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The team at Auria Biobank, part of Turku University Hospital’s Laboratory Division, have achieved ISO 20387:2020 accreditation. This makes Auria the fourth BBMRI-ERIC member biobank to demonstrate quality to this international standard.
Andrea Wutte, Head of Quality Management at BBMRI, said of the accreditation:
“It is a pleasure to see the development of Auria Biobank since 2015. In 2017, they were awarded a BBMRI-ERIC Quality Label for a sample collection at the biobank.
The entire team of Auria Biobank, and especially Aulikki Santavuori, had a clear goal in mind all these years; to prove the competence of their biobank activities, not only to keep samples of the highest quality available for research purposes, but to also show society that the samples donated are treated with the utmost care. This clearly promotes trust in scientific research.”
Andrea (AW) spoke with Aulikki Santavuori (AS), Auria’s Quality Manager, about their achievement.
AS: Accreditation is the verification of competence. It is a procedure that reliably states the competence of an operator according to international criteria. Accreditation of biobanking is used to ensure the competence, impartiality and consistency of biobanks to ensure traceability and high-quality handling of the biological materials and related data. Customers (both academic and industry researchers), authorities and operators in the industry can rely on the service quality of an accredited operator.
AS: Auria submitted its application to FINAS (Finnish Accreditation Service) at the end of January 2022 and received the decision in December, so the whole accreditation process lasted almost throughout the year 2022.
The accreditation process included three assessment visits to the premises of the biobank (preliminary and two technical assessment visits). Several biobank employees were interviewed during these visits. The processes of processing and storing of samples were monitored in the laboratory.
In addition, the application was accompanied by several documents to be reviewed by FINAS. As the result of evaluation visits of FINAS, we received a list of deviations from the standard. After giving a correction plan for every deficiency, it was possible to obtain a positive accreditation decision.
Application submission and evaluation visits were, however, a kind of tip of an iceberg in the process. The preparatory work started immediately in August 2018, when the standard ISO 20387:2018 was published.
Under the leadership of the Quality Manager, but together with the entire biobank staff, we self-assessed our quality management system and evaluated which requirements we already met and which are items that we needed to improve further.
According to the to-do list created as described before, progress was made step by step until we thought that we could submit the application to FINAS. However, we had a good basis, after all, we had built our Quality Management System from the start of our operations since 2014.
There was still a lot of work to be done, and we wouldn’t have moved to this point without the active involvement of our employees. So, the greatest thanks to them for this achievement!
AS: We hope, that when researchers are seeking for biological samples or associated services offered by biobanks, they will choose Auria Biobank.
AS: Of course, I would suggest:
AS: Concerning accreditation, we will continue to develop our quality management system. Now the scope of accreditation includes certain liquid samples (whole blood, serum, plasma, DNA, cerebrospinal fluid), but in the future, we may apply an extension and include the tissue samples, too in the scope of accreditation.
However, at the moment, the organisation of public healthcare, social welfare and rescue services will be reformed in Finland. The responsibility for organising these services will be transferred from municipalities to wellbeing services counties from 1.1.2023. This reformation also affects the operation and organisation of biobanks.
Auria Biobank received FINAS-accreditation decision on 20 Dec 2022 (accreditation standard SFS-EN ISO 20387:2020*).
*Standard ISO 20387:2018 has been approved by CEN to a European standard EN ISO 20387:2020, which has the status of a Finnish national standard SFS-EN ISO 20387:2020. Details of the scope of the accreditation, see B001.