ΕΝ 15224:2012

Healthcare services – Quality management systems. Requirements based on EN ISO 9001:2008

The standard EN 15224 combines the advantages of ISO 9001 with the quality requirements of health services. It defines the issues that include the efficiency, the adequacy, the safety and reliability of healthcare processes. EN 15524 includes 11 quality characteristics of the healthcare services.

These 11 characteristics are as follows:

  1. Appropriate, correct care
  2. Availability
  3. Continuity of the care
  4. Effectiveness
  5. Efficiency
  6. Consistency
  7. Care based on evidence and knowledge
  8. Patient care, including physical, psychological and social integrity of the care
  9. Involvement of the patient
  10. Patient safety
  11. Prompt care and accessibility

The standard requirements can be applied to all healthcare organizations, such as primary, secondary and higher provision of healthcare services, hospitals, clinics, rehabilitation services, chronic diseases handling, healthcare centers, diagnostic laboratories, private practices, dental practices, pharmacies, nursing homes, provision of services for people with special needs etc. 


  • Improvement of provision of health services to the clients,
  • Assurance of compliance with laws and other requirements,
  • Management commitment regarding provision of high quality services,
  • Improvement of adequacy and working conditions of personnel,
  • Saving of resources by reduction of costs due to low/deficient quality,
  • Improvement of communication between departments,
  • Reduction of resources needed for risk assessment,  
  • Improvement in the control of documents, data and files,
  • Cost reduction in the material and medication management,
  • Reduction of the patients’ complaints,
  • Improvement of the positive attitude of personnel towards quality issues,

TÜV HELLAS offers certification services according to ΕΝ 15224:2012 with extensive experience in Quality Systems Certifications of healthcare organizations, both of the public and private sector. The audit teams of TÜV HELLAS are composed by experienced healthcare experts, such as doctors, nurses, biologists etc.

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