After the successful establishment of a quality management system in November 2015, the Hannover Unified Biobank (HUB) is certified by TÜV Nord in accordance to DIN EN ISO 9001: 2008. This is particularly noteworthy, because only a very few biobanks in Germany have gone the way of certification successfully.
In addition to the creation of quality assurance structures and steered documents, the definition of the core processes of the biobank and the development of a quality management manual (QMH) are at the forefront of HUB's efforts. The generation of administrative and agreement documents, such as the HUB law-by, a data protection concept, an interface agreement and patient consents also create mandatory structures and quality assurance in contact with patients and partners.
But the quality assessment of biobanks has a continuing need for improvement. As there is currently no uniform standard existing for biobanking in human medicine, the International Organization for Standardization (ISO) and the German Institute for Standardization (DIN) attempts to fill this gap. HUB is actively involved in the consultative bodies and takes part in shaping the new national standard for biobanks. Appropriate standards and supplements - nationally and internationally - are expected in 2017.