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

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

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 17043 & ILAC Guide 13 Reference Material Providers ISO/IEC Guide 34 October 9, 2011

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 17010. 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

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

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

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….

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

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

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

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

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

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

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 17025. 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 14001 certification/registration and subsequently to product certification. Q&A#90 Customer Customer Customer Country A Country B Country C October 9, 2011

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

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

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

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

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