Quality Management System
The Quality Management System adopted by the Josep Carreras Leukaemia Research Institute (FIJC) adheres to the stipulations of standard ISO 9001, enabling:
- The ability to coherently provide activities that satisfy the requirements of its interest groups and the applicable regulatory requirements to be demonstrated.
- And the increased satisfaction of the interest groups* through the application of the system, including processes for continuing improvement.
*By interest groups we understand: patients; the scientific community; health authorities; partners; companies; friends; donors; supporters; and society in general.
The Quality Management System has the following structure:
The main documents are:
• Code of Good Governance and Code of Ethics, Code of Conduct, Manual on the Prevention of Money Laundering, Crime prevention Manual.
• Organisational chart, job description for every post, staff qualifications table, welcoming protocol for new incorporations.
• Strategic Plan describing the actions necessary at every level to achieve the mission, its aims and programmes.
• Indicator Dossier and the Annual Report to determine, collate and analyse the appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continuing improvements to the system may be made. Data generated from the monitoring and measuring of results are included as are those from any other relevant source.
• Process Map, through the application of continuing improvement measures to maintain quality in the technical, administrative and operational fields.
• The Risk Evaluation Matrix enumerates the risks each process may present, evaluates their probability and severity, and proposes actions to reduce or eliminate them.
The General Procedures describe specific ways of performing an activity or process, ensuring effective planning, operation and control for every post, as described in the Quality Manual.
The Standardised Operational Procedures describe the specific way to carry out an activity or REDMO procedure.
The Registers are the basis for verifying the correct application of the quality management system, and provide objective evidence concerning the activities performed and the results obtained. The most outstanding ones are:
- Continuous training registers, training plan, certificates, evaluations.
- Quality reports, incident reports including corrective actions.
- Audit results.
- Compliance and administration reports
- Minutes of meetings.
- Monitoring and result measurements, the Indicator Dossier, for example.
In order to determine whether the Quality Management Systemis meeting and maintaining the needs required of it, an Annual Internal Audit is held. The internal auditor is, in turn audited by an external auditor.
