[ ISO 20387:2018 Introduction ]

The bio-health industry has been strengthened at the national level in these days, the demand for biobanking is increasing. Biobanking refers to systematically collects, preserves, analyzes, and distributes bio-information used in industry, research, and development.

Biological materials refer to living organisms such as microorganisms, plants, animals, and human body, as well as materials or parts of organisms and multicellular organisms.

ISO 20387 is for competence, impartiality and consistent operation of biobanks, and it includes quality control requirements to ensure biological material and data collections of appropriate quality. Biobank users, regulatory authorities, organizations and schemes, accreditation bodies and others can also use this document in confirming the competence of biobanks.

However, food and feed production, laboratories undertaking analysis for food and feed, and therapeutic use don’t apply to biological material.

[ The effectiveness of ISO 20387 certification ]

• •  It has been developed with the objective of promoting confidence in biobanking
• •  It demonstrates competent biobank operation appropriately
• •  It can promote cooperation between biobank and stakeholders, and help harmonize between institutions through information exchange and management.

[ Requirements of ISO 20387 ]

• Scope
• Normative references
• Terms and definitions
• General requirements
• Structural requirements
• Resource requirements
• Process Requirements
• Quality management system requirements

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