The EA Multilateral and Bilateral Agreements Serving the

The EA Multilateral and Bilateral Agreements Serving the European Economy and Society

Contents What is the EA MLA? The structure of the EA MLA The peer evaluation system EA MLA/BLA signatories

EA MLA (1) v The MLA is an agreement signed between the EA accreditation body members to recognise the equivalence, reliability and therefore acceptance of accredited certifications, inspections, calibration certificates and test reports across Europe. v The MLA eliminates the need for suppliers of products or services to be certified in each country where they sell their products or services, and therefore provides a means for goods and services to cross boundaries in Europe and throughout the world.

EA MLA (2) v It delivers confidence in the service supplied by accredited laboratories, inspection and certification bodies, thereby providing the framework for goods and services to cross borders in Europe and throughout the world, acting as a "passport for trade". v The National Accreditation Body's mark on test reports and certificates is the assurance of the benefits of the MLA.

EA MLA (3) The EA Multilateral Agreement accepts: v the equivalence of the operation of the accreditation systems administered by EA Members; v that the certificates and reports issued by organisations accredited by EA Members are equally reliable.

EA MLA (4) Benefits for governments and regulators (1) v v Flexibility of approach: accreditation delivers a multi-discipline solution that can be applied to support or act as an alternative to legislation; Increased confidence in data that is used to establish baselines for monitoring and enforcement; Trade facilitation due to internationally accepted testing and measurement practices, data generated by an accredited laboratory may lead to the more ready acceptance of exported goods in overseas markets. This reduces costs and eases exports and imports, as it reduces or eliminates the need for retesting in another country;

EA MLA (5) Benefits for governments and regulators (2) v v Efficient Government: Accreditation delivers a balance between risk and protection as it reduces the need for government and regulators to carry out additional audits, and so employ additional inspection staff; Create a competitive environment: businesses are able to differentiate their products and services, as well as being able to exploit overseas opportunities opened up through the mutual recognition arrangements.

EA MLA (6) Benefits for industry and business community (1) v v Whatever the technical field and the market, industry can make an informed choice by procuring from an accredited organisation. Accreditation saves business time and money as it removes the need to re-test or certify a product in each and every country where it is sold. The EA MLA is a European network that supports industry and trade by removing barriers to trade: an accredited test performed in one country is recognised in all the other MLA signatory countries. For the manufacturer or the importer, it ensures greater access to new growth areas, and speed to market.

EA MLA (7) Benefits for industry and business community (2) How to ensure that a certificate or test report is acceptable? v v v check that there is an accreditation mark on the report or certificate; check that the accreditation mark is a mark of an accreditation body signatory to the EA MLA (ILAC or IAF MRA/MLA); check that the supplier is accredited for the competence, the tests, the results you need; check that the tests have been carried out against international standards. Alternatively, check that the standards, methods used can be accepted in the country of destination; in case of problems, contact the national accreditation body.

EA MLA (8) Benefits for European citizens (1) v v The EA MLA benefits all European citizens as accreditation underpins the quality of the air we breathe, the safety of the food we eat, the safety of our working environment. As an example, there is an ongoing project to develop accreditation for the certification of services performed by the breast cancer units (diagnosis, treatment) throughout Europe. It is a clear expectation of the European Parliament to make the same high quality services available to all women in Europe.

EA MLA (9) Benefits for European citizens (2) Accreditation: • Delivers Public Confidence: Despite a complex global marketplace, accreditation gives us confidence through ensuring consistently high standards in the quality of products or services purchased. • Minimises product failure or recalls: Product testing carried out by a reliable independent organisation will minimise products failing or potential recalls. • Prevents dangerous outbreaks: Tests conducted by accredited laboratories will prevent the risk of outbreaks (from food poisoning to water contamination) that can be hazardous to the public.

EA Multilateral Agreement June 2007 Rev 5

EA-1/06 (1) 1. 2. 3. The Agreement is based on the results of the evaluations carried out in accordance with the EA procedure. The parties entering the Agreement are the Accreditation Bodies in each country on behalf of which the Agreement was signed. EA MLA members shall not in any way market or promote their accreditation services in another EA Member country. This will not prevent an AB from providing accreditation services if requested by a CAB or AB, taking into account the principles of the Cross Frontier Policy.

EA-1/06 (2) 4. On the basis of the equivalence of the operation of the Schemes operated by the Signatories and hereby declared, each Signatory to this Agreement will: i. ii. iii. accept the other Schemes operated by the other Signatories as equivalent to its own Scheme(s); recognise as being equally reliable the certificates and/or reports from the organisations accredited by the Signatories under their equivalent Schemes; recommend and 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;

EA-1/06 (3) On the basis of the equivalence of the operation of the Schemes operated by the Signatories and hereby declared, each Signatory to this Agreement will: iv. investigate all complaints initiated by a Signatory resulting from certificates and/or reports issued by an accredited organisation of its own Scheme(s); v. notify all other Signatories and the MLA secretariat as soon as possible of any significant changes that have occurred or will occur in its status or in the operational practices of its Scheme(s); vi. nominate and commit itself to providing a number of peer evaluators in proportion to its size and to the needs of the MLA Council;

EA-1/06 (4) On the basis of the equivalence of the operation of the Schemes operated by the Signatories and hereby declared, each Signatory to this Agreement will: vii. operate according to the criteria specified in the relevant European Standards, published in the ISO/IEC 17000 and EN 45000 series of standards, or other internationally recognised normative documents, supplemented by EA application documents, if necessary; viii. commit its evaluators to participate in training and retraining as appropriate.

EA-1/06 (5) 5. An EA member may refer at any time to its signatory status of the MLA. If the member is not a signatory to all MLA schemes, it shall specify to which MLA it is signatory. 6. If, in accordance with the procedures set out in EA documentation, it is agreed that a further Accreditation Body will participate in the Agreement covering the scheme, a new signature sheet shall be signed by the new Accreditation Body and duly authorized by the Chairman of the MLA committee. The new Signatory shall be added to EA-1/08 and the list of MLA signatories available on the EA website. An analogous rule shall apply if it is agreed that a Signatory may extend its Scheme(s).

EA-1/06 (6) 7. If a Signatory, for any reason whatsoever, has to withdraw from this Agreement or to reduce the extent of its Scheme(s), the other Signatories shall be notified in writing not later than three months in advance of withdrawing or reducing. Upon withdrawal of a Signatory or reducing the extent of its Scheme(s), EA-1/08 and the list available on the EA website shall be amended accordingly. 8. This Agreement supersedes any previous Multilateral Agreement, which may exist between the Signatories.

EA-1/06 (7) 9. Any amendment of the text of this Agreement shall be made in accordance with the rules of procedure established by EA. 10. In the event of an appeal the matter shall be dealt with in accordance with EA-2/01 -S 3 EA Procedure for the Investigation and Resolution of Complaints & Appeals. 11. It is recognised and accepted by each of the Signatories that this Agreement does not create any rights, liabilities or obligations that would have binding effect in national, international or European Community law.

Contents What is the EA MLA? The structure of the EA MLA The peer evaluation system EA MLA/BLA signatories

Structure of EA MLA (1) New structure five tiers Tier 1: ISO/IEC 17011 Tier 2: accreditation activity (scope) in which the AB has demonstrated competence (like testing; calibration; certification of products, management systems, persons; inspection) Tier 3: generic standards or normative documents used by the AB to assess the CAB technical competence for each accreditation activity (like ISO/IEC 17025, 17020, 17021, 17024, ISO 15189, EN 45011)

Structure of EA MLA (2) Tier 4: sector specific standards or normative documents used in combination with one of the generic standards of tier 3 (like ISO/TS 22003, ISO/IEC 27006 or schemes like WADA) Tier 5: standards or normative documents used by the accredited CAB to deliver an accredited conformity assessment service, like test methods or standards at the laboratories, ISO 9001 or other management systems standards, product specification or standards, national or international schemes or normative documents issued by the regulators.

Structure of EA MLA (3) New accreditation activities in the MLA Whenever a new standard or normative document used for accreditation comes to the market, the EA General Assembly will decide whether it should be classified under the MLA and by what mechanism; a new accreditation activity (Tier 2) or a new normative document under one of the endorsed accreditation activities (Tier 3).

Structure of EA MLA (4) New sector specific schemes in the MLA The criteria and the process for accepting a new sector specific scheme into the list of endorsed EA sector specific schemes (Tier 4) are given in EA-2/11 EA Policy for Sector Schemes.

Scopes of EA MLA Accreditation of laboratories Testing, calibration medical analysis EN ISO/IEC 17025 ISO 15189 Accreditation of certification bodies Certification of poducts EN 45011 Certification of management systems EN ISO/IEC 17021 Certification of persons EN ISO/IEC 17024 Inspection EN ISO/IEC 17020 Accreditation of inspection bodies (ISO/IEC Guide 65)

Activities of the EA-member ABs (1) v Accreditation covered by the EA MLA üTesting laboratories üCalibration laboratories üInspection bodies üCertification bodies for products üCertification bodies for persons üCertification bodies for management systems (QMS, EMS, OHSAS, FSMS, ISMS)

Activities of the EA member ABs (2) v. Accreditation not covered by EA MLA üEMAS verifiers - FAB üGHG verifiers üPT providers üRM producers üAttestors for public procurement üGood Laboratory Practise

Contents What is EA MLA? The structure of EA MLA The peer evaluation system EA MLA/BLA signatories

Management of the EA MLA v v v The strength of the EA MLA is maintained through a robust peer evaluation process. The purpose of these rigorous on-site evaluations is to verify the Accreditation Body signatories' continuing conformity with the internationally accepted criteria. ABs are evaluated against the international standard ISO/IEC 17011, other related criteria such as application documents from EA, ILAC or IAF and applicable criteria on behalf of European or national regulators and industrial schemes. The MLA process is overseen by the European Commission, the EA Advisory Board and the national authorities.

EA Policy and Procedures for the Multilateral Agreement November 2008 Rev 05 Effective from 18 January 2009

EA-2/02 (1) v v The document describes the procedures that EA has adopted for the evaluation and re-evaluation of nationally recognised ABs, the operation of their accreditation systems and their accredited organisations when these ABs are or wish to be signatories to EA Multilateral Agreement or wish to enter into mutual recognition with an EA Multilateral Agreement as an individual AB. The procedure is fully based on the common ILAC/IAF document for the evaluation of single ABs.

EA-2/02 (2) Criteria (1) v v ISO/IEC 17000 series of standards and other ISO/IEC guides ILAC, IAF, EA guides mandatory for the EA MLA Applicant ABs and signatories shall bring these guidance documents to the attention of the accredited organisations for their use as accreditation criteria supporting the requirements in the accreditation standards.

EA-2/02 (3) Criteria (2) v Supplementary requirements, the AB ü shall be fully operational; ü shall have sufficient experience in the assessment of its accredited organisations and have carried out at least one accreditation in each of the certification accreditation programs and inspection program for which it applies, for laboratory accreditation in the testing field at least four accreditations and for laboratory accreditation in the calibration field at least four accreditations; ü shall implement or fulfil other requirements of EA as described in the documents listed in EA-1/01 in accordance with the document categories described in EA -2/12.

EA-2/02 (4) Criteria (3) v Proficiency Testing and other Laboratory Comparisons ü The AB shall demonstrate that it has an effective policy in place in accordance with ISO/IEC 17011 and ILAC/EA mandatory documents to ensure appropriate participation by its accredited bodies in PT and other laboratory comparison activities. The AB shall ensure that accredited bodies implement appropriate corrective action where necessary. ü Every applicant AB or Signatory to the MLA in the fields of calibration and testing shall ensure its laboratories participate in regional or national PTs and other laboratory comparisons where available and appropriate. ABs shall ensure that the results of the regional activities are reviewed and appropriate corrective action taken as necessary.

EA-2/02 (5) Criteria (4) v. Subcontracting The Accreditation Body (AB) can only subcontract assessment activities to ABs having signed the MLA for that particular activity (IAF/ILAC or an MLA from a recognised region).

Types of evaluation v Pre-evaluation v Full (initial) evaluation v Extraordinary evaluations The duration and the tasks of the extraordinary evaluations are basically determined by the EA MAC. v Re-evaluation Given the long interval (approximately 4 years) between evaluations, the duration of a re-evaluation is comparable to that of an initial evaluation.

Peer evaluation process (1) The AB applies for the first time or for extension of scopes. The AB has to specify and justify the scope (testing, calibration etc. ) for which it seeks signatory status The MAC Secretariat checks the completeness and asks further documents, if needed The MAC Management Group acceps the application and assigns the EA team (a Team Leader, a deputy and team members)

Application v v ü ü ü ü Application form (Annex 1 of EA-2/02) Supplementary documents, the AB shall submit Quality Manual List of documents supporting the Quality Manual Statement on the regional group to which the applicant belongs, if any Full details of the staffing Specified criteria, which includes formal rules or regulations that apply to the applicant's operation and the responsibilities and obligations of its accredited bodies Checklist (EA-MAC/01 -S 17) Statistical information (EA-MAC/01 -S 16) Results of the self-assessment on the basis of the KPIs and management review For cal and test, report on PTs including an overview of the performance level Implementation of EA Cross Frontier Policy Participation in EA committees etc. Policy for implementation of ILAC/IAF mark Policy for implementation of the EA-2/11

Peer evaluation process (1) The AB applies for the first time or for extension of scopes. The AB has to specify and justify the scope (testing, calibration etc. ) for which it seeks signatory status The MAC Secretariat checks the completeness and asks further documents, if needed The MAC Management Group accepts the application and assigns the EA team (a Team Leader, a deputy and team members)

EA team (1) v v v Evaluators will be chosen - from the pool of evaluators - to provide a balanced set of skills covering the full scope of evaluation. The team chosen shall consist of representatives from a cross-section of AB full members of EA or of other regions, if relevant. The team may include one observer as trainee or for other reasons as accepted by the MAC-MG. No member of the team should be associated with any AB that has provided consultancy service to the accreditation body being evaluated for at least 5 years preceding the evaluation.

EA team (2) Evaluators should ü be open minded and mature, ü possess sound judgement, analytical skills and tenacity, ü have the ability to perceive situations in a realistic way to understand complex operations from a broad perspective, ü have good interpersonal skills ü be able to communicate clearly in English

EA team (3) Team Leader (TL) shall ü have at least 3 years experience in the operation of an AB and has appropriate technical background and experience in assessment, ü have participated successfully in at least two evaluations of ABs as a TM, ü have sound knowledge of the application of the appropriate EN/ISO/IEC standard for ABs and relevant MLA requirements, ü have enough working experience in an AB to be able to understand requirements of any of the relevant standards that are applicable to the accreditation of CABs, ü be a full time staff member of an AB, ü have the experience in chairing meetings and in reaching consensus on delicate points

EA team (4) Team Member (TM) shall ü have at least 3 year experience in the operation of an AB and has appropriate technical background and experience in assessment, ü have successfully completed relevant training course(s) and should have experience as trainee in peer evaluation of ABs, ü have experience in at least one standard that is applicable to the accreditation of a CAB, ü have experience in at least one technical field in which a CAB operates, ü have preferably participated in an EA/ILAC/IAF working group/committee, ü be preferably a staff member of an AB.

Peer evaluation process (2) The EA team performs the document review (quality management system documents, procedures of the AB etc. ) Where applicable, a pre-evaluation is conducted. The EA team carries out the on-site evaluation. The evaluation combines evaluation of the management system at the AB office and observations to evaluate how the AB perform accreditation.

Document review The TL will normally conduct the document review (the TL can delegate some of the review to TM(s)) before each evaluation visit. There is no prescribed format for the document review. Under normal circumstances the document review is for use by the team and the AB. Only when the document review gives an indication that proceeding with the on-site evaluation is not useful, a brief written report shall be prepared for the MAC-MG stating the reasons.

Peer evaluation process (2) The EA team performs the document review (quality management system documents, procedures of the AB etc. ) Where applicable, a pre-evaluation is conducted. The EA team carries out the on-site evaluation. The evaluation combines evaluation of the management system at the AB office and observations to evaluate how the AB perform accreditation.

Pre-evaluation v v v The TM has studied the documents and the documents review report of the TL before the pre-evaluation takes place. On-site evaluation of 2 days. The report provides a brief overview of the AB’s legal status and impartiality, the scope and accreditation activity of the AB and other general information including cross frontier accreditation activity. In addition all non-conformities, concerns and comments should be mentioned. A recommendation for the MAC-MG on when and how to proceed must be included. At a later stage some of these issues can be used in the report of the full initial visit as well.

Peer evaluation process (2) The EA team performs the document review (quality management system documents, procedures of the AB etc. ) Where applicable, a pre-evaluation is conducted. The EA team carries out the on-site evaluation. The evaluation combines evaluation of the management system at the AB office and observations to evaluate how the AB perform accreditation.

On-site evaluation (1) v v Normally the on-site evaluation visit including witnessing is performed during one week. Appropriate measures to collect information are: v v v careful study of the documents passed by the AB in advance including information on accreditation scope, accreditation activities and cross frontier accreditation activities of the AB interviews with the ABs management, staff, experts, assessors, clients or authorities vertical audits of files analysis of minutes from AB’s committees, SOPs, accreditation procedures etc. witnessing and observation

On-site evaluation (2) v The evaluation visit has to be carefully prepared in close interaction between TL, TMs and the AB. All necessary documents have to be provided to the TL and/or to the TMs in due time. v The content and extent of the documents have to be in such a condition that the evaluation can be prepared and carried out in good manner and successfully, and by this way the time at site can be used for the verification and witnessing. In case the extent or the content of the documents are not enough, further documents have to be demanded by interaction with the AB. The evaluation visit will be postponed if the documents are not satisfying.

On-site evaluation (3) v The AB must send all necessary documents translated at least 3 months in advance of a visit to allow for preparation and for requesting additional information. v The Team Members must start reviewing the documents directly after receipt. In essence the Team Leader should be able to prepare a substantial part of the report before the on-site evaluation. This part of the preparation is the same for all types of evaluations. The total time involved in studying of the documentation may take on average 3 to 5 days for the TL and 2 to 4 days for the TMs.

On-site evaluation (4) Witnessing and observing v Normally, there shall be one witness of an initial accreditation or re-accreditation of a CAB for every scope, or two surveillances. The TL makes a selection of them. If the witnesses are not satisfactory, or in case of unforeseen events, their number might be increased. In no case the number should be less than two (for a single scope AB). v The form of the witness report contains the elements to be observed during the witness.

Duration of on-site evaluation (1) Day Action Evaluators Sunday Preparation: key issues and evaluation plan TL and 4 TMs Monday Office (whole team) and preparation of witnessing and observing TL and 4 TMs Tuesday Office and witnessing/observing; vertical audits (flexible split between TL and TMs) TL and 4 TMs Thursday Office and witnessing/observing; vertical audits (flexible split between TL and TMs) and preparation of the final evaluation report TL and 4 TMs Friday Office for finalising the report and presentation to the AB TL and 4 TMs Full day of witnessing Wednesday Full day of witnessing

Duration of on-site evaluation (2) v For a single scope AB the on-site evaluation takes 3, 5 days with a TL and a TM. v Elements extending the duration: ü extensive travel and travel circumstances ü need of translation ü multi-site AB-offices ü possibilities for witnessing/observing ü cultural differences ü requirements from regulators ü requirements from special schemes (Bluetooth, etc. )

Classification of findings v Non-conformity (NC): Finding where the AB does not meet a requirement of the applicable EN/ISO/IEC standard(s), its own QM system or the MLA rules (obligations) in a way that discredits competence or jeopardizes the quality of its work. The evaluated AB is expected to respond to a NC by taking immediate corrective action and providing the team with evidence of implementation. v Concern (CN): Finding where the AB’s practice may develop into a NC or the team is not fully satisfied. The evaluated AB is expected to respond to a CN by providing the team with an appropriate action plan and time schedule. v Comment (Cm): Finding about documents or AB’s practices with a potential of improvement, but still fulfilling the requirements. The evaluated AB is not required to respond to a Cm but may do so if it wishes.

Peer evaluation process (3) The EA team drafts the evaluation report at the end of the evaluation. Findings have been approved with the AB at the closing meeting. A TFG appointed by the MAC Management Group looks at the evaluation report in order to issue a recommendation for the MAC on the result of the peer evaluation. The MAC makes a decision. Note: for applicants to EA membership, the recommendation made by the MAC has to be confirmed by the EA General Assembly where the final decision is to be taken.

Reporting and corrective actions v v v General information on the AB Compliance with requirements (KPI-report focussing on evidence how the AB handles the addressed key issues Witnessing (list of witnesses/observations with individual summary reports (type of CAB, scope in general terms, type of assessment)) List of findings (complete list of elaborated findings including the report about the way the findings have been closed and recommendation of the evaluation team) Appendix (Organisation chart with key personnel, Report on participation in international PTs/ILCs, Statistical Information, Confidentiality Declaration, Evaluation plan etc. ) One month between draft report + corrective actions proposed. One month for team to react. One month for finalising report + recommendation

Peer evaluation process (3) The EA team drafts the evaluation report at the end of the evaluation. Findings have been approved with the AB at the closing meeting. A TFG appointed by the MAC Management Group looks at the evaluation report in order to issue a recommendation for the MAC on the result of the peer evaluation. The MAC makes a decision. Note: for applicants to EA membership, the recommendation made by the MAC has to be confirmed by the EA General Assembly where the final decision is to be taken.

TFG review v v v TFG consists of 3 MAC members and a MAC-MG member. The composition shall not compromise the independence of the TFG. The TFG is requested to comment on the general impression of the performance of the evaluation team, the reporting and the classification of findings. The TFG is expected to communicate with the evaluation team and, in exceptional cases, with the AB under evaluation when there are open, missing or unclear issues in the report in order to solve or clarify the situation. MAC members are informed on the composition of the TFG, well in advance of the meetings, to anticipate on a specific situation in an AB.

TFG report TFG conclusions: v Statements on findings observed by the evaluation team: Clearly identify the findings, which TFG, AB and team do not agree upon. It is beneficial if a table is provided with the following column headings: finding, team’s view, AB’s view and TFG’s view. v Recommendation with justification: The TFG can recommend in line with the team, in such case no further justification is required. v The TFG can propose, well founded, that the AB has to deal with certain issues first and provide for instance proof in writing or through an additional visit. v The TFG can disagree with the team’s recommendation. This should obviously be reflected in the above-mentioned statements. v

Peer evaluation process (3) The EA team drafts the evaluation report at the end of the evaluation. Findings have been approved with the AB at the closing meeting. A TFG appointed by the MAC Management Group looks at the evaluation report in order to issue a recommendation for the MAC on the result of the peer evaluation. The MAC makes a decision.

EA MAC decision (1) v The evaluation report, the corrective actions and the recommendations of the Team Leader and the EAMAC Task Force Group (TFG) (see Annex 7) shall be submitted as the final report to the listed members of the EA-MAC. v The EA-MAC shall decide: ü in the case of an initial evaluation, whether or not the Applicant Body may enter the EA MLA; ü in the case of a re-evaluation, whether or not the Applicant Body will remain, with or without conditions, a Signatory to the EA MLA, whether or not sanctions need to be applied.

EA MAC decision (2) v In the case of an initial evaluation: ü Approval with establishing of the period of the first reevaluation. Normally a 2 -year period is used for initial evaluations after entering into the MLA. This procedure does not apply to ‘extension(s) of scope’. ü Defer approval pending submittal of required evidence of corrective actions for NCs and concerns and/or an additional visit by one or more members of the team. ü Disapproval with a new evaluation being required.

EA MAC decision (3) v In the case of a re-evaluation: ü Continuation without condition (re-evaluation in 4 years) ü Continuation with conditions (e. g. extraordinary evaluations, shortened re-evaluation interval). An extraordinary evaluation may already have been agreed by the TFG and AB and can in such case already commence upon approval by the MAC-MG. If no agreement was reached the MAC must decide. ü Suspending the AB for a maximum of 6 months, with an extraordinary visit. ü Immediate withdrawal of signatory status to a particular MLA.

EA MAC decision (4) v In case of serious lack of confidence during evaluations: ü When an evaluation team detects a situation at an AB that results in a total lack of confidence in the AB’s operations and in the issued accreditations, the team will have to deviate from the normal reporting procedure as described in the EA-MAC flowchart. ü In this case the team will immediately send to the MAC-MG the report of the evaluation without awaiting the corrective actions of the AB. ü During the evaluation the AB’s management must be informed that serious problems are detected.

Peer evaluation activities (1)

Peer evaluation activities (2)

Peer evaluation activities (3) 2006 2007 Number of evaluation reports 12 16 Extraordinary evaluation required 2 5 Number of decisions withouut conditions Number of suspensions 2 7 0 1

Contents What is EA MLA? The structure of the EA MLA The peer evaluation system EA MLA/BLA signatories

EA MLA/BLA signatories (1) Scopes Testing Calibration Inspection Product certification QMS certification EMS certification Persons certification MLA 27 25 24 24 25 22 22 BLA 6 7 4 1 2 2

EA & MLA Members Calibration ; testing ; products, quality management systems and persons certification ; inspection Calibration ; testing ; products, quality management systems and persons certification Calibration ; testing ; products and quality management systems certification; inspection Calibration; testing; products and quality management systems certification Persons and quality management system certification Environnemental management systems certification Calibration ; testing Full members non signatories Contracts of Cooperation (European countries) November 2009

EA MLA Signatories Austria Belgium Bulgaria France Germany Greece Malta Netherlands Norway Slovenia Spain Sweden Czech Rep. Ireland Poland Switzerland Denmark Italy Portugal Turkey Estonia Latvia Romania United Kingdom Finland Lithuania Slovakia

EA BLA Signatories v v v v v Australia Brazil Hong-Kong Israel New-Zealand Russia South-Africa Singapore Ukraine Tunisia

Finally v The international accreditation network is growing as more economies have set up competent national Accreditation Bodies. Since 2003, the number of new established Accreditation Bodies has grown by almost 40% globally. In Europe, all Member States have established a national Accreditation Body. Countries candidate to the EU membership have also progressed the setting up of a competent accreditation system. v The number of accredited bodies in Europe has increased significantly in the last five years. Today there are more than 20 000 bodies accredited by EA MLA members, compared to 14 000 in 2004, representing growth of more than 35%. At the international level, there almost 29 000 accredited laboratories, representing the same growth rate since 2004.

Thank you for your kind attention! Questions?