ISO20387 Implementation workbook
Authors/Creators
-
De Wilde, Annemieke
(Project manager)
-
Debucquoy, Annelies
(Project member)1, 2
- De Schuyteneer, Amber (Project member)3
-
Devriendt, Céline
(Project member)3
-
Eeckhout, Delphine
(Project member)4
-
Guns, Johan
(Project member)5, 3
- Linsen, Loes (Project member)6, 7
-
Merhi, Ahmad
(Project member)8
-
moons, pieter
(Project member)9, 10
- Van Wichelen, Greet (Project member)3
-
Huizing, Manon
(Project member)10
- Emmerechts, Katia (Project member)1
-
Smits, Elke
(Project member)9, 11
- 1. Belgian Cancer Registry
-
2.
KU Leuven
- 3. Brussels Biobank
-
4.
Ghent University Hospital
- 5. Vrije Universiteit Brussel
-
6.
Katholieke Universiteit Leuven
- 7. UZLeuven Biobank
-
8.
Institute of Pathology and Genetics
- 9. University of Antwerp
- 10. Biobank Antwerp
-
11.
Antwerp University Hospital
Description
This document was developed by the Belgian node of Biobanking and BioMolecular Research Infrastructure (BBMRI.be) to support the implementation of ISO20387:2018 - General requirements for Biobanking in Belgian biobanks. This document is inspired by German Biobank Node Quality Manual, Polish Biobank Quality Manual and Swiss Biobank Platform Quality Manual.
This document is intended to be used internally for the biobank to guide them towards ISO20378:2018 accreditation. Additionally, the biobank can choose to use this document as an internal reference document to describe all aspects of its quality management system (QMS) and can use it as documentation for auditors, customers and external collaborators. When fully completed, this document provides a framework for the qualification of the biobank’s QMS requirements according to ISO20387:2018 - General requirements for Biobanking.
It is up to the biobank to decide how to use this document, ranging from a source of information to help them evaluate their existing documentation; to the basis of a newly established QMS; trough anything in between, in the way that best suits its needs.
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Additional details
Related works
- Cites
- Book: 10.1007/978-3-031-12559-1 (DOI)
- Book: https://swissbiobanking.ch/documents/ (Other)
- Book: 10.5281/zenodo.4882752 (DOI)
- Book: 10.1089/bio.2023.0140 (DOI)
- Other: https://www.iso.org/standard/67888.html (Other)
Funding
- Belgian Federal Science Policy Office
- ESFRI-FED - B3-ISO High quality BioBanking in Belgium