

suc

h as

wor

kloa

d, jo

b de

sign

, fat

igue

or

sui

tabi

lity

of p

roce

dure

s, an

d th

e ac

tiviti

es o

f oth

er in

tere

sted

pa

rtie

s (s

ee 1

. Con

text

of t

he

orga

nisa

tion)

;

I.2.2

, I.2

.3, I

.9.1

(in

gene

ral)

323.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

1. T

he o

rgan

isat

ion

shal

l:(b

) eva

luat

e th

e ris

ks re

ferr

ed to

in

poin

t (a)

by

appl

ying

app

ropr

iate

ris

k as

sess

men

t met

hods

;

I.2.2

333.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

1. T

he o

rgan

isat

ion

shal

l:(c

) dev

elop

and

put

in p

lace

safe

ty

mea

sure

s, w

ith id

entifi

catio

n of

ass

ocia

ted

resp

onsi

bilit

ies

(see

2.3

. Org

anis

atio

nal r

oles

, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

);

I.3 (i

n ge

nera

l)

343.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

1. T

he o

rgan

isat

ion

shal

l:(d

) dev

elop

a s

yste

m to

mon

itor

the

effec

tiven

ess

of s

afet

y m

easu

res

(see

6.1

. Mon

itorin

g);

I.3 (i

n ge

nera

l)

91Ve

rsio

n 9.

0 (0

1/03

/202

1). U

ncon

trol

led

whe

n pr

inte

d. D

ownl

oad

the

late

st v

ersi

on a

t era

.eur

opa.

eu.

© 2

021

EU A

genc

y fo

r Rai

lway

s. A

ll rig

hts

rese

rved

.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

353.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

1. T

he o

rgan

isat

ion

shal

l:(e

) rec

ogni

se th

e ne

ed to

co

llabo

rate

with

oth

er in

tere

sted

pa

rtie

s (s

uch

as ra

ilway

un

dert

akin

gs, i

nfra

stru

ctur

e m

anag

ers,

man

ufac

ture

r, m

aint

enan

ce s

uppl

ier,

entit

y in

ch

arge

of m

aint

enan

ce, r

ailw

ay

vehi

cle

keep

er, s

ervi

ce p

rovi

der

and

proc

urem

ent e

ntity

), w

here

ap

prop

riate

, on

shar

ed ri

sks

and

the

putt

ing

in p

lace

of a

dequ

ate

safe

ty m

easu

res;

I.2.1

, I.7

(in

gene

ral)

363.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

1. T

he o

rgan

isat

ion

shal

l:(f

) com

mun

icat

e ris

ks to

sta

ff an

d in

volv

ed e

xter

nal p

artie

s (s

ee 4

.4.

Info

rmat

ion

and

com

mun

icat

ion)

.

I.1.(h

) par

tially

co

vere

d), I

.9.4

(p

artia

lly c

over

ed)

373.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

2. W

hen

asse

ssin

g ris

k,

an o

rgan

isat

ion

shal

l tak

e in

to a

ccou

nt th

e ne

ed to

de

term

ine,

pro

vide

and

sus

tain

a

safe

wor

king

env

ironm

ent

whi

ch c

onfo

rms

to a

pplic

able

le

gisl

atio

n, in

par

ticul

ar D

irect

ive

89/3

91/E

EC.

I.2.3

383.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.2.

Pl

anni

ng fo

r cha

nge

3.1.

2.1.

The

org

anis

atio

n sh

all

iden

tify

pote

ntia

l saf

ety

risks

and

ap

prop

riate

saf

ety

mea

sure

s (s

ee

3.1.

1. R

isk

asse

ssm

ent)

bef

ore

the

impl

emen

tatio

n of

a c

hang

e (s

ee 5

.4. M

anag

emen

t of c

hang

e)

in a

ccor

danc

e w

ith th

e ris

k m

anag

emen

t pro

cess

set

out

in

Regu

latio

n (E

U) N

o 40

2/20

13,

incl

udin

g co

nsid

erat

ion

of th

e sa

fety

risk

s fr

om th

e ch

ange

pr

oces

s its

elf.

I.2.2

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

92

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

393.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

1. T

he o

rgan

isat

ion

shal

l est

ablis

h sa

fety

ob

ject

ives

for r

elev

ant

func

tions

at r

elev

ant l

evel

s to

mai

ntai

n an

d, w

here

re

ason

ably

pra

ctic

able

, im

prov

e its

saf

ety

perf

orm

ance

.

I.1.(b

) and

(c )

403.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

2. T

he s

afet

y ob

ject

ives

sh

all:

(a) b

e co

nsis

tent

with

the

safe

ty

polic

y an

d th

e or

gani

satio

n’s

stra

tegi

c ob

ject

ives

(whe

re

appl

icab

le);

I.1.(b

)

413.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

2. T

he s

afet

y ob

ject

ives

sh

all:

(b) b

e lin

ked

to th

e pr

iorit

y ris

ks th

at in

fluen

ce th

e sa

fety

pe

rfor

man

ce o

f the

org

anis

atio

n;

I.1.(b

) and

(c )

423.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

2. T

he s

afet

y ob

ject

ives

sh

all:

(c) b

e m

easu

rabl

e;

433.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

2. T

he s

afet

y ob

ject

ives

sh

all:

(d) t

ake

into

acc

ount

app

licab

le

lega

l and

oth

er re

quire

men

ts;

I.1.(b

)

443.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

2. T

he s

afet

y ob

ject

ives

sh

all:

(e) b

e re

view

ed a

s re

gard

s th

eir

achi

evem

ents

and

revi

sed

as

appr

opria

te;

453.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

2. T

he s

afet

y ob

ject

ives

sh

all:

(f) b

e co

mm

unic

ated

.

463.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

3. T

he o

rgan

isat

ion

shal

l hav

e pl

an(s

) to

desc

ribe

how

it w

ill a

chie

ve

its s

afet

y ob

ject

ives

.

I.1.(d

)

93Ve

rsio

n 9.

0 (0

1/03

/202

1). U

ncon

trol

led

whe

n pr

inte

d. D

ownl

oad

the

late

st v

ersi

on a

t era

.eur

opa.

eu.

© 2

021

EU A

genc

y fo

r Rai

lway

s. A

ll rig

hts

rese

rved

.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

473.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

4. T

he o

rgan

isat

ion

shal

l des

crib

e th

e st

rate

gy

and

plan

(s) u

sed

to m

onito

r th

e ac

hiev

emen

t of t

he

safe

ty o

bjec

tives

(see

6.1

. M

onito

ring)

.

I.3 (i

n ge

nera

l)

484.

SU

PPO

RT4.

1.

Reso

urce

s4.

1.1.

The

org

anis

atio

n sh

all p

rovi

de th

e re

sour

ces,

incl

udin

g co

mpe

tent

sta

ff an

d eff

ectiv

e an

d us

eabl

e eq

uipm

ent,

need

ed

for t

he e

stab

lishm

ent,

impl

emen

tatio

n,

mai

nten

ance

and

con

tinua

l im

prov

emen

t of t

he s

afet

y m

anag

emen

t sys

tem

.

I.1.(e

), II.

3, IV

.3, I

V.4,

IV

.5

494.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

1. T

he o

rgan

isat

ion’

s co

mpe

tenc

e m

anag

emen

t sy

stem

sha

ll en

sure

th

at s

taff

havi

ng a

role

th

at a

ffect

s sa

fety

are

co

mpe

tent

in th

e sa

fety

-re

late

d ta

sks

for w

hich

th

ey a

re re

spon

sibl

e (s

ee 2

.3. O

rgan

isat

iona

l ro

les,

resp

onsi

bilit

ies,

acco

unta

bilit

ies

and

auth

oriti

es),

incl

udin

g at

le

ast:

(a) i

dent

ifica

tion

of th

e co

mpe

tenc

ies

(incl

udin

g kn

owle

dge,

ski

lls, n

on-t

echn

ical

be

havi

ours

and

att

itude

s)

requ

ired

for s

afet

y-re

late

d ta

sks;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

504.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

1. T

he o

rgan

isat

ion’

s co

mpe

tenc

e m

anag

emen

t sy

stem

sha

ll en

sure

th

at s

taff

havi

ng a

role

th

at a

ffect

s sa

fety

are

co

mpe

tent

in th

e sa

fety

-re

late

d ta

sks

for w

hich

th

ey a

re re

spon

sibl

e (s

ee 2

.3. O

rgan

isat

iona

l ro

les,

resp

onsi

bilit

ies,

acco

unta

bilit

ies

and

auth

oriti

es),

incl

udin

g at

le

ast:

(b) s

elec

tion

prin

cipl

es (b

asic

ed

ucat

iona

l lev

el, p

sych

olog

ical

an

d ph

ysic

al fi

tnes

s re

quire

d);

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

94

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

514.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

1. T

he o

rgan

isat

ion’

s co

mpe

tenc

e m

anag

emen

t sy

stem

sha

ll en

sure

th

at s

taff

havi

ng a

role

th

at a

ffect

s sa

fety

are

co

mpe

tent

in th

e sa

fety

-re

late

d ta

sks

for w

hich

th

ey a

re re

spon

sibl

e (s

ee 2

.3. O

rgan

isat

iona

l ro

les,

resp

onsi

bilit

ies,

acco

unta

bilit

ies

and

auth

oriti

es),

incl

udin

g at

le

ast:

(c) i

nitia

l tra

inin

g, e

xper

ienc

e an

d qu

alifi

catio

n;I.6

(in

gene

ral),

II.6

(in

gene

ral),

III.1

, III.

7, IV

.8

524.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

1. T

he o

rgan

isat

ion’

s co

mpe

tenc

e m

anag

emen

t sy

stem

sha

ll en

sure

th

at s

taff

havi

ng a

role

th

at a

ffect

s sa

fety

are

co

mpe

tent

in th

e sa

fety

-re

late

d ta

sks

for w

hich

th

ey a

re re

spon

sibl

e (s

ee 2

.3. O

rgan

isat

iona

l ro

les,

resp

onsi

bilit

ies,

acco

unta

bilit

ies

and

auth

oriti

es),

incl

udin

g at

le

ast:

(d) o

ngoi

ng tr

aini

ng a

nd p

erio

dic

upda

te o

f exi

stin

g co

mpe

tenc

ies;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

95Ve

rsio

n 9.

0 (0

1/03

/202

1). U

ncon

trol

led

whe

n pr

inte

d. D

ownl

oad

the

late

st v

ersi

on a

t era

.eur

opa.

eu.

© 2

021

EU A

genc

y fo

r Rai

lway

s. A

ll rig

hts

rese

rved

.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

534.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

1. T

he o

rgan

isat

ion’

s co

mpe

tenc

e m

anag

emen

t sy

stem

sha

ll en

sure

th

at s

taff

havi

ng a

role

th

at a

ffect

s sa

fety

are

co

mpe

tent

in th

e sa

fety

-re

late

d ta

sks

for w

hich

th

ey a

re re

spon

sibl

e (s

ee 2

.3. O

rgan

isat

iona

l ro

les,

resp

onsi

bilit

ies,

acco

unta

bilit

ies

and

auth

oriti

es),

incl

udin

g at

le

ast:

(e) p

erio

dic

asse

ssm

ent o

f co

mpe

tenc

e an

d ch

ecks

of

psyc

holo

gica

l and

phy

sica

l fit

ness

to e

nsur

e th

at

qual

ifica

tions

and

ski

lls a

re

mai

ntai

ned

over

tim

e;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

544.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

1. T

he o

rgan

isat

ion’

s co

mpe

tenc

e m

anag

emen

t sy

stem

sha

ll en

sure

th

at s

taff

havi

ng a

role

th

at a

ffect

s sa

fety

are

co

mpe

tent

in th

e sa

fety

-re

late

d ta

sks

for w

hich

th

ey a

re re

spon

sibl

e (s

ee 2

.3. O

rgan

isat

iona

l ro

les,

resp

onsi

bilit

ies,

acco

unta

bilit

ies

and

auth

oriti

es),

incl

udin

g at

le

ast:

(f) s

peci

fic tr

aini

ng in

rele

vant

pa

rts

of th

e sa

fety

man

agem

ent

syst

em in

ord

er to

del

iver

thei

r sa

fety

-rel

ated

task

s.

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

554.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

2. T

he o

rgan

isat

ion

shal

l pro

vide

a tr

aini

ng

prog

ram

me,

as

refe

rred

to

in p

oint

s (c

), (d

) and

(f) o

f pa

ragr

aph

4.2.

1, fo

r sta

ff pe

rfor

min

g sa

fety

-rel

ated

ta

sks

whi

ch e

nsur

es th

at:

(a) t

he tr

aini

ng p

rogr

amm

e is

del

iver

ed a

ccor

ding

to

the

iden

tified

com

pete

ncy

requ

irem

ents

and

indi

vidu

al

need

s of

the

staff

;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

564.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

2. T

he o

rgan

isat

ion

shal

l pro

vide

a tr

aini

ng

prog

ram

me,

as

refe

rred

to

in p

oint

s (c

), (d

) and

(f) o

f pa

ragr

aph

4.2.

1, fo

r sta

ff pe

rfor

min

g sa

fety

-rel

ated

ta

sks

whi

ch e

nsur

es th

at:

(b) w

here

app

licab

le, t

he tr

aini

ng

ensu

res

that

sta

ff ca

n op

erat

e un

der a

ll op

erat

ing

cond

ition

s (n

orm

al, d

egra

ded

and

emer

genc

y);

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

96

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

574.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

2. T

he o

rgan

isat

ion

shal

l pro

vide

a tr

aini

ng

prog

ram

me,

as

refe

rred

to

in p

oint

s (c

), (d

) and

(f) o

f pa

ragr

aph

4.2.

1, fo

r sta

ff pe

rfor

min

g sa

fety

-rel

ated

ta

sks

whi

ch e

nsur

es th

at:

(c) t

he d

urat

ion

of th

e tr

aini

ng

and

the

freq

uenc

y of

the

refr

eshe

r tra

inin

g ar

e ap

prop

riate

fo

r the

trai

ning

obj

ectiv

es;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

584.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

2. T

he o

rgan

isat

ion

shal

l pro

vide

a tr

aini

ng

prog

ram

me,

as

refe

rred

to

in p

oint

s (c

), (d

) and

(f) o

f pa

ragr

aph

4.2.

1, fo

r sta

ff pe

rfor

min

g sa

fety

-rel

ated

ta

sks

whi

ch e

nsur

es th

at:

(d) r

ecor

ds a

re k

ept f

or a

ll st

aff (s

ee 4

.5.3

. Con

trol

of

docu

men

ted

info

rmat

ion)

;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

594.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

2. T

he o

rgan

isat

ion

shal

l pro

vide

a tr

aini

ng

prog

ram

me,

as

refe

rred

to

in p

oint

s (c

), (d

) and

(f) o

f pa

ragr

aph

4.2.

1, fo

r sta

ff pe

rfor

min

g sa

fety

-rel

ated

ta

sks

whi

ch e

nsur

es th

at:

(e) t

he tr

aini

ng p

rogr

amm

e is

re

gula

rly re

view

ed a

nd a

udite

d (s

ee 6

.2. I

nter

nal a

uditi

ng) a

nd

chan

ges

mad

e w

hen

nece

ssar

y (s

ee 5

.4. M

anag

emen

t of

chan

ge).

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

604.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

3.

Back

to w

ork

arra

ngem

ents

sha

ll be

in

plac

e fo

r sta

ff fo

llow

ing

acci

dent

s/in

cide

nts

or

long

abs

ence

s fr

om w

ork,

in

clud

ing

prov

idin

g ad

ditio

nal t

rain

ing

whe

re

such

a n

eed

is id

entifi

ed.

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

97Ve

rsio

n 9.

0 (0

1/03

/202

1). U

ncon

trol

led

whe

n pr

inte

d. D

ownl

oad

the

late

st v

ersi

on a

t era

.eur

opa.

eu.

© 2

021

EU A

genc

y fo

r Rai

lway

s. A

ll rig

hts

rese

rved

.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

614.

SU

PPO

RT4.

3.

Awar

enes

s4.

3.1.

Top

man

agem

ent

shal

l ens

ure

that

they

and

th

eir s

taff

havi

ng a

role

that

aff

ects

saf

ety

are

awar

e of

th

e re

leva

nce,

impo

rtan

ce

and

cons

eque

nces

of

thei

r act

iviti

es a

nd h

ow

they

con

trib

ute

to th

e co

rrec

t app

licat

ion

and

the

effec

tiven

ess

of th

e sa

fety

m

anag

emen

t sys

tem

, in

clud

ing

the

achi

evem

ent

of s

afet

y ob

ject

ives

(see

3.

2. S

afet

y ob

ject

ives

and

pl

anni

ng).

I.1.(g

) (pa

rtia

lly

cove

red)

624.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

1. T

he o

rgan

isat

ion

shal

l defi

ne a

dequ

ate

com

mun

icat

ion

chan

nels

to

ens

ure

that

saf

ety-

rela

ted

info

rmat

ion

is

exch

ange

d am

ong

the

diffe

rent

leve

ls o

f the

or

gani

satio

n an

d w

ith

exte

rnal

inte

rest

ed p

artie

s in

clud

ing

cont

ract

ors,

part

ners

and

sup

plie

rs.

I.7 (i

n ge

nera

l), I.

9.6

(par

tially

cov

ered

), II.

5 (in

gen

eral

), III

.9, I

V.9,

A

rt. 5

(1),

Art

. 5(3

)

634.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

2. T

o en

sure

that

sa

fety

-rel

ated

info

rmat

ion

reac

hes

thos

e m

akin

g ju

dgem

ents

and

dec

isio

ns,

the

orga

nisa

tion

shal

l m

anag

e th

e id

entifi

catio

n,

rece

ipt,

proc

essi

ng,

gene

ratio

n an

d di

ssem

inat

ion

of s

afet

y-re

late

d in

form

atio

n.

I.7 (i

n ge

nera

l), I.

9.6

(par

tially

cov

ered

), II.

5 (in

gen

eral

), III

.9,

IV.9

, Art

. 4(2

), A

rt. 4

(3),

Art

. 4(6

)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

98

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

644.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l ens

ure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(a) r

elev

ant,

com

plet

e an

d un

ders

tand

able

for t

he in

tend

ed

user

s;

I.7 (i

n ge

nera

l)

654.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l ens

ure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(b) v

alid

;I.7

(in

gene

ral)

664.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l ens

ure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(c) a

ccur

ate;

I.7 (i

n ge

nera

l)

674.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l ens

ure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(d) c

onsi

sten

t;I.7

(in

gene

ral)

684.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l ens

ure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(e) c

ontr

olle

d (s

ee 4

.5.3

. Con

trol

of

doc

umen

ted

info

rmat

ion)

;I.7

(in

gene

ral)

694.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l ens

ure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(f) c

omm

unic

ated

bef

ore

it ta

kes

effec

t;I.7

(in

gene

ral)

704.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l ens

ure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(g) r

ecei

ved

and

unde

rsto

od.

I.7 (i

n ge

nera

l)

714.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

1. T

here

is a

des

crip

tion

of

the

safe

ty m

anag

emen

t sys

tem

in

clud

ing:

(a) t

he id

entifi

catio

n an

d de

scrip

tion

of th

e pr

oces

ses

and

activ

ities

rela

ted

to s

afet

y of

rail

oper

atio

ns, i

nclu

ding

sa

fety

-rel

ated

task

s an

d as

soci

ated

resp

onsi

bilit

ies

(see

2.3

. Org

anis

atio

nal r

oles

, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

);

I.8 (i

n ge

nera

l)

99Ve

rsio

n 9.

0 (0

1/03

/202

1). U

ncon

trol

led

whe

n pr

inte

d. D

ownl

oad

the

late

st v

ersi

on a

t era

.eur

opa.

eu.

© 2

021

EU A

genc

y fo

r Rai

lway

s. A

ll rig

hts

rese

rved

.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

724.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

1. T

here

is a

des

crip

tion

of

the

safe

ty m

anag

emen

t sys

tem

in

clud

ing:

(b) t

he in

tera

ctio

n of

thes

e pr

oces

ses;

I.8 (i

n ge

nera

l)

734.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

1. T

here

is a

des

crip

tion

of

the

safe

ty m

anag

emen

t sys

tem

in

clud

ing:

(c) t

he p

roce

dure

s or

oth

er

docu

men

ts d

escr

ibin

g ho

w th

ese

proc

esse

s ar

e im

plem

ente

d;

I.8 (i

n ge

nera

l)

744.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

1. T

here

is a

des

crip

tion

of

the

safe

ty m

anag

emen

t sys

tem

in

clud

ing:

(d) t

he id

entifi

catio

n of

co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

with

a d

escr

iptio

n of

th

e ty

pe a

nd e

xten

t of s

ervi

ces

deliv

ered

;

I.8 (i

n ge

nera

l), I.

9 (in

ge

nera

l)

754.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

1. T

here

is a

des

crip

tion

of

the

safe

ty m

anag

emen

t sys

tem

in

clud

ing:

(e) t

he id

entifi

catio

n of

co

ntra

ctua

l arr

ange

men

ts a

nd

othe

r bus

ines

s ag

reem

ents

, co

nclu

ded

betw

een

the

orga

nisa

tion

and

othe

r par

ties

iden

tified

und

er (d

), ne

cess

ary

to c

ontr

ol th

e sa

fety

risk

s of

the

orga

nisa

tion

and

thos

e re

late

d to

th

e us

e of

con

trac

tors

;

I.8 (i

n ge

nera

l), I.

9 (in

ge

nera

l)

764.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

1. T

here

is a

des

crip

tion

of

the

safe

ty m

anag

emen

t sys

tem

in

clud

ing:

(f) r

efer

ence

to d

ocum

ente

d in

form

atio

n re

quire

d by

this

Re

gula

tion.

I.8 (i

n ge

nera

l)

774.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

an

annu

al s

afet

y re

port

is s

ubm

itted

to th

e re

leva

nt n

atio

nal s

afet

y au

thor

ity

(or a

utho

ritie

s) in

acc

orda

nce

with

Art

icle

9(6

) of D

irect

ive

(EU

) 20

16/7

98, i

nclu

ding

:

(a) a

syn

thes

is o

f the

dec

isio

ns

on th

e le

vel o

f sig

nific

ance

of t

he

safe

ty-r

elat

ed c

hang

es, i

nclu

ding

an

ove

rvie

w o

f sig

nific

ant

chan

ges,

in a

ccor

danc

e w

ith

Art

icle

18(

1) o

f Reg

ulat

ion

(EU

) No

402/

2013

;

Ann

ex V

(ECM

M

aint

enan

ce R

epor

t)

(in g

ener

al),

Art

. 8(5

)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

100

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

784.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

an

annu

al s

afet

y re

port

is s

ubm

itted

to th

e re

leva

nt n

atio

nal s

afet

y au

thor

ity

(or a

utho

ritie

s) in

acc

orda

nce

with

Art

icle

9(6

) of D

irect

ive

(EU

) 20

16/7

98, i

nclu

ding

:

(b) t

he o

rgan

isat

ion’

s sa

fety

ob

ject

ives

for t

he fo

llow

ing

year

(s) a

nd h

ow s

erio

us ri

sks

for

safe

ty in

fluen

ce th

e se

ttin

g of

th

ese

safe

ty o

bjec

tives

;

Ann

ex V

(ECM

M

aint

enan

ce R

epor

t)

(in g

ener

al),

Art

. 8(5

)

794.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

an

annu

al s

afet

y re

port

is s

ubm

itted

to th

e re

leva

nt n

atio

nal s

afet

y au

thor

ity

(or a

utho

ritie

s) in

acc

orda

nce

with

Art

icle

9(6

) of D

irect

ive

(EU

) 20

16/7

98, i

nclu

ding

:

(c) t

he re

sults

of i

nter

nal a

ccid

ent/

inci

dent

inve

stig

atio

n (s

ee 7

.1.

Lear

ning

from

acc

iden

ts a

nd

inci

dent

s) a

nd o

ther

mon

itorin

g ac

tiviti

es (s

ee 6

.1. M

onito

ring,

6.

2. In

tern

al a

uditi

ng a

nd

6.3.

Man

agem

ent r

evie

w),

in

acco

rdan

ce w

ith A

rtic

le 5

(1) o

f Re

gula

tion

(EU

) No

1078

/201

2;

Ann

ex V

(ECM

M

aint

enan

ce R

epor

t)

(in g

ener

al),

Art

. 8(5

)

804.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

an

annu

al s

afet

y re

port

is s

ubm

itted

to th

e re

leva

nt n

atio

nal s

afet

y au

thor

ity

(or a

utho

ritie

s) in

acc

orda

nce

with

Art

icle

9(6

) of D

irect

ive

(EU

) 20

16/7

98, i

nclu

ding

:

(d) d

etai

ls o

f pro

gres

s on

ad

dres

sing

out

stan

ding

re

com

men

datio

ns fr

om th

e na

tiona

l inv

estig

atio

n bo

dies

(s

ee 7

.1. L

earn

ing

from

acc

iden

ts

and

inci

dent

s);

Ann

ex V

(ECM

M

aint

enan

ce R

epor

t)

(in g

ener

al),

Art

. 8(5

)

814.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

an

annu

al s

afet

y re

port

is s

ubm

itted

to th

e re

leva

nt n

atio

nal s

afet

y au

thor

ity

(or a

utho

ritie

s) in

acc

orda

nce

with

Art

icle

9(6

) of D

irect

ive

(EU

) 20

16/7

98, i

nclu

ding

:

(e) t

he o

rgan

isat

ion’

s sa

fety

in

dica

tors

set

out

to e

valu

ate

the

orga

nisa

tion’

s sa

fety

per

form

ance

(s

ee 6

.1. M

onito

ring)

;

Ann

ex V

(ECM

M

aint

enan

ce R

epor

t)

(in g

ener

al),

Art

. 8(5

)

101

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

824.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

an

annu

al s

afet

y re

port

is s

ubm

itted

to th

e re

leva

nt n

atio

nal s

afet

y au

thor

ity

(or a

utho

ritie

s) in

acc

orda

nce

with

Art

icle

9(6

) of D

irect

ive

(EU

) 20

16/7

98, i

nclu

ding

:

(f) w

here

app

licab

le, t

he

conc

lusi

ons

of th

e an

nual

repo

rt

of th

e sa

fety

adv

isor

, as

refe

rred

to

in R

ID (1

), on

the

activ

ities

of

the

orga

nisa

tion

rela

ting

to th

e tr

ansp

ort o

f dan

gero

us g

oods

(2).

Ann

ex V

(ECM

M

aint

enan

ce R

epor

t)

(in g

ener

al),

Art

. 8(5

)

834.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

2.

Crea

ting

and

upda

ting

4.5.

2.1.

The

org

anis

atio

n sh

all

ensu

re th

at w

hen

crea

ting

and

upda

ting

docu

men

ted

info

rmat

ion

rela

ted

to th

e sa

fety

m

anag

emen

t sys

tem

ade

quat

e fo

rmat

s an

d m

edia

are

use

d.

I.8 (i

n ge

nera

l)

844.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

3.

Cont

rol o

f do

cum

ente

d in

form

atio

n4.

5.3.

1. T

he o

rgan

isat

ion

shal

l con

trol

doc

umen

ted

info

rmat

ion

rela

ted

to th

e sa

fety

man

agem

ent s

yste

m, i

n pa

rtic

ular

its

stor

age,

dis

trib

utio

n an

d th

e co

ntro

l of c

hang

es,

to e

nsur

e its

ava

ilabi

lity,

su

itabi

lity

and

prot

ectio

n w

here

ap

prop

riate

.

I.8 (i

n ge

nera

l), I.

9 (in

ge

nera

l), II

.7, I

II.10

, IV

.10

854.

SU

PPO

RT4.

6.

Inte

grat

ion

of h

uman

and

or

gani

satio

nal

fact

ors

4.6.

1. T

he o

rgan

isat

ion

shal

l dem

onst

rate

a

syst

emat

ic a

ppro

ach

to in

tegr

atin

g hu

man

an

d or

gani

satio

nal

fact

ors

with

in th

e sa

fety

m

anag

emen

t sys

tem

. Thi

s ap

proa

ch s

hall:

(a) i

nclu

de th

e de

velo

pmen

t of

a s

trat

egy

and

the

use

of

expe

rtis

e an

d re

cogn

ised

m

etho

ds fr

om th

e fie

ld o

f hum

an

and

orga

nisa

tiona

l fac

tors

;

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

102

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

864.

SU

PPO

RT4.

6.

Inte

grat

ion

of h

uman

and

or

gani

satio

nal

fact

ors

4.6.

1. T

he o

rgan

isat

ion

shal

l dem

onst

rate

a

syst

emat

ic a

ppro

ach

to in

tegr

atin

g hu

man

an

d or

gani

satio

nal

fact

ors

with

in th

e sa

fety

m

anag

emen

t sys

tem

. Thi

s ap

proa

ch s

hall:

(b) a

ddre

ss ri

sks

asso

ciat

ed w

ith

the

desi

gn a

nd u

se o

f equ

ipm

ent,

task

s, w

orki

ng c

ondi

tions

and

or

gani

satio

nal a

rran

gem

ents

, ta

king

into

acc

ount

hum

an

capa

bilit

ies

as w

ell a

s lim

itatio

ns,

and

the

influ

ence

s on

hum

an

perf

orm

ance

.

I.2.3

(in

gene

ral),

II.3

(in

gen

eral

), IV

.3, I

V.4,

IV

.5

875.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

1. W

hen

plan

ning

, de

velo

ping

, im

plem

entin

g an

d re

view

ing

its

oper

atio

nal p

roce

sses

, the

or

gani

satio

n sh

all e

nsur

e th

at d

urin

g op

erat

ion:

(a) r

isk

acce

ptan

ce c

riter

ia a

nd

safe

ty m

easu

res

are

appl

ied

(see

3.

1.1.

Ris

k as

sess

men

t);

I.3 a

nd I.

9.6

(in

gene

ral)

885.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

1. W

hen

plan

ning

, de

velo

ping

, im

plem

entin

g an

d re

view

ing

its

oper

atio

nal p

roce

sses

, the

or

gani

satio

n sh

all e

nsur

e th

at d

urin

g op

erat

ion:

(b) p

lan(

s) to

ach

ieve

the

safe

ty

obje

ctiv

es a

re d

eliv

ered

(see

3.2

. Sa

fety

obj

ectiv

es a

nd p

lann

ing)

;

I.1.(d

), I.3

, I.9

.3

895.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

1. W

hen

plan

ning

, de

velo

ping

, im

plem

entin

g an

d re

view

ing

its

oper

atio

nal p

roce

sses

, the

or

gani

satio

n sh

all e

nsur

e th

at d

urin

g op

erat

ion:

(c) i

nfor

mat

ion

is c

olle

cted

to

mea

sure

the

corr

ect a

pplic

atio

n an

d eff

ectiv

enes

s of

the

oper

atio

nal a

rran

gem

ents

(see

6.

1. M

onito

ring)

.

I.3 (i

n ge

nera

l), I.

9.6

(in g

ener

al),

I.9.5

(in

gen

eral

), I.7

(in

gene

ral)

103

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

905.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

2. T

he o

rgan

isat

ion

shal

l ens

ure

that

its

oper

atio

nal a

rran

gem

ents

co

nfor

m to

the

safe

ty-

rela

ted

requ

irem

ents

of

app

licab

le Te

chni

cal

Spec

ifica

tions

for

Inte

rope

rabi

lity

and

rele

vant

nat

iona

l ru

les

and

any

othe

r re

leva

nt re

quire

men

ts

(see

1. C

onte

xt o

f the

or

gani

satio

n).

II.2,

Art

. 4(1

)

915.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

3. T

o co

ntro

l ris

ks

whe

re re

leva

nt fo

r the

sa

fety

of o

pera

tiona

l ac

tiviti

es (s

ee 3

.1.1

. Ris

k as

sess

men

t), a

t lea

st th

e fo

llow

ing

shal

l be

take

n in

to a

ccou

nt:

(a) i

dent

ifica

tion

of th

e sa

fe

boun

darie

s of

tran

spor

t for

traffi

c pl

anni

ng a

nd c

ontr

ol b

ased

on

the

desi

gn c

hara

cter

istic

s of

the

infr

astr

uctu

re;

925.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

3. T

o co

ntro

l ris

ks

whe

re re

leva

nt fo

r the

sa

fety

of o

pera

tiona

l ac

tiviti

es (s

ee 3

.1.1

. Ris

k as

sess

men

t), a

t lea

st th

e fo

llow

ing

shal

l be

take

n in

to a

ccou

nt:

(b) t

raffi

c pl

anni

ng, i

nclu

ding

tim

etab

le a

nd tr

ain

path

al

loca

tion;

935.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

3. T

o co

ntro

l ris

ks

whe

re re

leva

nt fo

r the

sa

fety

of o

pera

tiona

l ac

tiviti

es (s

ee 3

.1.1

. Ris

k as

sess

men

t), a

t lea

st th

e fo

llow

ing

shal

l be

take

n in

to a

ccou

nt:

(c) r

eal-t

ime

traffi

c m

anag

emen

t in

nor

mal

mod

e an

d in

deg

rade

d m

odes

with

the

appl

icat

ion

of

traffi

c re

stric

tions

of u

se a

nd

the

man

agem

ent o

f tra

ffic

disr

uptio

ns;

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

104

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

945.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

3. T

o co

ntro

l ris

ks

whe

re re

leva

nt fo

r the

sa

fety

of o

pera

tiona

l ac

tiviti

es (s

ee 3

.1.1

. Ris

k as

sess

men

t), a

t lea

st th

e fo

llow

ing

shal

l be

take

n in

to a

ccou

nt:

(d) s

ettin

g of

con

ditio

ns

for r

unni

ng e

xcep

tiona

l co

nsig

nmen

ts.

955.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

4. T

o co

ntro

l th

e al

loca

tion

of

resp

onsi

bilit

ies

whe

re

rele

vant

for t

he s

afet

y of

ope

ratio

nal a

ctiv

ities

, th

e or

gani

satio

n sh

all

iden

tify

resp

onsi

bilit

ies

for

plan

ning

and

ope

ratin

g th

e ra

il ne

twor

k an

d de

fine

how

rele

vant

task

s aff

ectin

g th

e sa

fe d

eliv

ery

of a

ll se

rvic

es a

re a

lloca

ted

to c

ompe

tent

sta

ff w

ithin

the

orga

nisa

tion

(see

2.3

. Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

) and

to o

ther

ex

tern

al q

ualifi

ed p

artie

s w

hen

appr

opria

te (s

ee 5

.3.

Cont

ract

ors,

part

ners

and

su

pplie

rs).

I.9.1

and

I.9.

2 (in

ge

nera

l)

105

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

965.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

5. T

o co

ntro

l in

form

atio

n an

d co

mm

unic

atio

n w

here

re

leva

nt fo

r the

saf

ety

of o

pera

tiona

l act

iviti

es

(see

4.4

. Inf

orm

atio

n an

d co

mm

unic

atio

n), r

elev

ant

staff

(e.g

. sig

nalle

rs) s

hall

be in

form

ed a

bout

spe

cific

ro

utin

g re

quire

men

ts fo

r tr

ains

and

mov

emen

ts o

f ve

hicl

es in

clud

ing

rele

vant

ch

ange

s w

hich

may

resu

lt in

a h

azar

d, te

mpo

rary

or

perm

anen

t ope

ratio

nal

rest

rictio

ns (e

.g. d

ue to

tr

ack

mai

nten

ance

) and

co

nditi

ons

for e

xcep

tiona

l co

nsig

nmen

ts w

here

ap

plic

able

.

I.7, I

I.5, I

II.6,

III.9

, III.

10,

IV.9

, Art

. 4(2

), A

rt. 4

(6)

975.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

6. T

o co

ntro

l co

mpe

tenc

e w

here

re

leva

nt fo

r the

saf

ety

of

oper

atio

nal a

ctiv

ities

(see

4.

2. C

ompe

tenc

e), t

he

orga

nisa

tion

shal

l ens

ure,

in

acco

rdan

ce w

ith a

pplic

able

le

gisl

atio

n (s

ee 1

. Con

text

of

the

orga

nisa

tion)

, for

its

staff

:

(a) c

ompl

ianc

e w

ith th

eir t

rain

ing

and

wor

k in

stru

ctio

ns, a

nd

corr

ectiv

e ac

tions

are

take

n w

here

requ

ired;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

106

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

985.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

6. T

o co

ntro

l co

mpe

tenc

e w

here

re

leva

nt fo

r the

saf

ety

of

oper

atio

nal a

ctiv

ities

(see

4.

2. C

ompe

tenc

e), t

he

orga

nisa

tion

shal

l ens

ure,

in

acco

rdan

ce w

ith a

pplic

able

le

gisl

atio

n (s

ee 1

. Con

text

of

the

orga

nisa

tion)

, for

its

staff

:

(b) s

peci

fic tr

aini

ng in

cas

e of

an

ticip

ated

cha

nges

affe

ctin

g th

e ru

nnin

g of

ope

ratio

ns o

r the

ir ta

sk a

ssig

nmen

t;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

995.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

6. T

o co

ntro

l co

mpe

tenc

e w

here

re

leva

nt fo

r the

saf

ety

of

oper

atio

nal a

ctiv

ities

(see

4.

2. C

ompe

tenc

e), t

he

orga

nisa

tion

shal

l ens

ure,

in

acco

rdan

ce w

ith a

pplic

able

le

gisl

atio

n (s

ee 1

. Con

text

of

the

orga

nisa

tion)

, for

its

staff

:

(c) a

dopt

ion

of a

dequ

ate

mea

sure

s fo

llow

ing

acci

dent

s an

d in

cide

nts.

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

100

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.1.

The

org

anis

atio

n sh

all m

anag

e th

e sa

fety

ris

ks a

ssoc

iate

d w

ith

phys

ical

ass

ets

thro

ugho

ut

thei

r life

cycl

e (s

ee 3

.1.1

. Ri

sk a

sses

smen

t), f

rom

de

sign

to d

ispo

sal,

and

fulfi

l the

hum

an fa

ctor

s re

quire

men

ts in

all

phas

es

of th

e lif

e cy

cle.

I.2 (i

n ge

nera

l)

107

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

101

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.2.

The

org

anis

atio

n sh

all:

(a) e

nsur

e th

at th

e as

sets

are

us

ed fo

r the

pur

pose

inte

nded

w

hile

mai

ntai

ning

thei

r saf

e op

erat

iona

l sta

te a

nd th

eir

expe

cted

leve

l of p

erfo

rman

ce;

102

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.2.

The

org

anis

atio

n sh

all:

(b) m

anag

e th

e as

sets

in n

orm

al

and

degr

aded

ope

ratio

ns;

103

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.2.

The

org

anis

atio

n sh

all:

(c) d

etec

t as

soon

as

reas

onab

ly

prac

ticab

le in

stan

ces

of n

on-

com

plia

nce

with

ope

ratin

g re

quire

men

ts b

efor

e or

dur

ing

the

oper

atio

n of

the

asse

t, in

clud

ing

the

appl

icat

ion

of

rest

rictio

ns o

f use

as

appr

opria

te

to e

nsur

e a

safe

ope

ratio

nal s

tate

of

the

asse

t (se

e 6.

1. M

onito

ring)

.

III.6

, III.

9, II

I.10

104

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.3.

The

org

anis

atio

n sh

all e

nsur

e th

at it

s as

set m

anag

emen

t ar

rang

emen

ts, w

here

ap

plic

able

, con

form

to a

ll es

sent

ial r

equi

rem

ents

as

set

out

in th

e re

leva

nt

Tech

nica

l Spe

cific

atio

ns

for I

nter

oper

abili

ty

and

any

othe

r rel

evan

t re

quire

men

ts (s

ee

1. C

onte

xt o

f the

or

gani

satio

n).

II. 2

(in

gene

ral),

Art

. 4(

1)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

108

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

105

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.4.

To

cont

rol r

isks

w

here

rele

vant

for t

he

supp

ly o

f mai

nten

ance

(see

3.

1.1.

Ris

k as

sess

men

t), a

t le

ast t

he fo

llow

ing

shal

l be

take

n in

to a

ccou

nt:

(a) t

he id

entifi

catio

n of

the

need

for m

aint

enan

ce to

kee

p th

e in

fras

truc

ture

in a

saf

e op

erat

iona

l sta

te, b

ased

on

the

plan

ned

and

real

use

of t

he

infr

astr

uctu

re a

nd it

s de

sign

ch

arac

teris

tics;

III.4

106

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.4.

To

cont

rol r

isks

w

here

rele

vant

for t

he

supp

ly o

f mai

nten

ance

(see

3.

1.1.

Ris

k as

sess

men

t), a

t le

ast t

he fo

llow

ing

shal

l be

take

n in

to a

ccou

nt:

(b) t

he m

anag

emen

t of t

he

rem

oval

of t

he a

sset

from

op

erat

ion

for m

aint

enan

ce, w

hen

defe

cts

have

bee

n id

entifi

ed o

r w

hen

asse

t con

ditio

n de

grad

es

outs

ide

the

limits

of a

saf

e op

erat

iona

l sta

te a

s re

ferr

ed to

in

poin

t (a)

;

III.4

, Art

. 4(2

), A

rt. 4

(4)

107

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.4.

To

cont

rol r

isks

w

here

rele

vant

for t

he

supp

ly o

f mai

nten

ance

(see

3.

1.1.

Ris

k as

sess

men

t), a

t le

ast t

he fo

llow

ing

shal

l be

take

n in

to a

ccou

nt:

(c) t

he m

anag

emen

t of t

he

retu

rn to

ope

ratio

n of

the

asse

t w

ith e

vent

ual r

estr

ictio

ns o

f use

af

ter m

aint

enan

ce h

as b

een

deliv

ered

to e

nsur

e it

is in

a s

afe

oper

atio

nal s

tate

;

III.4

108

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.4.

To

cont

rol r

isks

w

here

rele

vant

for t

he

supp

ly o

f mai

nten

ance

(see

3.

1.1.

Ris

k as

sess

men

t), a

t le

ast t

he fo

llow

ing

shal

l be

take

n in

to a

ccou

nt:

(d) t

he m

anag

emen

t of

mon

itorin

g an

d m

easu

rem

ent

equi

pmen

t to

ensu

re th

at it

is fi

t fo

r its

inte

nded

pur

pose

.

II.3

(in g

ener

al),

III.6

, III

.9, I

II.10

, IV.

3, IV

.4,

IV.5

109

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

109

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.5.

To

cont

rol

info

rmat

ion

and

com

mun

icat

ion

whe

re

rele

vant

for t

he s

afe

man

agem

ent o

f ass

ets

(see

4.4

. Inf

orm

atio

n an

d co

mm

unic

atio

n), t

he

orga

nisa

tion

shal

l tak

e in

to

acco

unt:

(a) t

he e

xcha

nge

of re

leva

nt

info

rmat

ion

with

in th

e or

gani

satio

n or

with

ext

erna

l en

titie

s re

spon

sibl

e fo

r m

aint

enan

ce (s

ee 5

.3.

Cont

ract

ors,

part

ners

and

su

pplie

rs),

in p

artic

ular

on

safe

ty-

rela

ted

mal

func

tions

, acc

iden

ts,

inci

dent

s as

wel

l as

on e

vent

ual

rest

rictio

ns o

f use

of t

he a

sset

;

I.7 (i

n ge

nera

l), I.

9.6,

II.

5, II

I.6, I

II.9,

III.1

0,

IV.9

, Art

. 4(2

), A

rt. 4

(6),

Art

. 5(1

), A

rt. 5

(2),

Art

. 5(3

)

110

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.5.

To

cont

rol

info

rmat

ion

and

com

mun

icat

ion

whe

re

rele

vant

for t

he s

afe

man

agem

ent o

f ass

ets

(see

4.4

. Inf

orm

atio

n an

d co

mm

unic

atio

n), t

he

orga

nisa

tion

shal

l tak

e in

to

acco

unt:

(b) t

he tr

acea

bilit

y of

all

nece

ssar

y in

form

atio

n in

clud

ing

the

info

rmat

ion

rela

ted

to

poin

t (a)

(see

4.4

. Inf

orm

atio

n an

d co

mm

unic

atio

n an

d 4.

5.3.

Con

trol

of d

ocum

ente

d in

form

atio

n);

I.7 (i

n ge

nera

l), I.

8,

I.9.6

, II.5

(in

gene

ral),

II.

7, II

I.4 (i

n ge

nera

l),

III.9

, IV.

9, A

rt. 4

(5)b

111

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.5.

To

cont

rol

info

rmat

ion

and

com

mun

icat

ion

whe

re

rele

vant

for t

he s

afe

man

agem

ent o

f ass

ets

(see

4.4

. Inf

orm

atio

n an

d co

mm

unic

atio

n), t

he

orga

nisa

tion

shal

l tak

e in

to

acco

unt:

(c) t

he e

stab

lishm

ent a

nd

mai

nten

ance

of r

ecor

ds in

clud

ing

the

man

agem

ent o

f cha

nges

aff

ectin

g th

e sa

fety

of a

sset

s (s

ee

5.4.

Man

agem

ent o

f cha

nge)

.

I.7, I

.8, I

I.2 (i

n ge

nera

l),

II.5

(in g

ener

al),

II.7,

III

.10,

IV.1

0, A

rt. 4

(5)b

112

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

1. T

he o

rgan

isat

ion

shal

l ide

ntify

and

con

trol

sa

fety

risk

s ar

isin

g fr

om

outs

ourc

ed a

ctiv

ities

, in

clud

ing

oper

atio

ns

or c

oope

ratio

n w

ith

cont

ract

ors,

part

ners

and

su

pplie

rs.

I.9.1

, Art

. 9(2

)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

110

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

113

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

2. T

o co

ntro

l the

sa

fety

risk

s re

ferr

ed to

in

par

agra

ph 5

.3.1

, the

or

gani

satio

n sh

all d

efine

th

e cr

iteria

for t

he s

elec

tion

of th

e co

ntra

ctor

s, pa

rtne

rs

and

supp

liers

and

the

cont

ract

requ

irem

ents

they

ha

ve to

mee

t, in

clud

ing:

(a) t

he le

gal a

nd o

ther

re

quire

men

ts re

late

d to

sa

fety

(see

1. C

onte

xt o

f the

or

gani

satio

n);

I.9 (i

n ge

nera

l)

114

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

2. T

o co

ntro

l the

sa

fety

risk

s re

ferr

ed to

in

par

agra

ph 5

.3.1

, the

or

gani

satio

n sh

all d

efine

th

e cr

iteria

for t

he s

elec

tion

of th

e co

ntra

ctor

s, pa

rtne

rs

and

supp

liers

and

the

cont

ract

requ

irem

ents

they

ha

ve to

mee

t, in

clud

ing:

(b) t

he le

vel o

f com

pete

nce

requ

ired

to d

eliv

er th

e ta

sks

set o

ut in

the

cont

ract

(see

4.2

. Co

mpe

tenc

e);

I.9.2

115

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

2. T

o co

ntro

l the

sa

fety

risk

s re

ferr

ed to

in

par

agra

ph 5

.3.1

, the

or

gani

satio

n sh

all d

efine

th

e cr

iteria

for t

he s

elec

tion

of th

e co

ntra

ctor

s, pa

rtne

rs

and

supp

liers

and

the

cont

ract

requ

irem

ents

they

ha

ve to

mee

t, in

clud

ing:

(c) t

he re

spon

sibi

litie

s fo

r the

ta

sks

to b

e pe

rfor

med

;I.9

.6

111

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

116

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

2. T

o co

ntro

l the

sa

fety

risk

s re

ferr

ed to

in

par

agra

ph 5

.3.1

, the

or

gani

satio

n sh

all d

efine

th

e cr

iteria

for t

he s

elec

tion

of th

e co

ntra

ctor

s, pa

rtne

rs

and

supp

liers

and

the

cont

ract

requ

irem

ents

they

ha

ve to

mee

t, in

clud

ing:

(d) t

he e

xpec

ted

safe

ty

perf

orm

ance

to b

e m

aint

aine

d du

ring

the

cont

ract

;

I.9.3

, Art

. 9(3

)

117

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

2. T

o co

ntro

l the

sa

fety

risk

s re

ferr

ed to

in

par

agra

ph 5

.3.1

, the

or

gani

satio

n sh

all d

efine

th

e cr

iteria

for t

he s

elec

tion

of th

e co

ntra

ctor

s, pa

rtne

rs

and

supp

liers

and

the

cont

ract

requ

irem

ents

they

ha

ve to

mee

t, in

clud

ing:

(e) t

he o

blig

atio

ns re

latin

g to

th

e ex

chan

ge o

f saf

ety-

rela

ted

info

rmat

ion

(see

4.4

. Inf

orm

atio

n an

d co

mm

unic

atio

n);

I.9.6

118

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

2. T

o co

ntro

l the

sa

fety

risk

s re

ferr

ed to

in

par

agra

ph 5

.3.1

, the

or

gani

satio

n sh

all d

efine

th

e cr

iteria

for t

he s

elec

tion

of th

e co

ntra

ctor

s, pa

rtne

rs

and

supp

liers

and

the

cont

ract

requ

irem

ents

they

ha

ve to

mee

t, in

clud

ing:

(f) t

he tr

acea

bilit

y of

saf

ety-

rela

ted

docu

men

ts (s

ee 4

.5.

Doc

umen

ted

info

rmat

ion)

.

I.9.6

119

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

3.

In a

ccor

danc

e w

ith th

e pr

oces

s se

t out

in

Art

icle

3 o

f Reg

ulat

ion

(EU

) No

1078

/201

2, th

e or

gani

satio

n sh

all m

onito

r:

(a) t

he s

afet

y pe

rfor

man

ce o

f al

l act

iviti

es a

nd o

pera

tions

of

con

trac

tors

, par

tner

s an

d su

pplie

rs to

ens

ure

that

they

co

mpl

y w

ith th

e re

quire

men

ts

set o

ut in

the

cont

ract

;

I.9.5

, Art

. 4(4

), A

rt. 9

(3)

120

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

3.

In a

ccor

danc

e w

ith th

e pr

oces

s se

t out

in

Art

icle

3 o

f Reg

ulat

ion

(EU

) No

1078

/201

2, th

e or

gani

satio

n sh

all m

onito

r:

(b) t

he a

war

enes

s of

con

trac

tors

, pa

rtne

rs a

nd s

uppl

iers

of

safe

ty ri

sks

they

ent

ail t

o th

e or

gani

satio

n’s

oper

atio

ns.

I.9.2

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

112

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

121

5.

OPE

RATI

ON

5.4.

M

anag

emen

t of

cha

nge

5.4.

1. T

he o

rgan

isat

ion

shal

l im

plem

ent a

nd

cont

rol c

hang

es to

the

safe

ty m

anag

emen

t sys

tem

to

mai

ntai

n or

impr

ove

the

safe

ty p

erfo

rman

ce. T

his

shal

l inc

lude

dec

isio

ns a

t th

e di

ffere

nt s

tage

s of

the

chan

ge m

anag

emen

t and

th

e su

bseq

uent

revi

ew o

f sa

fety

risk

s (s

ee 3

.1.1

. Ris

k as

sess

men

t).

122

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

1. T

he o

rgan

isat

ion

shal

l ide

ntify

the

emer

genc

y si

tuat

ions

an

d as

soci

ated

tim

ely

mea

sure

s to

be

take

n to

m

anag

e th

em (s

ee 3

.1.1

. Ri

sk a

sses

smen

t) a

nd to

re-

esta

blis

h no

rmal

ope

ratin

g co

nditi

ons

in a

ccor

danc

e w

ith R

egul

atio

n (E

U)

2015

/995

.

123

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

2. T

he o

rgan

isat

ion

shal

l ens

ure

that

, for

ea

ch id

entifi

ed ty

pe o

f em

erge

ncy:

(a) t

he e

mer

genc

y se

rvic

es c

an

be p

rom

ptly

con

tact

ed;

124

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

2. T

he o

rgan

isat

ion

shal

l ens

ure

that

, for

ea

ch id

entifi

ed ty

pe o

f em

erge

ncy:

(b) t

he e

mer

genc

y se

rvic

es

are

prov

ided

with

all

rele

vant

in

form

atio

n bo

th in

adv

ance

, to

pre

pare

thei

r em

erge

ncy

resp

onse

, and

at t

he ti

me

of a

n em

erge

ncy;

I.7.(j

)

113

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

125

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

2. T

he o

rgan

isat

ion

shal

l ens

ure

that

, for

ea

ch id

entifi

ed ty

pe o

f em

erge

ncy:

(c) fi

rst a

id is

pro

vide

d in

tern

ally

.

126

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

3. T

he o

rgan

isat

ion

shal

l ide

ntify

and

do

cum

ent t

he ro

les

and

resp

onsi

bilit

ies

of a

ll pa

rtie

s in

acc

orda

nce

with

Re

gula

tion

(EU

) 201

5/99

5.

127

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

4. T

he o

rgan

isat

ion

shal

l hav

e pl

ans

for a

ctio

n,

aler

ts a

nd in

form

atio

n in

cas

e of

em

erge

ncy,

in

clud

ing

arra

ngem

ents

to:

(a) a

lert

all

staff

with

re

spon

sibi

lity

for e

mer

genc

y m

anag

emen

t;

128

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

4. T

he o

rgan

isat

ion

shal

l hav

e pl

ans

for a

ctio

n,

aler

ts a

nd in

form

atio

n in

cas

e of

em

erge

ncy,

in

clud

ing

arra

ngem

ents

to:

(b) c

omm

unic

ate

info

rmat

ion

to a

ll pa

rtie

s (e

.g. r

ailw

ay

unde

rtak

ings

, con

trac

tors

, au

thor

ities

, em

erge

ncy

serv

ices

), in

clud

ing

emer

genc

y in

stru

ctio

ns fo

r pas

seng

ers;

I.7 (i

n ge

nera

l)

129

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

4. T

he o

rgan

isat

ion

shal

l hav

e pl

ans

for a

ctio

n,

aler

ts a

nd in

form

atio

n in

cas

e of

em

erge

ncy,

in

clud

ing

arra

ngem

ents

to:

(c) t

ake

any

deci

sion

s re

quire

d in

acc

orda

nce

with

the

type

of

emer

genc

y.

130

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

5. T

he o

rgan

isat

ion

shal

l des

crib

e ho

w

reso

urce

s an

d m

eans

for

emer

genc

y m

anag

emen

t ha

ve b

een

allo

cate

d (s

ee 4

.1. R

esou

rces

) and

ho

w tr

aini

ng re

quire

men

ts

have

bee

n id

entifi

ed (s

ee

4.2.

Com

pete

nce)

.

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

114

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

131

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

6. T

he e

mer

genc

y ar

rang

emen

ts a

re re

gula

rly

test

ed in

coo

pera

tion

with

ot

her i

nter

este

d pa

rtie

s and

up

date

d w

hen

appr

opria

te.

132

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

7. T

he o

rgan

isat

ion

shal

l coo

rdin

ate

emer

genc

y pl

ans

with

all

railw

ay

unde

rtak

ings

that

ope

rate

on

the

orga

nisa

tion’

s in

fras

truc

ture

, with

the

emer

genc

y se

rvic

es, s

o as

to fa

cilit

ate

thei

r rap

id

inte

rven

tion,

and

with

any

ot

her p

arty

that

cou

ld b

e in

volv

ed in

an

emer

genc

y si

tuat

ion.

133

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

8. T

he o

rgan

isat

ion

shal

l hav

e ar

rang

emen

ts

to h

alt o

pera

tions

and

ra

ilway

traffi

c pr

ompt

ly, i

f ne

cess

ary,

and

to in

form

al

l int

eres

ted

part

ies

of th

e ac

tion

take

n.

I.7 (i

n ge

nera

l)

134

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

9.

For c

ross

-bor

der

infr

astr

uctu

re, t

he

coop

erat

ion

betw

een

the

rele

vant

infr

astr

uctu

re

man

ager

s sh

all f

acili

tate

th

e ne

cess

ary

coor

dina

tion

and

prep

ared

ness

of t

he

com

pete

nt e

mer

genc

y se

rvic

es o

n bo

th s

ides

of

the

bord

er.

115

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ion

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. Unc

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d w

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ted.

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nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

135

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.1.

M

onito

ring

6.1.

1. T

he o

rgan

isat

ion

shal

l per

form

mon

itorin

g in

ac

cord

ance

with

Reg

ulat

ion

(EU

) No

1078

/201

2:

(a) t

o ch

eck

the

corr

ect

appl

icat

ion

and

the

effec

tiven

ess

of a

ll th

e pr

oces

ses

and

proc

edur

es in

the

safe

ty

man

agem

ent s

yste

m, i

nclu

ding

th

e op

erat

iona

l, or

gani

satio

nal

and

tech

nica

l saf

ety

mea

sure

s;

I.3 (i

n ge

nera

l), A

rt.

4(4)

, Art

. 7(1

), A

rt. 9

(3)

136

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.1.

M

onito

ring

6.1.

1. T

he o

rgan

isat

ion

shal

l per

form

mon

itorin

g in

ac

cord

ance

with

Reg

ulat

ion

(EU

) No

1078

/201

2:

(b) t

o ch

eck

the

corr

ect

appl

icat

ion

of th

e sa

fety

m

anag

emen

t sys

tem

as

a w

hole

, an

d if

it ac

hiev

es th

e ex

pect

ed

outc

omes

;

I.3 (i

n ge

nera

l), A

rt.

4(4)

, Art

. 7(1

), A

rt. 9

(3)

137

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.1.

M

onito

ring

6.1.

1. T

he o

rgan

isat

ion

shal

l per

form

mon

itorin

g in

ac

cord

ance

with

Reg

ulat

ion

(EU

) No

1078

/201

2:

(c) t

o in

vest

igat

e w

heth

er th

e sa

fety

man

agem

ent s

yste

m

conf

orm

s to

the

requ

irem

ents

in

this

Reg

ulat

ion;

I.3 (i

n ge

nera

l), A

rt.

4(4)

, Art

. 7(1

), A

rt. 9

(3)

138

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.1.

M

onito

ring

6.1.

1. T

he o

rgan

isat

ion

shal

l per

form

mon

itorin

g in

ac

cord

ance

with

Reg

ulat

ion

(EU

) No

1078

/201

2:

(d) t

o id

entif

y, im

plem

ent a

nd

eval

uate

the

effec

tiven

ess

of

the

corr

ectiv

e m

easu

res

(see

7.

2. C

ontin

ual i

mpr

ovem

ent)

, as

app

ropr

iate

, if a

ny re

leva

nt

inst

ance

of n

on-c

ompl

ianc

e to

po

ints

(a),

(b) a

nd (c

) is

dete

cted

.

I.3 a

nd I.

4 (in

gen

eral

), A

rt. 4

(4),

Art

. 7(1

), A

rt. 9

(3)

139

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.1.

M

onito

ring

6.1.

2. T

he o

rgan

isat

ion

shal

l reg

ular

ly m

onito

r at

all

leve

ls w

ithin

th

e or

gani

satio

n th

e pe

rfor

man

ce o

f saf

ety-

rela

ted

task

s an

d in

terv

ene

if th

ese

task

s ar

e no

t bei

ng

prop

erly

per

form

ed.

I.3 a

nd I.

4 (in

gen

eral

), A

rt. 4

(4),

Art

. 7(1

), A

rt. 9

(3)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

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ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

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nloa

d th

e la

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ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

116

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

140

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l con

duct

inte

rnal

au

dits

in a

n in

depe

nden

t, im

part

ial a

nd tr

ansp

aren

t w

ay to

col

lect

and

ana

lyse

in

form

atio

n fo

r the

pu

rpos

es o

f its

mon

itorin

g ac

tiviti

es (s

ee 6

.1.

Mon

itorin

g), i

nclu

ding

:

(a) A

sch

edul

e of

pla

nned

in

tern

al a

udits

whi

ch c

an b

e re

vise

d de

pend

ing

on th

e re

sults

of p

revi

ous

audi

ts a

nd

mon

itorin

g of

per

form

ance

;

I.3 (i

n ge

nera

l)

141

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l con

duct

inte

rnal

au

dits

in a

n in

depe

nden

t, im

part

ial a

nd tr

ansp

aren

t w

ay to

col

lect

and

ana

lyse

in

form

atio

n fo

r the

pu

rpos

es o

f its

mon

itorin

g ac

tiviti

es (s

ee 6

.1.

Mon

itorin

g), i

nclu

ding

:

(b) T

he id

entifi

catio

n an

d se

lect

ion

of c

ompe

tent

aud

itors

(s

ee 4

.2. C

ompe

tenc

e);

142

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l con

duct

inte

rnal

au

dits

in a

n in

depe

nden

t, im

part

ial a

nd tr

ansp

aren

t w

ay to

col

lect

and

ana

lyse

in

form

atio

n fo

r the

pu

rpos

es o

f its

mon

itorin

g ac

tiviti

es (s

ee 6

.1.

Mon

itorin

g), i

nclu

ding

:

(c) T

he a

naly

sis

and

eval

uatio

n of

th

e re

sults

of t

he a

udits

;I.3

(in

gene

ral)

117

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ion

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(01/

03/2

021)

. Unc

ontr

olle

d w

hen

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ted.

Dow

nloa

d th

e la

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ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

143

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l con

duct

inte

rnal

au

dits

in a

n in

depe

nden

t, im

part

ial a

nd tr

ansp

aren

t w

ay to

col

lect

and

ana

lyse

in

form

atio

n fo

r the

pu

rpos

es o

f its

mon

itorin

g ac

tiviti

es (s

ee 6

.1.

Mon

itorin

g), i

nclu

ding

:

(d) T

he id

entifi

catio

n of

the

need

fo

r cor

rect

ive

or im

prov

emen

t m

easu

res;

I.3 (i

n ge

nera

l)

144

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l con

duct

inte

rnal

au

dits

in a

n in

depe

nden

t, im

part

ial a

nd tr

ansp

aren

t w

ay to

col

lect

and

ana

lyse

in

form

atio

n fo

r the

pu

rpos

es o

f its

mon

itorin

g ac

tiviti

es (s

ee 6

.1.

Mon

itorin

g), i

nclu

ding

:

(e) T

he v

erifi

catio

n of

the

com

plet

ion

and

effec

tiven

ess

of

thes

e m

easu

res;

I.3 (i

n ge

nera

l)

145

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l con

duct

inte

rnal

au

dits

in a

n in

depe

nden

t, im

part

ial a

nd tr

ansp

aren

t w

ay to

col

lect

and

ana

lyse

in

form

atio

n fo

r the

pu

rpos

es o

f its

mon

itorin

g ac

tiviti

es (s

ee 6

.1.

Mon

itorin

g), i

nclu

ding

:

(f) T

he d

ocum

enta

tion

pert

aini

ng

to th

e ex

ecut

ion

and

resu

lts o

f au

dits

;

I.3 (i

n ge

nera

l)

146

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l con

duct

inte

rnal

au

dits

in a

n in

depe

nden

t, im

part

ial a

nd tr

ansp

aren

t w

ay to

col

lect

and

ana

lyse

in

form

atio

n fo

r the

pu

rpos

es o

f its

mon

itorin

g ac

tiviti

es (s

ee 6

.1.

Mon

itorin

g), i

nclu

ding

:

(g) T

he c

omm

unic

atio

n of

the

resu

lts o

f aud

its to

the

top

man

agem

ent.

I.1.(g

)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

118

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

147

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

1. T

op m

anag

emen

t sh

all r

egul

arly

revi

ew th

e co

ntin

uing

ade

quac

y an

d eff

ectiv

enes

s of

the

safe

ty m

anag

emen

t sy

stem

incl

udin

g at

leas

t co

nsid

erat

ion

of:

(a) d

etai

ls o

f pro

gres

s on

ad

dres

sing

out

stan

ding

act

ions

fr

om p

revi

ous

man

agem

ent

revi

ews;

I.1 a

nd I.

3 (in

gen

eral

)

148

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

1. T

op m

anag

emen

t sh

all r

egul

arly

revi

ew th

e co

ntin

uing

ade

quac

y an

d eff

ectiv

enes

s of

the

safe

ty m

anag

emen

t sy

stem

incl

udin

g at

leas

t co

nsid

erat

ion

of:

(b) c

hang

ing

inte

rnal

and

ex

tern

al c

ircum

stan

ces

(see

1.

Cont

ext o

f the

org

anis

atio

n);

I.1 a

nd I.

3 (in

gen

eral

)

149

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

1. T

op m

anag

emen

t sh

all r

egul

arly

revi

ew th

e co

ntin

uing

ade

quac

y an

d eff

ectiv

enes

s of

the

safe

ty m

anag

emen

t sy

stem

incl

udin

g at

leas

t co

nsid

erat

ion

of:

(c) t

he o

rgan

isat

ion’

s sa

fety

pe

rfor

man

ce re

late

d to

:(i)

the

achi

evem

ent o

f its

saf

ety

obje

ctiv

es;

I.1 a

nd I.

3 (in

gen

eral

)

150

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

1. T

op m

anag

emen

t sh

all r

egul

arly

revi

ew th

e co

ntin

uing

ade

quac

y an

d eff

ectiv

enes

s of

the

safe

ty m

anag

emen

t sy

stem

incl

udin

g at

leas

t co

nsid

erat

ion

of:

(c) t

he o

rgan

isat

ion’

s sa

fety

pe

rfor

man

ce re

late

d to

:(ii

) the

resu

lts fr

om it

s m

onito

ring

activ

ities

, inc

ludi

ng th

e in

tern

al

audi

t find

ings

, and

inte

rnal

ac

cide

nt/in

cide

nt in

vest

igat

ions

an

d st

atus

of t

heir

resp

ectiv

e ac

tions

;

I.1 a

nd I.

3 (in

gen

eral

)

119

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ion

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. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

151

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

1. T

op m

anag

emen

t sh

all r

egul

arly

revi

ew th

e co

ntin

uing

ade

quac

y an

d eff

ectiv

enes

s of

the

safe

ty m

anag

emen

t sy

stem

incl

udin

g at

leas

t co

nsid

erat

ion

of:

(c) t

he o

rgan

isat

ion’

s sa

fety

pe

rfor

man

ce re

late

d to

:(ii

i) th

e re

leva

nt o

utpu

ts fr

om

supe

rvis

ory

activ

ities

con

duct

ed

by th

e na

tiona

l saf

ety

auth

ority

;

I.1 a

nd I.

3 (in

gen

eral

)

152

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

1. T

op m

anag

emen

t sh

all r

egul

arly

revi

ew th

e co

ntin

uing

ade

quac

y an

d eff

ectiv

enes

s of

the

safe

ty m

anag

emen

t sy

stem

incl

udin

g at

leas

t co

nsid

erat

ion

of:

(d) r

ecom

men

datio

ns fo

r im

prov

emen

t.I.1

and

I.3

(in g

ener

al)

153

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

2.

Base

d on

th

e ou

tput

s of

its

man

agem

ent r

evie

w, t

he

top

man

agem

ent s

hall

take

ove

rall

resp

onsi

bilit

y fo

r the

pla

nnin

g an

d im

plem

enta

tion

of n

eede

d ch

ange

s to

the

safe

ty

man

agem

ent s

yste

m.

I.1.(g

)

154

7.

IMPR

OVE

MEN

T7.

1.

Lear

ning

from

ac

cide

nts

and

inci

dent

s

7.1.

1.

Acci

dent

s an

d in

cide

nts

rela

ted

to th

e or

gani

satio

n’s

railw

ay

oper

atio

ns s

hall

be:

(a) r

epor

ted,

logg

ed, i

nves

tigat

ed

and

anal

ysed

to d

eter

min

e th

eir

caus

es;

I.3 (i

n ge

nera

l)

155

7.

IMPR

OVE

MEN

T7.

1.

Lear

ning

from

ac

cide

nts

and

inci

dent

s

7.1.

1.

Acci

dent

s an

d in

cide

nts

rela

ted

to th

e or

gani

satio

n’s

railw

ay

oper

atio

ns s

hall

be:

(b) r

epor

ted

to n

atio

nal b

odie

s as

ap

prop

riate

.I.3

(in

gene

ral)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

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ted.

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nloa

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e la

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ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

120

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

156

7.

IMPR

OVE

MEN

T7.

1.

Lear

ning

from

ac

cide

nts

and

inci

dent

s

7.1.

2. T

he o

rgan

isat

ion

shal

l ens

ure

that

:(a

) rec

omm

enda

tions

from

the

natio

nal s

afet

y au

thor

ity, t

he

natio

nal i

nves

tigat

ing

body

and

in

dust

ry/in

tern

al in

vest

igat

ions

ar

e ev

alua

ted

and

impl

emen

ted

if ap

prop

riate

or m

anda

ted;

I.3 (i

n ge

nera

l), A

rt.

4(4)

157

7.

IMPR

OVE

MEN

T7.

1.

Lear

ning

from

ac

cide

nts

and

inci

dent

s

7.1.

2. T

he o

rgan

isat

ion

shal

l ens

ure

that

:(b

) rel

evan

t rep

orts

/info

rmat

ion

from

oth

er in

tere

sted

par

ties

such

as

railw

ay u

nder

taki

ngs,

infr

astr

uctu

re m

anag

ers,

entit

ies

in c

harg

e of

mai

nten

ance

and

ra

ilway

veh

icle

kee

pers

are

co

nsid

ered

and

take

n in

to

acco

unt.

I.3 (i

n ge

nera

l), I.

7 (in

ge

nera

l), II

I.9, I

V.9,

Art

. 4(

4), A

rt. 5

(2),

Art

. 5(3

)

158

7.

IMPR

OVE

MEN

T7.

1.

Lear

ning

from

ac

cide

nts

and

inci

dent

s

7.1.

3. T

he o

rgan

isat

ion

shal

l use

info

rmat

ion

rela

ting

to th

e in

vest

igat

ion

to re

view

the

risk

asse

ssm

ent (

see

3.1.

1. R

isk

asse

ssm

ent)

, to

lear

n w

ith

the

aim

of i

mpr

ovin

g sa

fety

an

d, w

here

app

licab

le, t

o ad

opt c

orre

ctiv

e an

d/or

im

prov

emen

t mea

sure

s (s

ee 5

.4. M

anag

emen

t of

chan

ge).

I.3 a

nd I.

4 (in

gen

eral

), A

rt. 4

(4)

121

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ion

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sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

159

7.

IMPR

OVE

MEN

T7.

2.

Cont

inua

l im

prov

emen

t7.

2.1.

The

org

anis

atio

n sh

all c

ontin

ually

impr

ove

the

adeq

uacy

and

eff

ectiv

enes

s of

its

safe

ty

man

agem

ent s

yste

m,

taki

ng in

to a

ccou

nt

the

fram

ewor

k se

t out

in

Reg

ulat

ion

(EU

) No

1078

/201

2 an

d at

leas

t the

ou

tput

s of

the

follo

win

g ac

tiviti

es:

(a) m

onito

ring

(see

6.1

. M

onito

ring)

;I.4

(in

gene

ral),

Art

. 4(

4), A

rt. 7

(1),

Art

. 9(3

)

160

7.

IMPR

OVE

MEN

T7.

2.

Cont

inua

l im

prov

emen

t7.

2.1.

The

org

anis

atio

n sh

all c

ontin

ually

impr

ove

the

adeq

uacy

and

eff

ectiv

enes

s of

its

safe

ty

man

agem

ent s

yste

m,

taki

ng in

to a

ccou

nt

the

fram

ewor

k se

t out

in

Reg

ulat

ion

(EU

) No

1078

/201

2 an

d at

leas

t the

ou

tput

s of

the

follo

win

g ac

tiviti

es:

(b) i

nter

nal a

uditi

ng (s

ee 6

.2.

Inte

rnal

aud

iting

);I.4

(in

gene

ral)

161

7.

IMPR

OVE

MEN

T7.

2.

Cont

inua

l im

prov

emen

t7.

2.1.

The

org

anis

atio

n sh

all c

ontin

ually

impr

ove

the

adeq

uacy

and

eff

ectiv

enes

s of

its

safe

ty

man

agem

ent s

yste

m,

taki

ng in

to a

ccou

nt

the

fram

ewor

k se

t out

in

Reg

ulat

ion

(EU

) No

1078

/201

2 an

d at

leas

t the

ou

tput

s of

the

follo

win

g ac

tiviti

es:

(c) m

anag

emen

t rev

iew

(see

6.3

. M

anag

emen

t rev

iew

);I.4

(in

gene

ral)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

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ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

122

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

162

7.

IMPR

OVE

MEN

T7.

2.

Cont

inua

l im

prov

emen

t7.

2.1.

The

org

anis

atio

n sh

all c

ontin

ually

impr

ove

the

adeq

uacy

and

eff

ectiv

enes

s of

its

safe

ty

man

agem

ent s

yste

m,

taki

ng in

to a

ccou

nt

the

fram

ewor

k se

t out

in

Reg

ulat

ion

(EU

) No

1078

/201

2 an

d at

leas

t the

ou

tput

s of

the

follo

win

g ac

tiviti

es:

(d) l

earn

ing

from

acc

iden

ts a

nd

inci

dent

s (s

ee 7

.1. L

earn

ing

from

ac

cide

nts

and

inci

dent

s).

I.4 (i

n ge

nera

l)

163

7.

IMPR

OVE

MEN

T7.

2.

Cont

inua

l im

prov

emen

t7.

2.2.

The

org

anis

atio

n sh

all p

rovi

de m

eans

to

mot

ivat

ing

staff

and

oth

er

inte

rest

ed p

artie

s to

be

activ

e in

impr

ovin

g sa

fety

as

par

t of i

ts o

rgan

isat

iona

l le

arni

ng.

164

7.

IMPR

OVE

MEN

T7.

2.

Cont

inua

l im

prov

emen

t7.

2.3.

The

org

anis

atio

n sh

all p

rovi

de a

str

ateg

y to

con

tinua

lly im

prov

e its

sa

fety

cul

ture

, rel

ying

on

the

use

of e

xper

tise

and

reco

gnis

ed m

etho

ds to

id

entif

y be

havi

oura

l iss

ues

affec

ting

the

diffe

rent

par

ts

of th

e sa

fety

man

agem

ent

syst

em a

nd to

put

in p

lace

m

easu

res

to a

ddre

ss th

ese.

123

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ion

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(01/

03/2

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hen

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ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

Ann

ex II

Map

ping

Tab

le R

U

NO

TE (1

)(1

) Com

mis

sion

Impl

emen

ting

Regu

latio

n (E

U) N

o 40

2/20

13 o

f 30

Apr

il 20

13 o

n th

e co

mm

on s

afet

y m

etho

d fo

r ris

k ev

alua

tion

and

asse

ssm

ent a

nd re

peal

ing

Regu

latio

n (E

C) N

o 35

2/20

09 (O

J L 1

21, 3

.5.2

013,

p. 8

).

NO

TE (2

)

(2)

Com

mis

sion

Reg

ulat

ion

(EU

) No

1078

/201

2 of

16

Nov

embe

r 201

2 on

a c

omm

on s

afet

y m

etho

d fo

r mon

itorin

g to

be

appl

ied

by ra

ilway

und

erta

king

s, in

fras

truc

ture

man

ager

s af

ter r

ecei

ving

a s

afet

y ce

rtifi

cate

or s

afet

y au

thor

isat

ion

and

by e

ntiti

es in

cha

rge

of m

aint

enan

ce (O

J L 3

20, 1

7.11

.201

2, p

. 8).

NO

TE (3

)(3

) Po

int 2

.1. o

f the

App

endi

x to

Ann

ex I

to D

irect

ive

(EU

) 201

6/79

8.

NO

TE (4

)(4

) Po

int 2

.2. o

f the

App

endi

x to

Ann

ex I

to D

irect

ive

(EU

) 201

6/79

8.

NO

TE (5

)

(5)

Com

mis

sion

Reg

ulat

ion

(EU

) 201

5/99

5 of

8 Ju

ne 2

015

amen

ding

Dec

isio

n 20

12/7

57/E

U c

once

rnin

g th

e te

chni

cal s

peci

ficat

ion

for i

nter

oper

abili

ty re

latin

g to

th

e ‘o

pera

tion

and

traffi

c m

anag

emen

t’ su

bsys

tem

of t

he ra

il sy

stem

in th

e Eu

rope

an U

nion

(OJ L

165

, 30.

6.20

15, p

. 1).

Regu

lati

on E

U 2

018/

762

(CSM

on

SMS)

- A

nnex

I - S

MS

requ

irem

ents

rela

ted

to R

ailw

ay U

nder

taki

ngs

Reg

EU 2

019/

779

- EC

M R

egul

atio

n

RU S

MS

docu

men

tati

on

refe

renc

es

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

11.

CO

NTE

XT

OF

THE

ORG

AN

ISAT

ION

Non

e1.

1. T

he o

rgan

isat

ion

shal

l:(a

) des

crib

e th

e ty

pe, e

xten

t and

ar

ea o

f its

ope

ratio

ns;

I.1.(a

) (pa

rtia

lly

cove

red)

21.

CO

NTE

XT

OF

THE

ORG

AN

ISAT

ION

Non

e1.

1. T

he o

rgan

isat

ion

shal

l:(b

) ide

ntify

the

serio

us ri

sks

for s

afet

y po

sed

by it

s ra

ilway

op

erat

ions

whe

ther

they

are

ca

rrie

d ou

t by

the

orga

nisa

tion

itsel

f, or

by

cont

ract

ors,

part

ners

or

supp

liers

und

er it

s co

ntro

l;

I.2 (i

n ge

nera

l)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

124

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

31.

CO

NTE

XT

OF

THE

ORG

AN

ISAT

ION

Non

e1.

1. T

he o

rgan

isat

ion

shal

l:(c

) ide

ntify

inte

rest

ed p

artie

s (e

.g.

regu

lato

ry b

odie

s, au

thor

ities

, in

fras

truc

ture

man

ager

s, co

ntra

ctor

s, su

pplie

rs, p

artn

ers)

, in

clud

ing

thos

e pa

rtie

s ex

tern

al

to th

e ra

ilway

sys

tem

, tha

t are

re

leva

nt to

the

safe

ty m

anag

emen

t sy

stem

;

I.2.1

(par

tially

co

vere

d), I

.9.1

(p

artia

lly c

over

ed)

41.

CO

NTE

XT

OF

THE

ORG

AN

ISAT

ION

Non

e1.

1. T

he o

rgan

isat

ion

shal

l:(d

) ide

ntify

and

mai

ntai

n le

gal

and

othe

r req

uire

men

ts re

late

d to

sa

fety

from

the

inte

rest

ed p

artie

s re

ferr

ed to

in p

oint

(c);

I.1.(b

) and

(f),

I.9.3

51.

CO

NTE

XT

OF

THE

ORG

AN

ISAT

ION

Non

e1.

1. T

he o

rgan

isat

ion

shal

l:(e

) ens

ure

that

the

requ

irem

ents

re

ferr

ed to

in p

oint

(d) a

re ta

ken

into

acc

ount

in d

evel

opin

g,

impl

emen

ting

and

mai

ntai

ning

the

safe

ty m

anag

emen

t sys

tem

;

I.1.(d

)

61.

CO

NTE

XT

OF

THE

ORG

AN

ISAT

ION

Non

e1.

1. T

he o

rgan

isat

ion

shal

l:(f

) des

crib

e th

e sc

ope

of th

e sa

fety

man

agem

ent s

yste

m,

indi

catin

g w

hich

par

t of t

he

busi

ness

is in

clud

ed o

r not

in it

s sc

ope

and

taki

ng in

to a

ccou

nt th

e re

quire

men

ts re

ferr

ed to

in p

oint

(d

).

I.1.(a

) (pa

rtia

lly

cove

red)

, I.9

.1

(par

tially

cov

ered

)

72.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip a

nd

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te le

ader

ship

an

d co

mm

itmen

t to

the

deve

lopm

ent,

impl

emen

tatio

n,

mai

nten

ance

and

con

tinua

l im

prov

emen

t of t

he s

afet

y m

anag

emen

t sys

tem

by:

(a) t

akin

g ov

eral

l acc

ount

abili

ty

and

resp

onsi

bilit

y fo

r saf

ety;

I.5.5

and

I.5

(in

gene

ral)

125

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ion

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03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

82.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip a

nd

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te le

ader

ship

an

d co

mm

itmen

t to

the

deve

lopm

ent,

impl

emen

tatio

n,

mai

nten

ance

and

con

tinua

l im

prov

emen

t of t

he s

afet

y m

anag

emen

t sys

tem

by:

(b) e

nsur

ing

com

mitm

ent t

o sa

fety

by

man

agem

ent a

t diff

eren

t le

vels

with

in th

e or

gani

satio

n th

roug

h th

eir a

ctiv

ities

and

in

thei

r rel

atio

nshi

ps w

ith s

taff

and

cont

ract

ors;

I.1.(g

) and

(h) (

part

ially

co

vere

d), I

.9.3

92.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip a

nd

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te le

ader

ship

an

d co

mm

itmen

t to

the

deve

lopm

ent,

impl

emen

tatio

n,

mai

nten

ance

and

con

tinua

l im

prov

emen

t of t

he s

afet

y m

anag

emen

t sys

tem

by:

(c) e

nsur

ing

that

the

safe

ty

polic

y an

d sa

fety

obj

ectiv

es a

re

esta

blis

hed,

und

erst

ood

and

are

com

patib

le w

ith th

e st

rate

gic

dire

ctio

n of

the

orga

nisa

tion;

I.1(a

) and

(b),

I.9.3

102.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip a

nd

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te le

ader

ship

an

d co

mm

itmen

t to

the

deve

lopm

ent,

impl

emen

tatio

n,

mai

nten

ance

and

con

tinua

l im

prov

emen

t of t

he s

afet

y m

anag

emen

t sys

tem

by:

(d) e

nsur

ing

the

inte

grat

ion

of th

e sa

fety

man

agem

ent

syst

em re

quire

men

ts in

to th

e or

gani

satio

n’s

busi

ness

pro

cess

es;

I.1(d

)

112.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip a

nd

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te le

ader

ship

an

d co

mm

itmen

t to

the

deve

lopm

ent,

impl

emen

tatio

n,

mai

nten

ance

and

con

tinua

l im

prov

emen

t of t

he s

afet

y m

anag

emen

t sys

tem

by:

(e) e

nsur

ing

that

the

reso

urce

s ne

eded

for t

he sa

fety

man

agem

ent

syst

em a

re a

vaila

ble;

I.1(e

)

122.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip a

nd

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te le

ader

ship

an

d co

mm

itmen

t to

the

deve

lopm

ent,

impl

emen

tatio

n,

mai

nten

ance

and

con

tinua

l im

prov

emen

t of t

he s

afet

y m

anag

emen

t sys

tem

by:

(f) e

nsur

ing

that

the

safe

ty

man

agem

ent s

yste

m is

effe

ctiv

e in

co

ntro

lling

the

safe

ty ri

sks

pose

d by

the

orga

nisa

tion;

I.1.(c

) (pa

rtia

lly

cove

red)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

126

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

132.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip a

nd

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te le

ader

ship

an

d co

mm

itmen

t to

the

deve

lopm

ent,

impl

emen

tatio

n,

mai

nten

ance

and

con

tinua

l im

prov

emen

t of t

he s

afet

y m

anag

emen

t sys

tem

by:

(g) e

ncou

ragi

ng s

taff

to

supp

ort c

ompl

ianc

e w

ith th

e sa

fety

man

agem

ent s

yste

m

requ

irem

ents

;

I.1.(g

) and

(h) (

part

ially

co

vere

d)

142.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip a

nd

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te le

ader

ship

an

d co

mm

itmen

t to

the

deve

lopm

ent,

impl

emen

tatio

n,

mai

nten

ance

and

con

tinua

l im

prov

emen

t of t

he s

afet

y m

anag

emen

t sys

tem

by:

(h) p

rom

otin

g co

ntin

ual

impr

ovem

ent o

f the

saf

ety

man

agem

ent s

yste

m;

I.4 (p

artia

lly c

over

ed)

152.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip a

nd

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te le

ader

ship

an

d co

mm

itmen

t to

the

deve

lopm

ent,

impl

emen

tatio

n,

mai

nten

ance

and

con

tinua

l im

prov

emen

t of t

he s

afet

y m

anag

emen

t sys

tem

by:

(i) e

nsur

ing

that

saf

ety

is

cons

ider

ed w

hen

iden

tifyi

ng

and

man

agin

g th

e or

gani

satio

n’s

busi

ness

risk

s an

d ex

plai

ning

how

co

nflic

t bet

wee

n sa

fety

and

oth

er

busi

ness

goa

ls w

ill b

e re

cogn

ised

an

d re

solv

ed;

I.2.2

and

I.2.

3 (p

artia

lly

cove

red)

, I.1

.(f),

I.9.1

162.

LE

AD

ERSH

IP2.

1.

Lead

ersh

ip a

nd

com

mitm

ent

2.1.

1. T

op m

anag

emen

t sh

all d

emon

stra

te le

ader

ship

an

d co

mm

itmen

t to

the

deve

lopm

ent,

impl

emen

tatio

n,

mai

nten

ance

and

con

tinua

l im

prov

emen

t of t

he s

afet

y m

anag

emen

t sys

tem

by:

(j) p

rom

otin

g a

posi

tive

safe

ty

cultu

re.

172.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.1.

A

doc

umen

t des

crib

ing

the

orga

nisa

tion’

s sa

fety

pol

icy

is e

stab

lishe

d by

the

top

man

agem

ent a

nd is

:

(a) a

ppro

pria

te to

the

orga

nisa

tion’

s ty

pe a

nd e

xten

t of

railw

ay o

pera

tions

;

I.1.(a

)

127

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

182.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.1.

A

doc

umen

t des

crib

ing

the

orga

nisa

tion’

s sa

fety

pol

icy

is e

stab

lishe

d by

the

top

man

agem

ent a

nd is

:

(b) a

ppro

ved

by th

e or

gani

satio

n’s

chie

f exe

cutiv

e (o

r a

repr

esen

tativ

e(s)

of t

he to

p-m

anag

emen

t);

I.1.(a

)

192.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.1.

A

doc

umen

t des

crib

ing

the

orga

nisa

tion’

s sa

fety

pol

icy

is e

stab

lishe

d by

the

top

man

agem

ent a

nd is

:

(c) a

ctiv

ely

impl

emen

ted,

co

mm

unic

ated

and

mad

e av

aila

ble

to a

ll st

aff.

I.1.(a

)

202.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.2.

The

saf

ety

polic

y sh

all:

(a) i

nclu

de a

com

mitm

ent t

o co

nfor

m w

ith a

ll le

gal a

nd o

ther

re

quire

men

ts re

late

d to

saf

ety;

I.1.(b

) (pa

rtia

lly

cove

red)

and

I.1.

(a) (

in

gene

ral)

212.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.2.

The

saf

ety

polic

y sh

all:

(b) p

rovi

de a

fram

ewor

k fo

r se

ttin

g sa

fety

obj

ectiv

es a

nd

eval

uatin

g th

e or

gani

satio

n’s

safe

ty p

erfo

rman

ce a

gain

st th

ese

obje

ctiv

es;

I.1.(b

) and

(c ),

and

I.1

.(a) (

in g

ener

al),

I.9.3

222.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.2.

The

saf

ety

polic

y sh

all:

(c) i

nclu

de a

com

mitm

ent t

o co

ntro

l saf

ety

risks

whi

ch a

rise

both

from

its

own

activ

ities

and

th

ose

caus

ed b

y ot

hers

;

I.1.(f

), an

d I.1

.(a) (

in

gene

ral),

I.9.

4 (in

ge

nera

l), I.

9.5

(in

gene

ral)

232.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.2.

The

saf

ety

polic

y sh

all:

(d) i

nclu

de a

com

mitm

ent t

o co

ntin

ual i

mpr

ovem

ent o

f the

sa

fety

man

agem

ent s

yste

m;

I.4 a

nd I.

1.(a

) (in

ge

nera

l)

242.

LE

AD

ERSH

IP2.

2.

Safe

ty p

olic

y2.

2.2.

The

saf

ety

polic

y sh

all:

(e) b

e m

aint

aine

d in

acc

orda

nce

with

the

busi

ness

str

ateg

y an

d th

e ev

alua

tion

of th

e sa

fety

pe

rfor

man

ce o

f the

org

anis

atio

n.

I.1.(c

) and

I.1.

(a) (

in

gene

ral)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

128

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

252.

LE

AD

ERSH

IP2.

3.

Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

2.3.

1. T

he re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

of s

taff

havi

ng

a ro

le th

at a

ffect

s sa

fety

(in

clud

ing

man

agem

ent

and

othe

r sta

ff in

volv

ed in

sa

fety

-rel

ated

task

s) s

hall

be

defin

ed a

t all

leve

ls w

ithin

the

orga

nisa

tion,

doc

umen

ted,

as

sign

ed a

nd c

omm

unic

ated

to

them

.

I.5 (i

n ge

nera

l)

262.

LE

AD

ERSH

IP2.

3.

Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

2.3.

2. T

he o

rgan

isat

ion

shal

l ens

ure

that

sta

ff w

ith

dele

gate

d re

spon

sibi

litie

s fo

r sa

fety

-rel

ated

task

s sh

all h

ave

the

auth

ority

, com

pete

nce

and

appr

opria

te re

sour

ces

to

perf

orm

thei

r tas

ks w

ithou

t be

ing

adve

rsel

y aff

ecte

d by

th

e ac

tiviti

es o

f oth

er b

usin

ess

func

tions

.

I.5 (i

n ge

nera

l), I.

6 (in

gen

eral

), II.

6 (in

ge

nera

l), II

I.1, I

II.7,

IV.8

272.

LE

AD

ERSH

IP2.

3.

Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

2.3.

3.

Del

egat

ion

of

resp

onsi

bilit

y fo

r saf

ety-

rela

ted

task

s sh

all b

e do

cum

ente

d an

d co

mm

unic

ated

to th

e re

leva

nt s

taff,

acc

epte

d an

d un

ders

tood

.

I.5 (i

n ge

nera

l)

129

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

282.

LE

AD

ERSH

IP2.

3.

Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

2.3.

4. T

he o

rgan

isat

ion

shal

l de

scrib

e th

e al

loca

tion

of

role

s re

ferr

ed to

in p

arag

raph

2.

3.1.

to b

usin

ess

func

tions

w

ithin

and

whe

re re

leva

nt,

outs

ide

the

orga

nisa

tion

(see

5.

3. C

ontr

acto

rs, p

artn

ers

and

supp

liers

).

I.5 (i

n ge

nera

l), I.

9.4

and

I.9.6

(in

gene

ral)

292.

LE

AD

ERSH

IP2.

4.

Cons

ulta

tion

of s

taff

and

othe

r pa

rtie

s

2.4.

1.

Staff

, the

ir re

pres

enta

tives

and

ex

tern

al in

tere

sted

par

ties,

as a

ppro

pria

te a

nd w

here

re

leva

nt, s

hall

be c

onsu

lted

in d

evel

opin

g, m

aint

aini

ng

and

impr

ovin

g th

e sa

fety

m

anag

emen

t sys

tem

in

the

rele

vant

par

ts th

ey a

re

resp

onsi

ble

for,

incl

udin

g th

e sa

fety

asp

ects

of o

pera

tiona

l pr

oced

ures

.

I.1.(h

)

302.

LE

AD

ERSH

IP2.

4.

Cons

ulta

tion

of s

taff

and

othe

r pa

rtie

s

2.4.

2. T

he o

rgan

isat

ion

shal

l fa

cilit

ate

the

cons

ulta

tion

of

staff

by

prov

idin

g th

e m

etho

ds

and

mea

ns fo

r inv

olvi

ng s

taff,

re

cord

ing

staff

’s op

inio

n an

d pr

ovid

ing

feed

back

on

staff

’s op

inio

n.

I.5.4

and

I.1.

(h)

313.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

1. T

he o

rgan

isat

ion

shal

l:(a

) ide

ntify

and

ana

lyse

all

oper

atio

nal,

orga

nisa

tiona

l an

d te

chni

cal r

isks

rele

vant

to

the

type

, ext

ent a

nd a

rea

of

oper

atio

ns c

arrie

d ou

t by

the

orga

nisa

tion.

Suc

h ris

ks s

hall

incl

ude

thos

e ar

isin

g fr

om h

uman

an

d or

gani

satio

nal f

acto

rs s

uch

as w

orkl

oad,

job

desi

gn, f

atig

ue

or s

uita

bilit

y of

pro

cedu

res,

and

the

activ

ities

of o

ther

inte

rest

ed

part

ies

(see

1. C

onte

xt o

f the

or

gani

satio

n);

I.2.2

, I.2

.3, I

.9.1

(in

gene

ral)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

130

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

323.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

1. T

he o

rgan

isat

ion

shal

l:(b

) eva

luat

e th

e ris

ks re

ferr

ed

to in

poi

nt (a

) by

appl

ying

ap

prop

riate

risk

ass

essm

ent

met

hods

;

I.2.2

333.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

1. T

he o

rgan

isat

ion

shal

l:(c

) dev

elop

and

put

in

plac

e sa

fety

mea

sure

s, w

ith

iden

tifica

tion

of a

ssoc

iate

d re

spon

sibi

litie

s (s

ee 2

.3.

Org

anis

atio

nal r

oles

, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

);

I.3 (i

n ge

nera

l)

343.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

1. T

he o

rgan

isat

ion

shal

l:(d

) dev

elop

a s

yste

m to

mon

itor

the

effec

tiven

ess

of s

afet

y m

easu

res

(see

6.1

. Mon

itorin

g);

I.3 (i

n ge

nera

l)

353.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

1. T

he o

rgan

isat

ion

shal

l:(e

) rec

ogni

se th

e ne

ed to

co

llabo

rate

with

oth

er in

tere

sted

pa

rtie

s (s

uch

as ra

ilway

un

dert

akin

gs, i

nfra

stru

ctur

e m

anag

ers,

man

ufac

ture

r, m

aint

enan

ce s

uppl

ier,

entit

y in

ch

arge

of m

aint

enan

ce, r

ailw

ay

vehi

cle

keep

er, s

ervi

ce p

rovi

der

and

proc

urem

ent e

ntity

), w

here

ap

prop

riate

, on

shar

ed ri

sks

and

the

putt

ing

in p

lace

of a

dequ

ate

safe

ty m

easu

res;

I.2.1

, I.7

(in

gene

ral)

363.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

1. T

he o

rgan

isat

ion

shal

l:(f

) com

mun

icat

e ris

ks to

sta

ff an

d in

volv

ed e

xter

nal p

artie

s (s

ee 4

.4.

Info

rmat

ion

and

com

mun

icat

ion)

.

I.1.(h

) par

tially

co

vere

d), I

.9.4

(p

artia

lly c

over

ed)

131

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

373.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.1.

Ri

sk a

sses

smen

t3.

1.1.

2. W

hen

asse

ssin

g ris

k,

an o

rgan

isat

ion

shal

l tak

e in

to

acco

unt t

he n

eed

to d

eter

min

e,

prov

ide

and

sust

ain

a sa

fe w

orki

ng

envi

ronm

ent w

hich

con

form

s to

ap

plic

able

legi

slat

ion,

in p

artic

ular

D

irect

ive

89/3

91/E

EC.

I.2.3

383.

PL

AN

NIN

G3.

1.

Actio

ns to

ad

dres

s ris

ks3.

1.2.

Pl

anni

ng fo

r cha

nge

3.1.

2.1.

The

org

anis

atio

n sh

all

iden

tify

pote

ntia

l saf

ety

risks

an

d ap

prop

riate

saf

ety

mea

sure

s (s

ee 3

.1.1

. Ris

k as

sess

men

t)

befo

re th

e im

plem

enta

tion

of

a ch

ange

(see

5.4

. Man

agem

ent

of c

hang

e) in

acc

orda

nce

with

th

e ris

k m

anag

emen

t pro

cess

se

t out

in th

e Re

gula

tion

(EU

) N

o 40

2/20

13 (1

), in

clud

ing

cons

ider

atio

n of

the

safe

ty ri

sks

from

the

chan

ge p

roce

ss it

self.

I.2.2

393.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

1. T

he o

rgan

isat

ion

shal

l es

tabl

ish

safe

ty o

bjec

tives

fo

r rel

evan

t fun

ctio

ns a

t re

leva

nt le

vels

to m

aint

ain

and,

whe

re re

ason

ably

pr

actic

able

, im

prov

e its

saf

ety

perf

orm

ance

.

I.1.(b

) and

(c )

403.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

2. T

he s

afet

y ob

ject

ives

sh

all:

(a) b

e co

nsis

tent

with

the

safe

ty

polic

y an

d th

e or

gani

satio

n’s

stra

tegi

c ob

ject

ives

(whe

re

appl

icab

le);

I.1.(b

)

413.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

2. T

he s

afet

y ob

ject

ives

sh

all:

(b) b

e lin

ked

to th

e pr

iorit

y ris

ks th

at in

fluen

ce th

e sa

fety

pe

rfor

man

ce o

f the

org

anis

atio

n;

I.1.(b

) and

(c )

423.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

2. T

he s

afet

y ob

ject

ives

sh

all:

(c) b

e m

easu

rabl

e;

https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32018R0762&from=it#ntr1-L_2018129EN.01002901-E0001












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IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

132

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

433.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

2. T

he s

afet

y ob

ject

ives

sh

all:

(d) t

ake

into

acc

ount

app

licab

le

lega

l and

oth

er re

quire

men

ts;

I.1.(b

)

443.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

2. T

he s

afet

y ob

ject

ives

sh

all:

(e) b

e re

view

ed a

s re

gard

s th

eir

achi

evem

ents

and

revi

sed

as

appr

opria

te;

453.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

2. T

he s

afet

y ob

ject

ives

sh

all:

(f) b

e co

mm

unic

ated

.

463.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

3. T

he o

rgan

isat

ion

shal

l ha

ve p

lan(

s) to

des

crib

e ho

w it

will

ach

ieve

its

safe

ty

obje

ctiv

es.

I.1.(d

)

473.

PL

AN

NIN

G3.

2.

Safe

ty

obje

ctiv

es a

nd

plan

ning

3.2.

4. T

he o

rgan

isat

ion

shal

l des

crib

e th

e st

rate

gy

and

plan

(s) u

sed

to m

onito

r th

e ac

hiev

emen

t of t

he

safe

ty o

bjec

tives

(see

6.1

. M

onito

ring)

.

I.3 (i

n ge

nera

l)

484.

SU

PPO

RT4.

1.

Reso

urce

s4.

1.1.

The

org

anis

atio

n sh

all p

rovi

de th

e re

sour

ces,

incl

udin

g co

mpe

tent

sta

ff an

d eff

ectiv

e an

d us

eabl

e eq

uipm

ent,

need

ed

for t

he e

stab

lishm

ent,

impl

emen

tatio

n, m

aint

enan

ce

and

cont

inua

l im

prov

emen

t of

the

safe

ty m

anag

emen

t sy

stem

.

I.1.(e

), II.

3, IV

.3, I

V.4,

IV.5

133

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

494.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

1. T

he o

rgan

isat

ion’

s co

mpe

tenc

e m

anag

emen

t sy

stem

sha

ll en

sure

that

sta

ff ha

ving

a ro

le th

at a

ffect

s sa

fety

are

com

pete

nt in

th

e sa

fety

-rel

ated

task

s fo

r w

hich

they

are

resp

onsi

ble

(see

2.3

. Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

), in

clud

ing

at le

ast:

(a) i

dent

ifica

tion

of th

e co

mpe

tenc

ies

(incl

udin

g kn

owle

dge,

ski

lls, n

on-t

echn

ical

be

havi

ours

and

att

itude

s) re

quire

d fo

r saf

ety-

rela

ted

task

s;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

504.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

1. T

he o

rgan

isat

ion’

s co

mpe

tenc

e m

anag

emen

t sy

stem

sha

ll en

sure

that

sta

ff ha

ving

a ro

le th

at a

ffect

s sa

fety

are

com

pete

nt in

th

e sa

fety

-rel

ated

task

s fo

r w

hich

they

are

resp

onsi

ble

(see

2.3

. Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

), in

clud

ing

at le

ast:

(b) s

elec

tion

prin

cipl

es (b

asic

ed

ucat

iona

l lev

el, p

sych

olog

ical

an

d ph

ysic

al fi

tnes

s re

quire

d);

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

514.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

1. T

he o

rgan

isat

ion’

s co

mpe

tenc

e m

anag

emen

t sy

stem

sha

ll en

sure

that

sta

ff ha

ving

a ro

le th

at a

ffect

s sa

fety

are

com

pete

nt in

th

e sa

fety

-rel

ated

task

s fo

r w

hich

they

are

resp

onsi

ble

(see

2.3

. Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

), in

clud

ing

at le

ast:

(c) i

nitia

l tra

inin

g, e

xper

ienc

e an

d qu

alifi

catio

n;I.6

(in

gene

ral),

II.6

(in

gene

ral),

III.1

, III.

7, IV

.8

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

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S

Vers

ion

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021)

. Unc

ontr

olle

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hen

prin

ted.

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nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

134

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

524.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

1. T

he o

rgan

isat

ion’

s co

mpe

tenc

e m

anag

emen

t sy

stem

sha

ll en

sure

that

sta

ff ha

ving

a ro

le th

at a

ffect

s sa

fety

are

com

pete

nt in

th

e sa

fety

-rel

ated

task

s fo

r w

hich

they

are

resp

onsi

ble

(see

2.3

. Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

), in

clud

ing

at le

ast:

(d) o

ngoi

ng tr

aini

ng a

nd p

erio

dic

upda

te o

f exi

stin

g co

mpe

tenc

ies;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

534.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

1. T

he o

rgan

isat

ion’

s co

mpe

tenc

e m

anag

emen

t sy

stem

sha

ll en

sure

that

sta

ff ha

ving

a ro

le th

at a

ffect

s sa

fety

are

com

pete

nt in

th

e sa

fety

-rel

ated

task

s fo

r w

hich

they

are

resp

onsi

ble

(see

2.3

. Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

), in

clud

ing

at le

ast:

(e) p

erio

dic

asse

ssm

ent o

f co

mpe

tenc

e an

d ch

ecks

of

psyc

holo

gica

l and

phy

sica

l fitn

ess

to e

nsur

e th

at q

ualifi

catio

ns a

nd

skill

s ar

e m

aint

aine

d ov

er ti

me;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

544.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

1. T

he o

rgan

isat

ion’

s co

mpe

tenc

e m

anag

emen

t sy

stem

sha

ll en

sure

that

sta

ff ha

ving

a ro

le th

at a

ffect

s sa

fety

are

com

pete

nt in

th

e sa

fety

-rel

ated

task

s fo

r w

hich

they

are

resp

onsi

ble

(see

2.3

. Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

), in

clud

ing

at le

ast:

(f) s

peci

fic tr

aini

ng in

rele

vant

pa

rts

of th

e sa

fety

man

agem

ent

syst

em in

ord

er to

del

iver

thei

r sa

fety

-rel

ated

task

s.

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

135

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

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nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

554.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

2. T

he o

rgan

isat

ion

shal

l pr

ovid

e a

trai

ning

pro

gram

me,

as

refe

rred

to in

poi

nts

(c),

(d)

and

(f) o

f par

agra

ph 4

.2.1

, for

st

aff p

erfo

rmin

g sa

fety

-rel

ated

ta

sks

whi

ch e

nsur

es th

at:

(a) t

he tr

aini

ng p

rogr

amm

e is

del

iver

ed a

ccor

ding

to

the

iden

tified

com

pete

ncy

requ

irem

ents

and

indi

vidu

al n

eeds

of

the

staff

;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

564.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

2. T

he o

rgan

isat

ion

shal

l pr

ovid

e a

trai

ning

pro

gram

me,

as

refe

rred

to in

poi

nts

(c),

(d)

and

(f) o

f par

agra

ph 4

.2.1

, for

st

aff p

erfo

rmin

g sa

fety

-rel

ated

ta

sks

whi

ch e

nsur

es th

at:

(b) w

here

app

licab

le, t

he

trai

ning

ens

ures

that

sta

ff ca

n op

erat

e un

der a

ll op

erat

ing

cond

ition

s (n

orm

al, d

egra

ded

and

emer

genc

y);

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

574.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

2. T

he o

rgan

isat

ion

shal

l pr

ovid

e a

trai

ning

pro

gram

me,

as

refe

rred

to in

poi

nts

(c),

(d)

and

(f) o

f par

agra

ph 4

.2.1

, for

st

aff p

erfo

rmin

g sa

fety

-rel

ated

ta

sks

whi

ch e

nsur

es th

at:

(c) t

he d

urat

ion

of th

e tr

aini

ng

and

the

freq

uenc

y of

the

refr

eshe

r tr

aini

ng a

re a

ppro

pria

te fo

r the

tr

aini

ng o

bjec

tives

;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

584.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

2. T

he o

rgan

isat

ion

shal

l pr

ovid

e a

trai

ning

pro

gram

me,

as

refe

rred

to in

poi

nts

(c),

(d)

and

(f) o

f par

agra

ph 4

.2.1

, for

st

aff p

erfo

rmin

g sa

fety

-rel

ated

ta

sks

whi

ch e

nsur

es th

at:

(d) r

ecor

ds a

re k

ept f

or a

ll st

aff

(see

4.5

.3. C

ontr

ol o

f doc

umen

ted

info

rmat

ion)

;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

594.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

2. T

he o

rgan

isat

ion

shal

l pr

ovid

e a

trai

ning

pro

gram

me,

as

refe

rred

to in

poi

nts

(c),

(d)

and

(f) o

f par

agra

ph 4

.2.1

, for

st

aff p

erfo

rmin

g sa

fety

-rel

ated

ta

sks

whi

ch e

nsur

es th

at:

(e) t

he tr

aini

ng p

rogr

amm

e is

re

gula

rly re

view

ed a

nd a

udite

d (s

ee 6

.2. I

nter

nal a

uditi

ng) a

nd

chan

ges

mad

e w

hen

nece

ssar

y (s

ee 5

.4. M

anag

emen

t of c

hang

e).

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

604.

SU

PPO

RT4.

2.

Com

pete

nce

4.2.

3.

Back

to w

ork

arra

ngem

ents

sha

ll be

in p

lace

fo

r sta

ff fo

llow

ing

acci

dent

s/in

cide

nts

or lo

ng a

bsen

ces

from

wor

k, in

clud

ing

prov

idin

g ad

ditio

nal t

rain

ing

whe

re s

uch

a ne

ed is

iden

tified

.

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

136

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

614.

SU

PPO

RT4.

3.

Awar

enes

s4.

3.1.

Top

man

agem

ent s

hall

ensu

re th

at th

ey a

nd th

eir s

taff

havi

ng a

role

that

affe

cts

safe

ty

are

awar

e of

the

rele

vanc

e,

impo

rtan

ce a

nd c

onse

quen

ces

of th

eir a

ctiv

ities

and

how

th

ey c

ontr

ibut

e to

the

corr

ect a

pplic

atio

n an

d th

e eff

ectiv

enes

s of

the

safe

ty m

anag

emen

t sys

tem

, in

clud

ing

the

achi

evem

ent

of s

afet

y ob

ject

ives

(see

3.

2. S

afet

y ob

ject

ives

and

pl

anni

ng).

I.1.(g

) (pa

rtia

lly

cove

red)

624.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

1. T

he o

rgan

isat

ion

shal

l defi

ne a

dequ

ate

com

mun

icat

ion

chan

nels

to

ensu

re th

at s

afet

y-re

late

d in

form

atio

n is

exc

hang

ed

amon

g th

e di

ffere

nt le

vels

of

the

orga

nisa

tion

and

with

ex

tern

al in

tere

sted

par

ties

incl

udin

g co

ntra

ctor

s, pa

rtne

rs

and

supp

liers

.

I.7 (i

n ge

nera

l), I.

9.6

(par

tially

cov

ered

), II.

5 (in

gen

eral

), III

.9, I

V.9,

A

rt. 5

(1),

Art

. 5(3

)

634.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

2. T

o en

sure

that

sa

fety

-rel

ated

info

rmat

ion

reac

hes

thos

e m

akin

g ju

dgem

ents

and

dec

isio

ns,

the

orga

nisa

tion

shal

l man

age

the

iden

tifica

tion,

rece

ipt,

proc

essi

ng, g

ener

atio

n an

d di

ssem

inat

ion

of s

afet

y-re

late

d in

form

atio

n.

I.7 (i

n ge

nera

l), I.

9.6

(par

tially

cov

ered

), II.

5 (in

gen

eral

), III

.9,

IV.9

, Art

. 4(2

), A

rt. 4

(3),

Art

. 4(6

)

137

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

644.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l en

sure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(a) r

elev

ant,

com

plet

e an

d un

ders

tand

able

for t

he in

tend

ed

user

s;

I.7 (i

n ge

nera

l)

654.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l en

sure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(b) v

alid

;I.7

(in

gene

ral)

664.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l en

sure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(c) a

ccur

ate;

I.7 (i

n ge

nera

l)

674.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l en

sure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(d) c

onsi

sten

t;I.7

(in

gene

ral)

684.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l en

sure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(e) c

ontr

olle

d (s

ee 4

.5.3

. Con

trol

of

docu

men

ted

info

rmat

ion)

;I.7

(in

gene

ral)

694.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l en

sure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(f) c

omm

unic

ated

bef

ore

it ta

kes

effec

t;I.7

(in

gene

ral)

704.

SU

PPO

RT4.

4.

Info

rmat

ion

and

com

mun

icat

ion

4.4.

3. T

he o

rgan

isat

ion

shal

l en

sure

that

saf

ety-

rela

ted

info

rmat

ion

is:

(g) r

ecei

ved

and

unde

rsto

od.

I.7 (i

n ge

nera

l)

714.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

1. T

here

is a

des

crip

tion

of

the

safe

ty m

anag

emen

t sys

tem

in

clud

ing:

(a) t

he id

entifi

catio

n an

d de

scrip

tion

of th

e pr

oces

ses

and

activ

ities

rela

ted

to s

afet

y of

rail

oper

atio

ns, i

nclu

ding

sa

fety

-rel

ated

task

s an

d as

soci

ated

resp

onsi

bilit

ies

(see

2.3

. Org

anis

atio

nal r

oles

, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

);

I.8 (i

n ge

nera

l)

724.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

1. T

here

is a

des

crip

tion

of

the

safe

ty m

anag

emen

t sys

tem

in

clud

ing:

(b) t

he in

tera

ctio

n of

thes

e pr

oces

ses;

I.8 (i

n ge

nera

l)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

138

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

734.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

1. T

here

is a

des

crip

tion

of

the

safe

ty m

anag

emen

t sys

tem

in

clud

ing:

(c) t

he p

roce

dure

s or

oth

er

docu

men

ts d

escr

ibin

g ho

w th

ese

proc

esse

s ar

e im

plem

ente

d;

I.8 (i

n ge

nera

l)

744.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

1. T

here

is a

des

crip

tion

of

the

safe

ty m

anag

emen

t sys

tem

in

clud

ing:

(d) t

he id

entifi

catio

n of

co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

with

a d

escr

iptio

n of

th

e ty

pe a

nd e

xten

t of s

ervi

ces

deliv

ered

;

I.8 (i

n ge

nera

l), I.

9 (in

ge

nera

l)

754.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

1. T

here

is a

des

crip

tion

of

the

safe

ty m

anag

emen

t sys

tem

in

clud

ing:

(e) t

he id

entifi

catio

n of

co

ntra

ctua

l arr

ange

men

ts a

nd

othe

r bus

ines

s ag

reem

ents

, co

nclu

ded

betw

een

the

orga

nisa

tion

and

othe

r par

ties

iden

tified

und

er (d

), ne

cess

ary

to c

ontr

ol th

e sa

fety

risk

s of

the

orga

nisa

tion

and

thos

e re

late

d to

th

e us

e of

con

trac

tors

;

I.8 (i

n ge

nera

l), I.

9 (in

ge

nera

l)

764.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

1. T

here

is a

des

crip

tion

of

the

safe

ty m

anag

emen

t sys

tem

in

clud

ing:

(f) r

efer

ence

to d

ocum

ente

d in

form

atio

n re

quire

d by

this

Re

gula

tion.

I.8 (i

n ge

nera

l)

774.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

an

annu

al s

afet

y re

port

is s

ubm

itted

to th

e re

leva

nt

natio

nal s

afet

y au

thor

ity (o

r au

thor

ities

) in

acco

rdan

ce w

ith

Art

icle

9(6

) of D

irect

ive

(EU

) 20

16/7

98, i

nclu

ding

:

(a) a

syn

thes

is o

f the

dec

isio

ns

on th

e le

vel o

f sig

nific

ance

of t

he

safe

ty-r

elat

ed c

hang

es, i

nclu

ding

an

ove

rvie

w o

f sig

nific

ant

chan

ges,

in a

ccor

danc

e w

ith

Art

icle

18(

1) o

f Reg

ulat

ion

(EU

) N

o 40

2/20

13;

Ann

ex V

(ECM

M

aint

enan

ce R

epor

t)

(in g

ener

al),

Art

. 8(5

)

139

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

784.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

an

annu

al s

afet

y re

port

is s

ubm

itted

to th

e re

leva

nt

natio

nal s

afet

y au

thor

ity (o

r au

thor

ities

) in

acco

rdan

ce w

ith

Art

icle

9(6

) of D

irect

ive

(EU

) 20

16/7

98, i

nclu

ding

:

(b) t

he o

rgan

isat

ion’

s sa

fety

ob

ject

ives

for t

he fo

llow

ing

year

(s) a

nd h

ow s

erio

us ri

sks

for

safe

ty in

fluen

ce th

e se

ttin

g of

th

ese

safe

ty o

bjec

tives

;

Ann

ex V

(ECM

M

aint

enan

ce R

epor

t)

(in g

ener

al),

Art

. 8(5

)

794.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

an

annu

al s

afet

y re

port

is s

ubm

itted

to th

e re

leva

nt

natio

nal s

afet

y au

thor

ity (o

r au

thor

ities

) in

acco

rdan

ce w

ith

Art

icle

9(6

) of D

irect

ive

(EU

) 20

16/7

98, i

nclu

ding

:

(c) t

he re

sults

of i

nter

nal

acci

dent

/inci

dent

inve

stig

atio

n (s

ee 7

.1. L

earn

ing

from

acc

iden

ts

and

inci

dent

s) a

nd o

ther

m

onito

ring

activ

ities

(see

6.1

. M

onito

ring,

6.2

. Int

erna

l aud

iting

an

d 6.

3. M

anag

emen

t rev

iew

), in

ac

cord

ance

with

Art

icle

5(1

) of

Regu

latio

n (E

U) N

o 10

78/2

012

(2);

Ann

ex V

(ECM

M

aint

enan

ce R

epor

t)

(in g

ener

al),

Art

. 8(5

)

804.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

an

annu

al s

afet

y re

port

is s

ubm

itted

to th

e re

leva

nt

natio

nal s

afet

y au

thor

ity (o

r au

thor

ities

) in

acco

rdan

ce w

ith

Art

icle

9(6

) of D

irect

ive

(EU

) 20

16/7

98, i

nclu

ding

:

(d) d

etai

ls o

f pro

gres

s on

ad

dres

sing

out

stan

ding

re

com

men

datio

ns fr

om th

e na

tiona

l inv

estig

atio

n bo

dies

(s

ee 7

.1. L

earn

ing

from

acc

iden

ts

and

inci

dent

s);

Ann

ex V

(ECM

M

aint

enan

ce R

epor

t)

(in g

ener

al),

Art

. 8(5

)

814.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

an

annu

al s

afet

y re

port

is s

ubm

itted

to th

e re

leva

nt

natio

nal s

afet

y au

thor

ity (o

r au

thor

ities

) in

acco

rdan

ce w

ith

Art

icle

9(6

) of D

irect

ive

(EU

) 20

16/7

98, i

nclu

ding

:

(e) t

he o

rgan

isat

ion’

s sa

fety

in

dica

tors

set

out

to e

valu

ate

the

orga

nisa

tion’

s sa

fety

per

form

ance

(s

ee 6

.1. M

onito

ring)

;

Ann

ex V

(ECM

M

aint

enan

ce R

epor

t)

(in g

ener

al),

Art

. 8(5

)

824.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

1.

Safe

ty m

anag

emen

t sy

stem

doc

umen

tatio

n4.

5.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

an

annu

al s

afet

y re

port

is s

ubm

itted

to th

e re

leva

nt

natio

nal s

afet

y au

thor

ity (o

r au

thor

ities

) in

acco

rdan

ce w

ith

Art

icle

9(6

) of D

irect

ive

(EU

) 20

16/7

98, i

nclu

ding

:

(f) w

here

app

licab

le, t

he

conc

lusi

ons

of th

e an

nual

repo

rt

of th

e sa

fety

adv

isor

, as

refe

rred

to

in R

ID (3

), on

the

activ

ities

of

the

orga

nisa

tion

rela

ting

to th

e tr

ansp

ort o

f dan

gero

us g

oods

(4).

Ann

ex V

(ECM

M

aint

enan

ce R

epor

t)

(in g

ener

al),

Art

. 8(5

)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

140

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

834.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

2.

Crea

ting

and

upda

ting

4.5.

2.1.

The

org

anis

atio

n sh

all

ensu

re th

at w

hen

crea

ting

and

upda

ting

docu

men

ted

info

rmat

ion

rela

ted

to th

e sa

fety

man

agem

ent

syst

em a

dequ

ate

form

ats

and

med

ia a

re u

sed.

I.8 (i

n ge

nera

l)

844.

SU

PPO

RT4.

5.

Doc

umen

ted

info

rmat

ion

4.5.

3.

Cont

rol o

f doc

umen

ted

info

rmat

ion

4.5.

3.1.

The

org

anis

atio

n sh

all

cont

rol d

ocum

ente

d in

form

atio

n re

late

d to

the

safe

ty m

anag

emen

t sy

stem

, in

part

icul

ar it

s st

orag

e,

dist

ribut

ion

and

the

cont

rol o

f ch

ange

s, to

ens

ure

its a

vaila

bilit

y,

suita

bilit

y an

d pr

otec

tion

whe

re

appr

opria

te.

I.8 (i

n ge

nera

l), I.

9 (in

ge

nera

l), II

.7, I

II.10

, IV

.10

854.

SU

PPO

RT4.

6.

Inte

grat

ion

of h

uman

and

or

gani

satio

nal

fact

ors

4.6.

1. T

he o

rgan

isat

ion

shal

l de

mon

stra

te a

sys

tem

atic

ap

proa

ch to

inte

grat

ing

hum

an a

nd o

rgan

isat

iona

l fa

ctor

s w

ithin

the

safe

ty

man

agem

ent s

yste

m. T

his

appr

oach

sha

ll:

(a) i

nclu

de th

e de

velo

pmen

t of

a st

rate

gy a

nd th

e us

e of

exp

ertis

e an

d re

cogn

ised

met

hods

from

the

field

of h

uman

and

org

anis

atio

nal

fact

ors;

864.

SU

PPO

RT4.

6.

Inte

grat

ion

of h

uman

and

or

gani

satio

nal

fact

ors

4.6.

1. T

he o

rgan

isat

ion

shal

l de

mon

stra

te a

sys

tem

atic

ap

proa

ch to

inte

grat

ing

hum

an a

nd o

rgan

isat

iona

l fa

ctor

s w

ithin

the

safe

ty

man

agem

ent s

yste

m. T

his

appr

oach

sha

ll:

(b) a

ddre

ss ri

sks

asso

ciat

ed w

ith

the

desi

gn a

nd u

se o

f equ

ipm

ent,

task

s, w

orki

ng c

ondi

tions

and

or

gani

satio

nal a

rran

gem

ents

, ta

king

into

acc

ount

hum

an

capa

bilit

ies

as w

ell a

s lim

itatio

ns,

and

the

influ

ence

s on

hum

an

perf

orm

ance

.

I.2.3

(in

gene

ral),

II.3

(in

gen

eral

), IV

.3, I

V.4,

IV

.5

141

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

875.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

1. W

hen

plan

ning

, de

velo

ping

, im

plem

entin

g an

d re

view

ing

its o

pera

tiona

l pr

oces

ses,

the

orga

nisa

tion

shal

l ens

ure

that

dur

ing

oper

atio

n:

(a) r

isk

acce

ptan

ce c

riter

ia a

nd

safe

ty m

easu

res

are

appl

ied

(see

3.

1.1.

Ris

k as

sess

men

t);

I.3 a

nd I.

9.6

(in

gene

ral)

885.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

1. W

hen

plan

ning

, de

velo

ping

, im

plem

entin

g an

d re

view

ing

its o

pera

tiona

l pr

oces

ses,

the

orga

nisa

tion

shal

l ens

ure

that

dur

ing

oper

atio

n:

(b) p

lan(

s) to

ach

ieve

the

safe

ty

obje

ctiv

es a

re d

eliv

ered

(see

3.2

. Sa

fety

obj

ectiv

es a

nd p

lann

ing)

;

I.1.(d

), I.3

, I.9

.3

895.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

1. W

hen

plan

ning

, de

velo

ping

, im

plem

entin

g an

d re

view

ing

its o

pera

tiona

l pr

oces

ses,

the

orga

nisa

tion

shal

l ens

ure

that

dur

ing

oper

atio

n:

(c) i

nfor

mat

ion

is c

olle

cted

to

mea

sure

the

corr

ect a

pplic

atio

n an

d eff

ectiv

enes

s of

the

oper

atio

nal a

rran

gem

ents

(see

6.1

. M

onito

ring)

.

I.3 (i

n ge

nera

l), I.

9.6

(in g

ener

al),

I.9.5

(in

gen

eral

), I.7

(in

gene

ral)

905.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

its

oper

atio

nal

arra

ngem

ents

con

form

to

the

safe

ty-r

elat

ed

requ

irem

ents

of a

pplic

able

Te

chni

cal S

peci

ficat

ions

for

Inte

rope

rabi

lity

and

rele

vant

na

tiona

l rul

es a

nd a

ny o

ther

re

leva

nt re

quire

men

ts (s

ee 1

. Co

ntex

t of t

he o

rgan

isat

ion)

.

II.2,

Art

. 4(1

)

915.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

3. T

o co

ntro

l ris

ks w

here

re

leva

nt fo

r the

saf

ety

of

oper

atio

nal a

ctiv

ities

(see

3.1

.1.

Risk

ass

essm

ent)

, at l

east

the

follo

win

g sh

all b

e ta

ken

into

ac

coun

t:

(a) p

lann

ing

of e

xist

ing

or n

ew

trai

n ro

utes

and

new

trai

n se

rvic

es,

incl

udin

g th

e in

trod

uctio

n of

new

ty

pes

of v

ehic

les,

the

need

to le

ase

vehi

cles

and

/or t

o hi

re s

taff

from

ex

tern

al p

artie

s an

d th

e ex

chan

ge

of in

form

atio

n on

the

mai

nten

ance

fo

r ope

ratio

nal p

urpo

ses

with

en

titie

s in

cha

rge

of m

aint

enan

ce;

I.7 (i

n ge

nera

l), A

rt.

5(1)

, Art

. 5(2

), A

rt. 5

(3)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

142

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

925.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

3. T

o co

ntro

l ris

ks w

here

re

leva

nt fo

r the

saf

ety

of

oper

atio

nal a

ctiv

ities

(see

3.1

.1.

Risk

ass

essm

ent)

, at l

east

the

follo

win

g sh

all b

e ta

ken

into

ac

coun

t:

(b) d

evel

opm

ent a

nd

impl

emen

tatio

n of

trai

n tim

etab

les;

935.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

3. T

o co

ntro

l ris

ks w

here

re

leva

nt fo

r the

saf

ety

of

oper

atio

nal a

ctiv

ities

(see

3.1

.1.

Risk

ass

essm

ent)

, at l

east

the

follo

win

g sh

all b

e ta

ken

into

ac

coun

t:

(c) p

repa

ratio

n of

trai

ns o

r veh

icle

s be

fore

mov

emen

t, in

clud

ing

pre-

depa

rtur

e ch

ecks

and

trai

n co

mpo

sitio

n;

945.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

3. T

o co

ntro

l ris

ks w

here

re

leva

nt fo

r the

saf

ety

of

oper

atio

nal a

ctiv

ities

(see

3.1

.1.

Risk

ass

essm

ent)

, at l

east

the

follo

win

g sh

all b

e ta

ken

into

ac

coun

t:

(d) r

unni

ng tr

ains

or m

ovem

ent o

f ve

hicl

es in

the

diffe

rent

ope

ratin

g co

nditi

ons

(nor

mal

, deg

rade

d an

d em

erge

ncy)

;

955.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

3. T

o co

ntro

l ris

ks w

here

re

leva

nt fo

r the

saf

ety

of

oper

atio

nal a

ctiv

ities

(see

3.1

.1.

Risk

ass

essm

ent)

, at l

east

the

follo

win

g sh

all b

e ta

ken

into

ac

coun

t:

(e) a

dapt

atio

n of

the

oper

atio

n to

requ

ests

for r

emov

al fr

om

oper

atio

n an

d no

tifica

tion

of

retu

rn to

ope

ratio

n is

sued

by

entit

ies

in c

harg

e of

mai

nten

ance

;

III.4

, III.

6, II

I.9, I

II.10

965.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

3. T

o co

ntro

l ris

ks w

here

re

leva

nt fo

r the

saf

ety

of

oper

atio

nal a

ctiv

ities

(see

3.1

.1.

Risk

ass

essm

ent)

, at l

east

the

follo

win

g sh

all b

e ta

ken

into

ac

coun

t:

(f) a

utho

risat

ions

for m

ovem

ents

of

veh

icle

s;

143

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

975.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

3. T

o co

ntro

l ris

ks w

here

re

leva

nt fo

r the

saf

ety

of

oper

atio

nal a

ctiv

ities

(see

3.1

.1.

Risk

ass

essm

ent)

, at l

east

the

follo

win

g sh

all b

e ta

ken

into

ac

coun

t:

(g) u

sabi

lity

of in

terf

aces

in tr

ain

driv

ing

cabs

and

trai

n co

ntro

l ce

ntre

s an

d w

ith e

quip

men

t use

d by

mai

nten

ance

sta

ff.

II.3,

IV.3

, IV.

4, IV

.5

985.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

4. T

o co

ntro

l the

al

loca

tion

of re

spon

sibi

litie

s w

here

rele

vant

for t

he s

afet

y of

ope

ratio

nal a

ctiv

ities

, th

e or

gani

satio

n sh

all

iden

tify

resp

onsi

bilit

ies

for

coor

dina

ting

and

man

agin

g th

e sa

fe ru

nnin

g of

trai

ns

and

mov

emen

ts o

f veh

icle

s an

d de

fine

how

rele

vant

ta

sks

affec

ting

the

safe

de

liver

y of

all

serv

ices

are

al

loca

ted

to c

ompe

tent

st

aff w

ithin

the

orga

nisa

tion

(see

2.3

. Org

anis

atio

nal

role

s, re

spon

sibi

litie

s, ac

coun

tabi

litie

s an

d au

thor

ities

) and

to o

ther

ex

tern

al q

ualifi

ed p

artie

s w

hen

appr

opria

te (s

ee 5

.3.

Cont

ract

ors,

part

ners

and

su

pplie

rs).

I.9.1

and

I.9.

2 (in

ge

nera

l)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

144

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

995.

O

PERA

TIO

N5.

1.

Ope

ratio

nal

plan

ning

and

co

ntro

l

5.1.

5. T

o co

ntro

l inf

orm

atio

n an

d co

mm

unic

atio

n w

here

re

leva

nt fo

r the

saf

ety

of o

pera

tiona

l act

iviti

es

(see

4.4

. Inf

orm

atio

n an

d co

mm

unic

atio

n), r

elev

ant

staff

(e.g

. tra

in c

rew

s) s

hall

be

advi

sed

of th

e de

tails

of a

ny

spec

ified

con

ditio

ns o

f tra

vel,

incl

udin

g re

leva

nt c

hang

es

whi

ch m

ay re

sult

in a

haz

ard,

te

mpo

rary

or p

erm

anen

t op

erat

iona

l res

tric

tions

(e.g

. du

e to

spe

cific

type

of v

ehic

les

or to

spe

cific

rout

es) a

nd

cond

ition

s fo

r exc

eptio

nal

cons

ignm

ents

, whe

re

appl

icab

le.

I.7, I

I.5, I

II.6,

III.9

, III.

10,

IV.9

, Art

. 4(2

), A

rt. 4

(6)

100

5.

OPE

RATI

ON

5.1.

O

pera

tiona

l pl

anni

ng a

nd

cont

rol

5.1.

6. T

o co

ntro

l com

pete

nce

whe

re re

leva

nt fo

r the

saf

ety

of

oper

atio

nal a

ctiv

ities

(see

4.2

. Co

mpe

tenc

e), t

he o

rgan

isat

ion

shal

l ens

ure,

in a

ccor

danc

e w

ith a

pplic

able

legi

slat

ion

(see

1.

Con

text

of t

he o

rgan

isat

ion)

, fo

r its

sta

ff:

(a) c

ompl

ianc

e w

ith th

eir t

rain

ing

and

wor

k in

stru

ctio

ns, a

nd

corr

ectiv

e ac

tions

are

take

n w

here

re

quire

d;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

101

5.

OPE

RATI

ON

5.1.

O

pera

tiona

l pl

anni

ng a

nd

cont

rol

5.1.

6. T

o co

ntro

l com

pete

nce

whe

re re

leva

nt fo

r the

saf

ety

of

oper

atio

nal a

ctiv

ities

(see

4.2

. Co

mpe

tenc

e), t

he o

rgan

isat

ion

shal

l ens

ure,

in a

ccor

danc

e w

ith a

pplic

able

legi

slat

ion

(see

1.

Con

text

of t

he o

rgan

isat

ion)

, fo

r its

sta

ff:

(b) s

peci

fic tr

aini

ng in

cas

e of

an

ticip

ated

cha

nges

affe

ctin

g th

e ru

nnin

g of

ope

ratio

ns o

r the

ir ta

sk

assi

gnm

ent;

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

145

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

102

5.

OPE

RATI

ON

5.1.

O

pera

tiona

l pl

anni

ng a

nd

cont

rol

5.1.

6. T

o co

ntro

l com

pete

nce

whe

re re

leva

nt fo

r the

saf

ety

of

oper

atio

nal a

ctiv

ities

(see

4.2

. Co

mpe

tenc

e), t

he o

rgan

isat

ion

shal

l ens

ure,

in a

ccor

danc

e w

ith a

pplic

able

legi

slat

ion

(see

1.

Con

text

of t

he o

rgan

isat

ion)

, fo

r its

sta

ff:

(c) a

dopt

ion

of a

dequ

ate

mea

sure

s fo

llow

ing

acci

dent

s an

d in

cide

nts.

I.6 (i

n ge

nera

l), II

.6 (i

n ge

nera

l), II

I.1, I

II.7,

IV.8

103

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.1.

The

org

anis

atio

n sh

all m

anag

e th

e sa

fety

risk

s as

soci

ated

with

phy

sica

l ass

ets

thro

ugho

ut th

eir l

ife c

ycle

(s

ee 3

.1.1

. Ris

k as

sess

men

t),

from

des

ign

to d

ispo

sal,

and

fulfi

l the

hum

an fa

ctor

s re

quire

men

ts in

all

phas

es o

f th

e lif

e cy

cle.

I.2 (i

n ge

nera

l)

104

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.2.

The

org

anis

atio

n sh

all:

(a) e

nsur

e th

at th

e as

sets

are

use

d fo

r the

pur

pose

inte

nded

whi

le

mai

ntai

ning

thei

r saf

e op

erat

iona

l st

ate,

in a

ccor

danc

e w

ith A

rtic

le

14(2

) of D

irect

ive

(EU

) 201

6/79

8 w

here

rele

vant

, and

thei

r exp

ecte

d le

vel o

f per

form

ance

;

105

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.2.

The

org

anis

atio

n sh

all:

(b) m

anag

e th

e as

sets

in n

orm

al

and

degr

aded

ope

ratio

ns;

106

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.2.

The

org

anis

atio

n sh

all:

(c) d

etec

t as

soon

as

reas

onab

ly

prac

ticab

le in

stan

ces

of n

on-

com

plia

nce

with

ope

ratin

g re

quire

men

ts b

efor

e or

dur

ing

the

oper

atio

n of

the

asse

t, in

clud

ing

the

appl

icat

ion

of re

stric

tions

of

use

as a

ppro

pria

te to

ens

ure

a sa

fe

oper

atio

nal s

tate

of t

he a

sset

(see

6.

1. M

onito

ring)

.

III.6

, III.

9, II

I.10

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

146

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

107

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.3.

The

org

anis

atio

n sh

all e

nsur

e th

at it

s as

set

man

agem

ent a

rran

gem

ents

, w

here

app

licab

le, c

onfo

rm

to a

ll es

sent

ial r

equi

rem

ents

as

set

out

in th

e re

leva

nt

Tech

nica

l Spe

cific

atio

ns fo

r In

tero

pera

bilit

y an

d an

y ot

her

rele

vant

requ

irem

ents

(see

1.

Cont

ext o

f the

org

anis

atio

n).

II. 2

(in

gene

ral),

Art

. 4(

1)

108

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.4.

To

cont

rol r

isks

whe

re

rele

vant

for t

he s

uppl

y of

m

aint

enan

ce (s

ee 3

.1.1

. Ris

k as

sess

men

t), a

t lea

st th

e fo

llow

ing

shal

l be

take

n in

to

acco

unt:

(a) t

he id

entifi

catio

n of

the

need

fo

r mai

nten

ance

to k

eep

the

asse

t in

a s

afe

oper

atio

nal s

tate

, bas

ed

on th

e pl

anne

d an

d re

al u

se o

f the

as

set a

nd it

s de

sign

cha

ract

eris

tics;

III.4

109

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.4.

To

cont

rol r

isks

whe

re

rele

vant

for t

he s

uppl

y of

m

aint

enan

ce (s

ee 3

.1.1

. Ris

k as

sess

men

t), a

t lea

st th

e fo

llow

ing

shal

l be

take

n in

to

acco

unt:

(b) t

he m

anag

emen

t of t

he

rem

oval

of t

he a

sset

from

op

erat

ion

for m

aint

enan

ce, w

hen

defe

cts

have

bee

n id

entifi

ed o

r w

hen

asse

t con

ditio

n de

grad

es

outs

ide

the

limits

of a

saf

e op

erat

iona

l sta

te a

s re

ferr

ed to

in

poin

t (a)

;

III.4

, Art

. 4(2

), A

rt. 4

(4)

110

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.4.

To

cont

rol r

isks

whe

re

rele

vant

for t

he s

uppl

y of

m

aint

enan

ce (s

ee 3

.1.1

. Ris

k as

sess

men

t), a

t lea

st th

e fo

llow

ing

shal

l be

take

n in

to

acco

unt:

(c) t

he m

anag

emen

t of t

he re

turn

to

ope

ratio

n of

the

asse

t with

ev

entu

al re

stric

tions

of u

se a

fter

m

aint

enan

ce h

as b

een

deliv

ered

to

ens

ure

it is

in a

saf

e op

erat

iona

l st

ate;

III.4

147

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

111

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.4.

To

cont

rol r

isks

whe

re

rele

vant

for t

he s

uppl

y of

m

aint

enan

ce (s

ee 3

.1.1

. Ris

k as

sess

men

t), a

t lea

st th

e fo

llow

ing

shal

l be

take

n in

to

acco

unt:

(d) t

he m

anag

emen

t of m

onito

ring

and

mea

sure

men

t equ

ipm

ent t

o en

sure

that

it is

fit f

or it

s in

tend

ed

purp

ose.

II.3

(in g

ener

al),

III.6

, III

.9, I

II.10

, IV.

3, IV

.4, I

V.5

112

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.5.

To

cont

rol i

nfor

mat

ion

and

com

mun

icat

ion

whe

re re

leva

nt fo

r the

saf

e m

anag

emen

t of a

sset

s (s

ee 4

.4. I

nfor

mat

ion

and

com

mun

icat

ion)

, the

or

gani

satio

n sh

all t

ake

into

ac

coun

t:

(a) t

he e

xcha

nge

of re

leva

nt

info

rmat

ion

with

in th

e or

gani

satio

n or

with

ext

erna

l en

titie

s re

spon

sibl

e fo

r m

aint

enan

ce (s

ee 5

.3. C

ontr

acto

rs,

part

ners

and

sup

plie

rs),

in

part

icul

ar o

n sa

fety

-rel

ated

m

alfu

nctio

ns, a

ccid

ents

, inc

iden

ts

as w

ell a

s on

eve

ntua

l res

tric

tions

of

use

of t

he a

sset

;

I.7 (i

n ge

nera

l), I.

9.6,

II.

5, II

I.6, I

II.9,

III.1

0, IV

.9,

Art

. 4(2

), A

rt. 4

(6),

Art

. 5(

1), A

rt. 5

(2),

Art

. 5(3

)

113

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.5.

To

cont

rol i

nfor

mat

ion

and

com

mun

icat

ion

whe

re re

leva

nt fo

r the

saf

e m

anag

emen

t of a

sset

s (s

ee 4

.4. I

nfor

mat

ion

and

com

mun

icat

ion)

, the

or

gani

satio

n sh

all t

ake

into

ac

coun

t:

(b) t

he tr

acea

bilit

y of

all

nece

ssar

y in

form

atio

n in

clud

ing

the

info

rmat

ion

rela

ted

to p

oint

(a

) (se

e 4.

4. In

form

atio

n an

d co

mm

unic

atio

n an

d 4.

5.3.

Con

trol

of

doc

umen

ted

info

rmat

ion)

;

I.7 (i

n ge

nera

l), I.

8,

I.9.6

, II.5

(in

gene

ral),

II.

7, II

I.4 (i

n ge

nera

l),

III.9

, IV.

9, A

rt. 4

(5)b

114

5.

OPE

RATI

ON

5.2.

A

sset

m

anag

emen

t5.

2.5.

To

cont

rol i

nfor

mat

ion

and

com

mun

icat

ion

whe

re re

leva

nt fo

r the

saf

e m

anag

emen

t of a

sset

s (s

ee 4

.4. I

nfor

mat

ion

and

com

mun

icat

ion)

, the

or

gani

satio

n sh

all t

ake

into

ac

coun

t:

(c) t

he e

stab

lishm

ent a

nd

mai

nten

ance

of r

ecor

ds in

clud

ing

the

man

agem

ent o

f cha

nges

aff

ectin

g th

e sa

fety

of a

sset

s (s

ee

5.4.

Man

agem

ent o

f cha

nge)

.

I.7, I

.8, I

I.2 (i

n ge

nera

l),

II.5

(in g

ener

al),

II.7,

III

.10,

IV.1

0, A

rt. 4

(5)b

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

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nloa

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e la

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ver

sion

at e

ra.e

urop

a.eu

.©

202

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Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

148

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

115

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

1. T

he o

rgan

isat

ion

shal

l ide

ntify

and

con

trol

sa

fety

risk

s ar

isin

g fr

om

outs

ourc

ed a

ctiv

ities

, inc

ludi

ng

oper

atio

ns o

r coo

pera

tion

with

con

trac

tors

, par

tner

s an

d su

pplie

rs.

I.9.1

, Art

. 9(2

)

116

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

2. T

o co

ntro

l the

saf

ety

risks

refe

rred

to in

par

agra

ph

5.3.

1, th

e or

gani

satio

n sh

all

defin

e th

e cr

iteria

for t

he

sele

ctio

n of

the

cont

ract

ors,

part

ners

and

sup

plie

rs a

nd th

e co

ntra

ct re

quire

men

ts th

ey

have

to m

eet,

incl

udin

g:

(a) t

he le

gal a

nd o

ther

re

quire

men

ts re

late

d to

saf

ety

(see

1.

Con

text

of t

he o

rgan

isat

ion)

;

I.9 (i

n ge

nera

l)

117

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

2. T

o co

ntro

l the

saf

ety

risks

refe

rred

to in

par

agra

ph

5.3.

1, th

e or

gani

satio

n sh

all

defin

e th

e cr

iteria

for t

he

sele

ctio

n of

the

cont

ract

ors,

part

ners

and

sup

plie

rs a

nd th

e co

ntra

ct re

quire

men

ts th

ey

have

to m

eet,

incl

udin

g:

(b) t

he le

vel o

f com

pete

nce

requ

ired

to d

eliv

er th

e ta

sks

set o

ut in

the

cont

ract

(see

4.2

. Co

mpe

tenc

e);

I.9.2

118

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

2. T

o co

ntro

l the

saf

ety

risks

refe

rred

to in

par

agra

ph

5.3.

1, th

e or

gani

satio

n sh

all

defin

e th

e cr

iteria

for t

he

sele

ctio

n of

the

cont

ract

ors,

part

ners

and

sup

plie

rs a

nd th

e co

ntra

ct re

quire

men

ts th

ey

have

to m

eet,

incl

udin

g:

(c) t

he re

spon

sibi

litie

s fo

r the

task

s to

be

perf

orm

ed;

I.9.6

149

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

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hen

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ted.

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nloa

d th

e la

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sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

119

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

2. T

o co

ntro

l the

saf

ety

risks

refe

rred

to in

par

agra

ph

5.3.

1, th

e or

gani

satio

n sh

all

defin

e th

e cr

iteria

for t

he

sele

ctio

n of

the

cont

ract

ors,

part

ners

and

sup

plie

rs a

nd th

e co

ntra

ct re

quire

men

ts th

ey

have

to m

eet,

incl

udin

g:

(d) t

he e

xpec

ted

safe

ty

perf

orm

ance

to b

e m

aint

aine

d du

ring

the

cont

ract

;

I.9.3

, Art

. 9(3

)

120

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

2. T

o co

ntro

l the

saf

ety

risks

refe

rred

to in

par

agra

ph

5.3.

1, th

e or

gani

satio

n sh

all

defin

e th

e cr

iteria

for t

he

sele

ctio

n of

the

cont

ract

ors,

part

ners

and

sup

plie

rs a

nd th

e co

ntra

ct re

quire

men

ts th

ey

have

to m

eet,

incl

udin

g:

(e) t

he o

blig

atio

ns re

latin

g to

th

e ex

chan

ge o

f saf

ety-

rela

ted

info

rmat

ion

(see

4.4

. Inf

orm

atio

n an

d co

mm

unic

atio

n);

I.9.6

121

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

2. T

o co

ntro

l the

saf

ety

risks

refe

rred

to in

par

agra

ph

5.3.

1, th

e or

gani

satio

n sh

all

defin

e th

e cr

iteria

for t

he

sele

ctio

n of

the

cont

ract

ors,

part

ners

and

sup

plie

rs a

nd th

e co

ntra

ct re

quire

men

ts th

ey

have

to m

eet,

incl

udin

g:

(f) t

he tr

acea

bilit

y of

saf

ety-

rela

ted

docu

men

ts (s

ee 4

.5. D

ocum

ente

d in

form

atio

n).

I.9.6

122

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

3.

In a

ccor

danc

e w

ith th

e pr

oces

s se

t out

in A

rtic

le 3

of

Regu

latio

n (E

U) N

o 10

78/2

012,

th

e or

gani

satio

n sh

all m

onito

r:

(a) t

he s

afet

y pe

rfor

man

ce o

f al

l act

iviti

es a

nd o

pera

tions

of

cont

ract

ors,

part

ners

and

sup

plie

rs

to e

nsur

e th

at th

ey c

ompl

y w

ith

the

requ

irem

ents

set

out

in th

e co

ntra

ct;

I.9.5

, Art

. 4(4

), A

rt. 9

(3)

123

5.

OPE

RATI

ON

5.3.

Co

ntra

ctor

s, pa

rtne

rs a

nd

supp

liers

5.3.

3.

In a

ccor

danc

e w

ith th

e pr

oces

s se

t out

in A

rtic

le 3

of

Regu

latio

n (E

U) N

o 10

78/2

012,

th

e or

gani

satio

n sh

all m

onito

r:

(b) t

he a

war

enes

s of

con

trac

tors

, pa

rtne

rs a

nd s

uppl

iers

of

safe

ty ri

sks

they

ent

ail t

o th

e or

gani

satio

n’s

oper

atio

ns.

I.9.2

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

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(01/

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021)

. Unc

ontr

olle

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ted.

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e la

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ver

sion

at e

ra.e

urop

a.eu

.©

202

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Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

150

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

124

5.

OPE

RATI

ON

5.4.

M

anag

emen

t of

cha

nge

5.4.

1. T

he o

rgan

isat

ion

shal

l im

plem

ent a

nd c

ontr

ol

chan

ges

to th

e sa

fety

m

anag

emen

t sys

tem

to

mai

ntai

n or

impr

ove

the

safe

ty p

erfo

rman

ce. T

his

shal

l inc

lude

dec

isio

ns a

t th

e di

ffere

nt s

tage

s of

the

chan

ge m

anag

emen

t and

th

e su

bseq

uent

revi

ew o

f sa

fety

risk

s (s

ee 3

.1.1

. Ris

k as

sess

men

t).

125

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

1. T

he o

rgan

isat

ion

shal

l ide

ntify

the

emer

genc

y si

tuat

ions

and

ass

ocia

ted

timel

y m

easu

res

to b

e ta

ken

to m

anag

e th

em (s

ee 3

.1.1

. Ri

sk a

sses

smen

t) a

nd to

re-

esta

blis

h no

rmal

ope

ratin

g co

nditi

ons

in a

ccor

danc

e w

ith

Regu

latio

n (E

U) 2

015/

995

(5).

126

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

, for

eac

h id

entifi

ed

type

of e

mer

genc

y:

(a) t

he e

mer

genc

y se

rvic

es c

an b

e pr

ompt

ly c

onta

cted

;

127

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

, for

eac

h id

entifi

ed

type

of e

mer

genc

y:

(b) t

he e

mer

genc

y se

rvic

es

are

prov

ided

with

all

rele

vant

in

form

atio

n bo

th in

adv

ance

, to

prep

are

thei

r em

erge

ncy

resp

onse

, an

d at

the

time

of a

n em

erge

ncy;

I.7.(j

)

128

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

, for

eac

h id

entifi

ed

type

of e

mer

genc

y:

(c) fi

rst a

id is

pro

vide

d in

tern

ally

.










151

Vers

ion

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(01/

03/2

021)

. Unc

ontr

olle

d w

hen

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ted.

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nloa

d th

e la

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ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

129

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

3. T

he o

rgan

isat

ion

shal

l id

entif

y an

d do

cum

ent t

he

role

s an

d re

spon

sibi

litie

s of

al

l par

ties

in a

ccor

danc

e w

ith

Regu

latio

n (E

U) 2

015/

995.

130

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

4. T

he o

rgan

isat

ion

shal

l hav

e pl

ans

for a

ctio

n,

aler

ts a

nd in

form

atio

n in

ca

se o

f em

erge

ncy

incl

udin

g ar

rang

emen

ts to

:

(a) a

lert

all

staff

with

resp

onsi

bilit

y fo

r em

erge

ncy

man

agem

ent;

131

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

4. T

he o

rgan

isat

ion

shal

l hav

e pl

ans

for a

ctio

n,

aler

ts a

nd in

form

atio

n in

ca

se o

f em

erge

ncy

incl

udin

g ar

rang

emen

ts to

:

(b) c

omm

unic

ate

info

rmat

ion

to a

ll pa

rtie

s (e

.g. i

nfra

stru

ctur

e m

anag

er, c

ontr

acto

rs, a

utho

ritie

s, em

erge

ncy

serv

ices

), in

clud

ing

emer

genc

y in

stru

ctio

ns fo

r pa

ssen

gers

;

I.7 (i

n ge

nera

l)

132

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

4. T

he o

rgan

isat

ion

shal

l hav

e pl

ans

for a

ctio

n,

aler

ts a

nd in

form

atio

n in

ca

se o

f em

erge

ncy

incl

udin

g ar

rang

emen

ts to

:

(c) t

ake

any

deci

sion

s re

quire

d in

acc

orda

nce

with

the

type

of

emer

genc

y.

133

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

5. T

he o

rgan

isat

ion

shal

l de

scrib

e ho

w re

sour

ces

and

mea

ns fo

r em

erge

ncy

man

agem

ent h

ave

been

al

loca

ted

(see

4.1

. Res

ourc

es)

and

how

trai

ning

requ

irem

ents

ha

ve b

een

iden

tified

(see

4.2

. Co

mpe

tenc

e).

134

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

6. T

he e

mer

genc

y ar

rang

emen

ts a

re re

gula

rly

test

ed in

coo

pera

tion

with

ot

her i

nter

este

d pa

rtie

s an

d up

date

d w

hen

appr

opria

te.

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

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ted.

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nloa

d th

e la

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ver

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at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

152

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

135

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

7. T

he o

rgan

isat

ion

shal

l en

sure

that

com

pete

nt s

taff

in c

harg

e, w

ith a

dequ

ate

lang

uage

ski

lls, c

an b

e co

ntac

ted

easi

ly a

nd w

ithou

t de

lay

by th

e in

fras

truc

ture

m

anag

er a

nd p

rovi

de th

e la

tter

with

the

right

leve

l of

info

rmat

ion.

136

5.

OPE

RATI

ON

5.5.

Em

erge

ncy

man

agem

ent

5.5.

8. T

he o

rgan

isat

ion

shal

l hav

e a

proc

edur

e to

co

ntac

t the

ent

ity in

cha

rge

of m

aint

enan

ce o

r the

railw

ay

vehi

cle

keep

er in

the

even

t of

an e

mer

genc

y.

I.7 (i

n ge

nera

l)

137

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.1.

M

onito

ring

6.1.

1. T

he o

rgan

isat

ion

shal

l per

form

mon

itorin

g in

ac

cord

ance

with

Reg

ulat

ion

(EU

) No

1078

/201

2:

(a) t

o ch

eck

the

corr

ect a

pplic

atio

n an

d th

e eff

ectiv

enes

s of

all

the

proc

esse

s an

d pr

oced

ures

in

the

safe

ty m

anag

emen

t sys

tem

, in

clud

ing

the

oper

atio

nal,

orga

nisa

tiona

l and

tech

nica

l saf

ety

mea

sure

s;

I.3 (i

n ge

nera

l), A

rt.

4(4)

, Art

. 7(1

), A

rt. 9

(3)

138

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.1.

M

onito

ring

6.1.

1. T

he o

rgan

isat

ion

shal

l per

form

mon

itorin

g in

ac

cord

ance

with

Reg

ulat

ion

(EU

) No

1078

/201

2:

(b) t

o ch

eck

the

corr

ect a

pplic

atio

n of

the

safe

ty m

anag

emen

t sys

tem

as

a w

hole

, and

if it

ach

ieve

s th

e ex

pect

ed o

utco

mes

;

I.3 (i

n ge

nera

l), A

rt.

4(4)

, Art

. 7(1

), A

rt. 9

(3)

139

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.1.

M

onito

ring

6.1.

1. T

he o

rgan

isat

ion

shal

l per

form

mon

itorin

g in

ac

cord

ance

with

Reg

ulat

ion

(EU

) No

1078

/201

2:

(c) t

o in

vest

igat

e w

heth

er th

e sa

fety

man

agem

ent s

yste

m

conf

orm

s to

the

requ

irem

ents

in

this

Reg

ulat

ion;

I.3 (i

n ge

nera

l), A

rt.

4(4)

, Art

. 7(1

), A

rt. 9

(3)

153

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

140

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.1.

M

onito

ring

6.1.

1. T

he o

rgan

isat

ion

shal

l per

form

mon

itorin

g in

ac

cord

ance

with

Reg

ulat

ion

(EU

) No

1078

/201

2:

(d) t

o id

entif

y, im

plem

ent a

nd

eval

uate

the

effec

tiven

ess

of

the

corr

ectiv

e m

easu

res

(see

7.

2. C

ontin

ual i

mpr

ovem

ent)

, as

app

ropr

iate

, if a

ny re

leva

nt

inst

ance

of n

on-c

ompl

ianc

e to

po

ints

(a),

(b) a

nd (c

) is

dete

cted

.

I.3 a

nd I.

4 (in

gen

eral

), A

rt. 4

(4),

Art

. 7(1

), A

rt.

9(3)

141

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.1.

M

onito

ring

6.1.

2. T

he o

rgan

isat

ion

shal

l re

gula

rly m

onito

r at a

ll le

vels

w

ithin

the

orga

nisa

tion

the

perf

orm

ance

of s

afet

y-re

late

d ta

sks

and

inte

rven

e if

thes

e ta

sks

are

not b

eing

pro

perly

pe

rfor

med

.

I.3 a

nd I.

4 (in

gen

eral

), A

rt. 4

(4),

Art

. 7(1

), A

rt.

9(3)

142

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l co

nduc

t int

erna

l aud

its in

an

inde

pend

ent,

impa

rtia

l and

tr

ansp

aren

t way

to c

olle

ct a

nd

anal

yse

info

rmat

ion

for t

he

purp

oses

of i

ts m

onito

ring

activ

ities

(see

6.1

. Mon

itorin

g),

incl

udin

g:

(a) A

sch

edul

e of

pla

nned

inte

rnal

au

dits

whi

ch c

an b

e re

vise

d de

pend

ing

on th

e re

sults

of

prev

ious

aud

its a

nd m

onito

ring

of

perf

orm

ance

;

I.3 (i

n ge

nera

l)

143

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l co

nduc

t int

erna

l aud

its in

an

inde

pend

ent,

impa

rtia

l and

tr

ansp

aren

t way

to c

olle

ct a

nd

anal

yse

info

rmat

ion

for t

he

purp

oses

of i

ts m

onito

ring

activ

ities

(see

6.1

. Mon

itorin

g),

incl

udin

g:

(b) T

he id

entifi

catio

n an

d se

lect

ion

of c

ompe

tent

aud

itors

(see

4.2

. Co

mpe

tenc

e);

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

154

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

144

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l co

nduc

t int

erna

l aud

its in

an

inde

pend

ent,

impa

rtia

l and

tr

ansp

aren

t way

to c

olle

ct a

nd

anal

yse

info

rmat

ion

for t

he

purp

oses

of i

ts m

onito

ring

activ

ities

(see

6.1

. Mon

itorin

g),

incl

udin

g:

(c) T

he a

naly

sis

and

eval

uatio

n of

th

e re

sults

of t

he a

udits

;I.3

(in

gene

ral)

145

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l co

nduc

t int

erna

l aud

its in

an

inde

pend

ent,

impa

rtia

l and

tr

ansp

aren

t way

to c

olle

ct a

nd

anal

yse

info

rmat

ion

for t

he

purp

oses

of i

ts m

onito

ring

activ

ities

(see

6.1

. Mon

itorin

g),

incl

udin

g:

(d) T

he id

entifi

catio

n of

the

need

fo

r cor

rect

ive

or im

prov

emen

t m

easu

res;

I.3 (i

n ge

nera

l)

146

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l co

nduc

t int

erna

l aud

its in

an

inde

pend

ent,

impa

rtia

l and

tr

ansp

aren

t way

to c

olle

ct a

nd

anal

yse

info

rmat

ion

for t

he

purp

oses

of i

ts m

onito

ring

activ

ities

(see

6.1

. Mon

itorin

g),

incl

udin

g:

(e) T

he v

erifi

catio

n of

the

com

plet

ion

and

effec

tiven

ess

of

thes

e m

easu

res;

I.3 (i

n ge

nera

l)

147

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l co

nduc

t int

erna

l aud

its in

an

inde

pend

ent,

impa

rtia

l and

tr

ansp

aren

t way

to c

olle

ct a

nd

anal

yse

info

rmat

ion

for t

he

purp

oses

of i

ts m

onito

ring

activ

ities

(see

6.1

. Mon

itorin

g),

incl

udin

g:

(f) T

he d

ocum

enta

tion

pert

aini

ng

to th

e ex

ecut

ion

and

resu

lts o

f au

dits

;

I.3 (i

n ge

nera

l)

155

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

148

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.2.

In

tern

al

audi

ting

6.2.

1. T

he o

rgan

isat

ion

shal

l co

nduc

t int

erna

l aud

its in

an

inde

pend

ent,

impa

rtia

l and

tr

ansp

aren

t way

to c

olle

ct a

nd

anal

yse

info

rmat

ion

for t

he

purp

oses

of i

ts m

onito

ring

activ

ities

(see

6.1

. Mon

itorin

g),

incl

udin

g:

(g) T

he c

omm

unic

atio

n of

the

resu

lts o

f aud

its to

the

top

man

agem

ent.

I.1.(g

)

149

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

1. T

op m

anag

emen

t sh

all r

egul

arly

revi

ew th

e co

ntin

uing

ade

quac

y an

d eff

ectiv

enes

s of

the

safe

ty

man

agem

ent s

yste

m in

clud

ing

at le

ast c

onsi

dera

tion

of:

(a) d

etai

ls o

f pro

gres

s on

ad

dres

sing

out

stan

ding

act

ions

fr

om p

revi

ous

man

agem

ent

revi

ews;

I.1 a

nd I.

3 (in

gen

eral

)

150

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

1. T

op m

anag

emen

t sh

all r

egul

arly

revi

ew th

e co

ntin

uing

ade

quac

y an

d eff

ectiv

enes

s of

the

safe

ty

man

agem

ent s

yste

m in

clud

ing

at le

ast c

onsi

dera

tion

of:

(b) c

hang

ing

inte

rnal

and

ext

erna

l ci

rcum

stan

ces

(see

1. C

onte

xt o

f th

e or

gani

satio

n);

I.1 a

nd I.

3 (in

gen

eral

)

151

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

1. T

op m

anag

emen

t sh

all r

egul

arly

revi

ew th

e co

ntin

uing

ade

quac

y an

d eff

ectiv

enes

s of

the

safe

ty

man

agem

ent s

yste

m in

clud

ing

at le

ast c

onsi

dera

tion

of:

(c) t

he o

rgan

isat

ion’

s sa

fety

pe

rfor

man

ce re

late

d to

:(i)

the

achi

evem

ent o

f its

saf

ety

obje

ctiv

es;

I.1 a

nd I.

3 (in

gen

eral

)

152

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

1. T

op m

anag

emen

t sh

all r

egul

arly

revi

ew th

e co

ntin

uing

ade

quac

y an

d eff

ectiv

enes

s of

the

safe

ty

man

agem

ent s

yste

m in

clud

ing

at le

ast c

onsi

dera

tion

of:

(c) t

he o

rgan

isat

ion’

s sa

fety

pe

rfor

man

ce re

late

d to

:(ii

) the

resu

lts fr

om it

s m

onito

ring

activ

ities

, inc

ludi

ng th

e in

tern

al

audi

t find

ings

, and

inte

rnal

ac

cide

nt/in

cide

nt in

vest

igat

ions

an

d st

atus

of t

heir

resp

ectiv

e ac

tions

;

I.1 a

nd I.

3 (in

gen

eral

)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

156

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

153

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

1. T

op m

anag

emen

t sh

all r

egul

arly

revi

ew th

e co

ntin

uing

ade

quac

y an

d eff

ectiv

enes

s of

the

safe

ty

man

agem

ent s

yste

m in

clud

ing

at le

ast c

onsi

dera

tion

of:

(c) t

he o

rgan

isat

ion’

s sa

fety

pe

rfor

man

ce re

late

d to

:(ii

i) th

e re

leva

nt o

utpu

ts fr

om

supe

rvis

ory

activ

ities

con

duct

ed

by th

e na

tiona

l saf

ety

auth

ority

;

I.1 a

nd I.

3 (in

gen

eral

)

154

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

1. T

op m

anag

emen

t sh

all r

egul

arly

revi

ew th

e co

ntin

uing

ade

quac

y an

d eff

ectiv

enes

s of

the

safe

ty

man

agem

ent s

yste

m in

clud

ing

at le

ast c

onsi

dera

tion

of:

(d) r

ecom

men

datio

ns fo

r im

prov

emen

t.I.1

and

I.3

(in g

ener

al)

155

6.

PERF

ORM

AN

CE

EVA

LUAT

ION

6.3.

M

anag

emen

t re

view

6.3.

2.

Base

d on

the

outp

uts

of it

s m

anag

emen

t rev

iew

, the

to

p m

anag

emen

t sha

ll ta

ke

over

all r

espo

nsib

ility

for t

he

plan

ning

and

impl

emen

tatio

n of

nee

ded

chan

ges

to th

e sa

fety

man

agem

ent s

yste

m.

I.1.(g

)

156

7.

IMPR

OVE

MEN

T7.

1.

Lear

ning

from

ac

cide

nts

and

inci

dent

s

7.1.

1.

Acci

dent

s an

d in

cide

nts

rela

ted

to th

e or

gani

satio

n’s

railw

ay o

pera

tions

sha

ll be

:

(a) r

epor

ted,

logg

ed, i

nves

tigat

ed

and

anal

ysed

to d

eter

min

e th

eir

caus

es;

I.3 (i

n ge

nera

l)

157

7.

IMPR

OVE

MEN

T7.

1.

Lear

ning

from

ac

cide

nts

and

inci

dent

s

7.1.

1.

Acci

dent

s an

d in

cide

nts

rela

ted

to th

e or

gani

satio

n’s

railw

ay o

pera

tions

sha

ll be

:

(b) r

epor

ted

to n

atio

nal b

odie

s as

ap

prop

riate

.I.3

(in

gene

ral)

158

7.

IMPR

OVE

MEN

T7.

1.

Lear

ning

from

ac

cide

nts

and

inci

dent

s

7.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

:(a

) rec

omm

enda

tions

from

the

natio

nal s

afet

y au

thor

ity, t

he

natio

nal i

nves

tigat

ing

body

and

in

dust

ry/in

tern

al in

vest

igat

ions

ar

e ev

alua

ted

and

impl

emen

ted

if ap

prop

riate

or m

anda

ted;

I.3 (i

n ge

nera

l), A

rt.

4(4)

157

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

159

7.

IMPR

OVE

MEN

T7.

1.

Lear

ning

from

ac

cide

nts

and

inci

dent

s

7.1.

2. T

he o

rgan

isat

ion

shal

l en

sure

that

:(b

) rel

evan

t rep

orts

/info

rmat

ion

from

oth

er in

tere

sted

par

ties

such

as

railw

ay u

nder

taki

ngs,

infr

astr

uctu

re m

anag

ers,

entit

ies

in

char

ge o

f mai

nten

ance

and

railw

ay

vehi

cle

keep

ers

are

cons

ider

ed a

nd

take

n in

to a

ccou

nt.

I.3 (i

n ge

nera

l), I.

7 (in

ge

nera

l), II

I.9, I

V.9,

Art

. 4(

4), A

rt. 5

(2),

Art

. 5(3

)

160

7.

IMPR

OVE

MEN

T7.

1.

Lear

ning

from

ac

cide

nts

and

inci

dent

s

7.1.

3. T

he o

rgan

isat

ion

shal

l us

e in

form

atio

n re

latin

g to

th

e in

vest

igat

ion

to re

view

th

e ris

k as

sess

men

t (se

e 3.

1.1.

Ri

sk a

sses

smen

t), t

o le

arn

with

the

aim

of i

mpr

ovin

g sa

fety

and

, whe

re a

pplic

able

, to

ado

pt c

orre

ctiv

e an

d/or

im

prov

emen

t mea

sure

s (s

ee

5.4.

Man

agem

ent o

f cha

nge)

.

I.3 a

nd I.

4 (in

gen

eral

), A

rt. 4

(4)

161

7.

IMPR

OVE

MEN

T7.

2.

Cont

inua

l im

prov

emen

t7.

2.1.

The

org

anis

atio

n sh

all

cont

inua

lly im

prov

e th

e ad

equa

cy a

nd e

ffect

iven

ess

of it

s sa

fety

man

agem

ent

syst

em, t

akin

g in

to a

ccou

nt

the

fram

ewor

k se

t out

in

Regu

latio

n (E

U) N

o 10

78/2

012

and

at le

ast t

he o

utpu

ts o

f the

fo

llow

ing

activ

ities

:

(a) m

onito

ring

(see

6.1

. M

onito

ring)

;I.4

(in

gene

ral),

Art

. 4(

4), A

rt. 7

(1),

Art

. 9(3

)

162

7.

IMPR

OVE

MEN

T7.

2.

Cont

inua

l im

prov

emen

t7.

2.1.

The

org

anis

atio

n sh

all

cont

inua

lly im

prov

e th

e ad

equa

cy a

nd e

ffect

iven

ess

of it

s sa

fety

man

agem

ent

syst

em, t

akin

g in

to a

ccou

nt

the

fram

ewor

k se

t out

in

Regu

latio

n (E

U) N

o 10

78/2

012

and

at le

ast t

he o

utpu

ts o

f the

fo

llow

ing

activ

ities

:

(b) i

nter

nal a

uditi

ng (s

ee 6

.2.

Inte

rnal

aud

iting

);I.4

(in

gene

ral)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

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ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

158

No.

Sect

ion

Sub-

sect

ion

Mai

n re

quire

men

t1s

t lev

el re

quire

men

t2n

d le

vel r

equi

rem

ent

Art

icle

s an

d A

nnex

II

- cor

resp

ondi

ng

requ

irem

ents

163

7.

IMPR

OVE

MEN

T7.

2.

Cont

inua

l im

prov

emen

t7.

2.1.

The

org

anis

atio

n sh

all

cont

inua

lly im

prov

e th

e ad

equa

cy a

nd e

ffect

iven

ess

of it

s sa

fety

man

agem

ent

syst

em, t

akin

g in

to a

ccou

nt

the

fram

ewor

k se

t out

in

Regu

latio

n (E

U) N

o 10

78/2

012

and

at le

ast t

he o

utpu

ts o

f the

fo

llow

ing

activ

ities

:

(c) m

anag

emen

t rev

iew

(see

6.3

. M

anag

emen

t rev

iew

);I.4

(in

gene

ral)

164

7.

IMPR

OVE

MEN

T7.

2.

Cont

inua

l im

prov

emen

t7.

2.1.

The

org

anis

atio

n sh

all

cont

inua

lly im

prov

e th

e ad

equa

cy a

nd e

ffect

iven

ess

of it

s sa

fety

man

agem

ent

syst

em, t

akin

g in

to a

ccou

nt

the

fram

ewor

k se

t out

in

Regu

latio

n (E

U) N

o 10

78/2

012

and

at le

ast t

he o

utpu

ts o

f the

fo

llow

ing

activ

ities

:

(d) l

earn

ing

from

acc

iden

ts a

nd

inci

dent

s (s

ee 7

.1. L

earn

ing

from

ac

cide

nts

and

inci

dent

s).

I.4 (i

n ge

nera

l)

165

7.

IMPR

OVE

MEN

T7.

2.

Cont

inua

l im

prov

emen

t7.

2.2.

The

org

anis

atio

n sh

all

prov

ide

mea

ns to

mot

ivat

ing

staff

and

oth

er in

tere

sted

pa

rtie

s to

be

activ

e in

im

prov

ing

safe

ty a

s pa

rt o

f its

or

gani

satio

nal l

earn

ing.

166

7.

IMPR

OVE

MEN

T7.

2.

Cont

inua

l im

prov

emen

t7.

2.3.

The

org

anis

atio

n sh

all p

rovi

de a

str

ateg

y to

co

ntin

ually

impr

ove

its s

afet

y cu

lture

, rel

ying

on

the

use

of e

xper

tise

and

reco

gnis

ed

met

hods

to id

entif

y be

havi

oura

l iss

ues

affec

ting

the

diffe

rent

par

ts o

f the

saf

ety

man

agem

ent s

yste

m a

nd

to p

ut in

pla

ce m

easu

res

to

addr

ess

thes

e.

159

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

Ann

ex II

I

REG

ULA

TIO

N 2

019/

779

Art

.15

ECM certified for F

reight W

agon

based on

Reg 445

/201

1

ECM certificate iss

ued un

der R

eg 445

/201

1 is eq

uivalent to

ECM

certificate issued

und

er Reg 779

/201

9 and is valid

for its orig

inal period

of validity

Expiratio

n of equ

ivalen

t ECM

Certificate after 1

6 of Ju

ne 202

0

Application for a

new

/ren

ewed

ECM

certificate based

on Reg 779

/201

9 is requ

ested from

16 of Ju

ne 202

0

ECM certificate is valid

up to 5 years (1

)

New

App

licant (ne

wcomer) E

CM fo

r Freight W

agon

s

NOTE

(1) By

virtue

of 3

.4.8 of the

ECM

Ce

rtificatio

n sche

me, ECM

certificate is

limite

d to 1 year for new

comer (app

licant

never registered

as E

CM in

the NVR

s)

Regulatio

n EU

201

9/77

9

(Sou

rce: Art. 3(2)‐a

, Art. 7(8), A

rt.16)

FLOW DIAGRA

M VALID ONLY FOR FREIGHT

WAG

ONS

(Before 16

of Jun

e 20

20)

(After 16 of Ju

ne 202

0)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

160

ECM has a CB attestation of ECM

for v

ehicles (no

t Freight W

agon

s)

based on

national law

s app

licable in

the fie

ld of R

egulation

779/20

19 re

leased

Attestation is eq

uivalent to

ECM

certificate issue

d un

der R

eg 779/2019 and is

valid

until its expira

tion date (at the

latest until 16

of Jun

e 2023)

Expiratio

n of attestatio

n (equ

ivalen

t to EC

M Certification) after 16 of

June

202

0

Application for E

CM certification based on

Reg

779/20

19 is re

quested from

16 of Ju

ne 202

0


up to 5 years (1

)EC

M fo

r veh

icle (n

ot freight w

agon

s)

with

out C

B attestation

(2)

ne

w App

licant (ne

wcomer) E

CM fo

r vehicles (n

ot freight w

agon

s) (2

)

NOTE

(1) By

virtue

of 3

.4.8 of the

ECM

Ce

rtificatio

n sche

me, ECM

certificate is

limite

d to 1 year for new

comer (app

licant

never registered

as E

CM in

the NVR

s)

Regulatio

n EU

201

9/77

9

(Sou

rce: Art. 7(8), Art. 15

(2), Art. 17

)

NOTE

(2) If EC

M

is also RU/IM se

e specific slide

7

FLOW DIAGRA

M VALID FOR VE

HICLES OTH

ERTH

AN FRE

IGHT

WAG

ONS

(After 16 of Ju

ne 202

0)

Before 16 of Ju

ne 202

0

161

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

ECM fo

r veh

icles (no

t Freight W

agon

s) has a CB attestation of

conformity

with

the principles and

criteria equ

ivalen

t to the

requ

iremen

ts of A

nnex III of R

egulation 44

5/20

11 issued

Attestation is eq

uivalent to

ECM

certification issue

d un

der R

eg 779

/2019

and is valid

until its expira

tion date (at the

latest until 16

of Jun

e 2023)

Expiratio

n of attestatio

n (equ

ivalen

t ECM

Certificate) after 16 of

June

202

0

Application for E


Reg

779/20

19 is re

quested from

16 of Ju

ne 202

0


up to 5 years (1

)EC

M fo

r veh

icle (n

ot freight w

agon

s)

with

out C

B attestation

(2)

ne

w App

licant (ne

wcomer) E

CM fo

r vehicles (n

ot freight w

agon

s) (2

)

NOTE

(1) By

virtue

of 3

.4.8 of the

ECM

Ce

rtificatio

n sche

me, ECM

certification is

limite

d to 1 year for new

comer (app

licant

never registered

as E

CM in

the NVR

s)

NOTE

(2) If EC

M

is also RU/IM se

e specific slide

7

Regulatio

n EU

201

9/77

9

(Sou

rce: Art. 7(8), Art. 15

.3, A

rt. 17)

FLOW DIAGRA

M VALID FOR VE

HICLES OTH

ERTH

AN FRE

IGHT

WAG

ONS

(After 16 of Ju

ne 202

0)

(Before 16

of Jun

e 2019

)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

162

New

App

licant for CB attestation of con

form

ity fo

r ou

tsou

rced

mainten

ance fu

nctio

ns based

on

natio

nal law

s on the fie

ld of R

eg 779

/201

9 for

vehicles (n

ot freight w

agon

s), app

licable before 16

of Ju

ne 201

9,

Application for n

ew/ren

ewed

attestatio

n of

conformity

for o

utsourced mainten

ance fu

nctio

ns

Expiratio

n of attestatio

n (equ

ivalen

t to EC

M certificate)

for o

utsourced mainten

ance fu

nctio

ns after 16 of Ju

ne

2020

app

lication for certification for o

utsourced mainten

ance fu

nctio

ns

based on

Reg 779/201

9 may be requ

ested from

16 of Ju

ne 202

0

Outsourced mainten

ance fu

nctio

ns

certificate is valid 5 years (1

)

Outsourced mainten

ance fu

nctio

ns with

out

CB attestatio

n of con

form

ity fo

r veh

icles

(not freight w

agon

s)

Outsourced mainten

ance fu

nctio

ns fo

r all

kind

of veh

icles

New

App

licants outsourced mainten

ance

functio

ns fo

r all kind

of veh

icles

NOTE

(1) By

virtue

of 3

.4.8 of the

ECM

Ce

rtificatio

n sche

me, certificate is lim

ited

to 1 year for new

comer (app

licant n

ever

coverin

g the role of o

utsourced maint.

functio

n)

Regulatio

n EU

201

9/77

9

(Sou

rce: Art. 7(8), Art. 10, A

rt. 15(4), A

rt. 17)

Outsourced mainten

ance fu

nctio

n has a

CB attestation

of con

form

ity based

on natio

nal law

s on the fie

ld of R

eg

779/20

19 fo

r veh

icles (no

t freight wagon

s), app

licable

before 16 of Ju

ne 201

9, re

leased

Expiratio

n of CB attestation of con

form

ity after 16 of Ju

ne

2020

CB issues attestatio

n of con

form

ity before 16

of Jun

e 2022

Attestation of con

form

ity is equ

ivalen

t to certificatio

n for

outsou

rced

mainten

ance fu

nctio

ns issued

und

er Reg 779

/201

9 and

is valid

until its expira

tion date (at the

latest until 16

of Jun

e 20

25)

OR

Voluntary

(Before 16

of Jun

e 20

22)

(Before 16

of Jun

e 20

22)

(After 16 of Ju

ne 202

0)

163

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

AN

NEX

ECM fo

r veh

icles (no

t Freight W

agon

s) not

subjected to Art. 15(2), 15(3), 15(4)

ECM fo

r veh

icles listed in Art. 15(1) of Safety Directive EU

20

16/798

and

not su

bjected to Art. 15(2), 15(3), 15(4)

(see

NOTE

for list of veh

icles)

They are re

quested to com

ply with

Reg EU 201

9/77

9 by

16 of Ju

ne 202

2 at th

e latest (2

)

NOTE

(2) If EC

M

is also RU/IM se

e specific slide

7

NOTE

Vehicles as in Art. 15(1) o

f Safety Directive 2016/798

(a) veh

icles registered

in a th

ird cou

ntry and

maintaine

d in accordance with

the law of that cou

ntry;

(b) veh

icles used

on ne

tworks or lines th

e track gauge of which is differen

t from th

at of the

main rail ne

twork with

in th

e Union

and

in re

spect o

f which fu

lfilm

ent o

f the

requ

iremen

ts laid dow

n in Article

14(2) is e

nsured

by international agreemen

ts with

third

cou

ntrie

s;

(c) freight wagon

s and pa

ssen

ger coa

ches which are in sh

ared

use with

third

cou

ntrie

s the

track gauge of which is differen

t from th

at of the

main rail ne

twork with

in th

e Union

; (d) veh

icles used

on the ne

tworks re

ferred

to in

Article 2(3), and military equ

ipmen

t and

special transpo

rt re

quiring

an ad

hoc national safety authority

permit to be de

livered

prio

r to their e

ntry into

service. In

this case derogations sh

all be granted for p

eriods not longer th

an 5 years.

Sub‐NOTE

for v

ehicles used

on pa

rticular network (le

tter (d

) abo

ve) a

s in Art. 2(3) of Safety Dire

ctive 2016/798

(a) p

rivately ow

ned railw

ay infrastructure, including

sidings, used by th

e ow

ner o

r by an

ope

rator for th

e pu

rpose of th

eir respe

ctive freight a

ctivities or for th

e transport o

f persons fo

r non

‐com

mercial

purposes, and

veh

icles u

sed exclusively on

such infrastructure;

(b) infrastructure and vehicles re

served

for strictly

local, historical or tou

rist u

se;

(c) light ra

il infrastructure occasionally used by heavy ra

il vehicles und

er th

e op

erational con

ditio

ns of the

light rail system, w

here it is necessary fo

r the

purpo

ses o

f con

nectivity

of tho

se veh

icles o

nly;

and

(d) veh

icles p

rimarily used on

light rail infrastructure bu

t equ

ippe

d with

some he

avy rail compo

nents n

ecessary to

enable transit to

be effected

on a confined

and

limite

d section of heavy ra

il infrastructure fo

r con

nectivity

purpo

ses o

nly.

Regulatio

n EU

201

9/77

9 and Re

gulatio

n EU

202

0/78

0

(Sou

rce: Art. 15(5), A

rt. 17)

FLOW DIAGRA

M VALID FOR VE

HICLES

OTH

ER THA

N FRE

IGHT

WAG

ONS

(After 16 of Ju

ne 202

0)(After 16 of Ju

ne 202

0)

GU

IDA

NC

E O

N E

CM

CER

TIFI

CA

TIO

N P

RO

CES

S

Vers

ion

9.0

(01/

03/2

021)

. Unc

ontr

olle

d w

hen

prin

ted.

Dow

nloa

d th

e la

test

ver

sion

at e

ra.e

urop

a.eu

.©

202

1 EU

Age

ncy

for R

ailw

ays.

All

right

s re

serv

ed.

164

Application for E


Reg EU 201

9/77

9

may be requ

ested

(at the

latest until 16

of Jun

e 20

22)

RU/IM com

pliance with

ECM

Regulation

checked via Safety Certification/Au

thorisa

tion

Process throu

gh:

‐ first issue

(ERA

/NSA

)‐ ren

ewal (E

RA/N

SA)

‐ Managem

ent o

f change by

RU/IM

for n

ewcomer ECM

(at the

latest until 16

of Jun

e 20

22)

NSA

ann

ual sup

ervisio

n

NOTE

(1) By

virtue

of 3

.4.8 of the

ECM

Ce

rtificatio

n sche

me, ECM

certificate is

limite

d to 1 year for new

comer (app

licant

never registered

as E

CM in

the NVR

s)

RU/IM (o

r new

comer RU/IM) registered

as

ECM or a

pplying for the

role of E

CM fo

r vehicles (n

ot Freight W

agon

s) used for its

own op

erations

RU/IM com

pliance with

ECM

Regulation may be

checked via Safety Certification/Au

thorisa

tion Process

through:

‐ ren

ewal (E

RA/N

SA)

‐ Managem

ent o

f change by

RU/IM

for registered

ECM

(at the

latest until 16

of Jun

e 20

22)


up to 5 years (1

)

OR

ECM certification is de

emed

evide

nce of com

pliance

with

5.2.4, 5.2.5 of A

nnex I and An

nex II of CSM

SMS

(Reg EU 201

8/76

2)

Regulatio

n EU

201

9/77

9 and Re

gulatio

n EU

20

20/780

(Sou

rce: Art. 3(2)‐b

, Art. 3(3), Art. 3(4), A

rt. 3(5), Art 7

(8), Art.

15(5), Art. 17

)

FLOW DIAGRA

M VALID FOR VE

HICLES OTH

ERTH

AN FRE

IGHT

WAG

ONS

(After 16 of Ju

ne 202

0)

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Print ISBN 978-92-9477-302-9 doi:10.2821/423550 TR-04-20-455-EN-CPDF ISBN 978-92-9477-303-6 doi:10.2821/731954 TR-04-20-455-EN-N

Guidance for ECM certification: ▶ Understanding the concept of ECM ▶ Clarification on the obligation of parties involved in the

maintenance process of vehicles