EA MLA Annual Report 2011

Transcription

1 EA MLA Annual Report 2011

2 Contents 1 Introduction 3 2 The EA MLA 4 3 Scope of the EA MLA 4 4 Signatories of the EA MLA 5 5 New Applicants 8 6 Expanded EA Membership 8 7 Growth of accredited Conformity Assessment Bodies 9 8 Peer Evaluation Process 11 9 Development of the EA MLA MLA monitoring and improvement activities 12 Annex 1 Signatories to the EA MLA 14 Annex 2 EA BLA Signatories 14 2 EA MLA Annual Report 2011

3 1 Introduction The EA Multilateral Agreement (EA MLA) report contains statistical information on the number of signatories to the EA MLA and a headline presentation of the key activities completed in 2011 to further develop the coverage of the MLA and to strengthen the operation of the peer evaluation system. The main objective of the peer evaluation activities is to evaluate the on-going compliance of the national accreditation bodies to the internationally agreed requirements and to ensure that regulators, stakeholders and the business community can have confidence in certificates and reports issued by conformity assessment bodies under the EA MLA. EA has been recognised by the Commission according to article 14 of Regulation (EC) nº 765/2008 Setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) 339/93 (Regulation 765/2008) to operate the peer evaluation system of national accreditation bodies. The recognition of EA is confirmed in the General Guidelines for Cooperation between the European Co-operation for Accreditation and the European Commission, the European Free Trade Association and the Competent National Authorities signed by the parties on 1 April Following article 11 of Regulation 765/2008 national authorities shall recognise the equivalence of services delivered by national accreditation bodies, which have successfully undergone peer evaluation by EA. Furthermore, national authorities shall accept reports and certificates issued by conformity assessment bodies accredited by those national accreditation bodies. EA and its accreditation body members invest significant effort and resource to maintain the integrity and robustness of the EA Multilateral Agreement (EA MLA) through a peer evaluation process. The purpose of these rigorous on-site evaluations is to verify the Accreditation Body signatories continuing compliance with the internationally agreed criteria for accreditation bodies. EA MLA Annual Report

4 2 The EA MLA The MLA is an agreement signed between the national accreditation bodies full members of EA to recognise the equivalence, reliability and therefore acceptance by the European market of accredited certification, inspection, calibration certificates and test reports issued by accredited conformity assessment bodies. EA MLA signatories are applying the international standards for accreditation of conformity assessment bodies in a harmonised way and the services provided by the national accreditation bodies are equivalent. Therefore, the marketplace can have trust and confidence in activities of the national accreditation bodies and accredited conformity assessment bodies. The EA MLA is providing the European market with a network of conformity assessment bodies competent within their scope of accreditation to issue reliable and credible statements of conformity for products and services and thereby reducing costs and adding value to business and consumers and contributes to the freedom of trade by eliminating technical barriers. The EA MLA provides a framework to realise the objective: Accredited once, accepted everywhere. 3 Scope of the EA MLA The scope of the EA MLA covers the following activities and standards: Accreditation of: Scope/Activity Standard Laboratories Testing and medical laboratories ISO/IEC ISO Calibration ISO/IEC Certification Certification of products EN Bodies (ISO/IEC Guide 65) Certification of persons ISO/IEC Certification of management systems ISO/IEC Inspection Bodies Inspection ISO/IEC Figure 1: The scopes of accreditation covered by the EA MLA 4 EA MLA Annual Report 2011

5 4 Signatories of the EA MLA National Accreditation Bodies are accepted into the EA MLA only after stringent evaluation of their operations and activities. The evaluation is conducted by a peer evaluation team assigned the task to determine compliance with the requirements laid down in: ISO/IEC 17011, the internationally accepted standard for accreditation bodies and in Regulation 765/2008. And the relevant standard for conformity assessment bodies including any additional requirements e.g. those set out in relevant sectoral legislation by the Commission. A list of full members signatories to the EA MLA and bilateral signatories (BLA 1 ) (as of 31st December 2011) is included in Annex 1. For the latest information, visit the EA website. During 2011, the following Accreditation Bodies have become new signatories: BAS (Bulgaria) in the fields of calibration and testing CYS-CYSAB (Cyprus) in the fields of testing and inspection OLAS (Luxembourg) in the fields of testing, inspection and certification of management systems and products. 1 Associate Members of EA are entitled to sign, after peer-evaluation and positive decision-making, a Bilateral Agreement with EA as signatory to the EA MLA. An Associate Member is identified by EU or EFTA as a potential candidate country or economy for EU or EFTA membership or is identified by the EU in the European Commission Neighbourhood Policy as a country or economy of particular importance. Further, accreditation bodies from non-eu/efta neighbourhood countries may in certain exceptional cases sign a Cooperation Agreement with EA and be accepted under the EA MLA through a Bilateral Agreement. EA MLA Annual Report

6 4 Signatories of the EA MLA continued The number of full members signatories by scope to the EA Multilateral Agreement has increased during recent years. Number of EA MLA Signatories Calibration Testing Inspection Management Systems Products Persons Figure 2: Number of EA MLA Signatories Figure 2 shows the increase in the number of signatories to the EA MLA from However, a decrease is noted in the number of Bilateral signatories to the EA MLA in 2011 (Figure 3). This is due to the termination of various Contracts of Cooperation with accreditation bodies outside Europe, as endorsed by the EA General Assembly of November 2011 (affecting for the greater part the fields of calibration and testing). This decision by the EA GA is the implementation of EA GA resolution 2008 (22) 14 recognising that reports and certificates issued by conformity assessment bodies accredited by signatories to the ILAC or IAF Arrangements are considered to be equally reliable to those issued under the accreditation within the EA MLA. Therefore, there was no need to continue the Contract of Cooperation and Bilateral Agreement with accreditation bodies outside Europe, that were also signatories to the IAF or ILAC Arrangements. Number of EA MLA Signatories Calibration Testing Inspection Management Systems Products Persons Figure 3: Number of EA BLA Signatories 6 EA MLA Annual Report 2011

7 4 Signatories of the EA MLA continued Figures 4 9 show the increase of the EA MLA signatories by scope between Figure 4: Number of EA MLA Signatories Calibration Figure 5: Number of EA MLA Signatories Testing Figure 6: Number of EA MLA Signatories Inspection Figure 7: Number of EA MLA Signatories Management Systems Figure 8: Number of EA MLA Signatories Products Figure 9: Number of EA MLA Signatories Persons EA MLA Annual Report

8 5 New Applicants During the past 12 months, the following accreditation bodies have applied to become signatories: IARM (The Former Yugoslav Republic of Macedonia) submitted its application to become Bilateral signatory to the MLA in the fields of testing, inspection and certification of products. After having received a preevaluation team IARM requested to include an extension of scope to calibration. The initial visit took place in October NAB-MALTA (Malta), MLA signatory in the field of testing, submitted its application for an extension of scope to calibration. The initial visit was performed in July (witness only) and November Expanded EA Membership The EA General Assembly in November 2011 endorsed the recommendation made by the MLA Council that ATCG (Montenegro) becomes an EA Full Member as Montenegro is identified as a candidate country by the EU. The General Assembly also endorsed the following recommendations made by the MLA Council: ALGERAC (Algeria), ATS (Serbia), BATA (Bosnia & Herzegovina), BSCA (Belarus), CAECP (Moldova), DA (Albania), DAK (Kosovo under UNSC Resolution 1244/1999), EGAC (EGYPT), GAC (Georgia), ISRAC (Israel), NAAU (Ukraine) and TUNAC (Tunisia) to become EA Associate Members with effect from 23 November Previously these countries have had a Contract of Cooperation with EA but the following the introduction of new category of members associate members the Contract of Cooperation has been changed into Associate Members of EA. 8 EA MLA Annual Report 2011

9 7 Growth of accredited Conformity Assessment Bodies In addition to the growth in signatories to the EA MLA, there has been a corresponding increase in the number of accredited conformity assessment bodies Figure 10: Total number of accredited organisations There has been a 20% increase in the number of accredited organisations since The increase is the result of: an increase in the number of accreditation bodies signatories to the EA MLA, and an increase in the number of conformity assessment bodies accredited by the EA MLA signatories Testing Labs Medical Labs Calibration Labs Inspection Bodies GHG Verifiers Figure 11: Number of accredited laboratories Figure 12: Number of accredited inspection bodies and GHG verifiers EA MLA Annual Report

10 7 Growth of accredited Conformity Assessment Bodies continued The number of accredited testing and calibration laboratories has increased to and 2589 respectively, an increase of 12% since There has been a significant increase in medical laboratory accreditation with 1871 laboratories accredited to ISO in 2011 compared to 647 in There has been a 10% increase in the number of accredited inspection bodies, while the number of Green House Gas (GHG) verifiers has remained constant Product CBs Persons CBs Management Systems CBs Organic Farming CBs Figure 13: Number of accredited certification bodies The number of organisations accredited to provide product certification has increased by 17% since 2008, while accredited person certification has risen by 10% during the same period. However, organisations accredited to certify organic food programmes have increased by 60% with 167 accredited in Accreditation of organisations that provide management systems certifications has risen by 9% since This has been driven by a growing number of organisations that provide accredited certification of occupational health and safety management systems, information security management systems and food safety management systems. 10 EA MLA Annual Report 2011

11 8 Peer Evaluation Process The EA peer evaluation process is under constant review. Regulation 765/2008 reinforces the role of EA and its peer evaluation activity in both voluntary and regulated sectors. EA shall support and harmonise the implementation of more stringent rules to achieve consistency throughout Europe, as well as greater transparency and acceptability to all, including national authorities. The peer evaluation process is being further strengthened to fully accommodate the specific needs of regulatory sectors to raise the reassurance of sectoral stakeholders and regulators that the Accreditation Bodies technical competence is thoroughly assessed. The peer evaluation process is on-going and extensive. The following table sets out an overview of the evaluations carried out in 2011: Evaluations 14 Extraordinary evaluations 5 Total man-days of evaluation effort 750 No conditions imposed 6 Suspensions 0 In progress or planned for The peer evaluation teams reported a total of 13 non-conformities and 81 concerns in Development of the EA MLA The EA MLA is under constant review so as to meet the needs of the market. EA is currently extending the MLA to include ISO (accreditation of greenhouse gas (GHG) verification) which is planned to launch in 2012/13. The extension of the EA MLA to include accreditation of verification bodies in the field of GHG is implemented among others to meet a request from the Commission to provide peer evaluation of national accreditation bodies accrediting verifiers according to the EU Regulation on accreditation and verification of GHG emission reports and tonnekilometre reports. EA MLA Annual Report

12 10 MLA monitoring and improvement activities In order to improve the effectiveness of the MLA, EA carries out a number of programmes. In 2011, the following activities took place: 10.1 IAF/ILAC Evaluation International accreditation agreements, managed by IAF (The International Accreditation Forum Inc.) and ILAC (The International Laboratory Accreditation Cooperation), have been structured to build on existing and developing regional MLAs established around the world, such as the EA MLA in Europe. Membership of the IAF MLA and ILAC MRA is recognised as being satisfied by membership of the EA MLA for recognised programs. As a result, both ILAC and IAF carry out regular evaluations of EA. A current IAF/ILAC evaluation is underway and consisted of three parts: office visits to Utrecht and Paris in July 2010 observation of three different EA evaluation teams active in RvA Netherlands (September 2010), SAS Switzerland (November 2010) and CAI Czech Republic (April 2011) observation of meetings of the MAC Management Group, the MAC Plenary and the Working Group Training in October The main conclusions in the report prepared by the ILAC/IAF peer evaluation team are: Strengths: The EA-MAC secretariat has been managed efficiently by the Chair and the secretariat. The decision making process was transparent and based on factual information together with technical discussion. The technical knowledge and skills of the EA peer evaluators were acknowledged. The meeting documents as well as the Peer Evaluation reports were well prepared and provided sufficient information to ensure correct decisions. Weaknesses: The quality management system and the EA policy and procedures for MLA (EA2/02) need improvement to ensure effective implementation and comply with the IAF/ILAC requirements. It should also be noted that the time taken to finalize peer evaluation reports were often outside the times required by EA. It has been difficult for the Secretariat to enforce implementation of the timeframes. Findings: The team has noted 8 non conformities, 6 concerns and 8 comments. The non-conformities was related to: EA peer evaluations is not conducted fully in line with EA-2/02 Policy and Procedure for the EA MLA e.g. re-evaluation intervals exceeding the time limit required, finalisation of the peer evaluation program or documents available to the peer evaluation team No EA program per se to promote the ILAC and IAF Arrangements The EA-2/02 Policy and Procedure for the EA MLA differs in several instances from the IAF/ILAC A2 Effective implementation of the management system for the EA Secretariat IAF or ILAC mandatory documents containing additional requirements was not included in the planning of the peer evaluation EA has in 2011 provided comments to the ILAC/IAF peer evaluation team to the findings including proposed corrective actions. The preliminary feedback from the IAF/ILAC peer evaluation team confirms that all findings are covered properly by actions carried out by EA. 12 EA MLA Annual Report 2011

13 10 MLA monitoring and improvement activities continued The IAF / ILAC peer evaluation team confirms the competence of EA MLA signatories as meeting the requirements of ISO/IEC and the mandatory IAF/ILAC documents. The final report from the team and the IAF/ILAC decision are expected in Feedback Complaints provide a valuable mechanism for receiving feedback relating to the effectiveness of the MLA. This often confirms that the MLA is working effectively and that the process in place is suitably robust. It can also provide information that can be used to improve areas of the MLA. No complaints or appeals regarding the EA MLA were raised during Continuous Improvement The following activities took place to improve the internal processes within EA: The MAC Management Group performed a management review during several sessions/ meetings in The need to answer the timeline and expectations from stakeholders was identified and would be further developed in 2011/2012. Internal audits were performed in June 2010 and in December Outstanding actions of the June 2010 were all closed and the proposed corrective actions of the December 2011 audit were forwarded to the auditor for review. The management systems of the EA Secretariat and the EA MAC Secretariat are under review to be combined into one system. Final approval is expected by spring The following document was updated: EA-2/02: To bring it in line with ISO/IEC and the appropriate requirements of the EU Regulation and day-to-day practices Training and knowledge sharing A number of training courses and workshops were carried out in 2011 to share best practice and to maintain the skills of peer assessment personnel: Training on ISO/IEC 17021:2011 (16 and 17 June, Brussels, 31 participants) Training on ISO/IEC 17021:2011 (8 and 9 September, Utrecht, 27 participants) 2 Trainings on ISO (27-28 and September, Bern-Wabern, a total of 42 participants) Team Leaders and Team Members refresher training (12 and 13 December, Brussels, 23 participants) Two harmonisation workshops (Paris, 13 and 14 September) on accreditation of Conformity Assessment Bodies for the purpose of Notification (practical use and implementation of the EA-2/17). EA MLA Annual Report

14 Annex 1 Signatories to the EA MLA 31 December 2011 CALIBRATION LABORATORIES TESTING AND MEDICAL LABORATORIES CERTIFICATION BODIES PRODUCTS CERTIFICATION BODIES PERSONS CERTIFICATION BODIES MANAGEMENT SYSTEMS INSPECTION BODIES Austria BMWFJ P P P P P P Belgium BELAC P P P P P P Bulgaria BAS P P P P P P Croatia HAA P P P P P P Cyprus CYS-CYSAB P P Czech Republic CAI P P P P P P Denmark DANAK P P P P P P Estonia EAK P P P P P P Finland FINAS P P P P P P France COFRAC P P P P P P Germany DAkkS P P P P P P Greece ESYD P P P P P P Hungary NAT P P P P P P Ireland INAB P P P P P Italy ACCREDIA P P P P P P Latvia LATAK P P P P P P Lithuania LA P P P P P P Luxemburg OLAS P P P P Malta NAB-MALTA P Netherlands RvA P P P P P P Norway NA P P P P P P Poland PCA P P P P P P Portugal IPAC P P P P P P Romania RENAR P P P P Slovakia SNAS P P P P P P Slovenia SA P P P P P P Spain ENAC P P P P P P Sweden SWEDAC P P P P P P Switzerland SAS P P P P P P Turkey TURKAK P P P P P P United Kingdom UKAS P P P P P P Annex 2 EA BLA Signatories 31 December 2011 Israel ISRAC* P P P South Africa SANAS P Ukraine NAAU* P Tunisia TUNAC* P P P * Accepted as associate member by the EA General Assembly in November 2011 (Resolution 2011 (28) 03) 14 EA MLA Annual Report 2011

15 EA MLA Annual Report

16 Contact For more information contact: EA Secretariat 75 avenue Parmentier F PARIS cedex 11 France secretariat@european-accreditation.org tel: 33 (0) EA MLA Annual Report 2011