

The requirements of this standard include the requirements of EN ISO 9001:2008, but they have an applicability that is specific for the health system (public or private) and they are founded on the key principles of the medical system: process approach, leadership, factual approach to decision making, assessment of patient’s satisfaction, requirement of the Ministry of Health that became obligatory starting February 2015 for hospitals. SR EN 15224:2013 also includes aspects related to clinical risk management, both for the reduction up to elimination of the malpractice cases, and for the preventive and adaptive management of the research activities in the research centers, university hospitals, and medical faculty and excellence centers. In other words, SR EN 15224:2013 covers the whole managerial area from the health care system, the scope being complementary and perfectly integrable with the performance indicators established by the Ministry of Health for hospitals, with the standards specific for hospitals’ accreditation, and with the requirements of Order 946/2005 regarding the internal financial control.
Unlike SR EN ISO 9001:2008 that addresses especially to the other economical areas, SR EN 15224:2013 is specifically tailored to the needs of healthcare providers: hospitals, inpatient and outpatient care facilities, doctors’ offices, research and excellence centers, including educational system from the medical field.
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