BETTER WORK AND STANDARDS PROGRAMME (BEST)

1. 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

2. Topics • The Role of Accreditation • What is ILAC? • What is APLAC? • Regional MRAs & the ILAC MRA • Role of APLAC in ILAC

3. Accreditation Bodies Accreditation Bodies Accreditation service Accreditation service Conformity assessment bodies Conformity assessment bodies Certification Body Certification Body Inspection Body Inspection Body Test Lab Test Lab Cal Lab Cal Lab Conformity Assessment Service Conformity Assessment Service Market Demands for competent conformity assessment Demands for competent conformity assessment Conforming product/service Product/ service Purchasers Regulators Requirements Suppliers Trade Organizations & Authorities Demands for facilitating trade Accreditation in the Market

4. 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

5. 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

6. 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

7. 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.

8. ILAC Organization Secretariat Executive Committee General Assembly Arrangement Council Arrangement Management Committee Finance & Audit Committee Arrangement Committee Accreditation Committee Marketing & Communications Committee Laboratory Committee

9. ILAC/IAF Joint Activities IAF Secretariat Joint Committee on Closer Cooperation ILAC Secretariat Joint Working Groups on Inspection & Harmonization Joint General Assembly Joint Development Support Committee

10. Status of ILAC MRA As of 24 May 2012: 76 members representing 68 economies are signatories to the Arrangement

11. MRAs BetweenAccreditation Bodies Laboratory accredited by one partner has equivalent competence to Laboratory accredited by the other(s) The Fundamental Purpose -

12. Mutual RecognitionThe Building Blocks of Confidence Mutual Evaluations Comparable Data Proficiency Testing of Labs Harmonised Operation of Accreditation Systems ISO/IEC 17011 Common Accreditation Criteria (ISO / IEC 17025)

13. 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

14. 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

15. Four Key Evaluation Topics • Performance of CAB assessments • Evaluation of management system • Proficiency testing results (for labs) • Traceability of measurement

16. 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

17. 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

18. 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

19. 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

20. 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

21. ILAC Signatories Come 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)

22. 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.

23. 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

24. APLAC EA IAAC The International Picture ILAC AFRAC SADCA EA European co-operation for Accreditation APLAC Asia Pacific Laboratory Accreditation Cooperation IAAC Inter-American Accreditation Cooperation SADCA Southern African Accreditation Cooperation AFRAC African Regional Accreditation Cooperation

25. What is APLAC? The Asia-Pacific Laboratory Accreditation Cooperation Regional Equivalent of ILAC

26. 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

27. APLAC Organization

28. 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)

29. 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

30. 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

31. 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

32. ILAC MRA Mark

33. 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