Schmitt, Sabrina
Meinung, Bettina
Becker, Karl-Friedrich
Slotta-Huspenina, Julia
Kiehntopf, Michael
Schirmacher, Peter
Hartfeldt, Christiane
Herpel, Esther
Hummel, Michael
2021-05-31
<p>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.</p>
<p>As a result, this handbook covers all currently accessible requirements for certification and accreditation of biobanks.</p>
<p>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.</p>
https://doi.org/10.5281/zenodo.4882752
oai:zenodo.org:4882752
hmj
Zenodo
https://zenodo.org/communities/gbn
https://doi.org/10.5281/zenodo.1420472
info:eu-repo/semantics/openAccess
Creative Commons Attribution Non Commercial No Derivatives 4.0 International
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biobanks
biobanking
biospecimen
quality management
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German Biobank Node: Handbook for quality management in biobanking
info:eu-repo/semantics/book