EA held a MAC Refresher Training for Team Members authorized in Calibration (EN ISO/IEC 17025), Reference Material Producers (EN ISO/IEC 17034), and Biobanking (EN ISO 20387:2018) on 5-6 June 2024 in Brussels, Belgium.

EA regularly organizes refresher training sessions for peer evaluators to improve their performance and harmonization of work. These sessions keep evaluators updated on new requirements, changes in peer-evaluation procedures, and areas for improvement, fostering the sharing of experiences among peers. While the harmonization of the biobanking standard is still in progress, EA is prepared to conduct evaluations within this scope. The training provided a valuable opportunity for evaluators to share their experiences in accrediting biobanking and served as an additional step in preparing EA for upcoming evaluations.

Eleven participants from National Accreditation Bodies (NABs) participated in the training led by Sergio Guzzi (ACCREDIA, the Italian NAB), Martina Bednarova (CAI, the Czech NAB), Zacharias Ioannidis (ESYD, the Greek NAB), and Simon Herren (SAS, the Swiss NAB).

The first part of the training covered general topics relevant to the three scopes related to the peer evaluation process. It included information on MAC activities and covered general topics from ISO/IEC 17011, NABs personnel, accreditation cycles, assessment programmes, and the risk-based approach. Practical aspects of the peer evaluation process were also discussed, such as preparation, evaluation of MLA scope extensions, selection and execution of witnessing and file reviews, and handling findings (writing, classification, closure, root cause, and extent analysis). Reporting procedures, including final report content and timelines, and behavior issues were also covered.

The next part of the training featured a common breakout session, focusing on group work regarding findings and reporting of peer evaluations. These two areas are crucial for harmonizing evaluators’ work across all accreditation schemes.

The third part of the training involved specific breakout sessions where participants discussed and exchanged experiences on issues and requirements specific to Calibration, Reference Material Producers, and Biobanking.

The training led to several common conclusions and improvement proposals for the evaluation process across all scopes. Key points included the importance of risk-based planning and execution of evaluations, timely contributions to evaluation reports and corrective action plans, and heightened awareness of context during peer evaluations (such as cultural differences, language barriers, diplomacy, open-mindedness, fortitude, tenacity, and collaboration). Additionally, the proposals emphasized thoroughly investigating issues before raising findings, carefully wording findings, and discussing and sharing findings with relevant AB staff before the closing meeting.

Calibration

In the calibration scope, several areas for further harmonization have been identified. These include witnessing in traceability and PT/ILC participation according to ILAC P10:07/2020 (ILAC Policy on Metrological Traceability of Measurement Results), traceability routes (3a and 3b), and traceability from NMIs (National Metrology Institutes) without CMCs (Calibration and Measurement Capabilities) in the BIPM KCDB, or non-accredited calibration laboratories. Additionally, there is a need to address the acceptance of CRMs (Certified Reference Materials) produced by non-accredited RMPs when accredited RMPs are available, and the assessment of in-house (internal) calibrations as all ISO/IEC 17025 requirements apply to these calibrations.

Proficiency Testing

Challenges have been identified in determining when PT/ILC (Proficiency Testing/Inter-laboratory comparisons) ( can be considered unavailable and in prioritizing the selection of PT/ILC providers (accredited, non-accredited, or small-scale ILCs organized by peer labs). Further considerations include implementing the new ILAC P9:01/2024 (ILAC Policy for Proficiency Testing and/or Interlaboratory Comparisons other than Proficiency Testing), defining accreditation scopes, and applying ILAC P14:09/2020 (ILAC Policy for Measurement Uncertainty in Calibration) and ILAC G18:01/2024 (Guideline for Describing Scopes of Accreditation). This also involves addressing flexible scopes in calibration, conformity statements, and decision rules.

Reference Material Producers

In the field of Reference Material Producers, experience was exchanged on current topics such as the requirements of the new ISO 33401:2024 (Reference materials — Contents of certificates, labels, and accompanying documentation) and ISO 33405:2024 (Reference materials — Approaches for characterization and assessment of homogeneity and stability). Additionally, there was a focus on the EA and ILAC documents used in the peer evaluation process, specifically EA-2/15:2023 (EA Requirements for the Accreditation of Flexible Scopes), ILAC G18:01/2024, the competence of assessment teams (including knowledge of the appropriate technical field, production conditions, statistical approaches, and data evaluation), and witnessing during evaluations.

As biobanking is set to become a new scope under EA MLA in the near future, this refresher training served as an opportunity to further prepare evaluators for upcoming evaluations. Discussions included feedback and challenges from the initial accreditations of biobanks under ISO 20387:2018 (Biotechnology — Biobanking — General requirements for biobanking) and the implementation of ILAC P9:01/2024 and ILAC P10:07/2020 in the biobanking area and general sample quality control. The presentation of accreditation scopes was also a key focus of the training.

As Sergio Guzzi, one of the trainers, emphasized during the session:

“It was a full and half day of in-person brainstorming, with the passionate contribution of 11 team members, each expressing freely and sharing their experiences with their colleagues. The time spent in presentations, working groups, and breakout sessions was very fruitful thanks to the attendees’ competence and produced some good inputs for the peer evaluation activities’ improvement and harmonization. Among others:

  • Personal characteristics and skills of a peer evaluator for effective activity, knowledge of the requirements and the process;
  • How to write a finding, how to evaluate a corrective action plan;
  • Tips from the calibration field: the importance of witnessing, correct interpretation of ILAC P10, evaluation of accreditation scopes and statements of conformity;
  • Highlights from the reference material field: need for flexibility due to the wide range of technical activities, importance of witnessing, evaluation of requirements related to subcontracting;
  • Updates from the biobanking field: first accreditations in the field, criticalities in the evaluation of the implementation of ILAC P9 and ILAC P10, scopes.”

Regular refresher training sessions are crucial for strengthening the EA MLA system, as they provide an opportunity to enhance the harmonization of evaluators’ work and perspectives on specific issues in the peer-evaluation process. Based on the outcomes, conclusions, and participant feedback, this refresher training successfully achieved its goals in Calibration, Reference Material Producers, and the new Biobanking scope.