EA Members participated in the EA September Technical Committees meetings. Here is a summary of what was discussed and decided.

Horizontal Harmonization Committee (HHC)

HHC Members met on the 13^th and 14^th of September in Paris Roissy, France.

The HHC organized a workshop on EA-1/22: EA Procedure and Criteria for the Evaluation of Conformity Assessment Schemes by EA Accreditation Body Members. On the agenda: the opportunities and obstacles of the EA 1/22 approaches toward scheme evaluation, the potential needed clarification within EA 1/22 regarding responsibilities, and which changes could increase the efficiency of the scheme evaluation procedure.

EA-1/22 is the mandatory document that shall ensure the procedure and criteria to be used by EA National Accreditation Bodies when evaluating a defined conformity assessment scheme are followed.

The revised draft of document EA-2/15 EA requirements for the accreditation of flexible scopes was approved by the HHC and will go for EA ballot. EA-2/15 sets out requirements that shall enable accredited Conformity Assessment Bodies (CABs) to assume responsibility for the management of all or part of its scope of accreditation without the necessity of a preliminary evaluation by the NAB for each new activity.

The HHC will organize a workshop on virtual organizations/sites at the HHC March 2024 meeting. Over the years, EA Members have faced more and more cases where a CAB is working in a virtual environment (clouds, databases, video-conferencing tools, etc.). Sometimes, it leads to a situation where the CAB doesn’t need a specific location or even no physical location at all anymore. They are virtual sites or virtual organizations, and it opens a lot of questions about whether to accept this and/or how to assess it.

 

 

Laboratory Committee (LC)

Laboratory Committee Members met on the 6^th and 7th of September 2023 in Brussels, Belgium.

Belén Villamiel (ENAC, Spain) was elected as the new LC Vice-Chair for two years (2023-2024, aligned with the term of office of the LC Chair)

The LC organized a workshop on Flexible Scopes for PT Providers on the 6^th of September with the support of EEE-PT¹ WG to discuss examples that highlight difficulties met by the NABs in the flexible scope approach for Proficiency Testing Providers.

Two documents are under revision: EA-4/21 INF Guidelines for the assessment of the appropriateness of small interlaboratory comparisons within the process of laboratory accreditation and EA-4/20 G Guidance for the assessment of laboratories against EN ISO 15189 and EN ISO 22870 Point-of-Care.

Several LC Members delivered presentations on:

• What has been changed in the revised EN ISO 15189, and what is expected from laboratory operators?

The standard ISO 15189 Medical laboratories — Requirements for quality and competence is world widely accepted in the field of medical laboratories/medical examinations. After ten years of use, ISO 15189 has been updated again with technical revisions. The new standard contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities for improvement, and impartiality and confidentiality requirements are more aligned with ISO/IEC 17025.

Besides applying to medical laboratories, ISO 15189 is also applicable to users, regulatory authorities, and accreditation bodies confirming or recognizing the competence of medical laboratories.

Benefits include increasing the effectiveness of the management system, decreasing the probability of generating invalid results and reducing potential harm to patients, laboratory personnel, the public, and the environment. Requirements in ISO 22870:2016 for point-of-care testing (POCT) have been incorporated as a new inclusion in the standard’s scope. A 3-year transition period will lead to a withdrawal of ISO 15189:2012 and ISO 22870:2016. While the transition period for implementing the new ISO 15189:2022 is set for the 5th of December 2025, laboratory operators are encouraged to start with the internal transition process.

 

• Digital Calibration Certificates

Regular calibration certificates might not be used much in the future. Instead, we should see Conformity Assessment Bodies start using digital calibration certificates (DCC), which are electronic documents. This change can help with manufacturing and quality control, especially when everything else in the organisations becomes more digital. The goal is to create common formats for sharing information in the measurement industry.

eAttestation, by combining the DCC with digital accreditation, could strengthen confidence for market participants in accreditation and thus in quality and safety and fasten the verification of integrity and authenticity for machines or by a single click.

 

Certification Committee (CC)

Certification Committee Members met on the 22^nd and 23^rd of  September 2023 in Brussels, Belgium.

The CC conducted a workshop on the impartiality of certification bodies in their overall internal activities. The next workshop is planned for the 20^th of March 2024 to consider the divergences between ISO/IEC 17029 – Conformity assessment — General principles and requirements for validation and verification bodies and other standards, including ISO/IEC 17020 – Conformity assessment — Requirements for the operation of various types of bodies performing inspection.

 

CC Members discussed several questions & answers (the initial competence and periodic performance evaluation of an auditor on-site according to ISO/IEC 17021-1, for instance) that will be later published on the CC FAQ page on the EA website.

The outcome of a CC survey on the revision of ISO/IEC 17065 – Conformity assessment — Requirements for bodies certifying products, processes, and services carried out in summer 2023 has been put forward to the IAF WG Products as an EA input. EA Members largely supported a revision of ISO/IEC 17065 and added comments regarding several points to be discussed during a revision. The survey was conducted upon request by the IAF Technical Committee WG 17065 to prepare a potential discussion within IAF in case of the likely revision (which is not yet approved by ISO CASCO).

Naturally, the collated replies to this survey will not precede or pre-empt the discussions and normative consensus to be found at the future ISO CASCO working group level. The launch of the ISO survey about the revision of ISO/IEC 17065 is due to start this year.

 

Inspection Committee (IC)

Inspection Committee Members met on 21-22 September in Brussels, Belgium.

The European Commission asked SERMI² to create a scheme to deal with the standardized access to vehicle on-board diagnostics information and repair and maintenance information (RMI) and the requirements and procedures for access to vehicle security information.

The Inspection Committee set up a Task Force Group EA/SERMI to deal with implementation and assessment issues, with Javier Barroso (ENAC, Spain) as convenor.

The SERMI scheme use is mandated by the Delegated Regulation (EU) N° 2021/1244 amending Regulation (EU) N° 2018/858.

IC Members attended a workshop on scoping, including flexibility, location, and IT technology assessment during the 2^nd day of the IC meeting. Scoping is a methodology for describing the competence of inspection bodies in scopes of accreditation issued by accreditation bodies.

 

¹ EA, Eurolab and Eurachem (EEE) Proficiency Testing (PT)

² Security-Related Vehicle Repair and Maintenance Information Scheme