ISO 20387 Biobanking Accreditation Program

ISO 20387 is a standard developed by the International Organization for Standardization (ISO) that provides guidelines for the management of biobanks, which are facilities that collect, process, store, and distribute biological samples for research purposes. The ISO 20387 standard is intended to ensure that biobanks are operated in a consistent and reliable manner and that the samples they hold are properly managed and protected.

An ISO 20387 biobanking accreditation program is a program developed to evaluate biobanks against the ISO 20387 standard and determine whether they meet the necessary requirements for the management of biological samples. To become accredited under an ISO 20387 biobanking accreditation program, a biobank must demonstrate that it has the necessary personnel, equipment, and procedures in place to properly manage and protect the biological samples it holds.

Accredited biobanks under an ISO 20387 biobanking accreditation program are required to undergo regular evaluations to ensure that they continue to meet the necessary standards and are able to properly manage and protect the biological samples they hold. This helps to ensure that the samples held by biobanks are properly managed and protected, which is important for the integrity and reliability of research using these samples.

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.

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 biobanks 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 organizations 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.