The German Biobank Network (GBN), Swiss Biobanking, BBMRI.pl and BBMRI.be have jointly published the Quality Handbook for Biobanks (QHB), a harmonised guidance document designed to support biobanks in establishing and improving their quality management systems. Developed by Nhu Tuyen Phan, Joséphine Uldry, Dr Agnieszka Matera-Witkiewicz and Mieke De Wilde – the Quality Management (QM) leads from Germany, Switzerland, Poland and Belgium respectively – the handbook was endorsed by the National Nodes of the European biobank network BBMRI-ERIC and released as an open-access publication on Zenodo in March 2026.
Collaborative initiative towards harmonised quality standards
From October 2023 onwards, the initiative has aimed to create a country-neutral, practical and freely accessible handbook aligned with the international biobanking standard, ISO 20387. Swiss Biobanking’s QM manual served as the foundation for this, and was further developed collaboratively to reflect shared European legal frameworks and common operational requirements.
Aligned with ISO 20387 and going beyond
The QHB’s structure follows the eight main chapters of ISO 20387, addressing areas such as governance, biobanking processes, and QM system. In addition to the core requirements of the standard, the handbook provides guidance on highly relevant practical topics, such as consent management, sustainability, and key performance indicators.
Structure
The QHB comprises three main components:
- The glossary includes more than 120 terms and definitions derived from:
- QM manuals from Belgium, Switzerland, Germany and Poland,
- international standards, such as ISO 20387, ISO 9000, ISO 9001, ISO 17000 and ISO/IEC Guide 99,
- the General Data Protection Regulation (GDPR).
- The main document provides recommendations and guidance on implementing ISO 20387 requirements, complemented by additional subchapters that address specific operational and strategic aspects.
- The template library contains over 130 templates for biobanking standard operating procedures (SOPs) and forms. Most templates are freely available, while some can be obtained upon request. Documents are provided in English, German and Polish.
International peer review and endorsement
To ensure the QHB’s relevance and accuracy, it underwent an extensive international peer-review process. Following the completion of the first draft in September 2025, detailed feedback was provided by a total of 25 reviewers from ten countries. Following revisions, the National Nodes of BBMRI-ERIC formally endorsed the handbook in February 2026.
Outlook
The QHB will be updated regularly to reflect revisions to ISO standards and other relevant international guidelines. A second version is planned for 2027, coordinated by BBMRI-ERIC. By publishing the QHB, the collaborating organisations are providing a shared European reference framework to strengthen quality, transparency, and harmonisation in biobanking.