ECRIN was awarded by the French standards association (AFNOR) the ISO 9001:2015 certification on the 30th of November 2020 for its capacity to provide high-quality operational services. ECRIN has, since its creation, applied the ICH GCP E6(R2) requirements but in 2017 began work to further enhance the standardization, effectiveness and performance of its quality management system (QMS). The major challenge related to this achievement being its application in a distributed research infrastructure (one head office with satellites in each member/observer country).
The certification is applied to ECRIN’s three principal services: the coordination of operational services to the management of multinational clinical trials in Europe, capacity development through the participation in infrastructure development projects and the certification of data centres (quality as a service). These services all have proven, effective processes to enable the best possible results to enhance our customer satisfaction.
The QMS at ECRIN is fit-for-purpose and has been adapted to the distributed infrastructure via an integrated, risk and process-based approach which ensures alignment of the quality performance with our external partners. Furthermore, it applies to the ECRIN Core Team based in the Paris head office, the European Correspondents (EuCos) based in the ECRIN member and observer countries, and more broadly to any external organization under contract to perform missions on behalf of ECRIN or external members of ECRIN Boards, where relevant to their mission for ECRIN. All staff are routinely trained on the various standard operating procedures to ensure a clear understanding and application of the “plan, do, check, act” approach.
Among the key principles of the ISO 9001:2015 certification are the importance of the customer focus, the strength of the leadership, strong stakeholder relationship management and the engagement of competent staff. The process-based approach used enables the capacity to identify areas for improvement and act on them as well as advancing the system through evidence. The quality management system will continue to implement improvements post-certification to further these results and prepare for the ISO 9001:2015 follow-up audit.