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.

QM manual

The GBN manual for quality management forms the crucial basis for implementing a harmonised quality management system at the sites of the German Biobank Alliance (GBA).

The manual is based on the standard documents DIN EN ISO 9001, 17025, 17020 and 15189 as well as DIN ISO 20387 "Biotechnology - Biobanking - General requirements for biobanking". It also takes into account the DIN/CEN technical specifications for preanalytical processes. Thus, it includes all currently existing certification and accreditation requirements for biobanks. It is updated and extended several times a year. Since the end of May 2020, the manual has also been availablein English.

Both the German manual and the English language version are available open access on the Zenodo platform.

Introduction of a quality management system

The following information provides an overview of the scope of the tasks and the workload:

At the beginning, the current status of the existing equipment of the respective biobank is documented with the employees. The processes and procedures to be certified/accredited have to be defined. The effort to be expended is planned and estimated in a project plan by assigning responsibilities. The employees are then trained in the procedure and implementation of the quality management system (QMS). The procedures, methods and processes to be certified/accredited must then be validated. Another essential component is the creation of a concept for data protection and data security. This is followed by the preparation of documents, starting with the quality policy and the definition of responsibilities and the description of procedures and methods. Each procedure has to be checked and verified. The QMS is "put into effect"; the employees adhere to the described processes in routine operations. At regular intervals,  the processes are checked with internal audits and improved if necessary. Once the QMS has been implemented, certification/accreditation is applied for from the relevant body. External independent experts check the QMS on the basis of the documents and in the course of an on-site visit and subsequently evaluate it. If they find deviations from the requirements, these are reassessed after measures have been implemented. At the end of the process, a certificate of certification/accreditation is issued.

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