Overview
ISO/TR 22758:2020 - "Biotechnology - Biobanking - Implementation guide for ISO 20387" is a technical report that helps biobanks implement the requirements of ISO 20387. It is a non-prescriptive supplement intended to be used alongside ISO 20387:2018. The report clarifies concepts, expands on selected clauses, and provides illustrative examples to assist biobanks in achieving appropriate quality management, technical practices, and personnel competency for the handling of biological material and associated data.
Key topics and requirements
ISO/TR 22758:2020 focuses on interpretation and practical guidance rather than new requirements. Important topics covered include:
- Fitness for the Intended Purpose (FIP): guidance on defining, assessing and documenting how biological material and associated data meet pre‑arranged research or R&D needs.
- Process landscape: mapping biobanking workflows and linking them to ISO 20387 process requirements.
- Conformity and accreditation: considerations for scope of conformity and conformity assessment practices relevant to biobanks.
- Resource, structural and process requirements: interpretative guidance for ISO 20387 clauses on personnel competency, facilities, equipment, storage, and biospecimen management.
- Quality management system (QMS): practical advice on implementing ISO 20387 QMS elements such as document control, nonconformance handling and continual improvement.
- Confidentiality and impartiality: guidance on maintaining data protection and objective operations within a biobank context.
Practical applications
ISO/TR 22758:2020 is intended to make ISO 20387 more actionable by providing examples and clarification. Typical uses include:
- Implementing an ISO 20387-compliant biobank quality management system.
- Defining and documenting biospecimen fitness criteria for research and development.
- Training and assessing personnel competency for sample handling, data curation and storage.
- Preparing for conformity assessment or accreditation to ISO 20387 by mapping processes and evidence.
- Supporting newly established biobanks as well as upgrading procedures in existing facilities.
Who would use this standard
- Biobank managers and quality managers
- Laboratory and repository staff responsible for biospecimen receipt, processing, storage and distribution
- Institutional administrators planning biobank governance and compliance
- Accreditation bodies and auditors assessing conformity with ISO 20387
- Researchers and project leads requiring assurance of biological material quality and data integrity
Related standards
- ISO 20387:2018 - Biobanking - General requirements for biobanking (primary normative standard this TR supports)
ISO/TR 22758:2020 is a practical companion for implementing biobanking standards, improving biospecimen quality, and aligning biobank operations with international best practices.
