Quality approach

The BRC was certified according to the French standard NF S96/900 in 2014 (certificate no. 2014/65580.3) for the reception, storage, conservation and availability for scientific purposes of frozen tissue samples from the human body, associated with clinical, biological and anatomopathological annotations. The scope of certification was extended for the Saint Antoine Biobank at the end of 2017.

This standard defines the rules for the quality management system of BRCs, completing the ISO 9001 standard. The NF S96-900 standard is based on the following requirements. First, the scientific rigor guarantees the origin and the quality of biological resources. The biobank infrastructure supplies expertise on the pre-analytical process and the sample storage supervised by the highly skilled BRC’s staff. Secondly, the ethical requirement takes account of the existing legislative framework and guarantees the samples and data associated protection and security. Finally, the economic regulation drives precise rules for access to collections.

A QMS is established in the BRC to coordinate the organization’s activities, which are “Management”, “Realisation” and “Support”.