DAkkS accredits first biobank
Deutsche Akkreditierungsstelle (DAkkS) has become one of the first national bodies in Europe to accredit a biobank in accordance with the DIN EN ISO 20387 standard. The Tissue Bank at the National Center for Tumour Diseases at Heidelberg University Hospital is the first biobank in Germany to demonstrate in a DAkkS case of accreditation that it meets the general requirements of the biobank standard, confirming its competence for all relevant processes from transport and preservation to storage and quality control of human tissue samples and the data associated with them. Further biobanks can now be expected to successfully complete the accreditation process.
Biobanks constitute an important part of various scientific fields. They provide access to a large pool of high-quality biological material and associated data. The data associated with a sample may include both measurement data and other characteristics and demographic information relating to the origin of the material. Biobanks are reliable bodies for the storage and processing of samples from clinical trials or other sources, and as such establish important prerequisites for reproducible research findings.
In the process of accrediting a biobank in accordance with DIN EN ISO 20387, DAkkS examines, as an independent body, whether the facility in question has the competence and impartiality to ensure proper operation. The DAkkS assessment teams look into the extent to which the biobank meets the requirements set out in the standard with regard to its management system, processes, premises, personnel and other essential elements. Accreditation in accordance with DIN EN ISO 20387 therefore acts to strengthen confidence in stored samples and the data associated with them.
Cooperation with the German Biobank Node
The foundation for this is the accreditation scheme developed by DAkkS in close cooperation with experts at the German Biobank Node (GBN) on the basis of DIN EN ISO 20387. In previous resolutions on this matter, the International Laboratory Accreditation Cooperation (ILAC) and the European co-operation for Accreditation (EA) had already confirmed that this standard can be used as the sole basis for the accreditation of biobanks.