1. International Recognition System for Accreditation
Better Quality Infrastructure
BEST Programme
Rajinder Raj Sud
Technical Adviser-BQI Component
UNIDO-BEST
October 9, 2011

2. National Conformity Assessment Infrastructure & Accreditation
National Accreditation Body (NAB)
National Metrology Institute
Calibration
Laboratories
Certification Bodies
Inspection
Bodies
Test
Laboratories
Industry, trade, agriculture, regulators (health, safety, environment, transport, manufacturing, etc)
October 9, 2011 2

3. Accreditations- Types & Standards
Test Laboratories ISO/IEC 17025
Calibration ISO/IEC 17025
Medical Laboratories ISO 15189
Inspection Bodies ISO/IEC 17020
Management System Certifiers ISO/IEC 17021
Product Certifiers ISO/IEC Guide 65
Personnel Certifiers ISO/IEC 17024
Good Laboratory Practice OECD GLP Standards
Proficiency Testing Providers ISO/IEC & ILAC Guide 13
Reference Material Providers ISO/IEC Guide 34
October 9, 2011

4. Accreditation ISO/IEC 17011
« General requirements for bodies providing assessment and accreditation »
Currently there are different standards for bodies which accredit laboratories and for those that accredit certification bodies.
ISO/CASCO Working Group 18 is developing a single accreditation standard to combine the requirements for accreditation of laboratory, inspection and certification bodies on the basis of ISO/IEC Guides 58 and 61 and of ISO/IEC TR This standard will be published as ISO/IEC 17011, General requirements for bodies providing assessment and accreditation. The final publication of the standard is expected in 2004.
October 9, 2011

5. Impact of the 1995 WTO TBT Agreement
Members obliged to use international standards for technical regulation, and conformity assessment
Members to participate in international recognition agreements
Encouraged to develop and participate in recognition agreements
Members needed to develop national systems for certifcation, testing, calibration, accreditation in compliance with international standards
Wide acceptance of accreditation as a basis for competence and recognition of labs globally
October 9, 2011

6. International Accreditation VISION : Once tested accepted everywhere
Developed in response to WTO/TBT Agreement objectives to reduce/remove trade barriers
Acceptance of foreign test data, requires confidence in the competence of foreign laboratories
Accreditation bodies developed as accreditation offers an accepted solution
Led to development of recognition arrangements to support trade-such as APLAC/ILAC, CIPM MRA, IAF/PAC, IEC schemes, GLP; in the 1990s
VISION : Once tested accepted everywhere
Mutual recognition by accreditation bodies potentially opens the markets to networks of laboratories and inspection bodies (in the case of ILAC) and to certification bodies (in the case of IAF).
It also eliminates any need for an assessment of a laboratory by foreign national authorities as the local accreditation body can be entrusted with that responsibility.
October 9, 2011

7. International and Regional Accreditation Bodies
International Laboratory Accreditation Co-operation (ILAC)
Asia Pacific Laboratory Accreditation
Cooperation (APLAC)
International Accreditation Forum (IAF)
Pacific Accreditation Cooperation (PAC)
October 9, 2011
details….

8. International Laboratory Accreditation Cooperation (ILAC)
Established in 1978 as an informal conference
Transformed in 1996 to a formal cooperation
ILAC recognition arrangement came into effect on 31 January 2001.
International Accreditation Forum (IAF)
Established in 1992 as an informal co-operation & incorporated in the US in 1998
IAF Multilateral Recognition Arrangement for certification bodies came into effect in 1998
43 signatories currently scope - Management systems & Product certification.
ILAC is an international co-operation between various laboratory accreditation schemes operated throughout the world. It was established in 1977, first as an informal conference. In 1996 it was formalized to a formal co-operation when 44 national bodies signed the memorandum of understanding. In January 2003 ILAC was incorporated in the Netherlands as a not for profit company.
Q&A#90
October 9, 2011

9. The Roles of (ILAC and APLAC) & (IAF and PAC)
To develop the principles and practice of accreditation
To harmonise procedures and criteria for accreditation
To assist in the development of new programmes
To facilitate mutual recognition of members’ programmes
To help reduce technical barriers to trade
To improve international acceptability of test, inspection results and certificates
October 9, 2011

10. THE ILAC MRA
The ILAC Arrangement is a global network of accredited testing and calibration laboratories that are assessed and recognised as being competent by ILAC Arrangement signatory accreditation bodies.
October 9, 2011

11. ILAC Arrangement and IAF MLA
73 Full Members (Arrangement signatories), 21 Associates, 18 Affiliates
APLAC + EA + IAAC+ SADCA + AFRAC
IAF
127 Accreditation Body Members,
4 Regional Groups with Special Recognition,
53 accreditation body members are MLA members
Many accreditation bodies are signatories to both IAF and ILAC agreements
ILAC has developed its approach to mutual recognition through confidence building at the bilateral level and then at the regional level. The ILAC Arrangement was created by the regional bodies agreeing that their own MRA activities were almost completely aligned. Those accreditation bodies who were members of ILAC but not signatories to regional MRAs could be admitted to the ILAC Arrangement by an evaluation process conducted by ILAC.
IAF began with its multilateral agreement at the global level before regional agreements were developed.
Where individual bodies are signatories to both the ILAC Arrangement and the IAF MLA, the overlapping elements are evaluated by teams with representation from both ILAC and IAF.
SANAS South African National Accreditation System
INMETRO Instituto Nacional de Metrologia Normalizacao e Qualidade Industrial
(The National Institute of Metrology, Standardization and Industrial Quality of
Brazil)
ISRAC Israel Laboratory Accreditation Authority
Q&A#91
October 9, 2011

12. ILAC Recognised Regional Cooperation Bodies
Regional Mutual Recognition Arrangements (MRA/MLA) that have been successfully peer evaluated and accepted by ILAC :
Asia Pacific Laboratory Accreditation Cooperation (APLAC) 
European co-operation for Accreditation (EA)
Inter American Accreditation Cooperation (IAAC),
Southern African Development Community in Accreditation (SADCA),  
African Accreditation Cooperation (AFRAC),
October 9, 2011

13. Growth of ILAC Accredited Labs
Worldwide there are almost 35,000 laboratories accredited by an ILAC signatory
October 9, 2011

14. Impact of Mutual Recognition Arrangement between accreditation bodies
ILAC Mutual Recognition Arrangement
Accreditor B
Accreditor C
Laboratory
Laboratory
Laboratory
Examples of MRAs between accreditation bodies are the ILAC Arrangement and the IAF MLA:
ILAC operates the ILAC Mutual Recognition Arrangement between ILAC member bodies. The arrangement, referred to as the ILAC Arrangement, enhances and falilitates the international acceptance of test and calibration data and the elimination of technical barriers to trade. Goods tested in one country by a laboratory accredited under the purview of signatories (which now total 44) to the Agreement should be accepted by other signatory countries. Each signatory to the Arrangement shall maintain conformance with ISO/IEC Guide 58 and shall ensure that all accredited laboratories comply with ISO/IEC
IAF operates the IAF Multilateral Recognition Agreement (MLA) whose member accreditation bodies recognize the results of each other’s accreditations as equivalent in accordance with ISO/IEC Guide 61 and ISO/IEC Guide 62. The MLA currently covers ISO 9000 certification/registration. IAF is moving to extend the Arrangement’s coverage to ISO certification/registration and subsequently to product certification.
Q&A#90
Customer
Customer
Customer
Country A
Country B
Country C
October 9, 2011

15. Aim of MRAs One Audit One Certificate Accepted Everywhere One Test One
Report
Accepted
Everywhere
This slide presents the ultimate objective whereby conformity assessment is carried only once and in the most efficient location for the market. The slide reflects the message of the World Standards Day from ISO, IEC and ITU in 2002 which was: “One standard, one test – Accepted everywhere”.
Elimination of redundant and costly activities involving duplication of work,testing,and certification
October 9, 2011

16. Alternatives to Accreditation
Recognition between laboratories on a bilateral basis
Peer recognition systems – IEC schemes- CB scheme for electrical products, IEC Ex, IEC FCS
Government designation
October 9, 2011

17. Application of ILAC/APLAC Recognition - Examples
APEC E & E MRA
ASEAN E & E MRA
Test reports from APLAC accredited labs are accepted for regulated products in the signatory countries without further testing
Acceptance in bilateral trade agreements
Acceptance by industry in non-regulated sectors on basis of confidences
Unilateral acceptance in some countries by regulators on basis of confidence
Use of accreditation as basis appointment as a “notified body” in the EU –recent directives
October 9, 2011

18. APLAC & ILAC MRAs FOR ACCREDITATION OF TESTING LABs: ITS IMPLICATIONS
Avoids re-test in importing countries provided test conducted to requirements/standards required by importing countries;
Spurred the development of private laboratories- competition between labs
Reliance on private sector laboratories by government increased in most developed countries.
Demand for accredited test reports by private sector
Does not mean automatic acceptance of products in all cases
October 9, 2011
signatory IAF, PAC

19. Relationship with Metrology CIPM – ILAC MOU
Cooperation
Links ILAC MRA to CIPM MRA
Recognition of KCDB for Traceability
Accreditation of calibration laboratories as acceptance criteria
October 9, 2011