Quality Management

The quality of biomaterials is of paramount importance for the success of biomedical research.

Under the umbrella of GBN, we are developing standards and solutions for the next generation of biobanking.

QMS Manual

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.

Questions?

germanbiobanknode@charite.de

Tel. +49. 30. 450 536 347


Fax +49. 30. 450 753 69 38

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