EN 15224:2016

Certification of quality management systems of health care


Institutions operative in the health and social services are facing particular challenges. As a leading organization for certification and assessment, the Swiss Association for Quality and Management Systems (SQS) is rendering a significant contribution to strengthening these institutions and their positioning in the healthcare market. Due to the rapidly changing technology and to continuously rising costs, a process oriented quality management system in the health and social services is a question of survival. Linked with these issues are the continuous process improvement and the achievement of an above-average quality of results. Therefore, a certified quality management system is providing an excellent basis.


EN 15224 «Quality management systems - EN ISO 9001:2015 for health care» is specifically tailored to health- and social services providers. The standard EN 15224 is based on the ISO 9001 standard and it is translating it for the specific requirements of health care organizations. Eleven quality features are defined in the EN 15224 standard:
- Appropriate and accurate care
- Availability
- Continuity of care
- Effectiveness
- Efficiency
- Consistency
- Evidence-based / knowledge-based care
- Patient-focused care, including physical, psychological and social integrity (ICF)
- Involvement of the patient
- Safety of the patient
- Timeliness/accessibility.

The standard EN 15224 is in extracts referring to the following additional requirements: Clinical process and risk management, patient orientation and patient safety, knowledge management, internal communication and protection of data.

Target groups

Target groups are public hospitals, private clinics, individual and group medical practices, institutions of the long-term scope as well as other organizations of health care of welfare.


Three years - annual surveillance audits and after three years a re-certification audit are conducted in the scope of continuous improvement.


SQS certificates are internationally valid and world-wide recognized through the IQNet partnership.


The standard EN 15224 can be combined with further system standards (in particular with ISO 9001 - Quality management) and it is suitable to fulfill health specific branch requirements as well to support further development towards business excellence.

Lead Auditor
Gisela Kessler-Berther
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