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 instructions 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 internal audit takes place in a biobank
20387
DIN standard for biobanking serves as basis
What types of audits are offered?
On-site and remote audits are carried out alternately.
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
18 months after the first audit, a second audit takes place, which pays particular attention to the results of the previous year. Further audits follow every 18 months.
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, there is close cooperation in the area of audits; the GBN and the European biobank network BBMRI-ERIC regularly coordinate their programmes. 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. Further information on the procedure can be found under 'Certification, Accreditation, Quality Label'.
Further information and links:
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