First biobank quality marked in BBMRI-ERIC Directory according to ISO 20387!
On behalf of BBMRI-ERIC, two independent certified and biobank experienced auditors (Prof. Dominik Strapagiel and Sylwia Dobrowolska) embarked on a 2-day on-site audit on behalf of BBMRI-ERIC. By strictly adhering to COVID-19 security and hygiene measures, both auditors carried out a full review of the biobank documents and assessed their accordance to the requirements of the biobank standard. The lead auditor, Prof. Strapagiel, submitted a standardized report and checklist to BBMRI-ERIC, confirming that the biobank adopted a management system based on the requirements and principles of ISO 203287:2018 and is working according to this standard. The Quality mark is now visible in the BBMRI-ERIC Directory. “This is really a great achievement by the head of the WMU Biobank, Dr. Agnieszka Matera-Witkiewicz, and her competent team. I would not be surprised if the WMU-Biobank submit an application for accreditation by the Polish Accreditation Center (PCA) in the near future,” said BBMRI-ERIC Head of Quality Management Andrea Wutte. “This is the right way to prove that biobanks are competent partners in biomedical research. Biobanks protect and manage, so to speak, the legacy of all donors: their valuable samples and data. One thing is crystal clear: these donors want to support biomedical research with the highest quality standards, in order to use their samples and data for the health and well-being of mankind. Now, in this pandemic, we are faced with the gravity of this responsibility.” Wroclaw Medical University Biobank (WMU Biobank) was established in 2017 as a key project listed within three scientific strategic activities proposed for the Polish University in 2016-2020: Translational Medicine/Integrated Biobank; Healthy Aging; and Clinical Epidemiology. WMU Biobank was created to ensure the enhancement of biological material availability not only for internal cooperation but also for external partners, where the highest quality standards will be accomplished. “This is a huge success and a great step forward for all biobanks as well as for our Quality Management Team. The onsite audit taken at Wroclaw Biobank on behalf of BBMRI-ERIC is hopefully the first in a long series. This experience should encourage other biobanks to do the same!” said Agnieszka Matera-Witkiewicz. WMU Biobank is a place where all entities from Wroclaw Medical University and University Clinical Hospital can store and collect biological material under unified, stable and supervised, continuously monitored conditions. An important goal for the biobank management was the aspiration for key certificates of achievement to confirm that the biobank operates on the basis of QMS convergent with the requirements of ISO 9001 and ISO 20387. A leading objective was also the fulfilment of the QMS-Self Assessment Survey requirements and positive audit results supervised by the Quality Management unit of BBMRI-ERIC. WMU Biobank as a BBMRI.pl consortium partner constantly develops, promotes and improves quality solutions. In 2019 it has achieved ISO 9001 certification in the field of biobanking for scientific, research & development and education purposes, as the first biobanking unit in Poland to do so. In 2021 WMU Biobank plans to take part in the accreditation process which will be organized by the Polish Centre for Accreditation to assess the competences according to ISO 20387.