The standard EN 15224 has been developed as a Sector Specific Quality Management System Standard in Healthcare, in order to combine the advantages of ISO 9001 with the particular quality requirements in health services.
EN 15224 was published in 2012 and was revised in 2016 to follow the new version of EN ISO 9001:2015.
As described in the forward of EN 15224, there are several potential benefits:
“The potential benefits to a healthcare organization of implementing a quality management system based on this standard are:
The World Health Organization (WHO), has defined Health as "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity" and has also identified as important for Health, the “five health components; body function, body structure, activity, participation and environmental factors”
The above are the basis and background for the concept of Health throughout the Standard.
Consequently, there are 11 quality characteristics described in this standard, which must be related to the quality requirements for each specific Healthcare Organization, either for Clinical Processes, or Resources, Support, Management and Administrative processes.
These 11 characteristics are:
The requirements of this Standard can be applied to all healthcare organizations (healthcare services, hospitals, clinics, rehabilitation services, chronic diseases management, healthcare centers, diagnostic laboratories, private practices, dental practices, pharmacies, nursing homes, provision of services for people with special needs, any support process subcontractors etc.)