The European Accreditation system and its impact to economy and society in the EU member states and beyond Thomas Facklam, EA MLA Council chair 10 th Anniversary of CYS-CYSAB 24 th 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? EA organizational structure MLA Signatories Standards for Accreditation The Development of European Accreditation EA in the global network

Origins of EA EA created as a legal entity on 26/06/2000 WEMC WECC WELAC EAL EAC  EA was created in 1997 but its origins extend back further

A not-for-profit association registered in the Netherlands in June 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? EA organizational structure MLA Signatories Standards for Accreditation The Development of European Accreditation EA in the global network

EA Organizational structure EA Advisory Board General Assembly Executive Committee Secretariat Multilateral Agreement council (MAC) Horizontal Harmonisation Committee Laboratory Committee Inspection Committee Certification Committee Communications & Publications Committee

Contents What is EA? EA organizational structure MLA Signatories Standards for Accreditation The Development of European Accreditation EA in the global network

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 and ISO/IEC 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 Austria Belgium Bulgaria Croatia France Estonia Czech Rep. Finland Denmark Norway Ireland Italy Latvia 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 Portugal Turkey Spain Malta Hungary Luxembourg Full details of the scope for MLA Signatories can be found on the EA website Cyprus Serbia FJRO Mazedonia

EA MLA Signatories IsraelTunisia South AfricaUkraine 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? EA organizational structure MLA Signatories Standards for Accreditation The Development of European Accreditation EA in the global network

Standards for accreditation (1) ISO/IEC 17011Accreditation Bodies Certification Bodies EMAS Verifiers Council Regulation 1221/2009 Eco-Management and Audit Scheme ISO/IEC Management Systems ISO/IEC Persons ISO Guide 65 (EN45011) Products

Standards for accreditation (2) ISO/IEC 17011Accreditation Bodies LaboratoriesInspection Bodies Testing and CalibrationInspection ISO/IEC ISO/IEC ISO/IEC Verification Bodies ISO Verification

Contents What is EA? EA organizational structure MLA Signatories Standards for Accreditation The Development of European Accreditation EA in the global network

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 –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? EA organizational structure MLA Signatories Standards for Accreditation The Development of European Accreditation EA in the global network

EA, a major member of ILAC and IAF ILAC 72 AB Full Members In 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 R Ó sza Ring, Treasurer Biserka Bajzek Brezak, Quality Manager Ignacio Pina, Jan van der Poel, Members of the Executive EA Executive Committee ( )

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

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.

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

NEW LEGISLATIVE FRAMEWORK OVERVIEW AIMS AND EXSPECTATIONS Enterprise and Industry

The New Legislative Framework  Regulation (EC) 765/2008 of European Parliament & Council of 9 July 2008 – for accreditation & market surveillance (OJ L218/30 of 13/08/2008)  Decision (EC) 768/2008 of European Parliament & Council of 9 July 2008 on common framework for the marketing of products (OJ L218/82 of 13/08/2008)

The New Legislative Framework REGULATION  Accreditation  Market surveillance - internal - imported products - imported products  general principles  Financing elements Applicable from 1 Jan 2010 Lex Specialis sectorals/GPSDDECISION  Definitions / obligations  Notification (criteria / process / accreditation)  Conformity assessment procedures  Safeguard mechanisms (& market surveillance)  marking Basis for future legislation

The Regulation & the Decision REGULATION  Covers elements not already included in sectoral legislation  Complementary to sectoral legislation  Applicable in all Member States from 1 January 2010  Creates direct rights and obligations for Member States and individuals DECISION  Covers elements already included in legislation  Sui Generis Decision -applies to European legislator (Council, EP and COMM)  No immediate effects for Member States or individuals  Better Regulation tool: model Articles - “toolbox”

Accreditation  Create and promote mutual confidence in the quality of CABs and their certificates  Common and transparent rules for the assessment of the competence and monitoring of conformity assessment bodies  Stabilise the European accreditation system

Scope for Accreditation  All product sectors  No exclusions  Includes services  Rules are applicable in the mandatory and voluntary sector

Accreditation  Public authority activity  1 national accreditation body (NAB) per Member State  Prevention of competition for NABs  Set of requirements for NABs  European Accreditation infrastructure: EA (European co-operation for accreditation)  Cross border accreditation (EA role)  Peer evaluation (EA role)

Implementation: Commission  The Commission must follow national adaptations of systems.  Commission must follow EA.  Guidelines signed between Commission, EA, EFTA & National Authorities 1 April 2009  Framework contract EA/COM  Overview rules for peer evaluation

Implementation: National Authorities  oversee NAB  ensure proper means at disposal  carry out regular monitoring  take corrective actions

Implementation: EA  Ensure openness, transparency, equivalence and competence in its procedures  Operate a rigorous peer evaluation system  Identify and raise awareness of tools for the implementation of EU legislation  Assist in the development of sectoral schemes where requested

Accreditation in support of notification  Accreditation is the preferred means  Facilitated notification procedure based on accreditation  Standard-based  Transparent  Peer evaluation

Notification without accreditation  « Alternative » procedure (Reg. 765/2008 Art. 5(2))  Member States must provide documentary evidence of competence

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

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.

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

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, B é n é dicte Ziemann, Fr é d é rique Laudinet, Julia Ledwon 75 avenue Parmentier FR Paris tel: /63 /65/64 fax: website: To contact the EA secretariat