ISO 20387:2018

Overview

ISO 20387:2018 - "Biotechnology - Biobanking - General requirements for biobanking" defines the general requirements for competence, impartiality and consistent operation of biobanks. It establishes quality control and management expectations to ensure biological material and associated data collections are of appropriate quality for research and development. The standard applies to biobanking of samples from multicellular organisms (human, animal, plant, fungus) and microorganisms, and is widely used for biobank accreditation, quality assurance and harmonized sample sharing.

Keywords: ISO 20387, biobanking standard, biobank accreditation, biobank quality management, biological material, sample preservation, traceability, data management.

Key topics and technical requirements

ISO 20387 covers the full lifecycle of biospecimens and related data. Major technical topics include:

• General requirements: competence, impartiality, confidentiality and consistent operation of a biobank.
• Structural and resource requirements: organizational structure, facilities, equipment, and personnel competence, training and assessment.
• Process requirements across the sample lifecycle:
  • Acquisition and accessioning (collection and documentation of new materials).
  • Reception, storage and distribution of biological material and associated data.
  • Transport and chain-of-custody considerations.
  • Preparation, preservation and storage methods to maintain sample integrity.
  • Traceability and documentation to link samples to data and provenance.
  • Quality control (QC) for materials, processes and associated data.
  • Validation and verification of methods used in biobanking.
  • Management of information and data, including reporting and control of nonconforming output.
• Quality management system (QMS): options for implementing documented QMS processes (Option A and B), document control, internal audits, corrective actions and continual improvement.
• Governance topics: confidentiality, complaints handling, impartiality, and external provider controls.

Practical applications

ISO 20387 is used to:

• Enable reproducible research by ensuring sample quality and standardized handling.
• Support biobank accreditation and third-party recognition of competence.
• Facilitate sample sharing and collaboration across institutions and countries.
• Reduce risk in sample transport, storage and data management through documented procedures and QC.
• Guide setup or upgrade of biobank operations, from equipment selection to staff training and validation of methods.

Who should use this standard

• Biobanks in academia, hospitals, industry (pharmaceutical/biotech) and research organizations
• Regulatory authorities, accreditation bodies and peer-assessment schemes
• Biobank users (researchers) seeking assurance on sample quality and traceability

Related standards

• ISO 15189 (clinical laboratories) - applies primarily to diagnostic/treatment human materials.
• ISO 8601 - referenced for date/time representation in documented information.

ISO 20387 is central for organizations seeking a robust, harmonized approach to biobanking quality, traceability and data integrity.