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APLAC - ITS ROLE AND STRUCTURE
2017/07 APLAC PR 007 issue no 40
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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 2017/07 APLAC PR 007 issue no 40
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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 Inaugural signing of extended MRA for PTP June 2014 2017/07 APLAC PR 007 issue no 40
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Asia Pacific Laboratory Accreditation Cooperation ctd
Incorporated in 2006: APLAC Constitution 2017/07 APLAC PR 007 issue no 40
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APLAC Membership Laboratory, inspection body, reference material producer (RMP) and proficiency testing producer (PTP) accreditation bodies in APEC economies Laboratory, inspection body, reference material producer (RMP) and proficiency testing provider (PTP) accreditation bodies in other economies with approval of three-fourths majority 2017/07 APLAC PR 007 issue 40
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APLAC Membership ctd Commitment to compliance with ISO/IEC 17011
Laboratories accredited to ISO/IEC (ISO for medical laboratories) Inspection bodies accredited to ISO/IEC 17020 RMPs accredited to ISO/IEC and Guide 34 PTPs accredited to ISO/IEC 17043 2017/07 APLAC PR 007 issue no 40
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Current APLAC Membership
All APEC economies except Chile Also Bangladesh, Bhutan, Cambodia, Gulf Region, India, Kazakhstan, Kuwait, Mongolia, Nepal, Pakistan, Saudi Arabia, Sri Lanka, Turkey, UAE 46 full members 13 associate members 2017/07 APLAC PR 007 issue no 40
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APLAC Full Members Australia: NATA Bangladesh: BAB
Brunei Darussalam: ABCi Canada: SCC; CALA; IQMH; DAP People’s Republic of China: CNAS Gulf Region: GAC Hong Kong: HKAS 2017/07 APLAC PR 007 issue no 40
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APLAC Full Membership, ctd
India: NABL, NABCB Indonesia: KAN Japan: JAB; IAJapan; VLAC Kazakstan: NCA Korea: KOLAS Malaysia: Standards Malaysia Mexico: ema Mongolia: MNAS 2017/07 APLAC PR 007 issue no 40
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APLAC Full Membership, ctd
New Zealand: IANZ Nepal: AERSSC Pakistan: PNAC Papua New Guinea: PNGLAS Peru: INACAL Philippines: PAB Russian Federation: AAC Analitica, RusAccreditation 2017/07 APLAC PR 007 issue no 40
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APLAC Full Membership, ctd
Saudi Arabia: SAC Singapore: SAC Sri Lanka: SLAB Chinese Taipei: TAF Thailand: BLA-DSS; BLQS-DMSc; NSC-ONSC USA: A2LA; AIHA-LAP, LLC; ANAB; IAS; NVLAP; PJLA Inc. 2017/07 APLAC PR 007 issue no 40
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APLAC Full Membership, ctd
UAE: ENAS Vietnam: BoA; AOSC Australasia: JAS-ANZ 2017/07 APLAC PR 007 issue no 40
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APLAC Associate Membership
Australia: PTA; ALAB Bhutan: NAFP Cambodia: NAFP CANC Korea: KTR; RRA; KASTO; KTC Kuwait: KAAS, PAI Mongolia: CGL Chinese Taipei: NIEA 2017/07 APLAC PR 007 issue no 40
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APLAC Associate Membership ctd
Thailand: FHI 360 (Thailand Office) Turkey: NAC 2017/07 APLAC PR 007 issue no 40
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APLAC’s Role Development of laboratory, inspection body, RMP and PTP accreditation procedures and practices in the APEC region Promotion of laboratory, inspection body, RMP and PTP accreditation as a trade facilitation tool Assistance to developing accreditation systems 2017/07 APLAC PR 007 issue no 40
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APLAC’s Role Recognition of competent test and calibration facilities, inspection bodies, reference material producers and proficiency testing providers in the APEC region 2017/07 APLAC PR 007 issue no 40
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APLAC’s Role Cooperation with other regional laboratory and inspection body accreditation organisations such as EA, IAAC, SADCA, AFRAC, ARAC Strong links with APEC SCSC & other APEC Specialist Regional Bodies, APLMF, APMP, PAC, PASC APLAC is a recognised Regional Cooperation Body of ILAC 2017/07 APLAC PR 007 issue no 40
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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 2017/07 APLAC PR 007 issue no 40
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APLAC’s Structure 2017/07 APLAC PR 007 issue no 40
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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 2017/07 APLAC PR 007 issue no 40
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Proficiency Testing Calibration Measurement (some with APMP) Testing
Inter-regional Programs 2017/07 APLAC PR 007 issue no 40
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Public Information “APLAC News Notes” published every 6 months by the APLAC Secretariat Publicity and information material APLAC website: 2017/07 APLAC PR 007 issue no 40
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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 2017/07 APLAC PR 007 issue no 40
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Training Accreditation body staff APLAC & ILAC MRA evaluators
Train the trainers Technical assessors Laboratory staff 2017/07 APLAC PR 007 issue no 40
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APLAC - Primary Objective
Acceptance of test, calibration and inspection reports, reference material certificates and proficiency testing provider reports amongst all signatories’ economies demands mutual confidence in technical competence Confidence cannot be legislated 2017/07 APLAC PR 007 issue no 40
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APLAC - Subsidiary Objectives
Information exchange Exchange of experts Training Proficiency Testing 2017/07 APLAC PR 007 issue no 40
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APLAC MRA Signatories NATA BAB CALA IQMH SCC CNAS GAC HKAS NABCB NABL
KAN JAB IAJapan VLAC NCA KOLAS 2017/07 APLAC PR 007 issue no 40
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APLAC MRA Signatories ctd
Standards Malaysia ema MNAS IANZ PNGLAS PNAC PAB AAC Analitica RusAccreditation SAC SLAB TAF BLA-DSS BLQS-DMSc NSC-ONSC AIHA-LAP, LLC A2LA ANAB 2017/07 APLAC PR 007 issue no 40
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APLAC MRA Signatories ctd
IAS NVLAP PJLA Inc. BoA JAS-ANZ 2017/07 APLAC PR 007 issue no 40
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Accreditation Assessment of laboratory, inspection body, RMP and PTP performance against international criteria (ISO/IEC 17025; ISO 15189; ISO/IEC 17020; ISO Guide 34 and ISO/IEC 17043) 2017/07 APLAC PR 007 issue no 40
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Accreditation ctd Means of determining competence of laboratories, inspection bodies, RMPs and PTPs to perform specific measurements, calibrations, tests or inspections, to certify reference materials competently, or the development and operation of proficiency testing schemes 2017/07 APLAC PR 007 issue no 40
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Accreditation ctd Formal recognition of that competence
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 2017/07 APLAC PR 007 issue no 40
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Accreditation ctd Demonstrated competence Specific tests
Defined measurements Types of calibrations Particular testing techniques Specific types of inspections Specific types of reference materials of providers of proficiency testing schemes 2017/07 APLAC PR 007 issue no 40
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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 2017/07 APLAC PR 007 issue no 40
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Accreditation Hierarchy of
Criteria ISO/IEC 17025/17020 Supplementary, Field-specific criteria (eg Electrical Testing) Technical Requirements of Specific Test Methods and Procedures 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 2017/07 APLAC PR 007 issue no 40
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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) 2017/07 APLAC PR 007 issue no 40
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APLAC MRA Single multilateral MRA for testing and calibration, 1997
Extended to include inspection, 2003 ISO separated out, 2007 Extended to include RMP, 2007 Extended to include PTP, 2014 Replaced network of bilateral MRAs 2017/07 APLAC PR 007 issue no 40
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APLAC MRA ctd Regional component of global ILAC Arrangement, November 2000 (test and calibration only) and October 2012 (inspection) 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 2017/07 APLAC PR 007 issue no 40
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APLAC MRA ctd Procedure: APLAC MR 001
Re-evaluation every 4 years maximum shorter interval for various causes 2017/07 APLAC PR 007 issue no 40
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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 2017/07 APLAC PR 007 issue no 40
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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: RMPs ISO/IEC 17043: PTPs 2017/07 APLAC PR 007 issue no 40
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APLAC MRA - Supplementary Requirements
Access to appropriate measurement traceability system Avoidance of conflict of interest Confidentiality Access to adequate comprehensive proficiency testing programs 2017/07 APLAC PR 007 issue no 40
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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 2017/07 APLAC PR 007 issue no 40
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APLAC MRA - Evaluation Preparation On-site visit Report
accreditation body accredited & applicant facilities Report corrective actions identified acceptance of corrective actions schedule for implementation Full review by APLAC MRA Council 2017/07 APLAC PR 007 issue no 40
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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 2017/07 APLAC PR 007 issue no 40
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APLAC MRA - Assisting Trade
APLAC MRA enhances acceptance of test, calibration and inspection reports, RM certificates and PTP reports amongst signatory economies APLAC MRA signatories recognise equivalence of each others’ accredited facilities APLAC MRA is an international recognition for accredited laboratories, inspection bodies,RMPs and PTPs 2017/07 APLAC PR 007 issue no 40
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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) 2017/07 APLAC PR 007 issue no 40
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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 2017/07 APLAC PR 007 issue no 40
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Contact APLAC website: https://www.aplac.org
2017/07 APLAC PR 007 issue no 40
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