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BETTER WORK AND STANDARDS PROGRAMME (BEST) 

A Programme of the Government of the People’s Republic of Bangladesh 

 BETTER QUALITY INFRASTRUCTURE (BQI) COMPONENT

Presentation on

International System to Recognise Laboratory Accreditation

The Roles of APLAC and ILAC

J.E.J. (Ned) Gravel Laboratory Accreditation Expert

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Topics

• The Role of Accreditation• What is ILAC?• What is APLAC?

• Regional MRAs & the ILAC MRA

• Role of APLAC in ILAC

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Accreditation in the Market

Demands for facilitating trade

Trade Organizations& Authorities

Product/service

Suppliers

PurchasersRegulators

Conforming product/service

Requirements

Market

CertificationBody

InspectionBody

Test Lab

Cal Lab

Conformity assessment bodies

Conformity Assessment Service

CertificationBody

InspectionBody

Test Lab

Cal Lab

Conformity assessment bodies

Conformity Assessment Service

Demands for competent conformity assessment

Demands for competent conformity assessment

Accreditation Bodies

Accreditation service

Accreditation Bodies

Accreditation service

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ILAC - The International Laboratory Accreditation Cooperation

• Established in 1977 to promote communication among laboratory accreditation bodies of the world

• Formalized as a cooperation in 1996 with 44 bodies signing a Memorandum of Understanding (MOU)

• On 2 November 2000, a mutual recognition arrangement (MRA) among those members which had successfully completed a peer evaluation was signed

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ILAC’s Global Role

Principal international forum for:• recognition of competent test, calibration and inspection

labs world-wide through its Arrangement• development and appropriate harmonization of laboratory

accreditation practice• promotion of laboratory accreditation as a trade facilitation

tool• assistance with developing laboratory accreditation

systems

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ILAC Goals

• Developing and harmonizing laboratory and inspection accreditation practices

• Promoting laboratory and inspection accreditation to industry, governments, regulators and consumers

• Assisting and supporting developing accreditation systems• Global recognition of laboratories and inspection facilities

via the ILAC Arrangement, thus facilitating acceptance of test, inspection and calibration data accompanying goods across national borders

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How is ILAC Structured?• General Assembly: highest decision making body

consisting of one representative from each member.

• General Assembly: meets yearly with a major international conference held every two years

• All classes of membership and other interested parties are allowed to contribute to ILAC’s work and direction.

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ILAC Organization

GeneralAssembly

ExecutiveCommittee

ArrangementManagementCommittee

ArrangementCommittee

AccreditationCommittee

Marketing & CommunicationsCommittee

ArrangementCouncil

Finance & AuditCommittee

Secretariat

LaboratoryCommittee

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ILAC/IAF Joint Activities

Joint Committeeon Closer Cooperation

IAFSecretariat

Joint GeneralAssembly

JointDevelopmentSupportCommittee

ILACSecretariat

Joint Working Groups on Inspection & Harmonization

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Status of ILAC MRA

As of 24 May 2012: 76 members representing 68 economies are signatories to the Arrangement

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MRAs BetweenAccreditation Bodies

Laboratory accredited by one partner

has equivalent competence to

Laboratory accredited by the other(s)

The Fundamental Purpose -

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Mutual RecognitionThe Building Blocks of Confidence

Common Accreditation Criteria(ISO / IEC 17025)

Comparable Data

Proficiency Testing of Labs

Harmonised Operation of Accreditation Systems

ISO/IEC 17011

Mutual Evaluations

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Criteria

• ISO/IEC Standards for accreditation bodies:– ISO/IEC 17011:2004

• ISO/IEC Standard for the accredited labs:-– ISO/IEC 17025:2005

• ISO/IEC Standards for medical labs:-– ISO 15189:2007

• ISO/IEC Standard for inspection bodies:-– ISO/IEC 17020:2012

• ISO/IEC Standard for PT providers:-– ISO/IEC 17043:2010

• ISO/IEC Standard for Ref Mat’l providers:-– ISO Guide 34:2009

• Alternative standards/supplementary requirements:– ILAC P-series documents

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ISO/IEC 17011:2004 • Conformity assessment - General requirements

for accreditation bodies accrediting conformity assessment bodies

• Purpose:– standard for operation of an accreditation

body (that accredits labs, inspection bodies and/or certification bodies)

– basis for mutual recognition agreements among accreditation bodies

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Four Key Evaluation Topics

• Performance of CAB assessments

• Evaluation of management system

• Proficiency testing results (for labs)

• Traceability of measurement

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Observation of Assessments by Evaluators

• Role of observer• ISO/IEC 17025 satisfied?• ISO/IEC 17011 satisfied?• Body’s own rules followed• Scope of accreditation covered adequately• Effectiveness of assessment team• Competence, technical expertise of

assessors

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Management System Evaluation

• Organization structure: – delegation of authority– committees – conflict of interest – impartiality

• Documented policies, procedures and arrangements and their implementation

• Assessor support system • Measurement traceability • Proficiency testing requirements

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Proficiency Testing• Participation by accredited laboratories in international

and regional programs (e.g. EA, APLAC, IAAC, CIPM)• National PT programs for labs• Other PT being used to monitor performance of labs

and AB policy on PT• Examples of new APLAC PT programs (related to

trade):– Telecommunications equipment– Chemical analysis and hardness of metals– Food analysis

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Measurement Traceability

• Calibration done by competent organizations• NMI is signatory to the CIPM• NMI performance is noted on the KCDB• Sources of traceability for the tests and calibrations

accredited are available or referred to other CIPM signatory.

• Definitions are in the VIM and ILAC P10

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Formal Monitoring and Re-evaluation

• Re-evaluation at maximum intervals of 4 years• For due cause, re-evaluation sooner• Re-evaluation similar to initial, but emphasis on:

– changes– compliance with latest issues of standards and

supplementary requirements– evidence that standards are maintained in accredited

laboratories• Different team leader used for re-evaluation

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ILAC SignatoriesCome from:• Signatories from recognized MRAs from

regional cooperations (currently EA, APLAC and IAAC) or

• Accreditation bodies not affiliated with a recognized regional MRA (ILAC Arrangement Management Committee must arrange for these evaluations relying on resources provided primarily from the recognized regions)

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The ILAC Model Provides:• Harmonized approach• Compliance with international agreed criteria• Demonstrable traceability of measurement• Resolution of differences• An appeal process based on international best

practice• Independence of judgment; and• An impartial and non-discriminatory mechanism

to assist in the identification of competent labs.

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Obligations of Signatories• Recognize equivalence of results• Recommend and promote acceptance• Investigate complaints• Notify others of significant changes• Contribute to Arrangement Council work• Participate in ILAC working meetings• Provide peer evaluators• Cooperate to extend Arrangement

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The International Picture

EA European co-operation for AccreditationAPLAC Asia Pacific Laboratory Accreditation CooperationIAAC Inter-American Accreditation CooperationSADCA Southern African Accreditation CooperationAFRAC African Regional Accreditation Cooperation

ILAC

EA APLAC

IAACSADCA

AFRAC

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What is APLAC?

The Asia-Pacific Laboratory Accreditation Cooperation

Regional Equivalent of ILAC

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ILAC Requirements on Regional Cooperations

• Peer evaluations in line with ILAC A2• ILAC Regional Cooperation Body Member • Must have evaluated at least three accreditation bodies

and carried out sufficient surveillance and re-evaluations• Formally constituted committee • Policy on traceability to SI• Means for proficiency testing activity and access to

technical expertise

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APLAC Organization

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MRAs in the Voluntary Sector - The APLAC Example

• Single multilateral MRA, 1997• Replaced network of bilateral MRAs• Regional component of global ILAC MRA, November

2000• 33 signatories representing 23 economies, June 2012• 4 associate members representing 4 economies

APLAC Mutual Recognition Arrangement (MRA)

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Existing Acknowledgment of APLAC MRA in APEC

• APLAC - a Specialist Regional Body of SCSC of APEC• Joint Ministerial Statement at APEC Vancouver (1997)• APEC Electrical and Electronic Equipment MRA• APEC TEL MRA - Use of MRA accreditation bodies• Some APEC economies using APLAC MRA

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APLAC Role in Support of ILAC

• Ensure the integrity of the APLAC MRA • Support inter-economy proficiency testing programs• Understand and promote use of the MRA to support

regulatory and industry needs • Contribute its fair share of senior peer evaluators to

assist ILAC in carrying out peer evaluations of other regions and unaffilated bodies

• Support development of accreditation infrastructure where it is lacking

• Support development of the body of knowledge

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APLAC Role in Support of ILAC (2)

• Avoid special requirements that causes divergence away from global harmonization

• Enhance mutually supportive relationships with other regions/bodies, including unaffiliated bodies, to reduce duplication and increase synergy

• Contribute articles to the ILAC News issues• Support the ILAC strategic plan, particularly the

marketing and communications aspects• Promote the recognition/acceptance of the ILAC

MRA Mark

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ILAC MRA Mark

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For more information . . .

ILAC Secretariat

Email: ilac@nata.asn.au

Web: www.ilac.org

APLAC Secretariat

Email: aplac@nata.asn.au

Web: www.aplac.org