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.

Audits

With internal audits, GBN prepares the biobanks of the German Biobank Alliance (GBA) for accreditations according to the biobanking standard DIN EN ISO 20387. This includes checking whether the processes of the audited biobank comply with the standard requirements - these are represented in GBN's QM manual with documents and forms. The GBA audit programme was developed in accordance with DIN EN ISO 19011, which specifies formal audit procedures.

Internal audits

Preparation for the accreditation according to DIN EN ISO 20387

Trained auditors

All auditors are specially trained by the German Biobank Node (GBN) in cooperation with TÜV SÜD to conduct the internal audits of the German Biobank Alliance (GBA).

2

auditors from GBN/GBA inspect the biobank

every 18

months an audit takes place in a biobank

20387

DIN standard for biobanking serves as basis

What types of audits are offered?

Currently, only remote audits take place.

Remote audit

Due to the pandemic, GBN has introduced remote audits, which are conducted virtually.

2 × 3 hours

The audit will take place on two dates for three hours.

On-site audit

In an on-site audit, the auditors visit the biobank and conduct the audit on-site.

1 × 6 hours

The audit takes place on one date for six hours.

What happens after an audit?

The biobank optimises its processes.

Audit report

The auditors hand over a report to the biobank that summarises the results of the audit and contains suggestions for improvement.

Further audit

Twelve months after the first audit, a second audit takes place, which pays particular attention to the results of the previous year. Further audits may follow.

Optimal preparation for accreditation

If the auditors detect no deviations from the standard during an audit, the respective biobank is optimally prepared for accreditation.

 

Since September 2019, biobanks can apply for accreditation according to DIN EN ISO 20387. The national accreditation authority (DAkkS) developed an accreditation programme for German biobanks in close cooperation with GBN. In addition, a training course for DAkkS expert assessors - from the GBA community among others - was designed and conducted in autumn 2019.

"The internal audits of the GBA are, from my point of view, perfect preparation for accreditation according to the ISO standard 20387 for biobanking. The auditors gave us valuable advice and made very specific suggestions as to where changes to our processes would be useful. They were very competent and gave us a new perspective with their 'view from outside'."

Prof. Dr. Christian Brandts

Head of the Interdisciplinary Biomaterial and Database Frankfurt (iBDF) and Deputy Spokesperson of the Network of Comprehensive Cancer Centers (CCC)

 

At the European level, close cooperation in the area of audits has taken place for a long time - GBN and the European biobank organisation BBMRI-ERIC regularly coordinate their programmes. If GBA biobanks wish to receive a quality mark (“Q-Mark”) in the European Directory for meeting the requirements of DIN EN ISO 20387:2020, this can only be granted after at least two GBN audits.   

Further information and links:

Questions?

germanbiobanknode@charite.de

Tel. +49. 30. 450 536 347


Fax +49. 30. 450 753 69 38

BMBF
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