It took more than two years to develop the Quality Handbook for Biobanks (QHB) — a unified quality manual designed to support biobanks across Europe in building and developing quality management systems compliant with the international ISO 20387 standard. The document was created through collaboration between quality coordinators from four BBMRI-ERIC member countries: BBMRI.pl, the German Biobank Network (GBN), Swiss Biobanking, and BBMRI.be.
One of the main authors of the handbook is Agnieszka Matera-Witkiewicz, Professor at Wroclaw Medical University, Head of the Laboratory for Screening Tests of Biological Activity and Biobanking, and Rector’s Plenipotentiary for Biobanking. She represents the Polish node of the European research infrastructure BBMRI-ERIC in the field of quality. Together with Nhu Tuyen Phan (Germany), Joséphine Uldry (Switzerland), and Mieke De Wilde (Belgium), she co-authored a document that is intended to become a European benchmark for quality management in biobanks.
European collaboration for research quality
The initiative began in October 2023 and from the outset aimed to develop a practical, neutral approach to implementing quality standards—aligned with international guidelines while remaining applicable to the daily operations of biobanks in any country.
The publication was prepared by quality management leaders from four countries and underwent extensive international peer review. A total of 25 experts from ten countries participated in the review process. The final version of the handbook was approved in February 2026 by national nodes of BBMRI-ERIC and its Directorate General. This marks the first initiative of its kind to receive full support from all European biobanking centers collaborating within BBMRI-ERIC.
The involvement of Prof. Matera-Witkiewicz highlights the growing role of Polish biobanks within the European biomedical research infrastructure. As she emphasizes, the key motivation behind her participation was the opportunity to create a tool that genuinely supports research quality.
“Collaboration is at the heart of scientific progress. This handbook is a practical tool that helps strengthen quality and improve research. The opportunity to contribute to a project with impact beyond national borders was the most important reason for my involvement,” she notes.
The work also required aligning shared operational principles across different legal and organizational systems.
“Regulatory differences were not the biggest challenge, as we agreed from the beginning that the handbook should be international in nature and not tied to any single country’s regulations. For me personally, as the only person managing an accredited biobank, it was particularly important to ensure that the handbook would be practical and help meet accreditation requirements,” she adds.
A European standard for the future
The authors plan regular updates to the handbook to reflect changes in international standards and the evolution of best practices in biobanking. The next version is scheduled for 2027 under the coordination of BBMRI-ERIC.
The creation of the Quality Handbook for Biobanks demonstrates the importance of European collaboration in building shared standards for biomedical research quality. For Wroclaw Medical University, it is another example of active participation in international initiatives that strengthen scientific infrastructure and support high-quality research.
