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German Biobank Node: Handbook for quality management in biobanking

Schmitt, Sabrina; Meinung, Bettina; Becker, Karl-Friedrich; Slotta-Huspenina, Julia; Kiehntopf, Michael; Schirmacher, Peter; 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. 

Currently, the related implementation handbook is being developed.

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04.b_GBN_QMH_Datengeheimnis.docx
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05.d_GBN_QMH_Verpflichtung_der_Leitung.docx
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05.e_GBN_VA_Nutzer-_und_Anforderungsmanagement.docx
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05.f_GBN_FB_Kontext.docx
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05.g_GBN_FB_Scope_Gewebebank.docx
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06.2a_GBN_FB_Kompetenz-_und_Verantwortungsmatrix.docx
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06.2b_GBN_FB_Funktionsbeschreibung.docx
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06.2c_GBN_FB_Mitarbeitermatrix.docx
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06.2d_GBN_FB_Besprechungsmatrix.docx
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06.2e_GBN_FB_Jahresschulungsplan.doc
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06.2f_GBN_VA_Kompetenzbewertung_Schulung.docx
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06.3a_GBN_VA_Prozess-_und_Prüfmittel.docx
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06.3b_GBN_FB_Prozessmatrix.docx
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06.3c_GBN_FB_Prozessmittelmatrix.docx
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06.3d_GBN_FB_Prüfmittelmatrix.docx
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06.3e_GBN_FB_Gerätebuch_Prozessmittel.docx
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06.3f_GBN_FB_Gerätebuch_Prüfmittel.docx
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06.4a_GBN_VA_externe_Dienstleistungen.docx
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06.4b_GBN_FB_Lieferantenbewertung.doc
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07.01a_GBN_VA_Neue Verfahren.docx
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07.02a_GBN_Hinweise_Primärprobennnahme _Blut.docx
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07.02b_GBN_Hinweise_Probennahme_Gewebe.docx
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07.03a_GBN_VA_Probeneingang_Blut.docx
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07.04a_GBN_VA_Probenanfrage.docx
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07.04b_GBN_VA_Probenversand.docx
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07.05a_GBN_VA_Probenvernichtung.docx
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07.06a_GBN_VA_Probenverarbeitung_Blut.docx
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07.07a_GBN_VA_Probeneinlagerung_Blut.docx
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07.07b_GBN_VA_Probeneinlagerung_Gewebe.docx
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07.08a_GBN_VA_Qualitätssicherung_Biobankprozesse.docx
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07.09a_GBN_FB_Validierungsplan.docx
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07.10a_GBN_FB_Checkliste_Datenintegrität.docx
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07.10b_GBN_FB_Datensicherungsplan.docx
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07.11a_GBN_VA_Fehlermanagement.docx
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07.13a_GBN_VA_Beschwerdemanagement.docx
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08.2b_GBN_Begriffe_und_Abkürzungen.docx
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08.2c_GBN_FB_Dokumentenverzeichnis.docx
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08.5b_GBN_FB_Chancen und Risikoanalyse.docx
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08.5c_GBN_FB_FMEA.xls
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08.8a_GBN_FB_Auditplanung_ZPM.xlsx
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08.8b_GBN_FB_Prozessaudit.docx
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08.8c_GBN_FB_Auditorenliste.docx
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08.9a_GBN_FB_Management_Review.docx
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