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German Biobank Node: Handbook for quality management in biobanking

Name: German Biobank Node: Handbook for quality management in biobanking
Keywords: biobanking, biosample, biobanks, biospecimen, sample, biomaterials, quality management

descriptionPublicationkeyboard_double_arrow_right Book , Other literature type 19 Oct 2018 hmj Publisher:Zenodo

Authors: Schmitt, Sabrina; Meinung, Bettina; Becker, Karl-Friedrich; Slotta-Huspenina, Julia; Kiehntopf, Michael; Schirmacher, Peter; Hartfeldt, Christiane; +2 Authors

doi: 10.5281/zenodo.2649142 , 10.5281/zenodo.4882752 , 10.5281/zenodo.3775056 , 10.5281/zenodo.3403067 , 10.5281/zenodo.1420473 , 10.5281/zenodo.3907371 , 10.5281/zenodo.1420472

German Biobank Node: Handbook for quality management in biobanking

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Abstract

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. The new version includes also the rulebook and a form sheet for a material certificate. Currently, the related implementation handbook according to ISO 20387 is being developed.

Related Organizations

Technical University of Munich
Germany
Charité - University Medicine Berlin
Germany
Jena University Hospital
Germany
University Hospital Heidelberg
Germany

Keywords

biobanking, biosample, biobanks, biospecimen, sample, biomaterials, quality management

3 Research products, page 1 of 1

German Biobank Node: Manual for Quality Management in Biobanking - English Version
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	citations This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).	2
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