GBA auditors – specifically trained staff of biobanks of the German Biobank Alliance (GBA) – met on 18 June 2019 for their annual meeting in Göttingen. They exchanged experiences made during the audits of ten GBA biobanks in the current year. Within the alliance, the cross-biobank, so-called “friendly audits” are a means of assessing whether the biobanks operate in compliance with the GBA standard consisting of a manual, rule book and questionnaire. The GBA standard was developed in accordance with multiple applied standards: DIN EN ISO 17025, 17020, 15189 and ISO 9001:2015, ISO 20387. The friendly audits are also meant to prepare GBA biobanks for an ISO 20387 accreditation – the standard on “Biotechnology – Biobanking – General requirements for biobanking” published in 2018. In Germany, ISO 20387 accreditations are not possible to date since the standard’s German translation has not been published yet. Accreditations are likely to become possible towards the end of 2019.
Auditors provided valuable feedback
The auditors shared their experiences during the meeting, talked about how they had perceived the audits and about the biobanks’ feedback. They agreed on ideas for the improvement of the friendly audit concept and on modifications of the document template used for the audit report. A communication training with a focus on “active listening” completed the day.
The GBA “friendly audit” concept
The friendly audit concept was developed by members of the GBA core team for quality management: Christiane Hartfeldt (German Biobank Node), Claudia Schuster and Sabrina Schmitt (BioMaterialBank Heidelberg), and Bettina Meinung (Integrated Biobank Jena). “Compared to hospital-internal audits, for instance, our system offers the advantage that the auditors not only have a ‘view from the outside’, but also afford biobank-specific expertise and are able to assess the conformity with the ISO 20387 standard for biobanking,” explains Christiane Hartfeldt.
Qualification of auditors
GBA biobanks have selected staff to act as auditors – prerequisites included several years of professional experience in biobanking as well as expertise in quality management. Representatives of the German Centres for Health Research (DZG) and the NAKO Health Study also count among GBA auditors. The selected employees were qualified during a training course in 2018. A second training round is planned for the end of 2019 – to expand the group of auditors and to qualify employees of the four biobanks that joined GBA in May 2019.
- GBN Manual for Quality Management in Biobanking
- Information on the "friendly audits" concept
- Information on the qualification of GBA auditors
- Documents on the ISO 20387 standard for biobanking
- Information on the GBA partner biobanks that joined in 2019