Thomas Facklam, EA - chair ACCREDITATION THE WAY TO CONFIDENCE  WORLD ACCREDITATION DAY 2014 June 5, Minsk, Belarus The EA Multilateral Agreement Benefits for signatories Thomas Facklam, EA - chair

Contents The European co-operation for Accreditation Purpose of EA The European Accreditation model EA Organizational structure EA Executive Committee (2014) Standards for accreditation Benefits of accreditation EA MLA and benefits for signatories Accreditation for the purpose of notification Future developments

The European co-operation for Accreditation (1) A not-for-profit association registered in the Netherlands in June 2000; 35 Full Members representing 35 European economies; 13 Associate Members; Out of these members, 4 have turned into a bilateral agreement with EA.

The European co-operation for Accreditation (2) A permanent secretariat of 5 persons: Martine Blum, Frédérique Laudinet, Lydie Mauger, Sandy Adonel,NN, EA Secretariat (Paris) Andreas Steinhorst, EA executive secretary EA is an active member of ILAC (International laboratory Accreditation Cooperation) and IAF (International Accreditation Forum) as a recog-nised regional cooperation.

Purpose of EA (1) The European co-operation for Accreditation (EA) is the Association of the national accreditation bodies that provide accreditation for bodies per- forming different types of conformity assessment activities such as: Calibration; Testing; Inspection; Certification of quality, environmental management systems; Certification of products/services; Certification of persons; Verification (EMAS, EU/ETS, ETV).

Purpose of EA (2) Provide Europe with an effective, reliable accreditation infrastructure; Develop accreditation criteria and guidelines supporting harmonisation of practices; Operate a sound, robust, reliable peer evaluation pro- cess to routinely evaluate members; Ensure equivalence of accreditation and equal reliabi-lity of accredited results; Cooperate with the European Commission and other European and international stakeholders.

The European Accreditation model Legal basis for accreditation in the EU REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93

The European Accreditation model Regulation 765/2008 EU excerpt related to accreditation and EA  CHAPTER I  GENERAL PROVISIONS  Article 2 Definitions  10. ‘accreditation’ shall mean an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity;

The European Accreditation model 12. ‘conformity assessment’ shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled;   16. ‘peer evaluation’ shall mean a process for the assessment of a national accreditation body by other national accreditation bodies, carried out in accordance with the requirements of this Regulation, and, where applicable, additional sectoral technical specifications;

The European Accreditation model CHAPTER II   ACCREDITATION  Article 3 Scope This Chapter shall apply to accreditation, used on a compulsory or voluntary basis, relating to conformity assessment, whether that assessment is compulsory or not, and irrespective of the legal status of the body performing the accreditation.

The European Accreditation model Article 10 Peer evaluation  1. National accreditation bodies shall subject themselves to peer evaluation organised by the body recognised under Article 14.   Article 14 European accreditation infrastructure  6. The first body recognised under this Regulation shall be the European cooperation for accreditation, provided that it has concluded an agreement as specified in paragraph 2.

The European Accreditation model A service of general interest Public authority status Not-for-profit organisations or directly incorporated in the government Mandate of the national government (stipulated in reg. No (EC) 765/2008) Last level of control of Conformity Assessment Services Active in voluntary and mandatory fields Compliance with current applicable rules and procedures Accountability to stakeholders No predominance of any single interest group Non-competition policy.

The European Accreditation model Obligation for a CAB to ask for accreditation from the NAB of its member state; Obligation for the NAB not to work in another member state but to subcontract any activities to the local AB; Obligation of all member states to support its NAB´s to be able to carry out the tasks described in regulation 765/2008 EU and all other tasks being delegated to the NAB; It shall be ensured that NAB´s are not carrying out activities which are not in line with either regulation 765/2008 EU and/or ISO/IEC 17011 especially the impartiality and independence of the NAB shall be maintained at all levels

EA Organizational structure General Assembly EA Advisory Board Executive Committee Secretariat Multilateral Agreement council (MAC) Horizontal Harmonisation Committee Laboratory Committee Inspection Committee Certification Committee Communications & Publications Committee

EA Executive Committee (2014) Thomas Facklam, Chairman Geir Samuelsen, Vice-Chairman Nicole VanLaethem, Chair of the MAC Peter Kronvall, Chair of the CPC Ignacio Pina, Chair of the HHC Rolf Straub, Chair of the IC Leopoldo Cortez, Chair of the CC Paolo Bianco, Chair of the LC Further members of the Executive: Rosza Ring (Treasurer), Biserka Bajzek Brezak, (Quality Manager), Vagn Andersen, Jan van der Poel

Eco-Management & Audit Scheme Standards for accreditation (1) Accreditation Bodies ISO/IEC 17011 Certification Bodies EMAS Verifiers Council Regulation 1221/2009 Eco-Management & Audit Scheme ISO Guide 65 (ISO/IEC 17065 and EN 45011) Products and Services ISO/IEC 17021 Management Systems ISO/IEC 17024 Persons

Standards for accreditation (2) Accreditation Bodies ISO/IEC 17011 Laboratories Inspection Bodies Verification Bodies ISO/IEC 17025 ISO/IEC 15189 ISO/IEC 17020 ISO 14065 Testing and Calibration Inspection Verification

EA MLA Signatories (1) Multilateral Agreements (MLAs): Create confidence and acceptance of accredited certifica- tions, inspections and test / calibration reports; By EA MLA Signatories status members 'granted accre- ditations are internationally recognized also through the ILAC and IAF Multilateral agreements. (eliminating the need for suppliers to be certified in each country where they sell / deliver their products or services); EA plays an important role in the effective operation of the Single Market (recognized by Regulation No (EC) 765/2008 and the Guidelines for cooperation and Frame-work Partnership agreement signed with the European Commission and EFTA).

EA MLA Signatories (2) Each signatory is subject to periodic rigorous evaluations by peer evaluation teams in order to verify Continuing compliance with the Regulation No (EC) 765/2008 and international standard for accreditation bodies (such as ISO/IEC 17011 and guidelines specific for any field of accreditation).

EA MLA Signatories rights & obligations (3) Operate according to the criteria specified in the relevant European Standards, published in the EN 45000 and ISO/IEC 17000 series of standards, or other in-ternationally recognised normative documents, supplemented by EA application documents, if necessary; Accept the other schemes operated by the other signatories as equivalent to their own; Recognise on an equal basis with their own the certificates and/or reports from the organisations accredited by the signatories under their scheme(s); Recommend & promote the acceptance of certificates and/or reports from the organisations accredited by the signatories under their scheme(s) by all users in countries of the signatories; Investigate all complaints initiated by a signatory resulting from certificates and/or reports issued by an accredited organisation of their own scheme(s); Notify all other signatories as soon as possible of any significant change that has occured or will occur in their status or in the operational practices of their scheme(s).

EA MLA Signatory member bodies from… (4) Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Hungary Greece Ireland Italy Latvia Lithuania Luxembourg Malta FYRO Macedonia Netherlands Norway Poland Portugal Romania Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey United Kingdom Bosnia and Herzegovina Israel Tunisia Ukraine 4 Associate Member accreditation bodies have signed the EA MLA 33 Full Member accreditation bodies have signed the EA MLA, out of which 26 have signed for all accreditation activities covered by the EA MLA.

The benefits for the clients and stakeholders of the EA MLA signatories (1) The EA MLA is a signed agreement between EA accreditation body members to recognize and accept the equivalence and reliability of their individual accreditation services and thus the certificates and reports issued by the organizations they accredit (conformity assessment results).

The benefits for the clients and stakeholders of the EA MLA signatories (2) The EA MLA is fully in line with the World Trade Organization (WTO) Agreement on Technical Barriers to Trade which strongly encourages countries to recognize the results of other countries’ conformity assessments such as testing, examination, inspection, calibration, verification and certification.

The benefits for the clients and stakeholders of the EA MLA signatories (3) Market confidence in the EA MLA and the conformity assessment results provided by organisations accredited by EA MLA signatories supports the free movement of goods and services in Europe and the rest of the world by acting as a ‘passport for trade’ through elimination of the need for products and services to be re-tested, re-calibrated, re-inspected or re-certified in each country into which they are imported and sold.

The Economics of Accreditation UK study It provides an economic rationale for accreditation and shows the place of UKAS in the quality infrastructure and the wider system of innovation that help to drive productivity, growth and public benefits. It arrives at a broad indicator of the financial value of accreditation in some business applications – amounting to around £600m per annum, but important areas where there are clear benefits – such as international trade, health and public safety- are identified but cannot be given a monetary value with currently available information.

German Study Conformity assessment market direct figures: According to the information provided by the Federal Statistical Agency and the DAkkS, there were about 5,380 CABs with approximately 86.100 employees in 2010. Their overall turnover amounted to € 8.8 billion, with around € 6 billion sales in Germany alone. Of the 5,380 companies, an estimated 3,300 manufacturing firms held about 4,300 accreditations.

However, the economic significance of Conformity Assessment (CA) and Accreditation (ACC) is much larger due to their indirect effects as: • On the one hand, both instruments are characterized by a “leverage effect”, simply because volume of sales made with products and services, which depend on CA and Acc, exceeds the turnover of CABs by a factor of 35-60. Without CA and Acc these products and services could not be traded, as buyers only accept them on the basis of a certificate by a CAB, preferably a CAB that has been accredited.

• On the other hand, the regulatory policy considerations in Europe demonstrate that many markets would not operate at all or not as efficiently, if CA and Acc could not be used for the internal market. Based on our analysis we expect the demand for CA and Acc to grow in the coming years. A simple trend analysis of the years from 2008 to 2010 shows that sales might grow by as much as 10% p.a., while the number of CABs will stagnate or even fall. Factors driving this development are the continued growth of international trade, involving an increasing specialization along the value chain and a regulatory policy that makes increasing use of accreditation.

The international prospective The EA MLA is recognized at international level by the International Laboratory Accreditation Cooperation (ILAC), and the International Accreditation Forum (IAF). Reports or certificates provided by organizations accredited by EA MLA signatories are also recognized by the signatories of the ILAC and IAF multilateral agreements.

The international prospective (2) It is the EA policy, that members of EA – full or associate shall fulfill the requirements defined in international standards like the 17000 series of standards plus the IAF/ILAC and EA mandatory documents and the conditions defined in regulation 765/2008 EU. IAF/ILAC MLA signatories wanting to become EA members need to be peer evaluated at the next period of peer evaluations by EA – results from previous peer evaluations by IAF/ILAC will be taken into account the same way as EA peer evaluations.

Accreditation for the purpose of notification DECISION No 768/2008/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (38) In order to ensure a consistent level of quality in the performance of conformity assessment it is necessary not only to consolidate the requirements that conformity assessment bodies wishing to be notified must fulfil, but also, in parallel, to set requirements that notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies must fulfill.

(39) The system set out in this Decision is complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, its use should also be encouraged for the purposes of notification. (40) If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards, it should be presumed to comply with the corresponding requirements set out in the relevant sectoral legislation.

Accreditation under Regulation (EC) 765/2008 Accreditation, performed according to the EN 17000 series of standards by nationally recognised accreditation bodies that are members of the European Co-operation for Accreditation (EA), is a technical backup in the assessment of the competence of the conformity assessment body seeking notification. Although it is not a requirement, it remains an important and privileged instrument for evaluating the competence and integrity of the bodies to be notified. For this reason, accreditation should be considered by national notifying authorities as the most favored technical basis for the assessment of conformity assessment bodies so as to reduce differences in the criteria applied for notification.

Accreditation in support of notification EA has established the mandatory document: EA-2/17- EA “Guidance on the horizontal requirements for the accreditation of conformity assessment bodies for notification purposes” This document contains horizontal criteria for conformity assessment bodies seeking accreditation for the purpose of notification, to carry out as notified bodies, third-party conformity assessment tasks under community harmonisation legislation.

The assessment of notified bodies cannot be made exclusively to document EA 2/17. This document shall be used in combination with the relevant harmonised standards for conformity assessment bodies (CAB standards) and the related guidance documents issued by EA, ILAC and IAF. It shall also be used together with the requirements specified in the relevant community harmonisation legislation (e.g. sectorial European Directives) and possible national requirements for which the notification is to take place. Other relevant regulatory guidance and requirement documents established at the European and national level, within the scope of the relevant technical harmonisation legislation, should be taken into account if and when applicable.

Dealing with conformity assessment schemes European governmental schemes – EA will establish for each directive/regulation and modules used, as applicable, define the preferred harmonized standard(s) and additional requirements to be used. National governmental schemes – the NAB will provide the same as below on a national level Private schemes should be evaluated by the “home AB(s)” and decide if it is accreditable, the results should be available for all EA AB´s and being subject to comments

EA secretariat to contact… Martine Blum, Frédérique Laudinet, Lydie Mauger, Sandy Adonel, Andreas Steinhorst 75 avenue Parmentier FR - 75011 Paris tel: + 33 1 40 21 24 62/63 /65/64 fax: + 33 1 40 21 24 00 email: secretariat@european-accreditation.org website: www.european-accreditation.org

Thank you very much for your attention Questions?

Congratulations on the World Accreditation Day!