The European co-operation for Accreditation (EA) is recognized by the European Commission to operate the peer-evaluation system of its Members, the National Accreditation Bodies (NAB), according to Article 14 of Regulation (EC) No 765/2008 ‘Setting out the requirements for accreditation relating to the marketing of products and repealing Regulation (EEC) 339/93’.
The main objectives of peer-evaluation activities are to:
- evaluate the ongoing compliance of EA Members with Regulation (EC) No 765/2008 and the international requirements (standards, etc.),
- ensure that regulators, stakeholders and the business community have confidence in the certificates and reports issued by accredited Conformity Assessment Bodies under the EA MLA.
National Accreditation Bodies are evaluated against Regulation (EC) No 765/2008, the international standard EN ISO/IEC 17011, and other relevant standards and 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 national authorities.
EA peer evaluators are highly qualified and experienced National Accreditation Body staff members. They attend regular training programs in order to maintain their evaluator competence and support the necessary development of EA peer-evaluation activities, including evolution of standards and regulations. Performance of EA evaluators is monitored by the Secretariat on a continuous basis.
Global recognition is a result of EA being regularly peer evaluated by its colleagues, IAF and ILAC peer evaluators.
Procedure
The strength of the EA MLA is maintained through a robust peer-evaluation process 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.
Compliance with the requirements means confidence in the conformity assessment results from Conformity Assessment Bodies accredited by the National Accreditation Body (NAB) so that signatories to the EA MLA can promote acceptance of these results.
The evaluation of a NAB aims to collect sufficient information, including during an on-site evaluation, about its assessments and decision-making process.
The EA peer-evaluation process is under regular review by EA internal auditors and ILAC/IAF peer evaluators as part of the evaluation program for regional cooperation MLAs.
EA peer evaluators are highly qualified, experienced NAB staff members who frequently attend training programs.
Peer evaluator performance is reviewed regularly, and EA peer evaluators can be mandated for peer evaluation at ILAC or IAF levels.
The European Commission attends meetings of the Multilateral Agreement Council (MAC) and NAB are encouraged to invite national authorities to observe peer evaluations of National Accreditation Bodies performed by EA.
| The peer-evaluation process consists of 4 main steps: |
|
|---|---|
| 1 | APPLICATION The NAB applies for MLA signatory status for specific scopes. The MAC Secretariat reviews the application and appoints an evaluation team. |
| 2 | DOCUMENT REVIEW & ON-SITE EVALUATION The evaluation team performs the document review (management system and supporting documents and procedures). Then, the team carries out the on-site evaluation. The evaluation combines an evaluation of the management system at the office with observation of assessments carried out by the National Accreditation Body. Findings are presented by a team and discussed with the National Accreditation Body at the closing meeting. |
| 3 | REPORT The team drafts the evaluation report. A MAC task force group review the evaluation report to issue a recommendation for consideration and decision by EA MAC. |
| 4 | DECISION The EA MAC takes a decision based on the evaluation report and TFG recommendation. The EA publications and website are updated accordingly. |
For more information, read EA-2/02 EA Procedure for the evaluation of a National Accreditation Body
Activity
During 2023, EA Members delivered more than 35,439 accreditations under the EA MLA, distributed as follows:
| Type of accreditation | 2023 |
|---|---|
| Calibration | 3,437 |
| Testing | 16,621 |
| Medical examinations | 3,928 |
| Products Certification | 2,103 |
| Management Systems Certification | 1,438 |
| Certification of persons | 859 |
| Inspection | 6,543 |
| Validation and Verification | 188 |
| Proficiency Testing Providers | 248 |
| Reference Material Producers | 74 |
| TOTAL | 35,439 |
There has been an increase of over 40% in the number of accreditations since 2013. Over this period, the European accreditation network has grown and new fields of activity using accreditation have developed. Recently, such developments have led to the expansion of the MLA for accreditation of proficiency testing providers. The MLA officially launched for Proficiency Testing Providers (EN ISO/IEC 17043) in April 2017 with 12 NABs becoming the first signatories and Reference Material Producers (EN ISO/IEC 17034) in May 2018 with 7 NABs becoming the first signatories.
| 2019 | 2020 | 2021 | 2022 | 2023 | |
|---|---|---|---|---|---|
| Total numbers of evaluations performed ¹ | 16 | 13* | 25 | 13 | 14 |
| Total numbers of reports discussed ² | 17 | 31** | 13**** | 15 | 17 |
| Total man-days for evaluation | 935 | 353*** | 1764 | 1,070 | 940 |
¹ Initial evaluations, re-evaluations with or without scope extensions and extraordinary evaluations (performed on site in the specific year)
² Reports of evaluations, but not necessarily conducted in the specific year
*13 evaluations, out of which only 8 document review for the peer evaluations were postponed to 2021
** 31 reports, out of which 18 were related to transition to ISO/IEC 17011:2017
***includes also the man-days for the participation of EA evaluators in IAF/ILAC evaluations
**** for which decision was made
Trust the EA MLA!
We commit to managing a transparent and efficient peer-evaluation system meeting market needs. Here’s the evidence!
For the market and regulators, peer evaluations have to be technically sound and adapted – One stakeholder says: “It is important that the EA evaluator’s competence is at the level of those they assess. This is the cost of confidence in the evaluation.”
The EA NABs provide their most competent human resources to the PE system – staff members with the most suitable skills to fulfil the tasks. Then EA provides the necessary training in the EA specific evaluation requirements and procedures.
One NAB, a member of the Multilateral Agreement Council, says: “We know we must work hard to deliver consistent peer-evaluation services. The EA evaluators must have a harmonized approach to peer evaluation for the MLA to be fully reliable.”
The EA training plan offers “refresher” workshops which aim to review changes in the EA and ILAC/IAF requirements, share experience amongst evaluators in order to maintain best practice and introduce improvements in the procedures.
Peer evaluations should foster harmonization and cross-fertilization between NABs!
One EA evaluator says: “I did my first peer evaluation as a team member in November 2017. It was a fantastic experience! I learnt a lot of the NAB practices. Once back home, I was able to share my experience with my colleagues and we were able to reconsider one of our processes in the light of the situation I had to evaluate. We gained a lot!”
The EA process shall not be a purely administrative process. It shall adapt to the operations of the NAB and the economic environment in general.
The Secretariat takes into account the constraints of the NAB. For example, splitting witnessing (observation) is a practice that has developed a lot over the past 3 years. New assessment techniques are also under consideration. The EA process strives to adapt to the changing world and new technologies, as do the EA NABs.
Decision-making must be transparent and consistent.
Harmonization again is a key word in the process. The Multilateral Agreement Council takes action to train its members in the decision-making rules. Observers from the European Commission and the EA Advisory Board are invited to attend the MAC meetings.
Decisions must be made widely public.
Decisions on MLA signatory status are made public on the EA website immediately after each meeting of the MAC (twice a year). Once a year in March/April, EA publishes its EA MLA report. Continuously, any changes or development regarding the EA MLA are immediately reported to all interested parties using EA materials (website, twitter, brochures, etc.)
The system must comply with ILAC/IAF requirements.
The EA peer-evaluation rules are 100% ILAC/IAF compatible! EA is engaged in the ILAC/IAF working group in charge of setting out the evaluation requirements. EA meets its obligations by nominating evaluators to be used by the ILAC/IAF peer-evaluation process. The results of peer evaluations of EA carried out by ILAC/IAF state that EA and the EA MLA Members are signatories to the ILAC/IAF mutual agreements!
And it is an evolving system that adapts to the changes in NAB
The biggest changes for me are the growth of MLA scopes and communication tools. Today is common to have 6-8 MLA scopes to peer-evaluate during the same week, so the number of peer-evaluators grew. It has also triggered change: we now focus more on understanding how the NAB gets access to competence and deploys it for its assessments and decision-making. Sampling is more relevant nowadays, due to the variety of conformity assessment activities that NABs accredit, and the bigger number of accredited bodies, but we have now better tools to facilitate our work, since the management of information inside the NABs has improved considerably in most cases. The communication boom made it possible, not only to decrease the delivery times, but also to react faster, and access any information almost instantaneously. The peer-evaluation (PE) system had to adapt itself to these new realities, but also to the implementation of Regulation (CE) No. 765/2008. It is not just a private agreement between accreditation bodies, it’s a binding agreement between national accreditation bodies and authorities, with legal implications. So, the PE system became more ‘professional’ and consistent, and aware of the use of accreditation in the regulatory area, which became more targeted in the sampling.
Click here to read the full interview of Leopoldo Cortez, EA Team Leader