BS ISO 20387:2018,Biotechnology – Biobanking – General requirements for biobanking.BS ISO 20387:2018 pdf free download here.
BS ISO 20387:2018 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.
BS ISO 20387:2018 is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development.
Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.
BS ISO 20387:2018 does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
This document has been developed with the objective of promoting confidence in biobanking. It contains requirements to enable biobanks to demonstrate competent biobank operation and the ability to provide biological material and associated data of appropriate quality for research and development.
This is intended to be achieved by the planning and implementation of policies, processes and procedures covering the life cycle of biological materials and their associated data. The use of this document facilitates cooperation, fosters exchange, and assists in the harmonization of practices among biobanks, researchers and other parties.
In this document, the following verbal forms are used:
—“shall” indicates a requirement;
—“should” indicates a recommendation:
—“may” indicates a permission;
—“can” indicates a possibility or a capability.
Further details can be found in the ISO/IEC Directives, Part 2
The biobank shall have procedures addressing biobanking of each type of biological material and associated data held. This includes processes such as collecting/procuring and/or acquiring and receiving, tagging, accessioning/logging, cataloguing/classifying, examining, preparing, preserving, storing, managing data, destroying, packaging as well as safeguarding, distributing and transporting. The biobank shall have procedures to ensure compliance with relevant biosecurity and biosafety requirements. The procedures shall also address risks and opportunities using a risk assessment.
The documentation shall include relevant information generated from procedures pertaining to the quality management system (see Clause 8) as well as the management of facilities/dedicated areas.
