ISO 20387 in France: Accreditation or certification?

The scope of ISO 20387 states that “users of biobanks, regulatory authorities, organizations and systems using peer assessment, accreditation bodies and other entities may also use this document to confirm or recognize the competence of biobanks.”

Therefore, any of these entities, in addition to the biobank internally, whether second party or third party like EQS, may use this standard and certify conformity of its implementation under its own responsibility.

In its response to Club3CR at the end of 2020, the Director General of Cofrac clearly validated that:

“A certification body may use this standard, provided it demonstrates its competence in the matter.”

For reference, extract from the Cofrac website dated 01/03/2022:

“Accreditation concerns only companies that perform control services… It is therefore aimed at testing and calibration laboratories, verification bodies, medical biology laboratories, and inspection, certification or qualification bodies.”