The QM manual of the German Biobank Node (GBN), the manual for quality management (QM) in biobanking, is now also available in an English language version. It is accessible Open Access on the Zenodo platform. For this first version of the translation, the most important documents of the German manual were translated into English. The remaining documents will follow soon.
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.
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