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High quality BioBanking in Belgium: the roads towards ISO 20387 accreditation (B3-ISO)

Research project EF/212/B3-ISO (Research action EF)

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Description :

Biobanks provide well characterized samples to researchers supporting biomedical research at all development stages. The European infrastructure for biobanking BBMRI-ERIC is reflected in the National Node BBMRI.be, established in 2013 at the Belgian Cancer Registry. In 2018, the Royal Decree on the biobanks changed the Belgian biobanking landscape as all human body material used for research now needs registration in an official Belgian biobank. Many standing, often academic, collections were thus absorbed into existing biobanks. At about the same time, the ISO 20387 accreditation, providing a quality framework for biobanks, was launched, but currently is not yet included in the portfolio of the Belgian accreditation organization BELAC. The ISO standard provides an excellent opportunity for the biobank infrastructure to harmonize the existing quality management systems and to expand their use to the add-on collections. Such increased quality level benefits the research community as high-quality sample collections are reflected into high impact research. In this proposal, BBMRI.be aims to develop a stepwise quality improvement program that can be implemented at the individual biobanks. At the same time, an accreditation program will be established together with BELAC, ultimately leading to ISO accreditation. This will have an impact on the sustainability of the Belgian biobanks within the European framework.