Book Open Access

German Biobank Node: Handbook for quality management in biobanking

Schmitt, Sabrina; Meinung, Bettina; Becker, Karl-Friedrich; Slotta-Huspenina, Julia; Kiehntopf, Michael; Schirmacher, Peter; Hartfeldt, Christiane; Herpel, Esther; Hummel, Michael

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.

 

Files (27.5 MB)
Name Size
HandbookForQualityManagement_6thVersion.zip
md5:cea972b3db1c9a6a9a49b6ac3378f703
27.5 MB Download
3,925
7,176
views
downloads
All versions This version
Views 3,925117
Downloads 7,17648
Data volume 9.6 GB1.3 GB
Unique views 3,184108
Unique downloads 1,88644

Share

Cite as