The German Biobank Node (GBN) has published its QM manual – the manual for quality management in biobanking. It is freely available as an “open access” publication on Zenodo (DOI: 10.5281/zenodo.1420473).
During the first funding phase of GBN, a “GBN manual” was created: The QM Working Group prepared a draft based on already established SOPs (standard operating procedures) in 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. As a result, the GBN manual as a process-oriented approach covers all currently available certification and accreditation requirements for biobanks.