20 years

EN 15224

Quality System in Healthcare Organizations

The standard EN 15224 concerns Health Care Services. Its requirements incorporate those of EN ISO 9001: 2015 with additional interpretations and specifications. It also includes aspects related to clinical systems throughout the design, operation and control of processes.

In the standard EN 15524, there are the following 11 quality characteristics that characterize the quality of health services:

  • Suitable and proper care
  • Availability
  • Continuity of care
  • Efficiency
  • Perfomance
  • Equality
  • Documented Care
  • Patient-centered care
  • Patient participation
  • Patient safety
  • Compliance with deadlines / accessibility

The term EN 15224 introduces the term clinical risk, which indicates any risk that could adversely affect the results for any of the quality requirements.

There are three types of direct customer-centric (patient-centric) processes in healthcare organizations:

  • Clinical processes,
  • Research processes and
  • Training processes.

This European standard EN 15224 applies to primary health care, pre-hospital and hospital care, tertiary care, nursing homes, asyla, preventive health care, mental health services, dental services, physiotherapy, and pharmacies.

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