08/12 1APLAC PR 007 issue no 32

APLAC - ITS ROLE AND STRUCTURE

08/12 2APLAC PR 007 issue no 32

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

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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

• Incorporated in 2006: APLAC Constitution

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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

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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

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Current APLAC Membership

• All APEC economies except Chile

• Also Bangladesh, India, Mongolia, Pakistan, Sri Lanka

• 38 full members

• 8 associate members

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APLAC Full Members

• Australia: NATA

• Brunei Darussalam

• Canada: SCC; CALA; QMP-LS

• People’s Republic of China: CNAS

• Hong Kong China: HKAS

• India: NABL, NABCB

• Indonesia: KAN

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APLAC Full Membership, ctd

• Japan: JAB; IAJapan; VLAC

• Korea: KOLAS

• Malaysia: Standards Malaysia

• Mexico: ema

• Mongolia: MNAS

• New Zealand: IANZ

• Pakistan: PNAC

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APLAC Full Membership, ctd

• Papua New Guinea: PNGLAS

• Peru: Indecopi

• Philippines: PAO

• Russia: AAC Analitica

• Singapore: SAC

• Sri Lanka: SLAB

• Chinese Taipei: TAF

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APLAC Full Membership, ctd

• Thailand: DMSc; DSS; NSC-ONAC

• USA: A2LA; ACLASS; AIHA-LAP, LLC ; IAS; L-A-B; NVLAP; PJLA

• Vietnam: BoA

• Australasia: JAS-ANZ

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APLAC Associate Membership

• Australia: PTA

• Bangladesh: BAB

• Korea: KTR; NIER; RRA; KASTO

• Chinese Taipei: NIEA

• Thailand: FHI 360 (Thailand Office)

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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

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APLAC’s Role

• Recognition of competent test and calibration facilities, inspection bodies and reference material producers in the APEC region

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APLAC’s Role

• Cooperation with other regional laboratory and inspection body accreditation organisations such as EA, IAAC, SADCA, AFRAC

• Strong links with APEC SCSC & other APEC Specialist Regional Bodies, APLMF, APMP, PAC, PASC

• APLAC is a recognised Regional Cooperation Body Member of ILAC

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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

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APLAC’s Structure

N om inatonsCom m ittee

Com m ittee 1Train ing

Com m ittee

Com m ittee 2Public

I nform ationCom m ittee

Com m ittee 3Proficiency

TestingCom m ittee

Com m ittee 4Technical

Com m ittee

Boardof

M anagem ent

M R ACouncil

G eneralAssem bly

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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

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Proficiency Testing

• Calibration

• Measurement (some with APMP)

• Testing

• Inter-regional Programs

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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

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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

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Training

• Accreditation body staff

• APLAC & ILAC MRA evaluators

• Train the trainers

– Technical assessors

– Laboratory staff

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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

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APLAC - Subsidiary Objectives

• Information exchange

• Exchange of experts

• Training

• Proficiency Testing

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APLAC MRA Signatories

• NATA

• CALA

• SCC

• CNAS

• HKAS

• NABL

• KAN

• JAB

• IAJapan

• VLAC

• KOLAS

• Standards Malaysia

• ema

• MNAS

• IANZ

• PNGLAS

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APLAC MRA Signatories ctd

• PNAC

• PAO

• AAC Analitica

• SAC

• SLAB

• TAF

• DSS

• DMSc

• NSC-ONAC

• AIHA-LAP, LLC

• A2LA

• ACLASS

• LAB

• IAS

• NVLAP

• PJLA

• BoA

• JAS-ANZ

08/12 26APLAC PR 007 issue no 32

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

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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

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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

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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

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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

ISO/IEC17025/17020

Supplementary, Field-specific

criteria (eg Electrical Testing)

Technical Requirements of Specific Test Methods and Procedures

08/12 31APLAC PR 007 issue no 32

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

4 Additional, regulator-specific criteria (eg reporting formats, labelling etc)

ISO/IEC17025/17020

Supplementary, Field-specific

criteria (eg Electrical Testing)

Technical Requirements of Specific Test Methods and Procedures

Regulatory Requirements

08/12 32APLAC PR 007 issue no 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)

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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

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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

08/12 35APLAC PR 007 issue no 32

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

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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

08/12 37APLAC PR 007 issue no 32

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

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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

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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

08/12 40APLAC PR 007 issue no 32

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

08/12 41APLAC PR 007 issue no 32

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)

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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

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Contact APLAC

• web site: http://www.aplac.org

• email: aplac@nata.com.au