September 25, 2019 Book Open Access

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

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    "description": "<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&nbsp;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>\n\n<p>As a result, this handbook covers all currently accessible requirements for certification and accreditation of biobanks.</p>\n\n<p>All documents are provided in German language and contain a generic rulebook, standard operation procedures and form sheets for biobanking processes. The&nbsp;arrangements of the documents are&nbsp;geared according to ISO 20387.&nbsp;</p>\n\n<p>This version includes a new version of the handbook and&nbsp;documents about business continuity management.&nbsp;</p>\n\n<p>Currently, the related implementation handbook according to ISO 20387 is being developed.</p>", 
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