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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  <identifier identifierType="DOI">10.5281/zenodo.3403067</identifier>
  <creators>
    <creator>
      <creatorName>Schmitt, Sabrina</creatorName>
      <givenName>Sabrina</givenName>
      <familyName>Schmitt</familyName>
      <nameIdentifier nameIdentifierScheme="ORCID" schemeURI="http://orcid.org/">0000-0001-9532-7441</nameIdentifier>
      <affiliation>Heidelberg University Hospital</affiliation>
    </creator>
    <creator>
      <creatorName>Meinung, Bettina</creatorName>
      <givenName>Bettina</givenName>
      <familyName>Meinung</familyName>
      <affiliation>Jena University Hospital</affiliation>
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    <creator>
      <creatorName>Becker, Karl-Friedrich</creatorName>
      <givenName>Karl-Friedrich</givenName>
      <familyName>Becker</familyName>
      <nameIdentifier nameIdentifierScheme="ORCID" schemeURI="http://orcid.org/">0000-0002-6801-4498</nameIdentifier>
      <affiliation>Technical University of Munich</affiliation>
    </creator>
    <creator>
      <creatorName>Slotta-Huspenina, Julia</creatorName>
      <givenName>Julia</givenName>
      <familyName>Slotta-Huspenina</familyName>
      <affiliation>Technical University of Munich</affiliation>
    </creator>
    <creator>
      <creatorName>Kiehntopf, Michael</creatorName>
      <givenName>Michael</givenName>
      <familyName>Kiehntopf</familyName>
      <affiliation>Jena University Hospital</affiliation>
    </creator>
    <creator>
      <creatorName>Schirmacher, Peter</creatorName>
      <givenName>Peter</givenName>
      <familyName>Schirmacher</familyName>
      <affiliation>Heidelberg University Hospital</affiliation>
    </creator>
    <creator>
      <creatorName>Hartfeldt, Christiane</creatorName>
      <givenName>Christiane</givenName>
      <familyName>Hartfeldt</familyName>
      <nameIdentifier nameIdentifierScheme="ORCID" schemeURI="http://orcid.org/">0000-0002-8553-8998</nameIdentifier>
      <affiliation>Charité Universitaetsmedizin Berlin</affiliation>
    </creator>
    <creator>
      <creatorName>Herpel, Esther</creatorName>
      <givenName>Esther</givenName>
      <familyName>Herpel</familyName>
      <nameIdentifier nameIdentifierScheme="ORCID" schemeURI="http://orcid.org/">0000-0002-0110-9257</nameIdentifier>
      <affiliation>Heidelberg University Hospital</affiliation>
    </creator>
    <creator>
      <creatorName>Hummel, Michael</creatorName>
      <givenName>Michael</givenName>
      <familyName>Hummel</familyName>
      <nameIdentifier nameIdentifierScheme="ORCID" schemeURI="http://orcid.org/">0000-0001-6717-605X</nameIdentifier>
      <affiliation>Charité Universitaetsmedizin Berlin</affiliation>
    </creator>
  </creators>
  <titles>
    <title>German Biobank Node: Handbook for quality management in biobanking</title>
  </titles>
  <publisher>Zenodo</publisher>
  <publicationYear>2019</publicationYear>
  <subjects>
    <subject>biobanks</subject>
    <subject>biobanking</subject>
    <subject>biomaterials</subject>
    <subject>quality management</subject>
  </subjects>
  <dates>
    <date dateType="Issued">2019-09-25</date>
  </dates>
  <resourceType resourceTypeGeneral="Book"/>
  <alternateIdentifiers>
    <alternateIdentifier alternateIdentifierType="url">https://zenodo.org/record/3403067</alternateIdentifier>
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  <relatedIdentifiers>
    <relatedIdentifier relatedIdentifierType="DOI" relationType="IsVersionOf">10.5281/zenodo.1420472</relatedIdentifier>
    <relatedIdentifier relatedIdentifierType="URL" relationType="IsPartOf">https://zenodo.org/communities/gbn</relatedIdentifier>
  </relatedIdentifiers>
  <rightsList>
    <rights rightsURI="https://creativecommons.org/licenses/by-nc-nd/4.0/legalcode">Creative Commons Attribution Non Commercial No Derivatives 4.0 International</rights>
    <rights rightsURI="info:eu-repo/semantics/openAccess">Open Access</rights>
  </rightsList>
  <descriptions>
    <description descriptionType="Abstract">&lt;p&gt;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&amp;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.&lt;/p&gt;

&lt;p&gt;As a result, this handbook covers all currently accessible requirements for certification and accreditation of biobanks.&lt;/p&gt;

&lt;p&gt;All documents are provided in German language and contain a generic rulebook, standard operation procedures and form sheets for biobanking processes. The&amp;nbsp;arrangements of the documents are&amp;nbsp;geared according to ISO 20387.&amp;nbsp;&lt;/p&gt;

&lt;p&gt;This version includes a new version of the handbook and&amp;nbsp;documents about business continuity management.&amp;nbsp;&lt;/p&gt;

&lt;p&gt;Currently, the related implementation handbook according to ISO 20387 is being developed.&lt;/p&gt;</description>
  </descriptions>
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