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EN 15224

The international standard EN 15224:2012 – Health care services. Quality management systems. Requirements based on ISO 9001:2008.

Standard EN 15224:2012 is designed specifically for the health care sector.

It is applicable to any organization that provides health care and care of patients, as well as for practitioners.

This quality standard is based on ISO 9001:2008 and takes into account the specifics of the health care institutions. Requirements of the ISO 9001:2008 are extended and include clarification, interpretation and additional specifications for health services.

Requirements of the standard are focused on the European standards of hospitals service quality.

The standard focuses on the health services delivery and risk management. These two important components indicate the degree of the quality of care provided to the patient.

The success of the standard in the EU due to increased competition of health care institutions and clients’ choice who are focused on safety, reliability, quality and transparency of health services.

EN 15224:2012 specifies a total of eleven qualitative characteristics of health services and highlights that the management of clinical risk is a part of all processes (planning, service delivery, quality control).

Advantages of this standard: improving patient safety, accessibility, effectiveness, efficiency of services, adequate and proper care of the patient, as well as improving safety culture and continuous improvement of service quality.

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