ISO 20387 – Biobanking Accreditation Program

The ISO 20387:2018 Standard specifies general requirements for the competence, impartiality and consistent operation of biobanks, including quality control requirements to ensure biological material and data collections are produced and maintained appropriately.  

ISO 20387 – Biobanking Accreditation Program

Our Biobanking Accreditation Program uses the ISO 20387 standard to promote confidence in biobanking. ISO 20387 contains requirements designed to demonstrate the competence of a biobank’s operation and the ability to provide biological material and associated data for research and development.

This Standard is applicable to all organisations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development. It does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use. 

The ISO 20387 international standard was developed to promote confidence in biobanking institutions and procedures. ISO 20387 establishes accreditation requirements for biological material and data quality that demonstrate an organization’s competence in proper handling, traceability, and long-term preservation of samples. We recognize the importance of biobanked material in multiple scientific disciplines and has implemented a program to accredit organizations to this international standard.

ISO 20387 accreditation involves an independent assessment of the biobanking organization that includes an examination of the quality management system, personnel qualifications and competence, material handling, storage environment and equipment, and reporting. Qualified assessors conduct a thorough evaluation of all factors affecting the storage of biological material and the demographic sample information.

To ensure continued compliance, accredited biobank organizations are regularly re-assessed to ensure they maintain their technical expertise and competence. Accredited organizations are also required to participate in proficiency testing programs (EQAs).

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Accreditation by U.S. Accreditation will boost the profile of your business and demonstrate its commitment to being a quality education provider, respected worldwide.