Quality management
Certification of biobanks according to the ISO 20387 standard, demonstrating the competence and control of biobanking activities.
The standard ISO 20387:2018 concerns Biobanks or Biological Resource Centres (BRC), as well as academic, institutional or private BRCs.
It consists of an auditor or a team of auditors experienced in Biobanks and BRCs. But also, a team experienced in ISO 9001 and/or NF S96-900 certification of BRCs and Biobanks.
Quality management system relating to any biobanking activity of human, microbial, animal, plant… origin
This framework can be combined with a ISO 9001 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.”
Nothing requires it. Furthermore, the establishment of an accreditation scheme, in addition to the need for creation by a party or a regulatory text, requires the definition of a flexible accreditation scope, the drafting of reference documents, the identification of assessors, the solicitation of Committees… All these steps take time, during which the level of appropriation of ISO 20387 by French biobanks allows them to maintain a recognized leadership through their certification by a third-party body.
Nothing prevents certification under NF S96-900, and since this standard is not cited in a regulatory text, any certification body can continue to respond to a certification request under this standard.
The decision of the national standardization body to withdraw a standard from its catalogue does not prevent its continued use (numerous examples exist in technical standards).
The market for the provision and valorization of biobanks will dictate the longer-term approach on the coexistence of ISO 20387 and NF S96-900, or even, as currently, on a more targeted international recognition focused on ISO 9001.
Even though the French standardization body cancelled the distribution of the NF S96-900 standard in summer 2023, the certificates issued by Euro Quality System remain valid.
Surveillance and renewal audits can continue to be carried out under this standard.
Although it is appropriate to consider a potential transition, EQS does not impose any mandatory switch to ISO 9001 and/or ISO 20387 and continues to offer certification under NF S96-900.
Euro Quality System (EQS) scrupulously applies the ethical and conflict-of-interest rules derived from IAF (International Accreditation Forum) MDs and COFRAC doctrines related to ISO 17021-1, including for standards such as NF S96-900 or ISO 20387 which are not part of our accreditation scopes, unlike for example ISO 9001 or ISO 14001.
As a result, it is ethically impossible for us to provide consulting and support, a fortiori jointly 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.
To date, the reference text cites NF S96-900, the annual data collection table cites NF S96-900 and ISO 9001, and both certifications are taken into account.
Active working groups have expressed good hope of eventually seeing ISO 20387 added as an eligibility criterion.
Our teams are available to provide you with information and advice.
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