Organization and Quality Management in Research Office
In order to achieve its Mission and Vision, the IRCCS Ospedale San Raffaele promotes and sustains the quality principles and good practices through designing, implementing and improving the Management System and internal processes. Since 2009 Ospedale San Raffaele has established the Organizational Development and Quality Management in Research Office (O&Q Office) to foster quality principles both in basic and clinical research.
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Definition, maintenance and alignment of the research organizational structure and processes:
- Organizational design and alignment
- Development and updating of internal regulations.
Promotion, assurance and improvement of the Quality Management System and Good Practices in Research:
- Process analysis and improvement;
- Development and review of procedures, policies and guidelines;
- Management of non-conformities and corrective and preventive actions (CAPAs);
- Training and tutoring;
- Supervising and supporting basic and clinical Research Units in the implementation of Quality System and relevant certification paths (i.e. ISO, GCP, GCLP), also acting as ISO and GCP Auditor, as well as GCP Quality Assurance.
Our office collaborates and is closely connected with other OSR’s departments and offices, especially with Medical Directorate, Quality Accreditation and clinical Risk Management Area, Clinical Trial Office, Research Integrity Office, Human Resource Department.
Furthermore, we nurture professional relationships also with external experts mainly through the SIMeF (Italian Society of Pharmaceutical Medicine) and the GIQAR Group (Italian Research Quality Assurance Group).