High Quality BioBanking in Belgium: the Road towards ISO20387 Accreditation (B3-ISO)

A large part of the irreproducibility of research on human body material originates from the biospecimens used and has been identified as a major undermining factor regarding the translation of research results into clinical applications. As, since the new Royal Decree on the biobanks in 2018, all human body material used for research, has to pass via a Belgian biobank, such biobanks can play an important role in reducing research variation by providing high quality, fit-for-purpose samples and associated data.

The European infrastructure for biobanking BBMRI-ERIC is reflected in the National Node BBMRI.be, established in 2013 at the Belgian Cancer Registry and connects 20 Belgian biobanks. Many of these biobanks arose from existing sample collections, sometimes with limited quality management systems (QMS). The biobank standard (ISO 20387), which was recently published and will be included in the portfolio of the Belgian accreditation organization BELAC, will allow biobanks to formalize their competences and because of its international recognition will allow the Belgian biobanks to demonstrate their readiness to support (inter)national translational research .

To harmonize and enhance the quality management activities of the BBMRI.be biobanks, BBMRI.be develops a stepwise quality improvement program that can be implemented at the individual biobanks.
A kickoff survey elucidated that the starting positions of the Belgian biobanks are diverse. The ambitions of the participating biobanks are in line with the goals of the project and will support substantial quality improvement. ISO20387 implementation support is needed in diverse domains. In cooperation with the participating biobanks, BBMRI.be coordinates the development of guidelines, templates and policies, the organization of webinars, and the development of an interactive FAQ tool. Templates are being harmonized and integrated in the domains of IT, ELSI and sustainability. Self-assessment tools and a stepwise auditing program is developed. At the same time, an accreditation program is being established together with BELAC, ultimately leading to ISO accreditation.

The setup of this program and the implementation of the ISO 20387 standard will substantially contribute to (inter)national translational research and foster collaborations between industry and academia in the biomedical sector.

Acknowledgements: The project is financed by BELSPO in the framework of the ESFRI-FED call.


De Wilde Annemieke (1), Annelies Debucquoy (1), Kimberly Buys (5), Céline Devriendt (2), Johan Guns (2), Ahmad Merhi (3), Loes Linsen (4), Pieter Moons (5), Silke Smeets (6), Elke Van Rossen (6, 7), Manon Huizing (5), Katia Emmerechts (1), Elke Smits (5)


BBMRI.be - Belgian Cancer Registry (1), Central Biobank, UZBrussel (2), IPG BioBank and Laboratory of Translational Oncology, Institut de Pathologie et de Génétique (3), AC Biobanking, University Hospitals Leuven (4), Biobank Antwerp, Antwerp University Hospital (5), BELAC, Federal Public Service Economy (6), SME, Self-employed and Energy (7)

Presenting author

Mieke De Wilde, BBMRI.be Quality Coordinator, Belgian Cancer Registry - BBMRI.be
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