The A2LA 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.
A2LA developed this accreditation program in conjunction with industry experts to deliver a quality assessment to ISO 20387. Our program ensures that the accreditation process fits to the specific activities being performed by each biobank or biorepository. This approach allows us to tailor the on-site assessment for biobanks that perform all critical activities (acquisition, collection, preparation preservation, testing, analysis, distribution) down to the small biobanks that might only be managing the associated data.
A2LA is also a member of ISBER, whose vision is to be the leading global biobanking forum for promoting harmonized high-quality standards, education, ethical principles, and innovation in the science and management of biorepositories.
Program Requirements
- ISO 20387:2018 Biotechnology – Biobanking – General requirements for biobanking
- R347 – General Requirements – Accreditation of ISO 20387 Biobanks
- R102 – Conditions for Accreditation
- R105 – Requirements When Making Reference to A2LA Accredited Status
- P102 – Policy on Metrological Traceability