Developments in European Accreditation Graham Talbot Chairman
World Accreditation Day 2010 2
Economic Drivers in Europe Trade Policy Promotion of free trade More open trade and investment More growth and jobs Lower consumer prices Size of European economy Dependency on trade for employment Growth in world trade 3
EA Background Association of European National Accreditation Bodies of EU/EFTA/candidate countries A not-for-profit association registered in the Netherlands Secretariat based in Paris (France)/Utrecht (The Netherlands) 5
EA Membership 32 Full Members 20 Contracts of Cooperation with non-eu/efta ABs 11 of which will be eligible to become EA Associate Members 29 Signatories to the EA Multilateral Agreement (22 of which are for all activities covered by the MLA) 11 Bilateral Agreement Signatories 6
Role of EA To define, harmonise and build consistency in accreditation as a service in Europe To maintain a multilateral agreement on mutual recognition between the accreditation schemes To be a technical resource on matters related to the implementation and operation of the European policies on accreditation To provide Europe with an effective and reliable accreditation infrastructure to serve the needs of the economy and society 7
EA accreditations - 2009 Calibration Laboratories 2,548 (2,269) Greenhouse Gas Verifiers 88 (74) Testing Laboratories 11,826 (11,022) Inspection Bodies 4,292 (4,877) Medical Laboratories 1,024 (647) Product CBs 903 (826) Organic Farming CBs 132 (106) Management System CBs 1,030 (1,106) Occupational H&S Management CBs 155 (141) Persons CBs 307 (289) Information Security Management System CBs 85 (74) Food Safety Management System CBs 165 (142) 8
The New European Legislative Package Regulation (EC) 765/2008 Sets out requirements for accreditation and market surveillance Decision 768/2008/EC A common framework for the marketing of products 9
Regulation (EC) 765/2008 The European legislation on accreditation and market surveillance Legal basis for accreditation and EA Strengthens use of accreditation and the EA MLA as the basis for Notification 10
Regulation (EC) 765/2008 Accreditation: One National Accreditation Body (NAB) per Member State (MS) Public authority activity Independent, not-for-profit Not compete with conformity assessment bodies Appropriately resourced by MS NABs to be members of EA Balanced participation of interested parties 11
Regulation (EC) 765/2008 Other accreditation requirements: Non-competition Cross-frontier accreditation restrictions Conformity assessment bodies must not impose excessive burden on economic operators Monitoring/peer evaluations 12
Regulation (EC) 765/2008 Market surveillance obligations placed on Member States Organise and conduct surveillance Withdraw/prohibit/restrict non-conforming products Ensure appropriate communication within Europe 13
EA s Relationship with the European Commission EA recognised as formal European accreditation infrastructure General Guidelines for Cooperation between EA and the European Commission, the European Free Trade Association (signed 1 April 2009) Framework Partnership Agreement between EA and the European Commission (signed 30 June 2010) 14
Impact of the Legislation on Access to the European Market The European Commission recognises: The continued value of accreditation to underpin trade That EA should maintain full collaboration with other Regional accreditation cooperations EA should maintain strong links with ILAC and IAF 15
EA Recognition Accredited reports and certificates issued under the accreditation of an ILAC or IAF accreditation body signatory are considered to be equally reliable to those issued under accreditation within the EA MLA and Bilateral Agreements 16
EA Recognition Accreditation bodies that are not Members of EA may not meet all of the criteria specified in Regulation (EC) 765/2008 that EA Members have to meet from 1 January 2010 (e.g, appointed by Government as a single national accreditation body, recognized by the Government as acting with public authority, being independent of commercial motivations and non-profit distributing, not competing with other accreditation bodies, not performing cross-frontier accreditation, etc) 17
Impact of the Legislation on Access to the European Market The acceptance in the EU of conformity assessment attestation certificates issued under accreditation by non-european ABs does not depend on the recognition between ABs 18
Acceptance of accredited conformity assessment attestations in the EU Voluntary Conformity Assessment area: Conformity assessment attestations issued under accreditation by non-european ABs not complying with the new European requirements, but signatories to IAF and ILAC MLA/MRA, can continue to be used on the European Market Specifiers and the marketplace are free to decide on acceptability 19
Acceptance of accredited conformity assessment attestations in the EU Mandatory Conformity Assessment area: National authorities of EU Member states may refuse attestations of conformity issued under accreditation by non-european ABs not complying with the new European requirements but signatories to IAF and ILAC MLA/MRA except where an EU to Country MRA is in place 20