Overview
EN ISO 20387:2020 / ISO 20387:2018 - Biotechnology - Biobanking - General requirements for biobanking defines general requirements for the competence, impartiality and consistent operation of biobanks. The standard establishes quality control and management expectations to ensure biological material and associated data collections are fit for research and development. It applies to biobanking of material from multicellular organisms (human, animal, plant, fungus) and microorganisms, and is intended for any organization performing biobanking activities.
Key topics and requirements
EN ISO 20387:2020 covers technical and management topics essential for reliable biobanking:
- General requirements for impartiality, confidentiality and consistent operation
- Structural and resource requirements: governance, personnel competence, facilities, equipment, and externally provided services
- Process requirements across the sample lifecycle:
- Collection, reception, transport, preparation, preservation and storage of biological material
- Traceability and unique identification of samples and associated data
- Quality control (of material, processes and data) and management of nonconforming outputs
- Validation and verification of methods, and reporting requirements
- Information and data management: documentation, data integrity and controlled access
- Quality management system (QMS) provisions, including documented information requirements and two QMS options (referenced in Clause 8)
- Annexes with documentation requirements and implementation guidance
Keywords: biobanking standard, sample traceability, quality control, data integrity, sample storage, ISO 20387.
Practical applications
EN ISO 20387:2020 is used to:
- Establish or harmonize biobank processes to improve sample quality and reproducibility of research
- Support accreditation, peer assessment and recognition of biobank competence
- Implement robust sample traceability and data governance for research collaboration and sample sharing
- Reduce risk of nonconforming or degraded biological materials through documented QC and validation
- Demonstrate impartiality and confidentiality practices required by funders, partners and regulators
This standard is specifically not intended for biological material used primarily for food/feed production or for clinical diagnostic and therapeutic workflows (for which ISO 15189 and other clinical standards are prioritized).
Who uses this standard
- Biobanks in universities, research institutes, biotechnology and pharmaceutical organizations
- Microbiology and biodiversity repositories
- Accreditation bodies, regulatory authorities and peer-assessment schemes
- Biobank users, data custodians and lifecycle managers seeking recognized quality practices
Related standards
- ISO 15189 (medical laboratories) - referenced for entities handling human materials for diagnostic and treatment purposes
- Applicable national, regional or sector-specific regulations may also apply alongside EN ISO 20387:2020
Adopting EN ISO 20387 helps organizations demonstrate competence in biobanking, protect sample integrity, and enable reliable downstream research and development.