Overview: ECRIN’s Quality Management System (QMS)
ECRIN has a quality management system (QMS), which is fit-for-purpose and has been adapted to its distributed infrastructure. It follows a risk and process-based approach, which is founded on the recommendations of the ISO 9001:2015 standard and the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP E6 (R2)).
It aims to coordinate and structure the organisation’s activities to meet customer and regulatory requirements, and to improve effectiveness and efficiency on an ongoing basis.
ECRIN is currently pursuing certification with ISO 9001:2015, the international standard specifying requirements for QMSs.
Scope and Application
ECRIN’s QMS covers all activities performed or delivered by the organisation and aims to ensure excellence in these activities.
The application of the ECRIN QMS is multi-faceted. On the one hand, it applies to ECRIN’s internal stakeholders, i.e. the ECRIN core team and European correspondents working in member and observer countries. It also applies to any external entities involved in ECRIN activities and services.
ECRIN (given its coordinating role and responsibility bestowed by the sponsor) must ensure that delivered services meet the sponsor’s expectations and are compliant with regulatory and quality requirements.
Quality as a Service
In addition to its QMS, ECRIN offers 'quality as a service'. One such service is data centre certification. The programme involves evaluating non-commercial data management centres (primarily in ECRIN member/observer countries) for compliance with published ECRIN data standards through on-site audits.