The German Biobank Node has updated its manual on quality management (QM) in biobanking. It has been published on the Zenodo platform as an open access document (in German, DOI: 10.5281/zenodo.1420473).
Revised rulebook, biosample certificate template added
The “rulebook” contained in the manual has been completely revised and elaborated in accordance with the ISO 20387 standard on “Biotechnology – Biobanking – General requirements for biobanking” published in 2018. The rulebook is essentially a superordinate document offering an overview of the manual’s contents. The manual now also contains a template for a certificate that biobanks can issue when samples are provided.
Manual available since 2018
GBN first published the QM manual in October 2018. Work on the manual had already started during the initial GBN funding phase: the QM working group drafted a document based on the standard operating procedures (SOPs) already in place at biobanks. Employees at the GBA sites in Heidelberg, Jena, and Munich subsequently finalised the document in accordance with the DIN EN ISO 9001:2015, 17025, 17020, 15189, and 20387 standards. The DIN/CEN technical specifications for pre-analytical processes were also taken into account. The manual takes a process-oriented approach, detailing all of the certification and accreditation requirements that biobanks must currently meet.