EA MLA Annual Report 2012

Transcription

1 EA MLA Annual Report 2012

2 Contents 1 Introduction 3 2 The EA MLA 4 3 Scope of the EA MLA 5 4 Signatories of the EA MLA 6 5 Decisions by the EA MLA Council on peer evaluation activities 9 6 New Applicants 10 7 Expanded EA Membership 10 8 Growth of accredited Conformity Assessment Bodies 11 9 Peer Evaluation Process Development of the EA MLA MLA monitoring and improvement activities 14 Annex 1 Full Members signatories to the EA MLA 16 Annex 2 Associate Members signatories to the EA MLA 16 Annex 3 Decisions taken by the EA MLA Council on membership 17 2

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 2012 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 (EC) No 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 (EC) No 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 national accreditation bodies that are Full Members of EA. 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 and Regulation (EC) No 765/

4 2 The EA MLA The MLA is an agreement signed between the national accreditation bodies Full and Associate 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 Associate Members 1 are eligible to enter into a Bilateral Agreement with the EA Full Member signatories of the EA MLA with the aim of establishing mutual confidence in the respective accreditation systems and in their accredited attestations of conformity 2. EA Associate Members shall comply with and meet the same requirements as Full Members when signing the EA MLA. EA MLA signatories are applying the international standards for accreditation of conformity assessment bodies in a harmonised way and the services provided by the EA MLA signatories are equivalent. Therefore, the marketplace can have trust and confidence in activities of the EA MLA signatories and their 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, thereby reducing costs and adding value to business and consumers and contributing to the freedom of trade by eliminating technical barriers. The EA MLA provides a framework to realise the objective: Accredited once, accepted everywhere. 1 Associate Members are from countries/economies identified by EU or EFTA as a potential candidate country or economy for EU or EFTA membership or identified by the EU in the European Commission Neighbourhood Policy as a country or economy of particular importance. 2 In this report the term EA MLA signatories covers those accreditation bodies either Full Members or Associate Members of EA who have signed the EA MLA Agreement. 4

5 3 Scope of the EA MLA The scope of the EA MLA covers the following activities and standards: Accreditation of: Scope/Activity Standard Testing ISO/IEC Laboratories Medical examination ISO Calibration ISO/IEC Certification of products EN (ISO/IEC 17065) Certification bodies 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 5

6 4 Signatories of the EA MLA 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 (EC) No 765/2008 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 EA MLA signatories (as of 31 December 2012) is included in Annex 1. For the latest information, visit the EA website. During 2012, the following accreditation bodies have become new EA MLA signatories: ATS (Serbia) in the fields of calibration, testing, inspection and certification of products BATA (Bosnia & Herzegovina) in the field of calibration, testing and inspection (Bilateral Agreement) IARM (The Former Yugoslav Republic of Macedonia) in the fields of calibration, testing, inspection and certification of products Three accreditation bodies have applied for extension of activities covered by the EA MLA and signed the EA MLA for the following activities: NAB-MALTA (Malta) in the field of calibration NAAU (Ukraine) in the field of calibration, testing and certification of management systems (Bilateral Agreement) OLAS (Luxembourg) in the field of calibration. The number of full members signatories by scope to the EA Multilateral Agreement has increased in recent years. Full Member signatories to the EA MLA Calibration Testing Inspection Management Systems Products Persons Figure 2: Number of EA Full Member signatories to the EA MLA 6

7 4 Signatories of the EA MLA continued Figure 2 shows the increase in the number of Full Member signatories to the EA MLA from The increase in Full Member signatories follows the adoption of Regulation (EC) No 765/2008 which states that the national accreditation body shall undergo EA peer evaluation when the national authorities will rely on the accreditation body to perform assessment of notified bodies. Associate Member signatories to the EA MLA Calibration Testing Inspection Management Systems Products Persons Figure 3: Number of EA Associate Member signatories to the EA MLA The number of Associate Member signatories to the EA MLA has fallen from (Figure 3) and increased slightly in This is due to the termination of various Contracts of Cooperation with accreditation bodies outside Europe, as endorsed by the EA General Assembly (GA) 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. In 2012 two Associate Members joined the EA MLA for calibration and testing and one Associate Member joined in the field of Management Systems. 7

8 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 8

9 5 Decisions by the EA MLA Council on peer evaluation activities The EA MLA Council (MAC) is responsible for the effective and impartial management and monitoring of the peer evaluation process and is the decision-making body for acceptance of national accreditation bodies entering into the Multilateral Agreement (MLA) and Bilateral Agreement (BLA) of EA. The MAC is composed of one representative from each EA Full Member, one observer from the EA Advisory Board representing the Member States and one observer from the European Commission. Associate Members may attend the MAC meetings as observers. The MAC has held two meetings in 2012, April in Copenhagen, Denmark, and September in Nicosia, Cyprus. The MAC has considered 16 reports during the year concerning conducted peer evaluations or further information on compliance with the requirements. The reports have related to: Application for EA MLA membership (3 reports) Re-evaluation reports (6 reports) Extraordinary evaluations (3 reports) Application for EA MLA membership for new activities evaluation performed in conjunction with a re-evaluation visit (3 reports) Other reporting on compliance with the EA MLA requirement and conditions imposed for membership of the EA MLA (1 report) Annex 3 lists the decisions taken by the MAC in 2012 on membership of the EA MLA. 9

10 6 New applicants During the past 12 months, the following accreditation bodies have applied to become signatories: ALGERAC (Algeria) submitted its application to become bilateral signatory to the MLA in the fields of calibration, testing, inspection and certification of management systems. The pre-evaluation was performed in December JSMO (Jordan Standards and Metrology Organization) submitted its application to become bilateral signatory to the MLA in the fields of testing. Depending on the outcome of a study of JSMO quality documentation by the Team Leader, a pre- or an initial evaluation will be organised in Expanded EA Membership The EA General Assembly in May 2012 endorsed the recommendation made by the MLA Council that ATS (Serbia) become an EA Full Member as Serbia is identified as a candidate country by the EU as of March 2012 (ATS was previously an Associate Member of EA). The General Assembly also endorsed the recommendations made by the MLA Council that JISMO (Jordan) and SEMAC (Morocco) become Associate Members of EA with effect from 23 May

11 8 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 body 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

12 8 Growth of accredited Conformity Assessment Bodies continued The number of accredited testing laboratories has seen yet another increase of just over 6.5% to Accredited medical laboratories also increased in number to 1973, up 5.5% on The total number of accredited calibration laboratories dropped slightly from 2589 to After the significant increase in the number of accredited inspection bodies in 2011, the figure appears to have stabilised in 2012, increasing by just 39 to The biggest increases of 2012 are in the number of organisations accredited to provide certification services. Organisations providing accredited product certification grew 40% in number. The number of organisations providing management system and person certification also grew, up 27% and over 16.5% respectively Product CBs Persons CBs Management Systems CBs Figure 13: Number of accredited certification bodies

13 9 Peer evaluation process The EA peer evaluation process is under constant review. Regulation (EC) No 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 analysis of the outcome of the peer evaluation from : Total number of evaluations performed Total number of reports discussed Total man-days of evaluation effort Additional info required Extraordinary evaluations on site No conditions imposed Decision deferred Suspension The peer evaluation teams reported a total of 44 non-conformities and 83 concerns in Evaluations, initials, re-evaluations with or without scope extensions and extraordinary evaluations (performed on site) in the specific year 4 Reports of evaluations, but not necessarily conducted in the specific year 13

14 10 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). A timetable for peer evaluation of accreditation bodies for accreditation activities based on EN ISO and the Accreditation and Verification Regulation No 600/ 2012 has been endorsed by the General Assembly. The goal is to have all accreditation bodies peer evaluated by June 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 tonne kilometre reports. 11 MLA monitoring and improvement activities In order to improve the effectiveness of the MLA, EA carries out a number of programmes. In 2012, the following activities took place: 11.1 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 programmes. As a result, both ILAC and IAF carry out regular evaluations of EA. The last IAF / ILAC evaluation of EA as a regional body was carried out during 2010 and The objective is to confirm the competence of the EA MLA signatories to be in line with the ISO/IEC and the mandatory IAF/ILAC documents: At the IAF/ILAC meetings held in October 2012 positive decisions were taken by IAF and ILAC on the acceptance of the EA MLA in the global Arrangements. Scope of recognition under the IAF MLA: Accreditation of Certification Bodies for certification of Management Systems and Accreditation of Certification Bodies for certification of Products. Scope of recognition under the ILAC Arrangement: Accreditation of laboratories for Calibration, Testing, Medical Examination and Accreditation of Inspection Bodies. 14

15 11 MLA monitoring and improvement activities continued The next peer evaluation of EA will start immediately with planning and the first on-site activity will take place mid-2014 with the evaluation of the EA Secretariat Feedback Complaints provide a valuable mechanism for receiving feedback relating to the effectiveness of the MLA. They often confirm that the MLA is working effectively and that the process in place is suitably robust. They 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 management systems of the EA Secretariat and the EA MAC Secretariat have been under review to be combined into one system. The joint management system was approved in According to EA procedures an internal audit of the MAC activities took place in The first part was performed in September 2012 and included the daily operations of the MAC Secretariat supporting the peer evaluation system and the operations of the MAC Management Group. Self-assessment a revised format for recording statistical information and a new reporting format have all been implemented in 2012 to improve the peer evaluation process. Improved pre-evaluation planning to gather greater insight in order to allocate the most effective team, and to inform the scheduling of the assessment. A pilot programme will take place in Training and knowledge sharing A number of training courses and workshops were carried out in 2012 to share best practice and to update the skills of peer assessment personnel: Training on ISO/IEC 17021:2011 for newcomer/potential peer evaluators was held in Brussels. 29 participants and 5 observers attended. Training to improve harmonisation of the MAC Task Force Groups and the procedures on decision-making in the EA MAC was held in conjunction with the MAC Meeting in Nicosia. Refresher training / workshop for evaluators in the field of ISO/IEC was held in Brussels. 12 participants attended. The audit was completed by witnessing the closing sessions of two EA peer evaluations in October and November It could be confirmed that the activities are generally performed according to the documented procedures. Possibilities for improvement have been identified and will be covered by actions already in development as part of the enhancement project. 15

16 Annex 1 Full Member signatories to the EA MLA 31 December 2012 CALIBRATION LABORATORIES TESTING AND MEDICAL LABORATORIES CERTIFICATION BODIES PRODUCTS CERTIFICATION BODIES PERSONS CERTIFICATION BODIES MANAGEMENT SYSTEMS INSPECTION BODIES Austria AA 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 FYROM IARM 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 P Malta NAB-MALTA P 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 Serbia ATS 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 Associate Member signatories to the EA MLA 31 December 2012 Bosnia & Herzegovina BATA P P P Israel ISRAC P P P Ukraine NAAU P P P P Tunisia TUNAC P P P 16

17 Annex 3 Decisions taken by the EA MLA Council on EA MLA membership At the meeting on April 2012 the following decision on EA MLA membership was taken: ATS (Serbia) becomes an EA Bilateral signatory in the fields of calibration, testing, inspection and certification of products. The next re-evaluation according to the regular schedule will be performed by June 2013, two years after the initial evaluation date. IARM (The Former Yugoslav Republic of Macedonia) becomes an EA MLA signatory in the fields of calibration, testing, inspection and certification of products. The next re-evaluation shall take place by October 2013, two years after the initial evaluation date. NAB-MALTA (Malta) becomes an EA MLA signatory in the field of calibration. The next re-evaluation, for the fields under the EA MLA, shall take place by September 2013, four years after the previous, originally planned, re-evaluation date. Based on the results of the extraordinary evaluation of November 2011, LATAK (Latvia) remains an EA MLA signatory in the fields of calibration, testing, inspection and certification of management systems, products and persons. The next re-evaluation shall take place by October 2013, four years after the previous re-evaluation date. OLAS (Luxemburg) remains an EA MLA signatory in the fields of testing, inspection and certification of management systems and products. OLAS becomes an EA MLA signatory in the field of calibration. ACCREDIA (Italy) remains an EA MLA signatory in the fields of calibration, testing, inspection and certification of management systems, products and persons. An extraordinary evaluation shall be performed before year-end The next re-evaluation shall take place around year-end 2014, four years after the previous re-evaluation date. HAA (Croatia) remains an EA MLA signatory in the fields of calibration, testing, inspection and certification of management systems, products and persons. The next re-evaluation shall take place around September 2015, four years after the previous re-evaluation date. NAAU (Ukraine) remains an EA Bilateral signatory in the field of certification of persons. NAAU becomes an EA Bilateral signatory in the fields of calibration, testing and certification of management systems. The next re-evaluation shall take place around November 2013, two years after the previous re-evaluation date, because of the considerable extension of scope. Based on the results of the extraordinary evaluation of December 2011, the decision on DAkkS (Germany) to remain an EA MLA signatory in the fields of calibration, testing, inspection and certification of management systems, products and persons is deferred till the next EA MAC meeting of September 2012 to enable the evaluation team to finish the evaluation based on the evidence provided by DAkkS on the outstanding non-conformities. 17

18 Annex 3 Decisions taken by the EA MLA Council on EA MLA membership continued At the meeting on September 2012 the following decision on EA MLA membership was taken: Based on the outcome of the extraordinary evaluation of year-end 2011, DAkkS remains an EA Multilateral Agreement signatory in the fields of calibration, testing, inspection and certification of management systems, products and persons. The next re-evaluation according to the regular schedule will be performed by mid-2014, four years after the previous regular evaluation date. BATA (Bosnia & Herzegovina) is approved to become an EA Bilateral Agreement signatory in the fields of calibration, testing and inspection. Based on the outcome of the initial evaluation of July 2012, the first re-evaluation shall take place by mid-2013, one year after the initial evaluation date. Based on the incompleteness of the re-evaluation report of September 2011, the decision on ESYD (Greece) to remain an EA Multilateral Agreement signatory in the fields of calibration, testing, inspection and certification of management systems, products and persons is deferred. NAT (Hungary) remains an EA Multilateral Agreement signatory in the fields of calibration, testing, inspection and certification of management systems, products and persons. The next re-evaluation shall take place around early autumn 2015, four years after the original scheduled re-evaluation date. Based on the latest information provided with respect to the ILNAS Bill, OLAS (Luxemburg) is required to provide the EA evaluation team (with a copy to the EA MAC Secretariat) before 1 July 2013, with clear evidence that the new Bill has been passed and is being implemented. 18

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20 For more information contact: EA Secretariat 75 avenue Parmentier F PARIS Cedex 11 FRANCE Tel: 33 (0) With support from the European Union With support from the EFTA Copyright EA 2013