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ONORM EN 15224:2017
Quality management systems - EN ISO 9001:2015 for healthcare (Austrian Standard)
EN 15224 is a sector specific quality management system standard for health care organisations. It is based on ISO 9001:2008 and replaces CEN/TS 15224:2006 Health services - Quality management systems - Guide for the use of EN ISO 9001:2000. This is a stand alone standard and can be used for certification in health care. The requirements in this standard are based on ISO 9001:2008 with interpretations and specifications for health care. The requirements have been modified and clarified according to the specific health care context. This quality management system does not include environmental aspects. Therefore it is recommended that organisations that apply a management system also apply an environmental management system according to EN ISO 14001. The structure of this quality management system standard is congruent with the structure of the environmental management system standard. New requirements have been added when considered relevant. This standard also includes aspects related to clinical risk management throughout the planning, operation and control of processes.
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Austrian Standards Institute [on]
