Quality management

The quality of biospecimens is crucial for the success of biomedical research.

The comprehensive quality programme of the German Biobank Node (GBN) supports biobanks on their way to an accreditation according to the biobanking standard DIN EN ISO 20387.


GBN offers various tools to support biobanks in establishing a quality management system. The QM manual with biobank-specific procedures and forms as well as the satisfaction survey for biobank users are freely available to all interested parties. Partners of the German Biobank Alliance (GBA) can also use a common QM software. Generic recommendations for action for the GBA partner biobanks are being developed as part of the “quality circles” series of events.

Satisfaction survey for users

How content are users of biobank services? Feedback from users helps biobanks to continuously improve their processes. GBN has developed a questionnaire that biobanks can use to ask for this feedback. Under this link you will find the survey template for biobanks. A detailed overview of the range of questions to create an individual survey can be requested by email. Surveying the users’ satisfaction meets the requirements of the standards DIN EN ISO 9001 and DIN EN ISO 20387.

QM software

In order to further strengthen the GBA-internal harmonisation, GBN has established a uniform software for the QM work of the GBA biobanks. The software package offers modules for document and process management as well as for the organisation and implementation of audits and measures management. It allows joint work on documents by all participating sites.

Recommendations for action

In the context of the "quality circles" series of events, recommendations for action are developed for GBA partners on various topics such as the handling of nitrogen tanks and cryogenic storage. Quality circles take place regularly and serve as an exchange platform for quality management within the GBA. 

QM manual

The QM manual has been available Open Access on the Zenodo platform since 2018 (in German), in an English version since 2020. It brings together biobank-specific standard operating procedures (SOPs) and forms in accordance with DIN EN ISO 20387. Further information on the QM manual can be found here.



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