10.5281/zenodo.3403067
https://zenodo.org/records/3403067
oai:zenodo.org:3403067
Schmitt, Sabrina
Sabrina
Schmitt
0000-0001-9532-7441
Heidelberg University Hospital
Meinung, Bettina
Bettina
Meinung
Jena University Hospital
Becker, Karl-Friedrich
Karl-Friedrich
Becker
0000-0002-6801-4498
Technical University of Munich
Slotta-Huspenina, Julia
Julia
Slotta-Huspenina
Technical University of Munich
Kiehntopf, Michael
Michael
Kiehntopf
Jena University Hospital
Schirmacher, Peter
Peter
Schirmacher
Heidelberg University Hospital
Hartfeldt, Christiane
Christiane
Hartfeldt
0000-0002-8553-8998
Charité Universitaetsmedizin Berlin
Herpel, Esther
Esther
Herpel
0000-0002-0110-9257
Heidelberg University Hospital
Hummel, Michael
Michael
Hummel
0000-0001-6717-605X
Charité Universitaetsmedizin Berlin
German Biobank Node: Handbook for quality management in biobanking
Zenodo
2019
biobanks
biobanking
biomaterials
quality management
2019-09-25
hmj
10.5281/zenodo.1420472
https://zenodo.org/communities/gbn
Creative Commons Attribution Non Commercial No Derivatives 4.0 International
This quality management handbook 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 regognized 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 handbook covers all currently accessible requirements for certification and accreditation of biobanks.
All documents are provided in German 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.
This version includes a new version of the handbook and documents about business continuity management.
Currently, the related implementation handbook according to ISO 20387 is being developed.