A biobank is a facility that collects, stores, and manages biological material and related data in an organized manner for research purposes. Biological material is an essential asset for the progress of biotechnology, an emerging sector on a world scale, which, according to OECD (Organisation for Economic Co-operation and Development) estimates, will have an impact on the world economy in 2030 and will account for 2.7% of global GDP overall.
Researchers using deposited materials require guarantees regarding the collection, transport, storage, traceability, and distribution of these samples (human, animal, microorganism, plant, and fungal). For the progress of research, it is essential that the biological materials deposited are of quality and that they are managed by the biobanks to ensure the reproducibility and comparability of the research results through standard processes and procedures.
These needs are met by the accreditation of biobanks according to EN ISO 20387:2020 Biotechnologies – Biobanking – General requirements for biobanking. These requirements demonstrate an organization’s competence in the handling, traceability, and long-term preservation of samples. The standard defines a broad framework of reference shared internationally for the collection storage, and subsequent use of biological materials and represents the reference for requesting and obtaining accreditation.
Accreditation provides a reliable index of the capabilities and adequacy of the biobank’s structure in terms of competence, impartiality, and consistent operation, in line with the international standard. Furthermore, the assessment process preparatory to the issue of the accreditation certificate provides valuable information to support the biobank in the fundamental process of simplifying the procedures, favoring a potential saving of time and money.
EN ISO 20387 is a harmonised standard due to its adoption by the European Standardisation organisations CEN-CENELEC based on a request made by the European Commission. The EA General Assembly decided to expand the EA MLA for biobanking as a level 2 conformity assessment activity using EN ISO 20387 as a new level 3 normative document.
The EA Multilateral Agreement Council concluded all arrangements, including the training of its members, who are making the decisions, to start with the peer evaluations of EA National Accreditation Bodies (NABs).
Some EA Members already accredited conformity assessment bodies, such as ENAC (the Spanish NAB) with the Instituto Valenciano de Oncología Foundation, and ACCREDIA (the Italian NAB) with the Multi-specialistic Biobank of the Pisan University Hospital.