The EN 15224 is a sector specific standard of quality management for healthcare organisations. It is based on the ISO 9001 standard and it includes tangible requirements for patient safety and management of clinical risks in the planning, realisation and management processes.
The EN 15224 system brings together the advantages of ISO 9001 with comprehensive healthcare quality requirements. It defines issues ranging from the effectiveness and suitability of care, to the safety and reliability of care processes. In EN 15524, there are 11 quality features which characterise the quality of healthcare and must be verified as part of a certification.
The 11 central features of EN 15224 are: