What ISO 20387:2018 Biotechnology - Biobanking - General Requirements for Biobanking requires
ISO 20387:2018 Biotechnology - Biobanking - General Requirements for Biobanking is the international standard specifying the management and technical requirements for biobanks to enable them to demonstrate competence in providing biological material and associated data of appropriate quality for research and development. The Standard was published by the International Organization for Standardization in August 2018 and is applicable to all biobanks regardless of size or scope including human, animal, plant, and microorganism biobanks. The Standard is structured around a management system that integrates with ISO 9001 quality management system principles and adopts a process approach focused on biospecimen lifecycle, traceability, and data quality. The Standard's core technical requirements include validated procedures for collection, processing, preservation, storage, retrieval, and distribution of biospecimens; characterisation of biospecimens including their stability, integrity, and identity; data quality and traceability through unique sample identifiers and provenance metadata; competence of biobank personnel including training and proficiency records; facilities and environmental conditions appropriate to the preserved biospecimens; equipment qualification, calibration, and maintenance; and risk-based approach to quality management. The Standard supports international harmonisation of biobanking practice and is increasingly referenced in national biobanking guidelines including the South Africa NHREC 2024 Guidelines, the Japan AMED BioBank governance, and the EU Health Data Space genomic data quality framework. Accreditation against ISO 20387 is conferred by national accreditation bodies that are signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement.
Pillar: Biotech & Genomics · Authority: International Organization for Standardization · Version: 1.0.0 · Last updated:
Primary source: https://www.iso.org/standard/67888.html
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- ISO 20387:2018 Biotechnology - Biobanking - General Requirements for Biobanking - international standard for biobank management and technical competence.
- ISO 20387:2018 - applies to all biobanks regardless of size or scope including human, animal, plant, and microorganism biobanks.
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