October 9, 2011 1

International Recognition System for Accreditation

Better Quality InfrastructureBEST Programme

Rajinder Raj SudTechnical Adviser-BQI

ComponentUNIDO-BEST

October 9, 2011 2

National Conformity Assessment Infrastructure & Accreditation

Industry, trade, agriculture, regulators (health, safety, environment, transport, manufacturing, etc)

CalibrationLaboratories

National Accreditation Body (NAB)

National Metrology Institute

TestLaboratories

Certification Bodies Inspection

Bodies

October 9, 2011 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 17043 & ILAC Guide 13

• Reference Material Providers ISO/IEC Guide 34

October 9, 2011 4

ISO/IEC 17011

« General requirements for bodies

providing assessment and accreditation »

AccreditationAccreditation

October 9, 2011 5

Impact of the 1995 WTO TBT Agreement

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

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

October 9, 2011 7

International Accreditation Forum (IAF)

International Laboratory International Laboratory Accreditation Co-operation (Accreditation Co-operation (ILACILAC))

Pacific Accreditation Cooperation (PAC)

Asia Pacific Laboratory Accreditation Cooperation (APLAC)

details….

International and Regional Accreditation Bodies

October 9, 2011 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)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.

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 MLAILAC Arrangement and IAF MLA

ILAC 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

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

Laboratory

Customer

Accreditor B Accreditor C

Laboratory Laboratory

Customer Customer

ILAC Mutual Recognition Arrangement

October 9, 2011 15

Aim of MRAsAim of MRAs

One Audit One Certificate

Accepted Everywhere

One Test One Report

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

signatory IAF, PAC

October 9, 2011 19

Relationship with MetrologyCIPM – ILAC MOU

• Cooperation

• Links ILAC MRA to CIPM MRA

• Recognition of KCDB for Traceability

• Accreditation of calibration laboratories as acceptance criteria