Book Open Access
This quality management manual as a process-oriented approach has been authored by the German Biobank Node (GBN) in cooperation with staff members of the biobanks Heidelberg, Jena and Munich. The basis for its comprehensive document collection are internationally regognised standards like DIN EN ISO 9001:2015, 17025, 17020, 15189 and ISO 20387. In addition, the DIN CEN technical specifications for preanalytical processes have been taken into account.
As a result, this manual covers all currently accessible requirements for certification and accreditation of biobanks.
All documents are provided in English language and contain a generic rulebook, standard operation procedures and form sheets for biobanking processes. The arrangements of the documents are geared according to ISO 20387.
Currently, the related implementation handbook according to ISO 20387 is being developed.
Schmitt, Sabrina, Meinung, Bettina, Becker, Karl-Friedrich, Slotta-Huspenina, Julia, Kiehntopf, Michael, Schirmacher, Peter, … Hummel, Michael. (2018). German Biobank Node: Handbook for quality management in biobanking. Zenodo. http://doi.org/10.5281/zenodo.3403067