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 flagging them in the BBMRI-ERIC Directory. An audit program concept paper is under development, supporting the biobanks to reach certification and accreditation by authorized national qualification bodies.
In 2017 focus was laid on 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 vitro diagnostic test systems.
SBP participates in Sub-WG 5, which was initiated in 2016 and handles the general quality management for biobanks. In regular monthly telephone conferences the following topics were/are discussed:
- Review of the self-assessment surveys developed to determine the quality grade of a biobank;
- Presentation of the current activities in the national nodes: in each telephone conference a different country. In September 2017 it was Switzerland’s turn and SBP presented its quality strategy. In addition, the Liquid Biobank Bern gave insights on their quality management system;
- Concept development of the audit program.
As part of this WG, SBP is strategically one step ahead and brought expertise in preparing for relevant future ISO standards before they are publicly available and allowing their development to be influenced according to Swiss stakeholders needs and expectations. 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 being active in the development of the BBMRI-ERIC self-assessment surveys. Moreover, SBP will advise on the construction of the audit program.