development of a national accreditation system...

SAA Implementation Training, Workshop 2, Quality Infrastructure System27 November 2008, Belgrade, J. Thiele

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Development of a national accreditation system

Experiences from Germany

Revision of the national accreditation system

Joachim ThieleBAM Federal Institute for Materials Research and Testing

Accreditation and Conformity Assessment; Berlin, Germany


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Content of presentationAim: improved understanding of

quality infrastructure elements and their relationPart I: Role of accreditation in Germany, Structure of the accreditation System (state and private institutions, independent laboratories, history)

Part II: New EU provisions concerning accreditation,Implications on accredited and notified BAM Certification Body


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Elements + Institutions of the Quality InfrastructureM Measurement PTB, DKDS Standardisation DINT Testing BAM, VDE, TÜV etc.Q Quality Management DGQ, DQS, SGS,TÜV Cert

etc.A Accreditation DAR, KOGBC Certification (accredited) Conf. Ass. Bodies

Accreditation: formal recognition by an independent body (3rd party)to perform tasks in a competent manner

Certification: Conformity with written requirements (standards: voluntary, directives: mandatory)


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Definitions(according to ISO/IEC 17000:2005; Conformity assessment - General vocabulary)

Accreditation: (attestation of competence)third-party attestation related to a conformity assessment bodyconveying formal demonstration of its competence to carry out specific conformity assessment tasks

Certification: (statement of conformity)Issue of a statement, based on a decision following review that specified requirements related to products, processes, systemsand persons have been fulfilled


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• Conformity Assessment activities:

testing, calibration, certification, inspection

• Conformity Assessment Bodies (CABs):

- laboratories (testing and calibration labs)- certification bodies for products, management systems (QMS, EMS), personnel

- inspection bodies

certification– first party certification: manufacturer (SDoC)– second party certification: customer (appointed supplier)– third party certification: independent body

(independent from manufacturer and customer)


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A i m s o f a c c r e d i t a t i o nA i m s o f a c c r e d i t a t i o n

- establishing confidence in the results of conformity assessment bodies

(test/calibration/inspection reports; certificates)

- establishing confidence in the results of conformity assessment bodies

(test/calibration/inspection reports; certificates)

- comparability of the results: tests, calibrations,certifications and inspections; intercomparisons, PT schemes

- comparability of the results: tests, calibrations,certifications and inspections; intercomparisons, PT schemes

- improvement of quality- improvement of quality

- meet the expectations of the clients and authorities- meet the expectations of the clients and authorities

- reasonable effort- reasonable effort

- mutual acceptance and recognition„once tested/certified – accepted worldwide“

Mutual recognition of accreditations in Europe and worldwideBased on same standards and procedures

- mutual acceptance and recognition„once tested/certified – accepted worldwide“

Mutual recognition of accreditations in Europe and worldwideBased on same standards and procedures


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Requirements for Accreditation BodiesEN ISO/IEC 17011

Requirements for certification bodies

Manage-ment-

Systems

Persons Products

EN ISO/IEC17021 EN

ISO/IEC17024

ISO Guide 65

= EN 45011(ISO Guide 28, 53,

67)

Requirementsfor

inspectionbodies

Requirementsfor

testingand

calibrationlaboratories

EN ISO/IEC17025

EN ISO/IEC17020

Terms -

ISO

/IEC

17000


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Requirements for accreditation bodiesEN ISO/IEC 17011

Manage-ment-

Systems

Persons Products

EN ISO/IEC17021

EN ISO/IEC17024

ISO Guide65 = EN 45011

(ISO Guide28, 53, 67)

Require-ments

forinspection

bodies

Require-ments

for labs

EN ISO/IEC17025

EN ISO/IEC17020Ter

ms

-IS

O/IE

C 1

7000

Mut

ual r

ecog

nitio

nIS

O/IE

C 1

7040

Suppliers De-

clarationon

conformity

EN ISO/IEC 17050-1

EN ISO/IEC 17050-2

Requirements for certification bodies


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Tasks of the DARTasks of the DAR

1.1.to coordinate the activities in the field of accreditation and recognition of laboratories, certification and inspection bodies for its members

2.2.to run central accreditation/recognition registers for the members database www.dar.bam.de/ast/indexe.html

The German Accreditation Council (DAR) is a working group established in 1991 by ministries of the German Federal Government, ministries of theGerman Federal States as well as by representatives of the German industry.

The German Accreditation Council (DAR) is a working group established in 1991 by ministries of the German Federal Government, ministries of theGerman Federal States as well as by representatives of the German industry.

3.3.to develop the DAR Rules and Procedures

The DAR itself does not carry out any accreditations, it is no legal entity.As to coordinate the various tasks in a better way, DAR Subcommittees have been established:ABT/Training of Assessors, ATF/Technical Issues.


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Structure and Members of DAR

DAR - GERMAN ACCREDITATION COUNCIL

ACCREDITATION BODIESSecretariat :Federal Institu te forMateria ls Researchand Testing (BAM), Berlin

GOVERNMENT,GERMAN INDUSTRY

DACHDAPGA-AGAZ TGA / DATech

AKS HannoverDAUDKDKBA

BMWDINBDI

i

KL-MESSBundesnetzagentur

CommitteeTraining ofAssessors

(ABT)

CommitteeTechnical Issues

(ATF)

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• AKS Hannover Akkreditierungsstelle Hannover(Accreditation Body Hannover)

• BDI Bundesverband der Deutschen Industrie e. V.(Confederation of German Industry)

• BMWi Bundesministerium für Wirtschaft und Technologie(Federal Ministry for Economics and Technology)

• DACH Deutsche Akkreditierungsstelle Chemie GmbH(German Accreditation Body Chemistry)

• DAP Deutsches Akkreditierungssystem Prüfwesen GmbH(German Accreditation System for Testing)

• DATech DATech Deutsche Akkreditierungsstelle Technik GmbH(German Accreditation Body for Technology)

• DAU Deutsche Akkreditierungs- und Zulassungsgesellschaft für Umweltgutachter mbH(German Accreditation and Approval Body for Environmental Verifiers)

• DIN Deutsches Institut für Normung e. V.(German Institute for Standardisation)

• DKD Deutscher Kalibrierdienst(German Calibration Service)

• GA-A GA-A - German Accreditation Association e.V.(German Accreditation Association)

• GAZ Gesellschaft für Akkreditierung und Zertifizierung mbH(Association for Accreditation and Certification)

• KBA Kraftfahrt-Bundesamt(German Federal Office of Road Transport) KL-MESS Koordinierungsstelle der Länder "Messgeräte"KL-MESS (German Coordination Body of the Federal States "Measuring Instruments" of the Metrology and Verification Authorities of the Federal States)

• Bundesnetzagentur Bundesnetzagentur für Elektrizität, Gas, Telekommunikation, Post und Eisenbahnen(Federal Network Agency for Eletricity, Gas, Telecommunications, Postal and Railway Markets)

• TGA Trägergemeinschaft für Akkreditierung GmbH(Association for Accreditation)

http://www.aks-hannover.de/http://www.dach-gmbh.de/http://www.din.de/


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European Commission (EC)Global Approach, EC Directives,Harmonized European Standards

European Commission (EC)Global Approach, EC Directives,Harmonized European Standards

Mandatory areaMandatory area Voluntary areaVoluntary area

DAR (German Accreditation Council) Secretariat: BAM

CEN/CLCCEN/CLCEuropean Cooperation

For AccreditationEA

European CooperationFor Accreditation

EA

ISO/IECISO/IEC

GovernmentalAccreditation Bodies

GovernmentalAccreditation Bodies

AKSHannover

AKSHannover DAUDAU DKDDKD KBAKBA DAPDAP DATech-TGA

DATech-TGA DACHDACH GA-AGA-A GAZGAZ

PrivateAccreditation Bodies

PrivateAccreditation Bodies

ZLGZLGZLSZLS

Governmental Notificationof German Notified Bodiesto European Commission

Governmental Notificationof German Notified Bodiesto European Commission

Special scopesof accreditation

Special scopesof accreditation


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Evaluation of private Accreditation Body Members of DAR

• Why? Demand from Ministry for Economy and Min. of Interior• Procedure for admission of new AB’s to the DAR in the voluntary

area • Surveillance of members operating under the umbrella of the DAR

• Evaluation is performed by the BAM (on contract with AB) by order of the DAR Chair

• BAM Evaluation Committee (Members BAM, DIN, BMWi)

• Using of the EA/ILAC/IAF evaluation rules (+ ISO/IEC 17040)

• Obligatory Rules for DAR member AB’s:- Standards (17000-series) - Instructions for Use of the Accreditation Certificate and of theAccreditation Symbol of the German Accreditation Council

(DAR-3-EM-03, DAR-3-EM-04)


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Results from the DAR

Uniform accreditation certificate and accreditation symbols for the accredited bodies


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• Joint training programs for German-speaking assessors in cooperation withSAS – SwitzerlandBMWA - Austria

• Uniform horizontal accreditation rules for all accreditation bodies as DAR recommendations(see DAR-Homepage: www.dar.bam.de)


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• Database of accredited bodies of all accreditation bodies operating in the DAR

DAR Homepage: www.dar.bam.dewww.deutscher-akkreditierungsrat.org

• Database of notified bodies as link and other databases

• Link to EA database of accredited bodies

http://www.dar.bam.de/http://www.deutscher-akkreditierungsrat.org/


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Register of accredited services, database:• over 3200 accreditedCABs• provided with full textsearch and keywordsearch• geographical selection• generation of actualstatistics summary ofaccredited bodies


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As of September 2008


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Source: www.dar.bam.de/ast/state.html (As of September 2008)


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Cooperation in international organisations:

Organisation of mutual recognition of accreditations

International Laboratory Accreditation Cooperation

International Accreditation Forum, Inc.


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German Signatories of the EA - MLA(Multilateral Recognition Arrangements between AB’s)

• MLA Calibration: DKD

• MLA Testing: DACH, DAP, DATech in TGA

• MLA Certification for Products: DAP, DATech in TGA• MLA Certification Management

Systems (QMS, EMS): TGA

• MLA Inspection: DAP, DATech in TGA

EA-MLA signatories are also ILAC-MRA and IAF-MLA signatories


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Signatories to the Multilateral Recognition Arrangements(for Testing and Calibration Laboratories) of the European Cooperation of Accreditation (EA)

PortugalIPAC

TurkeyTURKAK

PortugalIPAC

TurkeyTURKAK


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Mutual recognition of accreditationsin regional co-operations


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Part II:

New EU provisions concerning accreditation

accredited and notified BAM Certification Body


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National accreditation bodies/system for conformity assessment bodies:

LaboratoriesCertification bodiesInspection bodies

Harmonised technical requirements for

Conformity assessment bodies(testing, calibration, certification, inspection)

ISO/IEC 17000 series

Notification of competent conformity assessment bodiesbased on national and EU regulations

EC Global Approach for Conformity AssessmentFor the Single Market (regulated/mandatory area)

Free Trade of goods, services, persons, money: Confidence in and transparency of conformity assessment results and certificates

Tools:


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“Guide to the implementation of directives based on the New Approach and the Global Approach” (“Blue Guide”)

Internet download in all 11 official EU languages:

http://europa.eu.int/comm/enterprise/newapproach/newapproach.htm

Europe server (http://europa.eu.int).

Luxembourg: Office for Official Publications of the European Communities, 2000, ISBN 92-828-7500-8

© European Communities, 2000


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Global and New Approach are associated with the creation of the European single market in 1992:

• New Approach (Council resolution of 1985): Legislative and technical harmonization: limited to essential requirements - EC directives („Policy“of conformity assessment, CA => free trade, mutual recognition)

• Global Approach (Council resolution of 1989 and further decisions 1990 and 1993): Modular concept and European standards for conformity assessement („principles+rules +tools “ for CA)


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Standard elements of New Approach directives


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Essential requirements of EC directives


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Modular basic scheme of conformity assessment procedures


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Basic Modules


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Notified Bodies and basic principles of notification


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Recognition and notification of (notified) bodies


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The EN 45 000 series of standards relevant for notified bodies (updated by new ISO 17000ff. standards see below)

Remarks - Updated standards:EN 45 001 – EN ISO/IEC 17025EN 45 004 – EN ISO/IEC 17020

EN 45 002/3/10 – EN ISO/IEC17011

EN 45 012 – EN ISO/IEC 17021EN 45 013 – EN ISO/IEC 17024 EN 45 014 – ISO/IEC 17050-1,2


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General responsibilities of notified bodies


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Notified bodies and conformity assessment


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Notified bodies and subcontracting


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CE- or - Marking (in dependence on the applied procedure within the modular concept)


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The CE mark for European conformity (conformity of the product with the requirements of

all relevant European Directives)


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The – markfor conformity with European

Directive 1999/36/EC

(Transportable Pressure

Equipment)


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Principles of CE marking


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Affixing of the CE marking (1)


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Affixing of the CE marking (2)


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CE marking and other marks


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New development in Europe• Discussion of the results of the New Approach

• Looking for new ways to harmonise the work of notified bodies and equal basis for demonstration of their competence by using accreditation

• Using of EA and its peer evaluation system (MLA)

• Adoption of New Legislative Framework (“Goods package”; EU-Regulation on accreditation and market surveillance)

(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 the Regulation (EEC) No 339/93)


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• The New Legal Framework, the modernisation of the New Approach for marketing of products was adopted finally in Council on 23rd June 2008.

• This broad package of measures has the objective of removing the remaining obstacles to free circulation of products


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The New European Legislative framework covers• Accreditation and Market surveillance• Notified Bodies• Role and significance of CE marking• Common definitions & obligations/procedures• Objective of the New European Legislative

framework is to strengthen the system by reviewingthe main features and

• the addition of missing elements such as accreditation


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Main principles for Accreditation- Regulation applies both to the mandatory and voluntary areas

- Accreditation as public authority activity performed in general interest, free from commercial competition

- Last level of control providing confidence in the conformity assessmentsystem

- One single national governmentally recognised accreditation body per EU member state from 1 January 2010 : non-profit, not compete with the bodies they accredit, not compete with other accreditation bodies (national or cross national boundaries)

- Cross border accreditation only in certain cases

- Peer-evaluation system


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Proposed standards of conformity assessment becoming harmonised standards by mandate of CEN/CLC

(results of the CEN/CLC TC 1 meeting May 2008)

EN ISO/IEC 17011:2004 (Accreditation bodies)EN ISO/IEC 17020:1998 (Inspectionsbodies)EN ISO/IEC 17021:2006 (Certificationb bodies for Management Systems)EN ISO/IEC 17024:2003 (Certification bodies for persons)EN ISO/IEC 17025:2005 (Laboratories)EN 45011 (Certification bodies for products) Not on the listEN ISO/IEC 17065 Possibly to be replaced by the futureEN ISO/IEC 17000:2004 (Terms) Reference documentEN ISO/IEC 17040:2005 (Mutual recognition)EN ISO/IEC 17050-1:2004 (Declaration of conformity)EN ISO/IEC 17050-2:2004


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Further development in Germany

- Ministry for Economics and Technology took over thetask of external international representation of theGerman accreditation system from DAR

- establishment of the Accreditation Advisory Board at Ministry for Economics and Technology

- preparation of a German law on accreditation according the EU-Regulation on accreditation and market surveillance as legal basis for the establishment of thenew national AB

- DAR continues with the national coordination


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Accreditation Advisory Board• takes into account European and international developments, public

interests and economic efficiency• proposes statements and comments in support of the German position in

international committees and working groups• determines general and sector specific rules for accreditation• pluralistic membership:- government,- associations of economy and industry- consumers associations,- associations of conformity assessment bodies- accreditation bodiessecretariat was assigned to BAM


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Basic requirements for the new German accreditation body• Support the competitiveness of the German economy• Continuation and increase of confidence in German test

reports and certificates• fulfillment of the requirements of the EU-Regulation and

of ISO/IEC 17011• existing competence shall be included to the greatest

possible extent

Present situation: 20 accreditation bodies and designationauthorities in both areas, ~ 150 employees


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Possible organizational structure:• authority• hybrid structure (governmentally

recognized limited liability company with mixed shareholdership)

• governmentally recognized ltd. with industry as shareholder


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In the meantime, different mergings of private accreditation bodies are in progress


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Practical examples from BAM Certification Body (BZS)

Independent part of larger governmental organisation and its quality system

• Cooperation with BAM laboratories(ISO/IEC 17025)

• BZS accredited according EN 45011+EN 45012 by DAP member of DAR

• BZS is accredited by ZLS together with the relevant laboratories for 4 EC Directives


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Criteria for the Structureof a Certification Body according to DIN EN 45011 1(2)

• Impartiality• Documentation of Legal Status• General Manager and Personnel• Financial backing• Organization Chart (hierarchical structure and

responsibilities)• Evidence of Personnel Competence• Description of operating instructions• Governing Board


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Criteria for the Structure of a Certification Body according to DIN EN 45011 2(2)

• Statut of signs and marks• Separation of Testing, Assessment and

Certification Procedures• Quality Manual• Quality Audits• Surveillance• Procedures for treatment of complaints• Recording System


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• Notified body:meets the requirements from certain EC Directives

• appointed by the national government , after successful assessment according requirements of directives and/or of harmonised standards

• notified to the European Commission by national authorities (government),

• One identification number given by the European Commission


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Organisational Structure of BAM Certification Body


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Competences BAM certification body staff members:

- Quality Management of BAM and Certification Body

- Management and Coordination tasks withincertification operation process: between technical experts for testing and conformity assessment partners, other bodies

- Knowledge on application and interpretation of standards ISO/IEC 17025, EN 45011, EN 45012, ISO 9001 (ISO and IAF Guides respectively)(not: specific technical expert knowledge)


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Tasks of the BAM certification workinggroup (AKZ)

• Discussion of general questions and problemsof certification

• Representation of technical competence and interests of the BAM departments

• Development of general concepts for certification schemes

• Revision of rules and quality manual for the BAM certification


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Steps towards Certification

INQUIRYAPPLICATION

CONTRACTINGLABORATORY TESTING

CONFORMITY ASSESSMENT (4 eyes)ISSUE OF CERTIFICATE

INVOICEPUBLICATION


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Basis for all certification and assessment procedures: reliable test results

• The competent testing according to all elementsof EN ISO/IEC 17025

• - personnel- equipment- facilities- experience- audited QM- System (accredited testing laboratory)


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BAMCertification procedure


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BAM flyer part 1


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BAM flyer part 2


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Assessment and Certification in themandatory area (EC Directives, Laws)

• Certification Scope ZBGContainments for Dangerous Goodsfollowing the Dangerous Goods Act

• Certification Scope ZBEExplosives for Civil Uses (93/15/EEC)following the German Explosives Act

• Certification Scope ZBDGPressure Equipment (97/23/EC)Transportable Pressure Equipment (1999/36/EC)

• Certification Scope ZBATEXEquipment and Protective Systems in Potentially Explosive Atmospheres (94/9/EC)

Accreditation by ZLS (Central Body of the German Federal States for Safety)


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BAM acts as NOTIFIED BODY

• 94/9/EC Equipment and Protective Systems in Potentially Explosive Atmospheres(ATEX)

• 93/15/EEC Explosives for Civil Uses• 97/23/EC Pressure Equipment (PED)• 1999/36/EC Transportable Pressure Equipment (TPED)

with Identification Number 0589according to Directives


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Basis for CE marking:

• Fulfilment of the relevant modules(e.g. B+D or B+E etc.):

B: EC type examination certificateD: Quality assurance certificate(this case: CE + identification No.of NB)

(possible: involvement of one or more notified bodies)


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Evidence of the manufacturer for the EC conformity assessment according to module B+D by BAM by CE marking, including the identification No. of the

notified body (every body: 1 No)

05890589


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Example fo BAM certification and for cooperation with other notified bodies:

Gas warning device


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Marking of a gas cylinder valve with 0589


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Assessment and Certification in thevoluntary area

Certification Scope GENERAL (ZBA)

• Gas warning devices• Safety installations, i.a. for welding and cutting and allied

processes• Oxygen installations and oxygen compatibility• Reference objects in the optical area• Devices and test equipment for non-destructive material

testing• Mechanical-technological test equipment• Materials and products with protective function against

explosion pressure from interior and exterior, e.g. windows, doors and shutters

Accreditation by DAP (German Accreditation System for Testing)


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BAM Certification system I (Label): Type testing (without surveillance)


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BAM Certification system II (Label): Type testing with surveillance


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Gas warning DevicesExample: Portable gas detectors


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BAM certified gas detector 2003


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Cooperation with:

• Other notified bodies (BAM: PTB, DEMCO, Exam, TÜV etc. – contracts)

• Laboratories or inspection bodies (subcontracting, auditing, training)

• National and European group of notified bodies (annual meetings or regular task forces)


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Cross section of gas cylinder valves


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Test facility for endurance test of gas cylinder valves


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• Example for certification scope extension:Non-regulated area, but in the interest of publicsafety: voluntary testing and certification of windows and constructions against explosions from the inner and the outer sphere

Problem: different standards (US, EU, D) not suitablefor certification

Solution: creation of own specific certification base and agreed by contract with client

After discussion in Certif.WG + Advisory Board


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Example: resistance of windows and constructions againstexplosions (BAM Section II.3, Dr. Otto)


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Summary-Quality infrastructure (QI) is important for free trade andcontributes to reduce technical barriers to trade

-Each element of QI is essential for the entire system-Accreditation is an important tool to enhance confidence in

conformity assessment results and contributes to theirmutual recognition

-Accreditation according new regulation is basis to assess thecompetence of CAB‘s, the precondition for notification and

mutual recognition in the EU-Peer evaluation ensures equal procedures and competence of authorised national accreditation bodies


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German accreditation and conformity assessment system- Great variety due to historical reasons- 2 main areas: voluntary and mandatory (with some overlap)- Long time experience- International recognised- Use of international standards and EC Directives- Potential for increasing the efficiency- Challenge for the system to establish the one national accreditation

body according the new EC regulation and based on national accreditation law

Development of a national accreditation system � �Experiences from Germany ��Revision of the national accreditation systemContent of presentationDefinitions�(according to ISO/IEC 17000:2005; Conformity assessment - General vocabulary)�Structure and Members of DAR�Evaluation of private Accreditation Body Members of DAR�Results from the DAR�Register of accredited services, database:�• over 3200 accredited�CABs�• provided with full text�search and keyword�search�• gGerman Signatories of the EA - MLA�(Multilateral Recognition Arrangements between AB’s) �Signatories to the Multilateral Recognition Arrangements� (for Testing and Calibration Laboratories) of the European CooperatiGlobal and New Approach are associated with the creation of the European single market in 1992:Standard elements of New Approach directivesEssential requirements of EC directivesModular basic scheme of conformity assessment proceduresBasic ModulesNotified Bodies and basic principles of notificationRecognition and notification of (notified) bodiesThe EN 45 000 series of standards relevant for notified bodies (updated by new ISO 17000ff. standards see below)General responsibilities of notified bodiesNotified bodies and conformity assessmentNotified bodies and subcontractingThe CE mark for European conformity �(conformity of the product with the requirements of all relevant European Directives)The – mark for conformity with European Directive 1999/36/EC (Transportable Pressure Equipment)Principles of CE markingAffixing of the CE marking (1)Affixing of the CE marking (2)CE marking and other marksNew development in EuropeProposed standards of conformity assessment becoming harmonised standards by mandate of CEN/CLC�(results of the CEN/CLC TC 1 mFurther development in GermanyAccreditation Advisory Board�Criteria for the Structureof a Certification Body �according to DIN EN 45011 1(2)Criteria for the Structure of a Certification Body �according to DIN EN 45011 2(2)Organisational Structure of BAM Certification BodyTasks of the BAM certification working group (AKZ)Steps towards CertificationBasis for all certification and assessment procedures: reliable test resultsBAM�Certification procedure�BAM flyer part 1BAM flyer part 2Assessment and Certification in the�mandatory area (EC Directives, Laws)BAM acts as NOTIFIED BODYBasis for CE marking:Evidence of the manufacturer for the EC conformity assessment according to module B+D by BAM by CE marking, including the idExample fo BAM certification and for cooperation with other notified bodies: �Gas warning device Marking of a gas cylinder valve with 0589 Assessment and Certification in the�voluntary area�Certification Scope GENERAL (ZBA)BAM Certification system I (Label): �Type testing (without surveillance)BAM Certification system II (Label): �Type testing with surveillanceBAM certified gas detector 2003Cooperation with:Cross section of gas cylinder valvesExample: resistance of windows and constructions against explosions (BAM Section II.3, Dr. Otto)

development of a national accreditation system...

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