The International Laboratory Accreditation Cooperation ILAC The International

The International Laboratory Accreditation Cooperation (ILAC) & The International Accreditation Forum (IAF) Benefits of the ILAC & IAF Multilateral Mutual Recognition Arrangements ITU Regional Consultation on Conformance Assessment & Interoperability, September 2010

What is ILAC ? International Laboratory Accreditation Cooperation • Established in 1977 to promote communication among laboratory accreditation bodies around 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 was signed, among the 36 accreditation body members from 28 economies, which had successfully completed a peer evaluation • ILAC was incorporated in the Netherlands on 20 January 2003. • Approx. 33, 000 laboratories & over 6, 000 inspection bodies have now been accredited by the 67 ILAC Full Members.

ILAC’s Global Role Principal international forum for: • Recognition of competent test and calibration labs world-wide through its Mutual Recognition Arrangement (MRA) • Development and appropriate harmonization of laboratory accreditation practice across the globe • Promotion of laboratory accreditation as an effective mechanism for providing confidence in measurement results, which is essential for global trade facilitation and socio-economic issues • Assisting with the development of laboratory accreditation systems

ILAC Goals • Strengthen/deepen the existing ILAC MRA, promote the use of accredited labs & appropriately link this activity to intergovernmental trade activity • Continually promote the clear distinction between certification & accreditation to help reduce the confusion in the marketplace • Provide assistance to developing countries by providing appropriate pre-MRA support to new accreditation systems • Increase cooperation with all relevant stakeholders, i. e. labs, regulators, industry groups, standard writing bodies and governments

ILAC Membership Categories • MEMBERSHIP CATEGORIES: • CURRENTLY: (as of 3 Sept 2010) – – – Full Members (Signatories); Associates; Affiliates; Stakeholders; Regional Cooperation Bodies. – 67 Full Members from 55 economies; – 20 Associates from 20 economies; – 20 Affiliates from 19 economies; – 4 Regional Cooperation Bodies; – 25 Stakeholders. • Full Members & Associates have voting rights for all matters except admission of new Full Members, where voting is restricted to the Full Members only. There are currently 137 member organisations representing 89 economies.

ILAC Organisation Chart General Assembly Arrangement Council Advisory Committees Proficiency Testing Consultative Group Executive Committee Secretariat Arrangement Management Committee Laboratory Committee Financial Audit Committee Arrangement Committee Accreditation Committee Marketing & Communications Committee Joint Development Support Committee Joint Inspection Group

MRAs Between Accreditation Bodies The Fundamental Purpose of the ILAC Mutual Recognition Arrangement is to demonstrate that: A laboratory accredited by one signatory has equivalent competence to a Laboratory accredited by the other signatories.

The ILAC Vision Accredited once Accepted Everywhere Governments can take advantage of the ILAC Arrangement to further develop or enhance trade agreements. The ultimate aim is increased use and acceptance by industry as well as government of the results from accredited laboratories, including results from laboratories in other countries. In this way, the free-trade goal of 'product tested once and accepted everywhere' can be realised.

How does the ILAC Arrangement (MRA) Work? • The ILAC Arrangement is based on the results of an intensive evaluation of each accreditation body carried out by peers and in accordance with the relevant rules and procedures contained in several ILAC publications (P-Series or A-Series Documents). – Procedural Series (P Series) - Procedural and policy publications for the operation of the ILAC Arrangement, and which form part of the criteria for ILAC Arrangement evaluations. – ILAC-IAF Joint Publications (A Series) - Joint IAF and ILAC documents used for the evaluation of regions, unaffiliated bodies and inspection bodies.

How does the ILAC Arrangement (MRA) Work? • Each accreditation body signatory to the Arrangement agrees to abide by its terms and conditions and by the ILAC evaluation procedures and shall: – Maintain conformance with the current version of ISO/IEC 17011, related ILAC guidance documents, and a few, but important, supplementary requirements, and – Ensure that all accredited laboratories comply with ISO/IEC 17025 or ISO 15189 (for medical testing laboratories) and related ILAC policy and guidance documents.

How does the ILAC Arrangement (MRA) Work? • ISO Standards: – ISO/IEC 17011: 2004 - Conformity assessment -- General requirements for accreditation bodies accrediting conformity assessment bodies – ISO/IEC 17025: 2005 - General requirements for the competence of testing and calibration laboratories – ISO 15189: 2007 - Medical laboratories -- Particular requirements for quality and competence

The International Picture ILAC APLAC EA IAAC SADCA ILAC International Laboratory Accreditation Cooperation EA European Cooperation for Accreditation APLAC Asia Pacific Laboratory Accreditation Cooperation IAAC Inter-American Accreditation Cooperation SADCA Southern African Development Community Accreditation Unaffiliated Bodies Peer evaluated ABs who are not geographically located in one of the established regions

Status & Operation of the ILAC MRA • As of 3 September 2010, 67 Full Members representing 55 economies are signatories to the ILAC Arrangement (MRA). • The MRAs of the recognised regions underpin the ILAC Arrangement (MRA). • Currently, the MRAs of 3 of the 4 Regional Cooperation Body members in ILAC are recognised by ILAC (EA, APLAC and IAAC). • Recognition of a region is achieved after successful peer evaluation by ILAC. • Each recognised region undergoes a re-evaluation by ILAC every 4 years. • Signatories to the EA, APLAC and IAAC MRAs, who are also members of ILAC, are entitled to become signatories (Full Members) to the ILAC Arrangement.

Status & Operation of the ILAC MRA (cont’d) • Unaffiliated bodies are ABs who do not have a Regional Cooperation body in their geographical region. • ILAC relies on the evaluations undertaken by the recognised regions to grant and maintain ILAC signatory status for the ILAC members in their respective regions. • ILAC itself undertakes the evaluations of the regions, the unaffiliated bodies (those ABs who do not have a region in their geographical area) and those ABs who are part of a developing region, that has not yet obtained recognition (eg SADCA). • ILAC draws its peer evaluators from the regions and unaffiliated bodies.

Benefits of ILAC • The development of the MRA underpins cross border trade through the acceptance of accredited test results. “Tested once, accepted everywhere”. • A support structure to lead the co-ordination of a consistent approach and the harmonisation of best practice. • The provision of a platform to exchange information and enable knowledge transfer. • Support to developing and emerging economies. • Links with other international organisations such as IAF, ISO & ISO/CASCO, BIPM, IEC, OIML, WADA, IFCC, WHO and trade organisations.

In Summary: Primary Objective of the ILAC Arrangement • Eliminate testing as a Technical Barrier to Trade through • Recognition of Competence between • Accreditation Bodies

ILAC-MRA Mark

ILAC-MRA Mark (cont’d) • 47 ILAC Full Members have signed Licensing Agreements with ILAC, for the use of the Combined MRA Mark. • The Combined MRA Mark, is the ILAC-MRA Mark used in combination with the accreditation body’s own mark. • Once licensed, accreditation bodies can enter into a Sub-Licensing Agreement with their accredited laboratories for the use of the ILAC Laboratory Combined MRA Mark. • The ILAC Laboratory Combined MRA Mark is the ILAC-MRA Mark used in combination with the mark which an accredited lab is entitled to use.

International Partnerships • ILAC has signed a Memorandum of Understanding (MOU) with the following organisations: – – – – CIPM - ILAC Mo. U ICSCA - ILAC Mo. U IAF - ISO - ILAC Mo. U UNIDO - IAF - ILAC Mo. U IEC - ILAC Mo. U ILAC - IAF - OIML Mo. U WADA - ILAC Mo. U IFCC – ILAC Mo. U

International Partnerships (cont’d) • Joint BIPM/ILAC Statement on the roles of NMIs and NABs. • Joint Declaration of the BIPM, OIML and ILAC promoting the existing three MRAs. • Joint ISO-ILAC-IAF Communiqué on the alignment of ISO/IEC 17025: 2005 with ISO/IEC 9001 (2008) updated January 2009. • Joint ISO-ILAC-IAF Communiqué on the alignment of ISO 15189: 2007 with ISO/IEC 9001 (2008) released September 2009. • Agreement for Closer Cooperation was signed between ILAC and IAF in September 2005.

The IAF Vision To develop a single, worldwide program of conformity assessment, which reduces risk for business, regulators and the general public by ensuring that accredited certification may be relied upon.

What is IAF • The International Accreditation Forum (IAF) is a global association of; – Accreditation Bodies – Certification Body Associations – Industry associations – Other stakeholder organisations and scheme owners involved in conformity assessment activities in a variety of fields including management systems, products, services and personnel

What is IAF (cont’d) • Established in 1993 to operate a program for the accreditation of bodies dealing with conformity assessment. • On 22 January 1998 the Multilateral Recognition Arrangement (MLA) for Quality Management Systems (QMS) was signed and MLAs for Environmental Management Systems (EMS) and Product Certification (Product) were signed on 9 October 2004. • Accreditation Bodies that are members of the IAF MLAs (QMS, EMS and Product) are required to recognise the certificates issued by certification/registration bodies accredited by all of the other signatories to that MLA.

The objectives of IAF • To maintain and develop a Multilateral Recognition Arrangement (MLA) between its Accreditation Body Members to ensure recognition of accredited certification between signatories. • To act as a global forum to bring together accreditation bodies and stakeholder groups to facilitate global trade. • To develop appropriate harmonization of conformity assessment best practice • To promote accredited conformity assessment by working with, and influencing, key international organisations and industry groups

IAF Membership • MEMBERSHIP CATEGORIES: (membership numbers as at 26 July 2010) – 62 Accreditation Body Members; • 46 IAF MLA Signatory Accreditation Bodies – 18 Associate Members; • 9 Industry/User Groups • 9 CAB Groups – 4 Regional Cooperation Groups – 4 Observer Members

The IAF Structure

The IAF MLA • The IAF MLA is a network of accreditation body members of IAF that have been deemed competent through a stringent peer evaluation process. • Signatories to the IAF MLA will recognize as being equally reliable the certificates and/or reports issued by certification/registration bodies accredited by all other members of the IAF MLA. • The IAF MLA provides businesses with assurance that equivalent overseas certification/registration bodies operate to the same standard as those in their own country. • This acceptance removes technical barriers to international trade as businesses will not require multiple certifications. • This reduces time to market and well as additional cost to business.

Status of IAF MLA (cont’d) As at 26 July 2010 the number of IAF MLA signatories to each MLA are: • IAF QMS MLA: 3 Regional Accreditation Groups (EA, PAC & IAAC) and 44 Accreditation Bodies • IAF EMS MLA: 2 Regional Accreditation Groups (EA & PAC) and 39 Accreditation Bodies • IAF Product MLA: 2 Regional Accreditation Groups (EA & PAC) and 36 Accreditation Bodies Details can be found on the IAF website at www. iaf. nu

The benefits of accredited certification For Government: For business: For Society: • Flexible alternative to Legislation • • • Facilitator of trade • An efficient enforcement / monitoring tool Greater acceptance of products and services opening up market access • Avoid costs associated • with multiple certifications • Gain access to the growing number of tenders which specify accredited certification Public confidence in goods and services, despite complex global marketplace Minimises product failures or recalls

The IAF MLA Mark E • The IAF MLA mark can be used by accreditation bodies that are signatories to the MLA. • MLA signatories can license the MLA mark and use in conjunction with their own accreditation body logo, for example, SA M PL Accreditation Body Logo QMS NO 01

The IAF MLA Mark PL E • Businesses seeking certification will be able to see at a glance if the certification body issuing the certificate is accredited by an accreditation body that is a signatory to the IAF MLA. The certification body must include an indication as to which activity the accreditation is related. SA M Accreditation Body Logo QMS NO 01 • As a result, businesses will benefit from having increased confidence, signified by the presence of the IAF MLA Mark, that requirements have actually been met.

ILAC & IAF Joint Activities ILAC and IAF are engaged in a number of well established joint activities the most notable of which are: • Annual Joint General Assembly • Joint meetings of the ILAC & IAF Executives (3/year) • Joint peer evaluations for Regional Cooperation Bodies • Joint Development Support Committee (JDSC) • Joint Marketing & Communications Activities • Joint Working Group on Maintenance of A Series documents (ie ILAC/IAF common publications) • World Accreditation Day - 9 June • Tripartite Mo. Us with other international organisations

Network on Metrology, Accreditation and Standardization for Developing Countries (DCMAS network) Building corresponding technical infrastructures to support sustainable development and trade in developing countries and countries in transition.

DCMAS Network Members • • • Bureau International des Poids et Mesures (BIPM) International Accreditation Forum (IAF) International Electrotechnical Commission (IEC) International Laboratory Accreditation Co-operation (ILAC) International Organization for Standardization (ISO) International Trade Centre (ITC) Telecommunication Standardization Sector of ITU (ITU-T) International Organization of Legal Metrology (OIML) United Nations Industrial Development Organization (UNIDO) United Nations European Economic Commission for Europe (UNECE) - Working Party on Regulatory Cooperation and Standardization Policies (W. P. 6)

Terms of reference • Exchange information and experience • Provide a means of pooling expertise • Work with, and support the objectives of, global organizations, such as the WTO as well as the UN system • Liaise with international and local agencies to introduce MAS programs in developing countries • Provide information, speakers and training material for seminars and events

Role of ILAC & IAF in DCMAS network • To work with other partners in an integrated manner to provide holistic support to developing countries in metrology, accreditation and standards development. • Focus on the development of infrastructure in developing countries for the accreditation of laboratories (ILAC) and certification bodies (IAF). • This activity is channeled through the Joint ILAC/IAF Development Support Committee (JDSC) which has close links with UNIDO and other funding agencies. • The ILAC and IAF Co-Chairs of the JDSC hold positions on the ILAC and IAF Executive Committees and so have a direct voice at the planning and operational level in each organisation.

Importance of accreditation for developing countries • The use of an accreditation system reduces the possibility of goods being denied access on the basis of inadequate conformity assessment. For developing countries • Lack of access to recognised accreditation programmes prevents full integration into the world trading system • Developing an accreditation infrastructure is daunting if a government does not have the knowledge, experience or financial resources • For an accreditation programme to be viable it must also be sustainable in the long term and the development of an accreditation programme in each economy may not always be the best solution. • Regional Accreditation Bodies are being established to service the accreditation needs of more than one economy when it is not viable for each economy to maintain their own AB.

World Accreditation Day • World Accreditation Day – 9 June 2010 Global Acceptance • World Accreditation Day – 9 June 2011 Theme to be confirmed at Annual Meetings in Shanghai – October 2010

For more information …. . ILAC Secretariat Email: ilac@nata. com. au Web: www. ilac. org IAF Secretariat Email: Secretary 1@iaf. nu Web: www. iaf. nu