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APLAC - ITS ROLE AND STRUCTURE

APLAC - ITS ROLE AND STRUCTURE. APLAC - ITS ROLE & STRUCTURE. What is APLAC? The Role of APLAC Structure of APLAC Accreditation APLAC Mutual Recognition Arrangement APLAC MRA - supporting G2G MRAs and trade in the APEC region. Asia Pacific Laboratory Accreditation Cooperation.

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APLAC - ITS ROLE AND STRUCTURE

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  1. APLAC - ITS ROLE AND STRUCTURE APLAC PR 007 issue no 27

  2. APLAC - ITS ROLE & STRUCTURE • What is APLAC? • The Role of APLAC • Structure of APLAC • Accreditation • APLAC Mutual Recognition Arrangement • APLAC MRA - supporting G2G MRAs and trade in the APEC region APLAC PR 007 issue no 27

  3. Asia Pacific Laboratory Accreditation Cooperation • Established 1992 • Mutual Recognition Arrangement (MRA) inaugural signing 1997 • Inaugural signing of extended MRA for inspection November 2003 • Inaugural signing of extended MRA for RMP December 2007 • Incorporated in 2006: APLAC Constitution APLAC PR 007 issue no 27

  4. APLAC Membership • Laboratory, inspection body and reference material producer (RMP) accreditation bodies in APEC economies • Laboratory, inspection body and reference material producer (RMP) accreditation bodies in other economies with approval of three-fourths majority • Commitment to compliance with ISO/IEC 17011 APLAC PR 007 issue no 27

  5. APLAC Membership ctd • Laboratories accredited to ISO/IEC 17025 (ISO 15189 for medical laboratories) • Inspection bodies accredited to ISO/IEC 17020 • RMPs accredited to ISO Guide 34 in combination with ISO/IEC 17025 APLAC PR 007 issue no 27

  6. Current APLAC Membership • All APEC economies except Chile • Also Bangladesh, India, Mongolia, Pakistan, Sri Lanka • 37 full members • 6 associate members APLAC PR 007 issue no 27

  7. APLAC Full Members • Australia: NATA • Brunei Darussalam • Canada: SCC; CAEAL • People’s Republic of China: CNAS • Hong Kong China: HKAS • India: NABL • Indonesia: KAN APLAC PR 007 issue no 27

  8. APLAC Full Membership, ctd • Japan: JAB; IAJapan; VLAC; JCLA • Korea: KOLAS • Malaysia: SM • Mexico: ema • Mongolia: MASM • New Zealand: IANZ • Pakistan: PNAC APLAC PR 007 issue no 27

  9. APLAC Full Membership, ctd • Papua New Guinea: PNGLAS • Peru: Indecopi • Philippines: PAO • Russia: AAC Analitica • Singapore: SAC • Sri Lanka: SLAB • Chinese Taipei: TAF APLAC PR 007 issue no 27

  10. APLAC Full Membership, ctd • Thailand: DMSc; DSS; TLAS • USA: A2LA; ACLASS; AIHA; IAS; L-A-B; NVLAP; PJL • Vietnam: BoA • Australasia: JAS-ANZ APLAC PR 007 issue no 27

  11. APLAC Associate Membership • Australia: PTA • Bangladesh: BAB • Korea: KOTRIC; NIER • Chinese Taipei: NIEA • Thailand: FHI (Thailand Office) APLAC PR 007 issue no 27

  12. APLAC’s Role • Development of laboratory, inspection body and RMP accreditation procedures and practices in the APEC region • Promotion of laboratory, inspection body and RMP accreditation as a trade facilitation tool • Assistance to developing accreditation systems APLAC PR 007 issue no 27

  13. APLAC’s Role • Recognition of competent test and calibration facilities, inspection bodies and reference material producers in the APEC region APLAC PR 007 issue no 27

  14. APLAC’s Role • Cooperation with other regional laboratory and inspection body accreditation organisations such as EA, IAAC, SADCA • Strong links with APEC SCSC & other APEC Specialist Regional Bodies, APLMF, APMP, PAC, PASC • APLAC is a recognised Regional Cooperation Body Member of ILAC APLAC PR 007 issue no 27

  15. APLAC’s Structure • General Assembly • Board of Management • MRA Council • 5 permanent Committees • Proficiency Testing Committee • Public Information Committee • Technical Committee • Training Committee • Nominations Committee APLAC PR 007 issue no 27

  16. APLAC’s Structure APLAC PR 007 issue no 27

  17. APLAC’s Structure • Board of Management • meets at least twice a year • oversees management of APLAC’s activities • oversees the work of the APLAC committees • Committees report to members at each annual General Assembly APLAC PR 007 issue no 27

  18. Proficiency Testing • Calibration • Measurement (some with APMP) • Testing • Inter-regional Programs APLAC PR 007 issue no 27

  19. Public Information • “APLAC News Notes” published every 3 months by a different APLAC member each time • Publicity and information material • APLAC web site: http://www.aplac.org APLAC PR 007 issue no 27

  20. Technical • Guidance and interpretation documents • APLAC documents • management reviews; internal audits • reporting compliance with a specification • measurement uncertainty in testing • guidance on ISO/IEC 17020 • guidance for food testing laboratories • guidance on accreditation of RMPs • adoption of ILAC and EA documents • Input into ILAC documents APLAC PR 007 issue no 27

  21. Training • Accreditation body staff • APLAC & ILAC MRA evaluators • Train the trainers • Technical assessors • Laboratory staff APLAC PR 007 issue no 27

  22. APLAC - Primary Objective • Acceptance of test, calibration and inspection reports and reference material certificates amongst all signatories’ economies • demands mutual confidence in technical competence • Confidence cannot be legislated APLAC PR 007 issue no 27

  23. APLAC - Subsidiary Objecives • Information exchange • Exchange of experts • Training • Proficiency Testing APLAC PR 007 issue no 27

  24. NATA CAEAL SCC CNAL HKAS NABL KAN JAB IAJapan VLAC KOLAS DSM ema IANZ PNAC PAO APLAC MRA Signatories APLAC PR 007 issue no 27

  25. SAC AAC Analitica TAF DSS DMSc TLAS A2LA ACLASS LAB IAS NVLAP PJLA BoA JAS-ANZ APLAC MRA Signatories ctd APLAC PR 007 issue no 27

  26. Accreditation • Assessment of laboratory, inspection body and RMP performance against international criteria (ISO/IEC 17025; ISO/IEC 17020; ISO Guide 34) • Means of determining competence of laboratories, inspection bodies and RMPs to perform specific measurements, calibrations, tests or inspections, or to certify reference materials competently • Formal recognition of that competence APLAC PR 007 issue no 27

  27. Accreditation ctd • 3rd party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks (ISO/IEC 17000) • Key phrases • competence • specific…. tasks APLAC PR 007 issue no 27

  28. Accreditation ctd • Demonstrated competence • Specific tests • Defined measurements • Types of calibrations • Particular testing techniques • Specific types of inspections • Specific types of reference materials APLAC PR 007 issue no 27

  29. Accreditation ctd • Technical competence • Integrity • Transparency (as defined by WTO TBT) • Fairness • Scope of accreditation • products; types of test parameters types of inspections;matrices • measurement techniques, range, accuracy • test specification; test method APLAC PR 007 issue no 27

  30. ISO/IEC 17025/17020 Supplementary, Field-specific criteria (eg Electrical Testing) Technical Requirements of Specific Test Methods and Procedures Accreditation Hierarchy of Criteria 1 General technical competence and systems compliance criteria 2 Additional field-specific criteria, eg for emc testing laboratories 3 Additional test, calibration, inspection method criteria APLAC PR 007 issue no 27

  31. Accreditation Hierarchy of Criteria ISO/IEC 17025/17020 Supplementary, Field-specific criteria (eg Electrical Testing) Technical Requirements of Specific Test Methods and Procedures Regulatory Requirements 1 General technical competence and systems compliance criteria 2 Additional field-specific criteria, eg for emc testing laboratories 3 Additional test, calibration, inspection method criteria 4 Additional, regulator-specific criteria (eg reporting formats, labelling etc) APLAC PR 007 issue no 27

  32. APLAC MRA • Single multilateral MRA for testing and calibration, 1997 • Extended to include inspection, 2003 • ISO 15189 separated out, 2007 • Extended to include RMP, 2007 • Replaced network of bilateral MRAs • Regional component of global ILAC Arrangement, November 2000 (test and calibration only) APLAC PR 007 issue no 27

  33. APLAC MRA ctd • Facility accredited by one MRA partner has equivalent competence to facility accredited by other partners • Each signatory acknowledges equivalence of all other signatories • Signatories demonstrate compliance with ISO/IEC 17011 • Procedure: APLAC MR 001 • Re-evaluation every 4 years maximum • shorter interval for various causes APLAC PR 007 issue no 27

  34. APLAC Procedure MR 001 • Application; pre-evaluation; evaluation • Maintenance of signatory status • Criteria for accreditation bodies • ISO/IEC 17011 • Qualifications of evaluators • Expanded on in APLAC MR 004 APLAC PR 007 issue no 27

  35. APLAC Procedure MR 001 ctd • Criteria for accredited bodies • ISO/IEC 17025: laboratories • ISO 15189: medical laboratories • ISO/IEC 17020: inspection bodies • ISO Guide 34 in combination with ISO/IEC 17025: RMPs APLAC PR 007 issue no 27

  36. APLAC MRA - Supplementary Requirements • Access to appropriate measurement traceability system • Avoidance of conflict of interest • Confidentiality • Access to adequate comprehensive proficiency testing programs APLAC PR 007 issue no 27

  37. APLAC MRA - Evaluation Team • Peer review • Balance of skills and technical expertise • Evaluators • experienced in laboratory accreditation • technical expertise • proficiency testing experience • free from conflict of interest APLAC PR 007 issue no 27

  38. APLAC MRA - Evaluation • Preparation • On-site visit • accreditation body • accredited & applicant facilities • Report • corrective actions identified • acceptance of corrective actions • schedule for implementation • Full review by APLAC MRA Council APLAC PR 007 issue no 27

  39. APLAC MRA - Maintenance of Signatory Status • Accreditation body notifies changes • name; legal status; organisation structure • key staff • operational procedures • Re-evaluation • maximum every 4 years • after a shorter period with due cause • focus on changes • new team leader APLAC PR 007 issue no 27

  40. APLAC MRA - Assisting Trade • APLAC MRA enhances acceptance of test, calibration and inspection reports, and RM certificates amongst signatory economies • APLAC MRA signatories recognise equivalence of each others’ accredited facilities • APLAC MRA is an international recognition for accredited laboratories, inspection bodies and RMPs APLAC PR 007 issue no 27

  41. APLAC MRA - Assisting Trade • APLAC MRA reduces or eliminates need for re-testing or re-inspection of imported goods • Entry into global ILAC Arrangement (for testing and calibration only) APLAC PR 007 issue no 27

  42. APLAC MRA & Regulators • Laboratories and inspection bodies accredited for compliance with domestic & foreign regulations • MRA evaluations assure competence to assess to domestic & foreign regulations • APLAC MRA underpins APEC G2G MRAs APLAC PR 007 issue no 27

  43. Contact APLAC • web site: http://www.aplac.org • email: aplac@nata.asn.au APLAC PR 007 issue no 27

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