The team at Auria Biobank, part of Turku University Hospital’s Laboratory Division, has achieved ISO 20387:2020 accreditation. This makes Auria the fourth BBMRI-ERIC member biobank to demonstrate quality to this international standard.
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, Auria 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.
– 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, said Andrea Wutte, Head of Quality Management at BBMRI.
Auria Biobank continues to develop their quality management system. The current scope of accreditation includes certain liquid samples (whole blood, serum, plasma, DNA, cerebrospinal fluid). In the future, Auria may apply for an extension and also include the tissue samples in the scope of accreditation.
– 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, said Aulikki Santavuori, Auria’s Quality Manager.
Background to the award
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.