In march 2017 the update of EN 15224 was completed. This standard is a sector specific quality management standard for health care organizations and has incorporated the complete ISO 9001:2015 and some specific requirements, like clinical risk management. In order to promote high-quality health care, elements of ISO 9001 are extended by the addition of further aspects.
First and foremost these are the eleven quality features which should be a reference point in quality policy, quality planning and quality objectives. In addition to risk management the clinical risk management is highlighted explicitly, since risks in the core process and the security of patients have been becoming an increasingly important issue in the health care sector. The diffusion of the EN 15224 standard in the health care system has increased significantly. Especially regarding newly implemented quality management systems this standard is starting to get ahead of ISO 9001 certifications.
In the center of interest are clinical risk management, compliance with additional legal/regulatory burdens and the eleven quality features:
- adequate and correct health care
- continuity of health care
- health care based on evidence/knowledge
- health care focusing on the patient, including the physical,
- psychological and social integrity
- involvement of the patient
- patient safety and security
In principle, the standard is applicable for all service providers active in this sector as well as for doctors’ offices, hospitals, nursing homes, hospices, health care institutions, psychiatric nursing institutions, dentists’ offices, physiotherapeutic institutions, institutions providing labour protection services and pharmacies.
ISO 9001, ISO 13485, ISO 14001, ISO 27799, ISO 31000
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