Accreditation of Biobanking | New Programmes
About the UKAS biobanking accreditation programme
UKAS has established a pioneering pilot programme to develop the assessment approach and offer accreditation to biobanking Conformity Assessment Bodies (CABs) operating biobanks. The programme covers defined biological materials from humans, animals, plants and microorganisms, together with associated information and data.
ISO 20387:2018 sets out the general requirements for the competence, impartiality and consistent operation of biobanks. It also includes quality control requirements designed to ensure that biological material and data collections are produced, maintained and managed appropriately.
The standard is relevant to organisations undertaking biobanking activities for research and development, including those working with biological material from multicellular organisms such as humans, animals, fungi and plants, as well as microorganisms. It does not apply to biological material intended for food or feed production, laboratories undertaking analysis for food or feed production, or material intended for therapeutic use.
Associated Standards
- ISO 20387:2018 – Biotechnology – Biobanking – General requirements for biobanking.
Current status
Following an expression of interest notice issued in April 2019, UKAS hosted a series of webinars in December 2019 and January 2020 for interested stakeholders. The Development Team received a strong level of interest, with applicants progressing through the accreditation process and document reviews and pre-assessments underway.
The pilot development programme has made excellent progress. In a key milestone, UKAS was delighted to grant its first ISO 20387 accreditation to a biobank, NHS Greater Glasgow and Clyde, on 10 October 2024. This important achievement, and this was followed by further accreditations for Queen Mary University of London –- Pancreatic Cancer Research Fund Tissue Bank and Luxembourg Institute of Health Tissue Bank.
To date, all of the Biobank applications so far have been in the field of human biological material. Reflecting the maturity and successful progression of field so this area, human biobanking is now managed by UKAS’ has been moved into our Healthcare Operational team. Applications relating to manage. Any of the other biobanking fields will continue to be supported would come through the Development Team development to progress.
UKAS has also achieved a significant international milestone, successfully completing assessment under taken by EA colleagues to extend our MLA to include biobanking Biobanking accreditation. This to our MLA, this is a major achievement for the programme and an important recognition of the robust development work, technical expertise and collaborative effort that have underpinned its success
UKAS continues to welcome applications for this programme here.
For further information about the biobanking accreditation programme, please contact the Development Team.
