For a network of biobanks operating all over Germany, it is of utmost importance to implement a joint quality management system across all locations. Therefore, common documents were drafted during the first funding phase of GBN: The QM Working Group prepared a draft during several workshops based on already established SOPs (standard operating procedures) in the biobanks. Based on the standards documents DIN EN ISO 9001:2015, 17025, 17020, 15189, and the 2018 published document 20387 “Biotechnology – Biobanking – General requirements for biobanking” employees from biobanks in Heidelberg, Jena and Munich finalised this draft version subsequently. DIN/CEN technical specifications for pre-analytical processes were taken into account during this process. The GBN Manual is based on a process-oriented approach and covers all currently available certification and accreditation requirements for biobanks.
The QM manual is freely available “open access” on Zenodo.