General on accreditation Dr. Rózsa Ring Director, Hungarian Accreditation Board (NAT) EA Executive Committee member

Dr. Rózsa Ring Mathematician, Economist Mathematician, Economist Accreditation from 1988 Accreditation from 1988 Director of NAT from 1995 Director of NAT from 1995 EA Executive Committee member from 2006 EA Executive Committee member from 2006 EA Treasurer from 2009 EA Treasurer from 2009 EU accreditation expert EU accreditation expert UN/ECE rapporteur on accreditation UN/ECE rapporteur on accreditation Hungarian representative to the EA-GA, EA-MAC, FAB, ILAC Hungarian representative to the EA-GA, EA-MAC, FAB, ILAC Board member of 2 professional associations Board member of 2 professional associations Editorial Board member of 2 Journals on Quality Editorial Board member of 2 Journals on Quality Author/co-author of 10 books on quality Author/co-author of 10 books on quality  100 articles on accreditation  100 articles on accreditation  300 lectures on accreditation  300 lectures on accreditation Hungarian Accreditation Board (NAT) Introduction

Contents What is accreditation? Benefits of accreditation Reference normative documents International accreditation Multilateral Recognition Agreements / Arrangements

Status quo The term „accreditation” is not copyright and has a wide dictionary meaning:  International healthcare accreditation  Hospital accreditation  Educational accreditation  Diplomatic accreditation  Accreditation of investors  Accreditation of journalists

Accreditation Accreditation is a means of assessing, in the public interest, the technical competence and integrity of the organisations offering conformity assessment services. Accreditation, with its many potential benefits for the quality of goods and in the provision of services throughout the supply chain, is underpinning practical applications of an increasingly wide range of activities across all sectors of the economy, from fishing to forestry, construction to communications.

Accreditation and conformity assessment Accreditation body Conformity assessment body Product (service) Supplier Assess competence Assess conformity Accreditation Third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks (ISO/IEC 17011:2004)

Contents What is accreditation? Benefits of accreditation Reference normative documents International accreditation Multilateral Recognition Agreements / Arrangements

Benefits of accreditation (1) Accreditation is a mechanism used to ensure public confidence in relation to activities that impact on health, safety or the environment. It is a proven and transparent method used to measure an organization’s competence in their ability to implement legal regulations and government policy.

Benefits of accreditation (2) Accreditation is a policy tool that can enable Governments to formulate effective regulation while avoiding placing restrictive burdens on business. Accreditation delivers greater transparency and performance measurement monitoring within existing European legal frameworks. Accreditation is operated as a non-competitive activity carried out by or under the authority of the public authorities.

Benefits of accreditation (3) Accreditation plays a vital role in the notification and inspection process, removing the need for national Government departments to employ their own specialist personnel. The accreditation infrastructure provides a ‘passport for international trade’, promoting the competitiveness of the national economy.

Benefits of accreditation (4) Market Access: Accreditation is becoming increasingly more prevalent in the public and private sectors. In some cases, customers will specify accreditation as a legal requirement. However, in more and more cases, customers are stipulating the use of accredited services voluntarily to ensure they receive quality of results and a reliable service.

Benefits of accreditation (5) Accreditation provides a cost-effective value added service, involving 3rd party independent and confidential evaluation from technical experts to improve company’s performance – benchmarked against best practice in the sector in which it operates.

Benefits of accreditation (6) Independent assessment of the business will reduce the likelihood of product failures, inaccurate results, and internal inefficiencies, and as a result limit damage to the reputation.

Contents What is accreditation? Benefits of accreditation Reference normative documents International accreditation Multilateral Recognition Agreements / Arrangements

Standards for accreditation (1) ISO/IEC 17011Accreditation Bodies LaboratoriesInspection Bodies Testing and CalibrationInspection ISO/IEC ISO ISO/IEC 17020

Standards for accreditation (2) ISO/IEC 17011Accreditation Bodies Certification Bodies EMAS Verifiers Council Regulation 761/2001 Eco-Management and Audit Scheme ISO/IEC Environmental Management Systems ISO/IEC Quality Management Systems ISO/IEC Persons ISO Guide 65 (EN45011) Products

Regulation on accreditation on accreditation and market surveillance effective from 1 January 2010

Contents What is accreditation? Benefits of accreditation Reference normative documents International accreditation Multilateral Recognition Agreements / Arrangements

Accreditation bodies Accreditation of conformity assessment bodies  National  Regional  International accreditation bodies

International accreditation (1) International Laboratory Accreditation Cooperation International Accreditation Forum

International accreditation (2) International cooperation between the various laboratory accreditation schemes operation throughout the world. Started as a conference in 1977, ILAC was formalised as a cooperation in 1996 when 44 national accreditation bodies signed a MoU in Amsterdam.

International accreditation (3) Membership (1) : Recognised regional cooperation bodies APLAC Asia Pacific Laboratory Accreditation Cooperation EA European co-operation for Accreditation IAAC Inter American Accreditation Cooperation Regional cooperation bodies SADCA Southern African Development Community in Accreditation CAC-MAS-Q Central Asian Cooperation on Metrology Accreditation and Quality

International accreditation (4) Membership (2) : Full members – ILAC MRA signatories 65 Accreditation bodies from 49 economies Associate members 23 Accreditation bodies from 23 economies Affiliates National Coordination bodies Stakeholders

International accreditation (5) Structure Executive Committee Arrangement Committee Accreditation Committee Laboratory Committee Marketing & Communication Committee Arrangement Management Committee Joint Development Support Committee Finance & Audit Committee PT Consultative Group Joint Committee for Closer Cooperation Joint Committee for Inspection

International accreditation (6) The ILAC network consists of 125 bodies representing 82 different economies Worldwide there are almost laboratories accredited by ILAC signatories There are over 5000 accredited inspection bodies

International accreditation (7) The International Accreditation Forum, Inc. (IAF) is the world association of Accreditation Bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel and other similar programmes of conformity assessment. The IAF was formed from the first meeting of “Organisations that Accredit Quality System Registrars and Certification programs”, which was held on 28 January 1993 in Houston, USA.

International accreditation (8) Membership : Accreditation Body members 58 accreditation bodies from 53 economies Association Body members 17 associations (e.g. IQNet, IIOC, EOQ, EFAC) Special Recognition Groups (EA, IAAC, PAC, SADCA) Partners (ISO) Observers

International accreditation (9) Structure

Contents What is accreditation? Benefits of accreditation Reference normative documents International accreditation Multilateral Recognition Agreements / Arrangements

International MLA/MRA (1) Mutual Recognition Arrangement The aim of the ILAC Arrangement is to develop a global network of accredited testing, calibration and inspection facilities that can be relied on to provide accurate data. On 2 November 2000, 36 laboratory accreditation bodies from 28 economies signed the MRA (effective from 1 January 2000). Now there are 65 signatories from 49 economies The ILAC Arrangement builds upon existing or developing regional arrangements established around the world. The bodies participating in these regional arrangements are responsible for maintaining the necessary confidence in accreditation bodies from their region that are signatories to the ILAC Arrangement (EA, APLAC, IAAC).

International MLA/MRA (2) The ILAC MRA is based on the results of an intensive evaluation of each body carried out by peers and in accordance with the relevant rules and procedures contained in several ILAC publications.

International MLA/MRA (3) Each accreditation body signatory to the ILAC MRA 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 or ISO (for medical testing laboratories) and related ILAC policy and guidance documents.

International MLA/MRA (4) The first 14 members to join the IAF Multilateral Recognition Arrangement (MLA) for QMS signed the Arrangement in Guangzhou, China on 22 January At the IAF Annual Meetings held in Cape Town, South Africa in October 2004, the IAF MLAs for Environmental Management Systems (EMS) and Product Certification became operational with 27 EMS MLA and 21 Product MLA certificates being signed.

International MLA/MRA (5) IAF QMS MLA: 3 Regional Accreditation Groups (EA, PAC & IAAC) and 39 Accreditation Bodies IAF EMS MLA: 2 Regional Accreditation Groups (EA & PAC) and 36 Accreditation Bodies IAF Product MLA: 2 Regional Accreditation Groups (EA & PAC) and 28 Accreditation Bodies

International MLA/MRA (6) The purpose of the IAF MLA is to provide users in countries with accreditation bodies, that are IAF MLA members, assurance that equivalent certification/registration bodies in other countries operate to the same standard as those in their own country. International experts subject IAF MLA members to rigorous operational evaluations before and during their MLA membership to ensure that the high standards of the IAF are maintained.

International MLA/MRA (7) The Inter American Accreditation Cooperation created in Montevideo in 1996 and incorporated in Mexico in IAAC has 29 members from 23 economies of the region. IAAC is a recognised region of ILAC and IAF. Testing MLA: 11 signatories Calibration MLA: 8 signatories Product CB MLA: 4 signatories QMS CB MLA: 6 signatories EMS CB MLA: 5 signatories

International MLA/MRA (8) The Asia Pacific Laboratory Accreditation Cooperation established in 1995 by 16 economies of the region. APLAC has 37 members from 22 economies of the region. APLAC is a recognised region of ILAC. Testing MLA: 29 signatories Calibration MLA: 24 signatories Inspection MLA: 12 signatories RMP MLA: 4 signatories

International MLA/MRA (9) The Pacific Accreditation Cooperation has 23 members from 19 economies of the region. PAC is a recognised region of IAF. QMS CB MLA: 15 signatories EMS CB MLA: 12 signatories Product CB MLA: 5 signatories

International MLA/MRA (10) The European cooperation for Accreditation established in 1997 and registered in the Netherlands in EA has 34 members from 33 economies of the region and 20 CoC members. EA is a recognised region of ILAC and IAF. Testing MLA: 33 (27) signatories Calibration MLA: 32 (25) signatories Inspection MLA: 28 (24) signatories Product CB MLA: 25 (24) signatories QMS CB MLA: 25 signatories EMS CB MLA: 24 (22) signatories Persons CB MLA: 24 (22) signatories