The regularly updated QM manual of the German Biobank Node (GBN), the handbook for quality management (QM) in biobanking, is available open access on the Zenodo platform (DOI: 10.5281/zenodo.3697691). It forms the common basis for the cross-location quality management system of the German Biobank Alliance (GBA).
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 (SOP’s) 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 standards, and 20387 standard “Biotechnology - Biobanking - General requirements for biobanking” published in 2018. 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. The English version of the manual has been available since May 2020.