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.

Certification and accreditation

Quality is the central success factor of every biobank. Strategic and process-oriented quality management ensures consistently high quality and user satisfaction in the long term. Certification or accreditation of biobanks in accordance with applicable standards will continue to gain in importance and contribute to enhancing the reputation of these biobanks.

Certification according to DIN EN ISO 9001

In a certification procedure, an external certification body (e.g. TÜV Nord/Süd) checks in a system audit whether a biobank meets certain requirements. Currently, certification of the management system of biobanks is possible according to DIN EN ISO 9001. The current revision from 2015 is already applied by many biobanks. The QM manual developed as part of the first GBN funding phase is based on this, among other fundamentals.

Accreditation according to DIN EN ISO 20387

Accreditation demonstrates the conformity of processes to standards and the specific expertise of the relevant staff. Since 2020, DIN EN ISO 20387 -Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018, German version: DIN EN ISO 20387:2020) has been available as an accreditation standard.

With the help of "friendly audits", GBN has been preparing the biobanks of the German Biobank Alliance (GBA) for accreditation since 2019. In the run-up to an assessment by DAkkS, GBN offers GBA biobanks  an additional audit as a "dress rehearsal" during the application phase.

Application for accreditation

The accreditation process comprises four phases. It begins with the application for initial accreditation (document number: 72 FB 001.1) at the DAkkS Central Application Processing. The annex to the application (72 FB 005.41) specifies the scope of the accreditation, which includes process steps, sample types as well as tests and analyses. The DAkkS prepares a fee estimate on the basis of the application and its fee regulation. After review of the application and an optional preliminary meeting, all documents to be submitted (LI-EU_BB) must be sent to the DAkkS by the biobank.

The second phase of the accreditation process is the assessment.  The assessors conduct a document review. The subsequent inspection of the biobank takes place at best three months after the application has been submitted. After the inspection, the assessors write a report and set a deadline for the elimination of deviations. The assessors or the procedure manager of the DAkkS evaluate the corrective measures and prepare for the Accreditation Committee.

In the third phase, the committee examines and decides on the accreditation. In the case of a positive decision, the DAkkS issues an accreditation certificate and permission to use the accreditation symbol. In addition, the DAkkS  includes the biobank in question in the list of accredited bodies.

In the fourth phase, the DAkkS performs a surveillance assessment at the respective biobank approximately every 18 months. For re-accreditation, a repeat assessment is also required by the DAkkS after a maximum of five years.



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