Quality management standard EN 15224 was developed specifically for the health sector. It is aimed at medical practitioners, hospitals, and any institutions engaged in nursing or other health care. The emphasis of this standard is on hospital process and risk management. Both components are strong indicators of the degree of quality care in your institution.

Basically, the requirements of EN 15224 agree with those of ISO 9001. However, EN 15224 requires more. It defines a total of eleven quality characteristics for health care, and emphasizes that the management of clinical risk is included in all processes for planning, execution, and control.

The 11 central features of DIN EN 15224 are

  • Appropriate, correct care
  • Availability
  • Continuity of the care
  • Effectiveness
  • Efficiency
  • Consistency
  • Evidence-based, knowledge-based care
  • Patient care, including physical and psychological integrity of the care
  • Integration of the patient
  • Patient safety
  • Timeliness and accessibility

It is an independent and domain-specific standard. It can be applied by all organizations, clinical services within the meaning of the standard, including providing research and training associated. “Clinical” is here understood as a context, “in which patients and staff of care for a health problem interact”. The application therefore extends far beyond the medical activity, namely to detect diseases to cure, mitigate or prevent them, also on the care, physiotherapy and health. The EN 15224 can be used to certify health care organizations in the European conformity assessment procedure.