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

MARC21 XML Export

<?xml version='1.0' encoding='UTF-8'?>
<record xmlns="http://www.loc.gov/MARC21/slim">
  <leader>00000nam##2200000uu#4500</leader>
  <datafield tag="041" ind1=" " ind2=" ">
    <subfield code="a">hmj</subfield>
  </datafield>
  <datafield tag="653" ind1=" " ind2=" ">
    <subfield code="a">biobanks</subfield>
  </datafield>
  <datafield tag="653" ind1=" " ind2=" ">
    <subfield code="a">biobanking</subfield>
  </datafield>
  <datafield tag="653" ind1=" " ind2=" ">
    <subfield code="a">biomaterials</subfield>
  </datafield>
  <datafield tag="653" ind1=" " ind2=" ">
    <subfield code="a">quality management</subfield>
  </datafield>
  <controlfield tag="005">20220502140036.0</controlfield>
  <controlfield tag="001">3403067</controlfield>
  <datafield tag="700" ind1=" " ind2=" ">
    <subfield code="u">Jena University Hospital</subfield>
    <subfield code="a">Meinung, Bettina</subfield>
  </datafield>
  <datafield tag="700" ind1=" " ind2=" ">
    <subfield code="u">Technical University of Munich</subfield>
    <subfield code="0">(orcid)0000-0002-6801-4498</subfield>
    <subfield code="a">Becker, Karl-Friedrich</subfield>
  </datafield>
  <datafield tag="700" ind1=" " ind2=" ">
    <subfield code="u">Technical University of Munich</subfield>
    <subfield code="a">Slotta-Huspenina, Julia</subfield>
  </datafield>
  <datafield tag="700" ind1=" " ind2=" ">
    <subfield code="u">Jena University Hospital</subfield>
    <subfield code="a">Kiehntopf, Michael</subfield>
  </datafield>
  <datafield tag="700" ind1=" " ind2=" ">
    <subfield code="u">Heidelberg University Hospital</subfield>
    <subfield code="a">Schirmacher, Peter</subfield>
  </datafield>
  <datafield tag="700" ind1=" " ind2=" ">
    <subfield code="u">Charité Universitaetsmedizin Berlin</subfield>
    <subfield code="0">(orcid)0000-0002-8553-8998</subfield>
    <subfield code="a">Hartfeldt, Christiane</subfield>
  </datafield>
  <datafield tag="700" ind1=" " ind2=" ">
    <subfield code="u">Heidelberg University Hospital</subfield>
    <subfield code="0">(orcid)0000-0002-0110-9257</subfield>
    <subfield code="a">Herpel, Esther</subfield>
  </datafield>
  <datafield tag="700" ind1=" " ind2=" ">
    <subfield code="u">Charité Universitaetsmedizin Berlin</subfield>
    <subfield code="0">(orcid)0000-0001-6717-605X</subfield>
    <subfield code="a">Hummel, Michael</subfield>
  </datafield>
  <datafield tag="856" ind1="4" ind2=" ">
    <subfield code="s">11516442</subfield>
    <subfield code="z">md5:8412be1d657c7b41c33f8d55c1ee75de</subfield>
    <subfield code="u">https://zenodo.org/record/3403067/files/HandbookForQualityManagement_3thVersion.zip</subfield>
  </datafield>
  <datafield tag="542" ind1=" " ind2=" ">
    <subfield code="l">open</subfield>
  </datafield>
  <datafield tag="260" ind1=" " ind2=" ">
    <subfield code="c">2019-09-25</subfield>
  </datafield>
  <datafield tag="909" ind1="C" ind2="O">
    <subfield code="p">openaire</subfield>
    <subfield code="p">user-gbn</subfield>
    <subfield code="o">oai:zenodo.org:3403067</subfield>
  </datafield>
  <datafield tag="100" ind1=" " ind2=" ">
    <subfield code="u">Heidelberg University Hospital</subfield>
    <subfield code="0">(orcid)0000-0001-9532-7441</subfield>
    <subfield code="a">Schmitt, Sabrina</subfield>
  </datafield>
  <datafield tag="245" ind1=" " ind2=" ">
    <subfield code="a">German Biobank Node: Handbook for quality management in biobanking</subfield>
  </datafield>
  <datafield tag="980" ind1=" " ind2=" ">
    <subfield code="a">user-gbn</subfield>
  </datafield>
  <datafield tag="540" ind1=" " ind2=" ">
    <subfield code="u">https://creativecommons.org/licenses/by-nc-nd/4.0/legalcode</subfield>
    <subfield code="a">Creative Commons Attribution Non Commercial No Derivatives 4.0 International</subfield>
  </datafield>
  <datafield tag="650" ind1="1" ind2="7">
    <subfield code="a">cc-by</subfield>
    <subfield code="2">opendefinition.org</subfield>
  </datafield>
  <datafield tag="520" ind1=" " ind2=" ">
    <subfield code="a">&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;</subfield>
  </datafield>
  <datafield tag="773" ind1=" " ind2=" ">
    <subfield code="n">doi</subfield>
    <subfield code="i">isVersionOf</subfield>
    <subfield code="a">10.5281/zenodo.1420472</subfield>
  </datafield>
  <datafield tag="024" ind1=" " ind2=" ">
    <subfield code="a">10.5281/zenodo.3403067</subfield>
    <subfield code="2">doi</subfield>
  </datafield>
  <datafield tag="980" ind1=" " ind2=" ">
    <subfield code="a">publication</subfield>
    <subfield code="b">book</subfield>
  </datafield>
</record>