SBP’ involvement in BBMRI-ERIC activities
Working Group Quality focuses mainly on the implementation of quality tools for biobankers and researchers. A quality grade – determined by self-assessment surveys for CEN Technical Specifications (CEN/TS) – will be introduced to enhance the visibility of European biobanks, by highlighting them in the BBMRI-ERIC Directory. An audit program concept paper is under development, supporting biobanks in reaching certification and accreditation by authorized national qualification bodies.
In 2017 there were three main objectives:
- Enhancing visibility of biobanks in the BBMRI-ERIC Directory by introducing a quality grade;
- Concept paper development of the audit program: provide quality consultancy and peer-review audits;
- Contribution to international standard developments: ISO/TC 276 Biotechnology as well as ISO/TC 212 Clinical laboratory testing and in vitrodiagnostic test systems.
SBP participates in Sub-WG 5, initiated in 2016 as the general quality management group for biobanks. During monthly conference calls the following topics were discussed:
- Review of the self-assessment surveys developed to determine the quality grade of a biobank;
- Each month a different country presents its current activities. In September 2017 it was Switzerland’s turn and SBP presented its quality strategy. In addition, Liquid Biobank Bern gave insights into their quality management system;
- Concept development of the audit program.
With regards to this WG, SBP is leading the field strategically with its expertise in future ISO standards ahead of time and enabling future development to be influenced and developed by Swiss stakeholder requirements. In that context, SBP was the reference body for collecting comments on the future ISO 20387 for Switzerland in July 2017.
SBP was and will continue to be active in the development of the BBMRI-ERIC self-assessment surveys. Moreover, SBP will advise on the construction of the audit program.