Quality management

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.

Since 2019, the GBN has been preparing the biobanks of the German Biobank Alliance (GBA) for accreditation with internal audits. In the run-up to an assessment by the DAkkS, the GBN offers GBA biobanks an additional in-depth audit as a "dress rehearsal".

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.

Since 2017, the European biobank network BBMRI-ERIC has been awarding 'Quality Labels' as a proof of quality to biobanks in its member states. For biobanks, this is an opportunity to obtain proof of quality in preparation for, or in addition to, certification or accreditation, which will also appear in the Directory. As GBN has a proven audit programme that prepares for accreditation according to DIN EN ISO 20387, GBN and BBMRI-ERIC have agreed on a specific procedure for already audited GBA biobanks: 

1. Full compliance with DIN EN ISO 20387: In order to receive a Quality Label from BBMRI-ERIC, biobanks must fully comply with the requirements of DIN EN ISO 20387. At least two internal audits are required for a respective assessment of GBA biobanks. In order to receive a Quality Label, the audits must reveal no critical deviations or a maximum of ten percent non-critical deviations. 

2. Completion of the BBMRI-ERIC audit checklist: In addition to general information about the biobank and the responsible auditors, the GBN provides the findings of the internal audits (e.g. possible deviations) and the biobank documents inspected (with title, date and version). The BBMRI-ERIC QM team does not need the documents themselves. The information is then reviewed by the responsible GBN auditors. 

3. Send the audit checklist: If the GBN auditors recommend the award of a Quality Label, the fully completed audit checklist will be sent by GBN to the BBMRI-ERIC QM team. The documents will be kept confidential. 

4. Award of the Quality Label: After reviewing the submitted documents and a final discussion between the GBN lead auditor and the BBMRI-ERIC QM team, BBMRI-ERIC will award the Quality Label and make it visible in the Directory. As soon as a new version of DIN EN ISO 20387 is published, the Quality Label loses its validity. 

This procedure is used for Quality Labels according to DIN EN ISO 20387. In accordance with the regular procedure, biobanks can also obtain Quality Labels from BBMRI-ERIC for other norms and standards. Depending on the scope of the audit, BBMRI-ERIC distinguishes between Quality Labels at the biobank level and at the collection level. Quality Labels can also be awarded on the basis of valid certification or accreditation certificates from the relevant awarding bodies. Nhutuyen Nguyen (Tel. +49. 30. 450 536 374, e-mail: nhutuyen.nguyen@remove-this.charite.de), GBN coordinator for quality management, is available to answer questions.