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ISO 20387

ISO 20387 Biobanking - defines accreditation requirements and explains the operational activities and responsibilities of Biobank and its customers (excluding forensics and management systems certification bodies).

Quality Control Requirements in ISO 20387:2018 ISO 20387:2018 includes quality control (QC) requirements to verify the quality of data collections, biological material from multicellular organisms (e.g., human, animal, fungus, and plant), and microorganisms for research and development. QC includes implementing procedures to ensure compliance with relevant biosecurity and biosafety. Biosafety: Containment principles, technologies, and practices that are implemented to prevent unintentional exposure to pathogens and toxins, or their accidental release. Biosecurity: Institutional and personal security measures and procedures designed to prevent the loss, theft, misuse, diversion or intentional/unintentional release of pathogens, genetically modified organisms, toxin-producing organisms, or parts thereof, as well as such toxins that are held, transferred and/or supplied by the biobank. The standard maintains that the biobank shall define a minimum set of QC procedures to be performed on the biological material and associated data or a subset of it. Moreover, ISO 20387:2018 specifies QC requirements for a biobank’s processes and data: Processes: The biobank shall establish, document, implement, and periodically analyze procedures specifying QC activities throughout the biobanking processes. This includes QC criteria corresponding to predefined specifications to demonstrate fitness for the intended purpose of the biological material and associated data. Data: The biobank must define the type and frequency of the QC performed, and the QC should focus on accuracy, completeness, and consistency of data. Biobank users, regulatory authorities, organizations, and schemes using peer-assessment, accreditation bodies, and others may use ISO 20387:2018 in confirming or recognizing the competence of biobanks. 

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