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Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 12-10-2020
Publisher: National Standards Authority of Ireland
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.Only cited Standards give presumption of conformance to New Approach Directives/Regulations.Dates of withdrawal of national standards are available from NSAI.
ForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 General requirements5 Structural requirements6 Resource requirements7 Process requirements8 Quality management system requirementsAnnex A (normative) Documentation requirementsAnnex B (informative) Implementation guidance for Annex AAnnex C (informative) Quality management system optionsBibliography
This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.
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