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May 25, 2018
SBP, Switzerland, publication

ISO for Biobanks: Final step!

Swiss Biobanking Platform participates as the Swiss delegated body for the International Standard for biobanking (ISO 20387 – Biotechnology – Biobanking – General requirements for biobanking). Following the comment phase of July 2017, the standard proceeds now to the final step: the balloting process phase.

SBP encourages Swiss stakeholders to give opinion on the publication of this final draft. In case of interest, please contact Sofiane Nacia, SBP Quality Officer: sofiane.nacia@swissbiobanking.ch. Your votes need to be submitted by June 11th 2018. SBP will then take position according to the Swiss decision.

Background:

The project was started by screening all relevant Standards and Guidelines (e.g., ISO 15189, ISO/IEC 17020, ISO/ IEC 17025, ISO 9001, OECD, WHO), summing up the similarities and adding the necessary requirements for biobanking, which have been missing so far. ISO 20387 will set horizontal requirements for a biobank‘s infrastructure, personnel competence, quality management system, equipment, quality control, and the procedures for sample handling, processing and storage, including the validation and verification of methods. It will also be developed with the objectives of providing a reference framework and an universal language for suppliers and customers, facilitating trade and technology transfer by eliminating trade barriers by, e.g., considering relevant legislation (Nagoya Protocol, etc.), and enabling the successful implementation of trade agreements. Furthermore, ISO 20387 will enable a biobank‘s competence assessment and accreditation leading to stakeholder confidence and assurance, as well as the organization’s competitive positioning.

Dipl.-Ing. Lena Krieger
Project Manager
Secretary of ISO/TC 276

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