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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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Aplac its role and structure

APLAC - ITS ROLE AND STRUCTURE

APLAC PR 007 issue no 34


Aplac its role 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

APLAC PR 007 issue no 34


Asia pacific laboratory accreditation cooperation

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 34


Aplac membership

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 34


Aplac membership ctd

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

APLAC PR 007 issue no 34


Current aplac membership

Current APLAC Membership

  • All APEC economies except Chile

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

  • 38 full members

  • 9 associate members

APLAC PR 007 issue no 34


Aplac full members

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

APLAC PR 007 issue no 34


Aplac full membership ctd

APLAC Full Membership, ctd

  • Japan: JAB; IAJapan; VLAC

  • Korea: KOLAS

  • Malaysia: Standards Malaysia

  • Mexico: ema

  • Mongolia: MNAS

  • New Zealand: IANZ

  • Pakistan: PNAC

APLAC PR 007 issue no 34


Aplac full membership ctd1

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 34


Aplac full membership ctd2

APLAC Full Membership, ctd

  • Thailand: BLQS-DMSc; BLA-DSS; NSC-ONAC

  • USA: A2LA; ACLASS & FQS; AIHA-LAP, LLC ; IAS; A-S-B; NVLAP; PJLA Inc.

  • Vietnam: BoA

  • Australasia: JAS-ANZ

APLAC PR 007 issue no 34


Aplac associate membership

APLAC Associate Membership

  • Australia: PTA

  • Bangladesh: BAB

  • Bhutan, NAFP

  • Korea: KTR; NIER; RRA; KASTO

  • Chinese Taipei: NIEA

  • Thailand: FHI 360 (Thailand Office)

APLAC PR 007 issue no 34


Aplac s role

APLAC’s Role

  • Development of laboratory, inspection body, RMP and PTP 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 34


Aplac s role1

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 34


Aplac s role2

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 of ILAC

APLAC PR 007 issue no 34


Aplac s structure

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 34


Aplac s structure1

APLAC’s Structure

APLAC PR 007 issue no 34


Aplac s structure2

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 34


Proficiency testing

Proficiency Testing

  • Calibration

  • Measurement (some with APMP)

  • Testing

  • Inter-regional Programs

APLAC PR 007 issue no 34


Public information

Public Information

  • “APLAC News Notes” published every 3 months by a different APLAC member each time

  • Publicity and information material

  • APLAC website: http://www.aplac.org

APLAC PR 007 issue no 34


Technical

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 34


Training

Training

  • Accreditation body staff

  • APLAC & ILAC MRA evaluators

  • Train the trainers

    • Technical assessors

    • Laboratory staff

APLAC PR 007 issue no 34


Aplac primary objective

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 34


Aplac subsidiary objectives

APLAC - Subsidiary Objectives

  • Information exchange

  • Exchange of experts

  • Training

  • Proficiency Testing

APLAC PR 007 issue no 34


Aplac mra signatories

NATA

CALA

QMP-LS

SCC

CNAS

HKAS

NABCB

NABL

KAN

JAB

IAJapan

VLAC

KOLAS

Standards Malaysia

ema

MNAS

IANZ

PNGLAS

APLAC MRA Signatories

APLAC PR 007 issue no 34


Aplac mra signatories ctd

PNAC

PAO

AAC Analitica

SAC

SLAB

TAF

BLA-DSS

BLQS-DMSc

NSC-ONAC

AIHA-LAP, LLC

A2LA

ACLASS & FQS

A-S-B

IAS

NVLAP

PJLA Inc.

BoA

JAS-ANZ

APLAC MRA Signatories ctd

APLAC PR 007 issue no 34


Accreditation

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 34


Accreditation ctd

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 34


Accreditation ctd1

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 34


Accreditation ctd2

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 34


Aplac its role and structure

ISO/IEC

17025/17020

Supplementary,

Field-specific

criteria (eg Electrical Testing)

Technical Requirements of Specific Test Methods and Procedures

Accreditation Hierarchy of

Criteria

1General technical competence and systems compliance criteria

2Additional field-specific criteria, eg for emc testing laboratories

3Additional test, calibration, inspection method criteria

APLAC PR 007 issue no 34


Aplac its role and structure

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

1General technical competence and systems compliance criteria

2Additional field-specific criteria, eg for emc testing laboratories

3Additional test, calibration, inspection method criteria

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

APLAC PR 007 issue no 34


Aplac mra

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 34


Aplac mra ctd

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 34


Aplac procedure mr 001

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 34


Aplac procedure mr 001 ctd

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 Guide 43: PTPs

APLAC PR 007 issue no 34


Aplac mra supplementary requirements

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 34


Aplac mra evaluation team

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 34


Aplac mra evaluation

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 34


Aplac mra maintenance of signatory status

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 34


Aplac mra assisting trade

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 34


Aplac mra assisting trade1

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 34


Aplac mra regulators

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 34


Contact aplac

Contact APLAC

  • website: http://www.aplac.org

  • email: [email protected]

APLAC PR 007 issue no 34


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