The EA Multilateral Agreement Council (MAC) had its remote meeting on the 6th and 7th October 2021 with a wide participation from the National Accreditation Bodies (NABs).

The MAC elected three of its Management Group (MG) members. The MAC welcomes Kristina Hallman (SWEDAC, Sweden) as a new MG member and the re-elected Norman Brunner (AA, Austria) and Claudio Boffa (NAB-MALTA, Malta).

The MAC decided to lift the suspension and reinstate the EA BLA signatory status of NAAU (the National Accreditation body of Ukraine) in the field of Inspection (EN ISO/IEC 17020) and Product Certification (EN ISO/IEC 17065).

One of the main topics was related to the re-engineering of the peer-evaluation process which is close to its end. The MAC members agreed to send out for ballot the documents which already went through a commenting period:

  • MAC Terms of Reference;
  • EA-2/02 M – EA Procedure for the evaluation of a National Accreditation Body;
  • EA-2/02 S1 M – Description of competence criteria of the EA Secretariat personnel involved in the management of the peer-evaluation process lists the required knowledge, skills and personal attributes of the EA Secretariat personnel;
  • EA-2/02 S2 M – Circumstances and process of involving EA Technical Committees in peer-evaluation issues, describes the circumstances and process to follow in case of disagreement between the EA Peer Evaluation Team and the National Accreditation Body undergoing peer evaluation on a non-conformity caused by a different technical interpretation of a clause of an EA MLA Level 3 standard (and exceptionally Level 4 requirements from regulatory areas and sectorial schemes);
  • EA-2/02 S4 G – Procedure for remote peer evaluations during the COVID-19 pandemic provides guidance for planning and performing the peer evaluations during the COVID-19 pandemic.

Another two documents will be sent out for comments:

  • EA-2/02 S3 M – Risk-based approach for the planning of a peer evaluation explains the risk-based approach used for the planning of a peer evaluation, considering the specific indicators specific to a national accreditation body;
  • EA-2/02 S5 M –Procedure for remote decision-making.

 On-site peer evaluations

Due to the COVID-19 pandemic, all the evaluations in 2021 were carried out remotely, based on the EA MAC policy and procedure for remote peer-evaluations during the COVID-19 pandemic, approved by the MAC to support the necessary level of confidence in the EA peer-evaluation system during the sanitary crisis.

Since the pandemic is likely to get better and in most European countries the National Accreditation Bodies have started to do their assessments on-site, the MAC decided to start the on-site peer evaluations from 2022. However, as there is no certainty that the pandemic is over and since there are several restrictions, the MAC agreed that the following shall be considered:

  • it is not possible for the Team Leader to be on-site, due to travel restrictions, at least the Deputy Team Leader shall be on-site;
  • there are travel restrictions applicable in the country of the NAB under evaluation, the MG will decide on a case-by-case basis the deviation from the above principle of having an on-site peer evaluation;
  • it is accepted for Team Members not to be on-site if there are travel restrictions by their countries.

Roadmap towards the EA MLA for Biobanking accreditation.

The international standard ISO 20387 General requirements for biobanking has been published in 2018. This standard specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.

Many of the national accreditation bodies are offering accreditation to biobanking facilities, since accreditation is the best means to demonstrate the competence of biobanks.

EA is currently in the process of extending its Multilateral Agreement to include the mutual recognition of the accredited biobanking facilities.

EA has taken the first steps towards the launching of the new EA MLA on biobanking and approved the roadmap towards the EA MLA for Biobanking, which is describing the actions to be taken in order to reach this objective, such as revision of EA documents to include the activity and harmonized standard into EA MLA, training of the peer evaluators and preparation for the peer evaluation process.

For more information about the EA MLA see https://european-accreditation.org/mutual-recognition/the-ea-mla/