New version of QM manual now available

The German Biobank Node has updated its manual on quality management (QM) in biobanking. It has been published on the Zenodo platform as an open access document (German version: DOI: 10.5281/zenodo.3403067; English version pending).

Documents on business continuity now available

The new version of the quality management manual contains supplementary documents on the subject of business continuity. These relate to both the conception and establishment of a business continuity plan. The ISO 20387 standard on “Biotechnology – Biobanking – General requirements for biobanking” published in 2018 provides for such concepts to handle emergencies. The business continuity plan must also include a risk assessment of potential disaster scenarios and preventive measures.

Quality management manual published in 2018

GBN first published the QM manual in October 2018. Work on the manual had already started during the initial GBN funding phase: the QM working group drafted a document based on the standard operating procedures (SOPs) already in place at biobanks. Employees at the GBA sites in Heidelberg, Jena, and Munich subsequently finalised the document in accordance with the DIN EN ISO 9001:2015, 17025, 17020, 15189, and 20387 standards. The DIN/CEN technical specifications for pre-analytical processes were also taken into account. The manual takes a process-oriented approach, detailing all of the certification and accreditation requirements that biobanks must currently meet.

Links:

Questions?

germanbiobanknode@charite.de

Tel. +49. 30. 450 536 347


Fax +49. 30. 450 753 69 38

BMBF
top
Biobank Directory European Biobank Directory GBN products Download templates, manuals and other materials