BBMRI.at on the path to ISO 20387 – next cycle of quality cross-audits

BBMRI.at quality cross-audits

Since 2017, BBMRI.at has conducted structured internal quality management (QM) cross-audits across its partner biobanks. These audits follow a comprehensive program and are conducted as either on-site, remote (as developed during the COVID-19 pandemic), or hybrid audits.

In BBMRI.at cross audits, QM Coordinators from various BBMRI.at partners act as co-auditors, evaluating another biobank partner. This peer-to-peer setup encourages knowledge exchange, strengthens harmonization, and supports continuous improvement.

The audits enable biobanks to receive a specialized evaluation of their processes and enhance their own QM systems. At the same time, auditors gain valuable insight into the organizational structures and workflows of other biobanks – an important driver of standardization and harmonization within the BBMRI.at research infrastructure.

While earlier audit cycles focused on ISO 9001 and on CEN and ISO standards for sample pre-analytics (pre-examination), the current program has been expanded to cover the ISO 20387 (general requirements for biobanking) and ISO 21899 (validation and verification of processing methods).

New round of audits targeting ISO 20387

The latest audit on 25 November 2025 marked the launch of the third cross-audit cycle. The audit team – delegated by BBMRI.at partner biobanks and BBMRI.at coordination – assessed Biobank Graz for complaisance with several key chapters of ISO 20387:2018. In addition to the audit activities, participants received an impressive tour of Biobank Graz’s state-of-the-art facilities such as the huge paraffin block and slide archive, the liquid nitrogen storage facility, the Hamilton BiOS automated ultra-low temperature storage system for frozen liquid samples or the Hamilton liquid handling platform.

This expanded audit programme supports BBMRI.at biobank partners in preparing for formal accreditation according to ISO 20387, helping them meet international biobanking quality requirements.

With its current cross-audit program, BBMRI.at continues to serve as a pioneer among BBMRI-ERIC National Nodes. It not only facilitates peer evaluations for Austrian biobanks but also offers younger or emerging biobanks an opportunity to learn from well-established infrastructures. Entering its third cycle, the program further strengthens quality, collaboration, and harmonization across the BBMRI.at network.