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The SR EN 15224: 2013 standard defines the specific requirements for the application of the ISO 9001/2008 standard in the medical system. Thus, the standard is intended for the certification of hospital units with beds in continuous and day-care hospitals, specialized ambulators and integrated hospitals, individual medical practices, research centers and excellence.

The standard applies in the health care system the key principles of quality management: the approach based on process, leadership, fact-based approach in decision-making and patient satisfaction assessment, the requirement becomes mandatory for hospital units.

The standard also emphasizes the need to identify and assess clinical risk in order to reduce to eliminate malpractice cases. In other words, SR EN 15224: 2013 covers the full range of sanitary management, being complementary and perfectly integrated with the performance indicators established by the Ministry of Health and with the ANMCS – National Authority for Quality of Health Management.

For state hospitals, the implementation of the SR EN 15224: 2013 standard also meets the requirements of the specific managerial internal control regulations regulated by OSGG 600/2018.

The advantages of implementing and certifying the ISO 15224 standard:

  • the knowledge and application of specific legal requirements in the health care field,
  • the identification, understanding and management of medical,
  • research and educational processes as well as supporting supporting processes,
  • contributing to the effectiveness and efficiency of achieving the objectives proposed by the management of the sanitary units,
  • the continuous improvement of the overall performance of the sanitary units, the reduction of the clinical risks and the maximization of the patient satisfaction,
  • the increase of the score awarded by the CNAS and CASA OPSANJ,
  • obtaining a better score in the hospitalization accreditation process, to improve internal communication (vertically and horizontally),
  • to facilitate access to non-reimbursable funds in the medical field,
  • to increase managerial skills in order to involve staff in reducing non-conformities in the complementary health services it also uses the techniques, methods and tools of quality management in the sanitary units.