Incluye referencias bibliográficas. CONTENIDO: Scope -- Normative references -- Terms and definitions -- General requirements -- Structural requirements -- Resource requirements -- Process requirements -- Quality management system requirements -- Annex A (normative) Documentation requirements -- Annex B (informative) Implementation guidance for Annex A -- Annex C (informative) Quality management system options.
Forma Variante de Título: Biotechnologie - "Biobanking" - Exigences générales relatives au "biobanking". Título Alterno: International standard ISO 20387.
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.