Amandine Combe
Marketing and Communications Manager, EA

EA MLA for Biobanking

The European co-operation for Accreditation (EA) General Assembly decided to expand with immediate effect the EA Multilateral Agreement (MLA) for biobanking as a level 2 conformity assessment activity using EN ISO 20387 as a new level 3 normative document. 

EN ISO 20387 – Biotechnology — Biobanking — General requirements for biobanking is the international standard that establishes requirements for biological material and data quality. These requirements demonstrate an organization’s competence in proper handling, traceability, and long-term preservation of samples, including human, animal, microorganisms, plant, and fungal samples.  EN ISO 20387 is a harmonised standard due to its adoption by the European Standardisation organisations CEN-CENELEC based on a request made by the European Commission.

ISAC becomes an EA MLA Signatory in the field of Inspection

During the last meeting of the EA Multilateral Agreement Council (MAC), which manages the peer evaluation process and decides on the EA MLA signatory status of the national accreditation bodies (NABs), the MAC agreed that the Icelandic Board for Technical Accreditation (ISAC) should be accepted as an EA MLA signatory in the field of Inspection according to EN ISO/IEC 17020.

Launching of the EA MLA for EN ISO/IEC 17029:2019 and the Decision on the EA MLA Signatories for EN ISO/IEC 17029:2019

The MAC decided to launch the EA MLA for Validation and Verification bodies (EN ISO/IEC 17029) based on at least one successful transition to EN ISO/IEC 17029 (level 3) and EN ISO 14065:2020 (level 4), declared by a NAB, or at least one successful peer evaluation of a NAB against EN ISO/IEC 17029.

Commission Proposes Certification of Carbon Removals to Help Reach Net Zero Emissions

On 30 November 2022, the European Commission adopted a proposal for a Union certification framework for carbon removals. The proposal shall boost innovative carbon removal technologies and sustainable carbon farming solutions and contribute to the EU’s climate, environmental and zero-pollution goals. It shall, in particular, significantly improve the EU’s capacity to quantify, monitor, and verify carbon removals. For this purpose, the European Commission shall develop tailored certification methods for carbon removal activities delivering on climate and other environmental objectives.

Click here to read the full article.

Guidance on Remote Assessments

NABs have noted the benefits and the limitations of remote assessment techniques. EA published a general framework to provide guidance and improve harmonization among EA Members. The document includes the basic requirements, elements for the preparation and the conduct of the remote assessment, the reporting, and circumstances where remote assessment may not be appropriate.

Each NAB has the sole responsibility for designing the most appropriate assessment process, taking into account the phase of the accreditation cycle, the objective of the assessment, and the relevant risk factors, and ensuring that the same objectives and outcomes have been achieved. If the assessment is for initial accreditation, then the assessment will, under normal circumstances, have to include on-site elements.

Click here to read the document EA-2/21 G – Guidance on remote assessments.

Decisions on the Application of EA-2/17, the Mandatory Document on Accreditation for Notification Purposes

The preferred means to demonstrate the competence of a notified body is the accreditation by the NAB. To ensure that the notified bodies are accredited throughout Europe (EU, EFTA, and Turkey) in a harmonised way, EA published the document on Accreditation for Notification Purposes (EA-2/17). The application of this document is mandatory for all NABs when accrediting a conformity assessment body to become a notified body. EA-2/17 also applies to bodies performing assessment and verification of constancy of performance under the Construction Products Regulation.

The main purpose of the April 2020 revision was the definition of the so-called preferred harmonised standard(s) for the accreditation of notified bodies. That has been done for each Union harmonisation legislation and module, the specific conformity assessment procedure.

Within three years from publication, all accredited notified bodies shall comply with EA-2/17:2020. But what happens if a CAB seeking notification does not meet the requirements set out in EA-2/17: 2020 after the transition period in April 2023? Click here to read the decisions.