the european accreditation system and its impact to economy and society in the eu member states and...

The European Accreditation system and its impact to The European Accreditation system and its impact to economy and society in the EU member states and economy and society in the EU member states and

beyondbeyond

Thomas Facklam, EA MLA Council chairThomas Facklam, EA MLA Council chair

10th Anniversary of CYS-CYSAB24th October 2012, Nicosia, Cyprus

Contents

What is EA?

EA organizational structure

MLA Signatories

Standards for Accreditation

The Development of European Accreditation

EA in the global network

Contents

The role and importance of accreditation in today´s society and especially the operation of the Single Market

Examples of new legislation (GHG, EU/ETS, wastes etc.)

New Approach Directives, NLF, the Health Sector

The cooperation of EA with sector scheme owners

The role of small countries and small ABs in European and international accreditation

The importance of regional cooperation

Contents

What is EA?


MLA Signatories




Origins of EA

EA created as a legal entity on 26/06/2000

WEMC 1973-1982WECC 1976-1994 WELAC 1987-1994

EAL 1994-1997 EAC 1991-1997

EA was created in 1997 but its origins extend back further

• A not-for-profit association registered in the Netherlands in June 2000.

• 35 Full Members representing 35 European economies

• 13 Associate Members

• Out of these members, 4 have turned into a bilateral agreement with EA.

The European co-operation for Accreditation (1)

• A permanent secretariat of 5 persons:– Martine Blum, Bénédicte Ziemann, Frédérique

Laudinet, Julia Ledwon, EA Secretariat– Marga Zaffe, Secretary of the MLA Council

• EA is an active Member of ILAC (International laboratory Accreditation Cooperation) and IAF (International Accreditation Forum) as a recognised regional cooperation.

The European co-operation for Accreditation (2)

Purpose of EA (1)

• The European co-operation for Accreditation (EA) is the Association of the national accreditation bodies that provide accreditation for the following conformity assessment activities: – Calibration– Testing– Inspection– Certification of quality, environmental management systems– Certification of products– Certification of persons– Verification bodies & verifiers (EMAS, EU/ETS, ETV)

Purpose of EA (2)

• Provide Europe with an effective, reliable accreditation infrastructure

• Develop accreditation criteria and guidelines supporting harmonisation of practices

• Operate a sound, robust, reliable peer evaluation process

• Ensure equivalence of accreditation and equal reliability of accredited results

• Cooperate with the European Commission and other European, international stakeholders

The European Accreditation model

• A service of general interest• Public authority• Last level of control of CA services• Voluntary, mandatory fields• Mandate of the Government• Full compliance with applicable rules• Accountability to stakeholders• No predominance of any single interest group• Non-profit distributing• Non competition

Contents

What is EA?


MLA Signatories




EA Organizational structure

EA Advisory Board

General Assembly

Executive Committee

Secretariat

MultilateralAgreement

council(MAC)

HorizontalHarmonisation

Committee

LaboratoryCommittee

InspectionCommittee

Certification Committee

Communications & Publications

Committee

Contents

What is EA?


MLA Signatories




EA MLA Signatories• Multilateral Agreements (MLAs) create confidence in, and acceptance

of, accredited certifications, inspections and test reports, eliminating the need for suppliers to be certified in each country where they sell their products or services. EA’s role in supporting the effective operation of the Single Market is recognized by Regulation 765/2008, the Guidelines for cooperation and Framework Partnership agreement signed with the European Commission and EFTA.

• EA MLA Signatories and the accreditations they grant are internationally recognized through the ILAC and IAF Multilateral agreements.

• Each signatory is subject to routine rigorous evaluations by peer evaluation teams in order to verify continuing compliance with the Regulation 765/2008 and international standard for accreditation bodies (ISO/IEC 17011).

Operate according to the criteria specified in the relevant European Standards, published in the EN 45000 and ISO/IEC 17000 series of standards, or other internationally recognised normative documents, supplemented by EA application documents, if necessary

Accept the other schemes operated by the other signatories as equivalent to their own

Recognise on an equal basis with their own the certificates and/or reports from the organisations accredited by the signatories under their scheme(s)

Recommend & promote the acceptance of certificates and/or reports from the organisations accredited by the signatories under their scheme(s) by all users in countries of the signatories

Investigate all complaints initiated by a signatory resulting from certificates and/or reports issued by an accredited organisation of their own scheme(s)

Notify all other signatories as soon as possible of any significant change that has occured or will occur in their status or in the operational practices of their scheme(s)

EA MLA Signatories: rights & obligations

From the EA MLA Council minutes October 2011

Justification for Decision: CYS-CYSAB’s operations and the competence of their accredited CAB’s in the fields of (medical) testing and inspection appeared to be in accordance with EA requirements. CYS-CYSAB reacted constructively to all findings and showed effective implementation of some findings during the meeting. The proposed decision was shown on screen. All members voted in favor of the decision.

EA-MAC Decision: CYS-CYSAB becomes an EA MLA signatory in the fields of testing and inspection. The next re-evaluation shall take place by May 2013, two years after the initial evaluation visit.

EA MLA Signatories

United Kingdom

Poland

Germany

Greece

AustriaBelgium

Bulgaria

Croatia

France

Estonia

Czech Rep.

Finland

Denmark

NorwayIreland

ItalyLatvia

Lithuania

Netherlands

Slovakia

Slovenia

Sweden

Switzerland

33 Full Member accreditation bodies have signed the EA MLA, out of which 26 have signed for all accreditation activities covered by the EA MLA.

Romania

PortugalTurkey

Spain

Malta

Hungary

Luxembourg

Full details of the scope for MLA Signatories can be found on the EA website

Cyprus

Serbia

FJRO Mazedonia

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http://fr.wikipedia.org/wiki/Image:Flag_of_Turkey.svg

EA MLA Signatories

Israel Tunisia

South Africa Ukraine

4 Associate Member accreditation bodies have signed the EA MLA

Full details of the scope for MLA Signatories can be found on the EA website

Contents

What is EA?


MLA Signatories




Standards for accreditation (1)

ISO/IEC 17011Accreditation Bodies

Certification Bodies

EMAS Verifiers Council Regulation

1221/2009

Eco-Management and Audit Scheme

ISO/IEC 17021

Management Systems

ISO/IEC 17024

Persons

ISO Guide 65 (EN45011)

Products

Standards for accreditation (2)ISO/IEC 17011Accreditation Bodies

Laboratories Inspection Bodies

Testing and Calibration Inspection

ISO/IEC 17025ISO/IEC 15189

ISO/IEC 17020

Verification Bodies

ISO 14065

Verification

Contents

What is EA?


MLA Signatories




The Development of European Accreditation (1)

• The European legislation on accreditation and market surveillance

• Legal basis for accreditation and EA

• Strengthening use of accreditation and the EA MLA as a basis for notification

• Recognising EA as the European Accreditation Infrastructure

The Development of European Accreditation (2)

The EA Development Strategy 2010-2015

– Prepare for the new role

– Reconsider, improve organisation and structure

– Increase resources

– Reinforce relations with all stakeholders

– Reinforce cooperation with AB’s of the European Neighbouring Policy (ENP)

– Reinforce influence in ILAC and IAF

Contents

What is EA?


MLA Signatories




EA, a major member of ILAC and IAFILAC

• 72 AB Full MembersIn ILAC, Full Members are MLA

signatories.

• 21 AB Associate Members

• 18 AB Affiliate Members

• 1 Regional Cooperation Body (SADCA, South Africa)

• 3 Regional Cooperations (including EA)

• 26 Stakeholder Members

IAF

• 64 AB Members and 53 MLA signatories

• 18Associate Members

• 4 Regions (including EA)

• 4 Observers

•

Graham Talbot, Chairman

Daniel Pierre, Vice-Chairman

Thomas Facklam, Chair of the MAC

Vagn Andersen, Chair of the CPC

Merih Malmqvist Nilsson, Chair of the HHC

Rolf Straub, Chair of the IC

Leopoldo Cortez, Chair of the CC

Paolo Bianco, Chair of the LC

RÓsza Ring, Treasurer

Biserka Bajzek Brezak, Quality Manager

Ignacio Pina, Jan van der Poel, Members of the Executive

EA Executive Committee (2012-2014)

Contents







Co-operation of national bodies

What if accreditation bodies were competitive bodies? To maintain the necessary confidence in the accreditations granted, an extra layer would be necessary for supervision.

This would create extra costs. With no end...

EA and its members are neutral from commercial pressure. EA develops and maintains a high level of service for the benefit of the European economy: the European Commission and EFTA, the European industries, governments and citizens. All interested parties and stakeholders are involved in the EA activities. They can and do contribute to the EA work through membership in the EA Advisory Board, committees and working groups

New responsibilities for EA members Communication is a pivotal function for the consistent implementation of the new regulation. The latter formalizes EA members’ obligations to satisfy the expectations of national authorities and stakeholders, which entrust greater responsibility from their NAB. A Best Practice Guide on Communications with the Regulators has been published to assist EA and its members to develop and strengthen cooperation with both national and European regulators.

New responsibilities for EA Similarly EA itself shall enhance its communications with the EC: EA shall attend every SOGS meeting dealing with accreditation, as well as meetings of the EC Inter-Service Steering Group for Accreditation in order to discuss the benefits of accreditation with the various EC services; specific projects are underway with DGs Environment, Transport, Health & Consumer and Agriculture.

Furthermore, EA is given a prime role to define, harmonise and build consistency in accreditation as a service to trade with third countries, with the aim to reduce barriers to trade and to contribute to protecting health and safety. Following the European Union’s will to have close links with these countries, EA considers that relationships between EA and ABs in countries being part of the EU’s Neighbourhood Policy (1) and potential candidates for EU membership (2) should be strengthened in order to support the work of the EU, to embrace and support the effective development of ABs in these countries, to enable good cooperation with EA, and to facilitate a good understanding of EA’s practices.

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NEW LEGISLATIVE FRAMEWORK OVERVIEW

AIMS AND EXSPECTATIONS

Enterprise and Industry

The New Legislative Framework Regulation (EC) 765/2008Regulation (EC) 765/2008 of European Parliament & of European Parliament &

Council of 9 July 2008 – for accreditation & market Council of 9 July 2008 – for accreditation & market surveillance surveillance (OJ L218/30 of 13/08/2008)(OJ L218/30 of 13/08/2008)

Decision (EC) 768/2008Decision (EC) 768/2008 of European Parliament & of European Parliament & Council of 9 July 2008 on common framework for the Council of 9 July 2008 on common framework for the marketing of products (OJ L218/82 of 13/08/2008)marketing of products (OJ L218/82 of 13/08/2008)

The New Legislative Framework

REGULATIONREGULATION

AccreditationAccreditation Market surveillance Market surveillance

- internal- internal

- imported products- imported products general principles general principles Financing elements Financing elements

Applicable from 1 Jan 2010Applicable from 1 Jan 2010

Lex Specialis Lex Specialis

sectorals/GPSDsectorals/GPSD

DECISIONDECISION

Definitions / obligationsDefinitions / obligations Notification (criteria / process / Notification (criteria / process /

accreditation)accreditation) Conformity assessment Conformity assessment

proceduresprocedures Safeguard mechanisms (& market Safeguard mechanisms (& market

surveillancesurveillance)) markingmarking

Basis for future legislationBasis for future legislation

The Regulation & the DecisionREGULATION

Covers elements not already Covers elements not already included in sectoral legislationincluded in sectoral legislation

Complementary to sectoral Complementary to sectoral legislationlegislation

Applicable in all Member States Applicable in all Member States from 1 January 2010from 1 January 2010

Creates direct rights and Creates direct rights and obligations for Member States obligations for Member States and individualsand individuals

DECISION

Covers elements already included in Covers elements already included in legislation legislation

Sui Generis Decision -applies to Sui Generis Decision -applies to European legislator (Council, EP and European legislator (Council, EP and COMM) COMM)

No immediate effects for Member No immediate effects for Member States or individualsStates or individuals

Better Regulation tool: model Better Regulation tool: model Articles - “toolbox”Articles - “toolbox”

Accreditation Create and promote mutual confidence in the quality of Create and promote mutual confidence in the quality of

CABs and their certificates CABs and their certificates

Common and transparent rules for the assessment of Common and transparent rules for the assessment of the competence and monitoring of conformity the competence and monitoring of conformity assessment bodies assessment bodies

Stabilise the European accreditation systemStabilise the European accreditation system

Scope for Accreditation

All product sectorsAll product sectors No exclusionsNo exclusions Includes servicesIncludes services Rules are applicable in the mandatory and voluntary Rules are applicable in the mandatory and voluntary

sectorsector

Accreditation

Public authority activityPublic authority activity 1 national accreditation body (NAB) per Member State1 national accreditation body (NAB) per Member State Prevention of competition for NABsPrevention of competition for NABs Set of requirements for NABsSet of requirements for NABs European Accreditation infrastructure: EA (European European Accreditation infrastructure: EA (European

co-operation for accreditation)co-operation for accreditation) Cross border accreditation (EA role)Cross border accreditation (EA role) Peer evaluation (EA role)Peer evaluation (EA role)

Implementation: Commission

The Commission must follow national The Commission must follow national adaptations of systems.adaptations of systems.

Commission must follow EA.Commission must follow EA. Guidelines signed between Commission, EA, Guidelines signed between Commission, EA,

EFTA & National Authorities 1 April 2009EFTA & National Authorities 1 April 2009 Framework contract EA/COMFramework contract EA/COM Overview rules for peer evaluationOverview rules for peer evaluation

Implementation: National Authorities

oversee NABoversee NAB ensure proper means at disposalensure proper means at disposal carry out regular monitoringcarry out regular monitoring take corrective actionstake corrective actions

Implementation: EA

Ensure openness, transparency, equivalence and Ensure openness, transparency, equivalence and competence in its procedurescompetence in its procedures

Operate a rigorous peer evaluation systemOperate a rigorous peer evaluation system Identify and raise awareness of tools for the Identify and raise awareness of tools for the

implementation of EU legislationimplementation of EU legislation Assist in the development of sectoral schemes Assist in the development of sectoral schemes

where requestedwhere requested

Accreditation in support of notification

Accreditation is the preferred meansAccreditation is the preferred means Facilitated notification procedure based Facilitated notification procedure based

on accreditationon accreditationStandard-basedStandard-basedTransparentTransparentPeer evaluationPeer evaluation

Notification without accreditation

« Alternative » procedure (Reg. 765/2008 « Alternative » procedure (Reg. 765/2008 Art. 5(2))Art. 5(2))

Member States must provide Member States must provide documentary evidence of competencedocumentary evidence of competence

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Sector Schemes

It is an important goal for EA to provide the market in general and individual conformity assessment scheme owners in particular, with a harmonized view on accreditation and the implementation of the underlying standards. Conformity assessment scheme owners need to have a unified response from EA because one of the ultimate goals of their cooperation with EA is to be able to achieve recognition under the EA Multilateral Agreement of Mutual Recognition (EA MLA) for individual conformity assessment bodies working within their schemes thus facilitating the free movement of goods and services.

Scheme owner:

A scheme owner is an identifiable organization which has established a conformity assessment scheme and which can take responsibility for the conformity assessment scheme design. The following are examples of scheme owners:

•Standardization bodies;•Conformity Assessment Bodies;•Government authorities;•Organizations that use services provided by CABs;•Organizations that buy or sell products subject to conformity assessment activities;•Manufacturers and their associations that have established their own conformity assessment schemes.

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Draft regulations on Copper, Glass and Paper

As a result, with the current wording in the draft Regulations, the peer evaluation activity undertaken by EA will cover the application of the top-level harmonised standards which the national accreditation bodies use for accreditation of CABs, but as there are no defined criteria that the conformity assessment body has to comply with nor criteria for the management system of the end-of-waste producer, the peer evaluation has no means to take into account the technical specifications in the 3 draft Regulations (or indeed Regulation 333/2011).

EU ETS(The two new Regulations were published on the 12th July 2012 – the Monitoring & Reporting (M&R) Regulation (EU) 601/2012 and the Accreditation & Verification (A&V) Regulation (EU) 601/2012.)

Medical devices Proposed new Regulation without accreditation

Martine Blum, Bénédicte Ziemann, Frédérique Laudinet, Julia Ledwon75 avenue Parmentier FR - 75011 Paris

tel: + 33 1 40 21 24 62/63 /65/64fax: + 33 1 40 21 24 00

email: [email protected]: www.european-accreditation.org

To contact the EA secretariat

the european accreditation system and its impact to economy and society in the eu member states and...

Documents

origins of ea ea

cooperation of ea

purpose of ea

importance of accreditation

european accreditation

equivalence of accreditation

accreditation criteria

mla council ea