Audits
Biobanks of the German Biobank Network (GBN) are prepared for accreditation according to the biobanking standard DIN EN ISO 20387 with internal audits. This involves checking whether the processes of the audited biobank fulfil the requirements of the standard - these are mapped in the GBN's QM manual in the form of procedural instructions and forms. The audit programme for the GBN was developed in accordance with DIN EN ISO 19011, which specifies formal audit procedures.
Internal audits
Preparation for accreditation according to DIN EN ISO 20387
Trained auditors
All auditors of the German Biobank Network (GBN) are specially trained by the GBN in cooperation with TÜV SÜD to carry out internal audits.
2
auditors from the GBN assess the biobank
Every 18
months an internal audit takes place in a biobank
20387
DIN standard for biobanking serves as a 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 takes place on two dates for three hours.
On-site audit
In an on-site audit,
auditors visit the biobank and
carry out the assessment 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 provide the biobank with a report 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 takes particular account of the previous year's results. Further audits follow every 18 months.
Optimum preparation for accreditation
If the auditors do not discover any deviations from the standard during an audit, the biobank in question is optimally prepared for accreditation.
Since September 2019, biobanks have been able to apply for accreditation in accordance with 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 - including some from the GBN community - was designed and held in autumn 2019.
"In my view, GBN's internal audits are the perfect preparation for accreditation in accordance with 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 opened up a new perspective for us with their 'view from the outside'."
Prof. Dr Christian Brandts
Head of the Interdisciplinary Biomaterial and Database Frankfurt (iBDF) and deputy spokesperson for the Network of Centres of Excellence in Oncology (CCC)
There is close cooperation at European level in the area of audits; 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 necessary for a corresponding audit of the GBN biobanks. Further information on the procedure can be found under "Certification, Accreditation, Quality Label".