project sesei, european standards &...

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Project SESEI, European Standards

& Certification FIEO: 17th Feb 2014 Dinesh Chand Sharma

Director – Standardization, Policy and Regulation

FIEO| Delhi 17th Feb 2014 Slide 2

Outline

Project SESEI

European Standards

CE Marking


Project SESEI


Seconded European Standardization Expert in India local representative and a connect-between standardizers’ communities

in EU/EFTA and India

EU-India dialogue and cooperation on standards, R&D, Innovation, and policy/regulation around standardization

Project Owners EU Standards Organizations (ETSI, CENELEC and CEN),

European Commission and EFTA - European Free Trade Association

Priority Sector for this phase of the project (3 Year) ICT , Electrical Appliances including Consumer Electronics, Machinery

and Automotive

INDIA EUROPE Harmonized Standards

ISO, IEC, ITU, 3GPP, EN

Project SESEI


EUROPEAN STANDARDS


What is a standard?

It is a document that define

technical or quality requirements

with which current or future

products, production processes,

services or methods may comply


Always voluntary

Consensus based

Established by all interested parties

Driven mainly by business

Drafted by technical experts

Approved by a recognized, independent standardization body

Standard are :


Enhance safety of products

Promote common understanding

Facilitate trade by reducing TBs

Promote interoperability of products and services

Benefits of economies of scale

Support environmental sustainability

Facilitate the uptake of innovation and reflect the outcome of research and development

Why standards are important?


Who makes European standards?

CEN..............................

(European Committee for

Standardization)

CENELEC .......................

(European Committee for

Electrotechnical Standardization)

ETSI .............................

(European Telecommunications

Standards Institute)


Officially created as an international non-profit association based in Brussels on 30 Oct 1975

Responsible for planning, drafting and adoption of European Standards in all areas of economic activity with the exception of electrotechnology (CENELEC) and telecommunication (ETSI).

33 National Members work together to develop voluntary European Standards (ENs)

— These standards have a unique status as they becomes national standards in Member countries and conflicting standards are withdrawn

Vienna Agreement − signed by CEN in 1991 with ISO (International Organization for Standardization),

— 30% of CEN standards identical to ISO standards

1. Austria 2. Belgium 3. Bulgaria 4. Croatia 5. Cyprus 6. Czech Republic 7. Denmark 8. Estonia 9. Finland 10. France 11. Germany 12. Greece 13. Hungary 14. Iceland 15. Ireland 16. Italy 17. Latvia 18. Lithuania 19. Luxembourg 20. Malta 21. The Netherlands 22. Norway 23. Poland 24. Portugal 25. Romania 26. Slovakia 27. Slovenia 28. Spain 29. Sweden 30. Switzerland 31. The Former Yugoslav

Republic of Macedonia 32. Turkey 33. United Kingdom

EU Standards Organization - CEN

http://www.cen.eu/cen/


European Committee for Electrotechnical Standardization responsible for standardization in electrotechnical engineering field

non-profit technical organization set up under Belgian law, created in 1973 as a result of the merger of two previous European organizations: CENELCOM and CENEL.

33 National Members work together to develop voluntary European Standards (ENs)

— These standards have a unique status as they becomes national standards in Member countries and conflicting standards are withdrawn

Dresden Agreement – signed by CENELEC with IEC (International Electrotechnical Commission)

75% of CENELEC standards identical to IEC standards

EU Standards Organization - CENELEC

1. Austria 2. Belgium 3. Bulgaria 4. Croatia 5. Cyprus 6. Czech Republic 7. Denmark 8. Estonia 9. Finland 10. France 11. Germany 12. Greece 13. Hungary 14. Iceland 15. Ireland 16. Italy 17. Latvia 18. Lithuania 19. Luxembourg 20. Malta 21. The Netherlands 22. Norway 23. Poland 24. Portugal 25. Romania 26. Slovakia 27. Slovenia 28. Spain 29. Sweden 30. Switzerland 31. The Former Yugoslav

Republic of Macedonia 32. Turkey 33. United Kingdom


Recognized, Independent, not-for-profit organization, created in 1988

Active in all areas of ICT & Setting globally-applicable standards for

— telecommunications

— radiocommunications

— broadcasting

— related topics

Offer direct participation

750+ Member companies and organizations

Over 30 000 publications - freely available!

EU Standards Organization - ETSI


European Commission & Standards

Coordinates the standardisation policy and cooperate with the different stakeholders

Promotes the use of European standards to support EU legislation and policies to enhance the competitiveness of European industry

Coordinates the standardisation mandates (requests) to CEN/CENELEC/ETSI

Funds CEN/CENELEC/ETSI (operating and action grants)


Interestingly, standardisation is financed primarily by industry

followed by:

National Governments

European Commission/EFTA

93-95%

3-5%

2%

Who is paying for standardisation?


Abbreviations

ESOs = European Standardisation Organisations (CEN/CENELEC/ETSI)

OJEU = The Official Journal Of the EU

EC = European Commission

EN = European Standard

NA = New Approach


Standards vs Législation

Standards :

1. Voluntary

2. Consensual

3. Developed by independent organisations

4. Revised every 5 years

5. Provide specifications and test methods (interoperability, safety, quality, etc.)

Legislation :

1. Mandatory

2. Imposed by Law

3. Established by public authorities

4. Revised when legislators decide

5. Gives requirements to protect public interests


EU legislation & Standards

EU legislation makes reference to Standards

Direct reference: mandatory – mandatory for specific use

Indirect reference « New Approach »


The New Approach

Facilitate free movement of goods

in the Internal Market whilst ensuring a

high level of protection for consumers

Elimination of barriers to trade through technical harmonisation

http://upload.wikimedia.org/wikipedia/commons/e/e5/CE_Logo.svg

http://upload.wikimedia.org/wikipedia/commons/e/e5/CE_Logo.svg


New Approach

4) risk-based conformity assessment

2) use standards to translate essential requirements into technical products specifications or alternatives

3) standard(s) confer presumption of conformity

1) focus on essential health & safety requirements of product groups (danger/hazard) & harmonise through EU legislation

Through standards to leaner & more effective legislation

5) safe products = manufacturer’s responsibility

6) market surveillance by Member States = ex-post check if the products on the market are indeed safe


Legislative and normative processes

Directive

Mandate

Standards

Publication in the Official Journal


What is a mandate?

Given by the Commission to get standards that support EU legislation or policies

A non-binding invitation to the ESOs to develop standards

A reference framework for standardisation

Indispensable for harmonised standards supporting New Approach and NLF legislation

A means for Member States to give political and technical acceptance to standardisation work


What is in a Mandate? (content)

Reference to Legislation

Scope – Task – Objectives

Work programme

Standards to be

developed Time plan


There are 3 types of mandates

1 2 3

Study mandate

Programming mandate

Standardisation mandate

1+2 2+3

Examine feasibility of standardisation

Prepare programme for standardisation

Develop standards


Harmonised standards

The lists of harmonised standards are published in the Official Journal of the EU (OJEU)

The lists are continuously updated but not on regular intervals

Alternative sources of information:

DG Enterprise “European Standards web-site” (original source >> RSS Feeds are available)

National information channels (standards bodies, trade organisations ...)

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm



FIEO| Delhi 17th Feb 2014 Slide 25 25

Integration of Standards

“Vienna Agreement” with

“Dresden Agreement” with

MoU with

Towards integration of regional and global standardization


CE MARKING


EU Council Directives

There are 40+ enacted Directives, and several more in-draft

The EU Directives are intended to: — Protect all EU Citizens from harm — Improve Citizens’ well-being — Provide essential Safety in Workplace, Home Life, and Leisure Activities. — Now also to address Environmental Protection

Eg. and Senior of the Directives: The Low Voltage Directive 73/23/EEC (LVD) Created in 1973 to assure a degree of Electrical Safety.

— Home and Business’ have 230 Volts, 50 Hz, 1Ǿ. — Heavy Industry uses 400 Volts, 50 Hz, 3Ǿ — Objective: To prevent Electric Shock, Burns, Injuries, Fires and Property Damage — There are several Product Specific Test and Evaluation Standards covering every type of electrically

powered product.

— Latest version is designated 2006/95/EC

Two Directives were enacted to provide Environmental Protection:

— RoHS- Restrictions of Hazardous Substances used in manufacture Controls Levels of Lead, Mercury, Cadmium, Hexavalent Chromium etc, used in products in

order to minimize seepage in land fills

— WEEE - Electronic Waste Disposal is being controlled.


CE MARK Concept

The CE Mark with a Declaration of Conformity is analogous to a passport for products exported to the EU. Its intent is to IDENTIFY Compliant Products so they are not delayed or held in Customs.

The CE MARK protocol is essentially an honor system accepted by EU member countries. Manufacturers can Self-Declare Compliance by adding CE MARKS and signing a Declaration of Conformity. It is also required that a Technical File be created.

The Technical File is the backup document for the CE MARK and Declaration of Conformity. The Technical File is NOT typically included with the product shipment. The Technical File is intended to:

— Identify the Importer or Purchaser who is resident within the EU

— Describe the Product

— List Safety and Compliance Critical Parts

— Cite the applicable EU Directives

— List all Safety, EMC and Other Tests performed to Validate Compliance

— List Tests related to I.D. Number of each Test Standard used


CE MARK Deliverables Detailed Findings Report is the first document generated. It is generated after the 1st safety review of the product. It is specific to the Clients Product. It includes viable suggestions for Corrections

The Findings Report notes any discrepancy in the product’s construction and offers suggestions

for making corrections. When appropriate we even suggest sources for key components and

alternatives.

The Declaration of Conformity provided as a draft


CE Compliant Products Technical Report

EMC Test Report : EMC = ElectroMagnetic Compatibility

The “Technical File” or CE Mark Test Report

1. Includes a Declaration of Conformity (D.o.C). A separate D.o.C is also provided as a Certificate to accompany the shipping documents to an EU Port-of-Entry. Only one D.o.C. is required per shipment. This is regardless of the number of units in a single shipment.

2. The CE Mark Report is provided in pdf format and is known as a Technical File (TF). It is a detailed Report describing the product in detail and all of its testing. It bears the written opinion of a Competent and Independent 3rd Test Lab that the CE Marked Product has been evaluated and tested. It cites all of the Directives and Test Standards used in making the decision. The TF is used to set aside any challenges that a manufacturer may get as to the validity of the CE Mark.

4. If a customs official or a customer questions the validity of the CE Mark, a review of the TF should quickly

set aside any concerns. Typically, one hard copy is kept at the main office and one sent to each Importer/Agent.


All About CE Marking, NANDO, MRA & Market Surveillance

All About CE Marking NANDO

— Nando (New Approach Notified and Designated Organisations)

MRA

— Mutual recognition agreements

MS

— Market surveillance

http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/

http://ec.europa.eu/enterprise/newapproach/nando/







http://ec.europa.eu/enterprise/policies/single-market-goods/international-aspects/mutual-recognition-agreement/index_en.htm

http://ec.europa.eu/enterprise/policies/single-market-goods/international-aspects/mutual-recognition-agreement/index_en.htm

http://ec.europa.eu/enterprise/policies/single-market-goods/internal-market-for-products/market-surveillance/index_en.htm


1. Identify Applicable Directive

2. Verify Requirements

3. Need for notified body?

4. Check Conformity

5. Technical Document [ report ]

6. Affix CE Marking

6 Steps Summary for Manufacturer

http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/professionals/manufacturers/requirements/index_en.htm












Contact Details:

Dinesh Chand Sharma (Seconded European Standardization Expert in India)

Director – Standardization, Policy and Regulation

European Business Technology Centre, DLTA Complex, South Block, 1st Floor, 1, Africa Avenue, New Delhi

110029

Mobile: +91 9810079461, Tel: +91 11 3352 1500, [email protected]

Thank you!

mailto:[email protected]

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