First biobank quality mark in the BBMRI-ERIC Directory according to ISO 20387

It is truly a success for the BBMRI-ERIC network of biobanks. Our first biobank – Wroclaw Medical University Biobank (WMU Biobank) made a great effort to integrate the international standard for biobanks – ISO 20387:2018 – into their work processes. The standard implementation phase was started in 2019 and, in the next step, also led to the desire to have this performance confirmed by a peer review audit.  

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 and & 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. 

WMU Biobank

Agnieszka Matera-Witkiewicz, PhD of Pharmacy, M.Sc, Eng Biotechnology, R&D Project Manager (postgraduate), Clinical Trials Management (postgraduate), Associate Professor and Head of Wroclaw Medical University Biobank and Screening Laboratory of Biological Activity Assays and Collection of Biological Material, BBMRI.pl Quality Manager, BBMRI-ERIC Quality Expert and Auditor, Leading Auditor of Quality Management System (IRCAA18007), Polish Committee for Standardization TC Biotechnology representative, International Organization for Standardization (ISO) Expert TC Biotechnology in WG2 Biobanks and Bioresources; ESBB member. 

Author and Concept creator of Wroclaw Medical University Biobank-first Integrated Biobank in Poland with ISO 9001:2015 Quality Certificate “Biobanking for scientific, R&D and educational purposes” with nomination and special award in national competition “Leaders in University Management LUMEN”. Co-author and concept creator of “Quality Standards for Polish Biobanks Handbook”. 

As a BBMRI.pl QMS Team Coordinator, Agnieszka is also responsible for preparation of uniform QMS standards for biological material biobanking for scientific purposes in Polish Biobanking Network and implementation of common solutions in cooperation with BBMRI-ERIC. 

The Auditors

Prof. Dominik Strapagiel is the Biobank Lab Head in the Department of Molecular Biophysics, at the University of Łódź. He leads development of the integrated database which consists of genomic/omics data, health data, clinical data, and phenotypic data collected in the POPULOUS cohort study of the Biobank – Łódź project. He is also involved in the development of the Polish Biobank Network in Poland – BBMRI.pl. 

Dominik Strapagiel is lead auditor for ISO 9001 and ISO 27001 and is Delegate of the Polish Biobanking Node to the Assembly of Members of BBMRI-ERIC. 

Sylwia Dobrowolska is the Quality Manager in the Department of Molecular Biophysics, at the University of Łódź. She graduated biotechnology at the Faculty of Biotechnology and Food Sciences of the Łódź University of Technology. She completed post-graduate studies in Management and Quality Management Systems at the Łódź University of Technology. 

She is an internal auditor of the Quality Management System – ISO 9001 and Information Security Management System – ISO/IEC 27001. In the Biobank Laboratory, she deals with quality management, supervision of the maintenance of the system according to ISO 9001 and biobanking standards. 

Since 2018 Sylwia is also involved in the development of the Polish Biobank Network in Poland – BBMRI.pl.