ISO 20387

The scope of ISO 20387 states that "users of biobanks, regulatory authorities, organizations and systems using peer evaluation, 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 in-house biobank, whether it is a second or third party such as EQS, can use this standard and certify, under its own responsibility, the conformity of the implementation.

In his response to Club3CR at the end of 2020, the Director General of Cofrac clearly validated that: "a certification body can use this standard, it is up to them to demonstrate their competence in the matter."

For reference, an excerpt from the Cofrac website dated March 1, 2022 (FR version)states: "Accreditation concerns only companies that carry out testing services, ... It is therefore aimed at testing and calibration laboratories, verification bodies, medical biology laboratories and inspection, certification or qualification bodies."

Nothing requires this – Additionally, the implementation of an accreditation scheme, besides being requested by a party or regulatory text, requires the definition of a flexible scope of accreditation, the drafting of reference documents, the identification of evaluators, the solicitation of Committees, etc.; All these steps take time, during which the level of adoption of ISO 20387 by French CRBs allows them to maintain recognized leadership through their certification by a third-party organization. Thus, currently issued certificates would not be automatically canceled if an ISO 20387 accreditation program were launched.

Nothing prevents certification according to NF S96-900, and since this standard is not cited in any regulatory text, any certification body can continue to respond to a request for certification to this standard. The decision of the national standardization body to remove a standard from its catalog does not prevent its continued use (numerous examples exist in technical standards).
The market for the provision and valorization of CRBs will dictate the longer-term approach to the coexistence of ISO 20387 and NF S96-900, or even, as currently, to a more targeted international recognition on ISO 9001.

Even though the French standardization organization canceled the dissemination of the NF S96-900 standard in the summer of 2023, the certificates issued by Euro-Quality System remain valid. Surveillance and potential renewal audits can still be conducted according to this standard.

While it is advisable to consider a potential transition, EQS does not mandate any mandatory switch to ISO 9001 and/or ISO 20387. We continue to offer certification based on the NF S96-900 standard.

Euro-Quality Système (EQS) scrupulously applies the ethical rules and conflict of interest rules resulting from the MDs of the IAF (International Accreditation Forum) and the COFRAC doctrines linked to ISO 17021-1, including for standards such as NF S96-900 or ISO 20387, which are not part of our scope of accreditation such as ISO 9001 or ISO 14001.

As a result, it is ethically impossible for us to provide advice and support, especially in conjunction with a certification audit. We can only carry out pre-audits and/or mock audits under conditions defined by the doctrines and only before the initial audit of a standard.

Currently, the reference text mentions NF S96-900, and both NF S96-900 and ISO 9001 are considered in the annual data collection table.

Active working groups have expressed good hopes for ISO 20387 to be added as an eligibility criterion in the future.