Presentation on theme: "55th EOQ Congress, Budapest 2011"— Presentation transcript:
1 55th EOQ Congress, Budapest 2011 The European Accreditation Infrastructure and the Importance of the EA MLADr. Rózsa RingDirector, Hungarian Accreditation Board (NAT)Treasurer and Executive Committee member of EA55th EOQ Congress, Budapest 2011
2 Hungarian Accreditation Board (NAT) IntroductionDr. Rózsa RingMathematician, EconomistAccreditation from 1988Director of NAT from 1995EA Executive Committee member from 2006EA Treasurer from 2009EU accreditation expertUN/ECE rapporteur on accreditationHungarian representative to the EA-GA, EA-HHC, EA-MAC, FALB, ILAC, IAFBoard member of 2 professional associationsEditorial Board member of 2 Journals on QualityAuthor/co-author of 10 books on quality 150 articles on accreditation 360 lectures on accreditationHungarian Accreditation Board (NAT)
3 Contents What is accreditation? The European accreditation infrastructureThe EA Multilateral AgreementInternational recognition
4 Status quoThe term „accreditation” is not copyright and has a wide dictionary meaning:International healthcare accreditationHospital accreditationEducational accreditationDiplomatic accreditationAccreditation of investorsAccreditation of journalists
5 Accreditation and conformity assessment competenceAssessconformityAccreditationThird-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks(ISO/IEC 17011:2004)
6 Standards for accreditation (1) Accreditation BodiesISO/IEC 17011LaboratoriesInspection BodiesISO/IEC 17025ISO/IEC 15189ISO/IEC 17020Testing and CalibrationInspection
7 Standards for accreditation (2) Accreditation BodiesISO/IEC 17011Certification BodiesEMAS Verifiers Council Regulation 1221/2010Eco-Management and Audit SchemeISO/IEC 17021Environmental Management SystemsISO Guide 65 (EN45011)ProductsISO/IEC 17021Quality Management SystemsISO/IEC 17024Persons
8 Contents What is accreditation? The European accreditation infrastructureThe EA Multilateral AgreementInternational recognition
9 Regulation on accreditation on accreditation and market surveillanceeffective from 1 January 2010765/2008/EC Regulation
10 The European accreditation infrastructure (1) National accreditation bodies (Art. 4, 5, 6, 8)Cross border accreditation (Art. 7)Peer evaluation (Art. 10)Presumption of conformity for national accreditation bodies (Art. 11)
11 The European accreditation infrastructure (2) European accreditation infrastructure (Art. 13, 14)Agreement with the Commission for the tasks ofdevelop evaluation criteria and procedures for peer evaluationdevelop sectoral accreditation schemesmanagement of the peer evaluation scheme
12 EA created as a legal entity on 26/06/2000 Origins of EAEA was created in 1997 but its origins extend back furtherWEMCWECCWELACEALEACEA created as a legal entity on 26/06/2000
13 EA organizational structure GeneralAssemblyEA AdvisoryBoardExecutiveCommitteeSecretariatMultilateralAgreementCouncil(MAC)HorizontalHarmonisationCommitteeLaboratoryCommitteeInspectionCommitteeCertificationCommitteeCommunications& PublicationsCommittee
14 Development of European accreditation EA Development StrategyStrengthening use of accreditation and the EA MLA as a basis for notificationReinforce the peer evaluation systemReconsider, improve organisation and structureIncrease resourcesReinforce relations with all stakeholdersReinforce cooperation with AB’s of the European Neighbouring Policy (ENP)Reinforce influence in the international accreditation organisations
15 EA Accreditations - 2010 Accredited CABs: 23,404 Calibration Laboratories2,565Greenhouse Gas Verifiers78Testing Laboratories12,201Inspection Bodies4,691Medical (ISO 15189) Laboratories871PT Providers80Organic Farming CBs133Product CBs993Occupational H&S Management CBs174Information Security Management System CBs92Management System CBs1,029Food Safety Management System CBs174Persons CBs323
16 Contents What is accreditation? The European accreditation infrastructureThe EA Multilateral AgreementInternational recognition
17 EA MLA (1)The EA MLA is an agreement signed between the EA accreditation body members to recognise the equivalence, reliability and therefore acceptance of accredited certifications, inspections, calibration certificates and test reports across Europe.The EA MLA eliminates the need of products or services to be certified in each country where they are sold acting as a "passport for trade„.
18 EA MLA (2) The EA Multilateral Agreement accepts: the equivalence of the operation of the accreditation systems administered by EA MLA signatories;that the certificates and reports issued by organisations accredited by EA MLA signatories are equally reliable.
19 Structure of EA MLA (1) Tier 1: ISO/IEC 17011 Tier 2: accreditation activity (scope) in which the AB has demonstrated competence (like testing, calibration, certification of products, management systems, persons, inspection)Tier 3: generic standards or normative documents used by the AB to assess the CAB technical competence for each accreditation activity (like ISO/IEC 17025, 17020, 17021, 17024, ISO 15189, EN 45011)
20 Structure of EA MLA (2)Tier 4: sector specific standards or normative documents used in combination with one of the generic standards of tier 3 (like ISO/TS 22003, ISO/IEC or schemes like WADA)Tier 5: standards or normative documents used by the accredited CAB to deliver an accredited conformity assessment service, like test methods or standards at the laboratories, ISO 9001 or other management systems standards, product specification or standards, national or international schemes or normative documents issued by the regulators.
21 Scopes of EA MLA Accreditation of laboratories Testing, calibration medical analysisEN ISO/IEC 17025ISO 15189Accreditation of certification bodiesCertification of poductsEN 45011(ISO/IEC Guide 65)Certification of management systemsEN ISO/IEC 17021Certification of personsEN ISO/IEC 17024Accreditation of inspection bodiesInspectionEN ISO/IEC 17020
22 Activities of EA member ABs (1) Accreditation covered by the EA MLATesting laboratoriesCalibration laboratoriesInspection bodiesCertification bodies for productsCertification bodies for personsCertification bodies for management systems (QMS, EMS, OHSAS, FSMS, ISMS)
23 Activities of the EA member ABs (2) Accreditation not covered by EA MLAEMAS verifiers – FALBPT providers – in progressEU-ETS – in progressGHG verifiersRM producersAttestors for public procurementGood Laboratory Practise
24 EA MLA Signatories Austria France Luxembourg Slovenia Belgium Bulgaria 30 Full Member accreditation bodies have signed the EA MLA, out of which 25 have signed for all accreditation activities covered by the EA MLA.AustriaFranceLuxembourgSloveniaBelgiumBulgariaCroatiaGermanyMaltaSpainHungaryNetherlandsSwedenGreeceNorwaySwitzerlandIrelandPolandTurkeyCzech Rep.ItalyPortugalDenmarkUnited KingdomLatviaRomaniaEstoniaLithuaniaFinlandSlovakiaFull details of the scope for MLA Signatories can be found on the EA website
25 Contents What is accreditation? The European accreditation infrastructureThe EA Multilateral AgreementInternational recognition
26 International accreditation International Laboratory Accreditation CooperationInternational Accreditation Forum
27 International recognition (1) ILAC MRA signatories71 accreditation bodies from 56 economiesIAF MLA signatories49 accreditation bodies from 44 economies
28 International recognition (2) Inter American Accreditation Cooperation Asia Pacific Laboratory Accreditation Cooperation Pacific Accreditation Cooperation Southern African Development Community Accreditation
30 Worldwide growth in the number of accredited laboratories since 2003
31 Worldwide growth in the number of accredited inspection bodies since 2004
32 FinallyThe international accreditation network is growing as more economies have set up competent national Accreditation Bodies. Since 2004, the number of new established Accreditation Bodies has grown by almost 45% globally. In Europe, all Member States and all candidate countries have established a national Accreditation Body.The number of accredited bodies in Europe has increased significantly in the last 6 years. Today there are more than bodies accredited by EA members, compared to in 2004, representing growth of more than 65%. At the international level, there are almost accredited laboratories, representing a similar growth rate since 2004.