Overview

This standard specifies requirements for a quality management system where an organization: a) needs to demonstrate its ability to consistently provide health care services that meet requirements from customers as well as applicable statutory and regulatory requirements, and professional standards; b) aims to enhance customer satisfaction through the effective application of the system, including continual improvement of the management system, the clinical processes and the assurance of conformity to requirements related to the quality characteristics; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical, psychological and social integrity; patient involvement; patient safety, timelines and accessibility. Compared with the previous edition CEN/TS 15224:2005 (Technical Specification), this European Standard is not only a guideline for the health care industry on the interpretation of EN ISO 9001 for the implementation of a quality management system, but it is a stand-alone standard to be used as a basis for the certification in health care. The European Standard EN 15224 has been prepared by Technical Committee CEN/TC 362 "Health services - Quality management systems" (secretariat: SIS, Sweden) with the collaboration of German experts. Working Committee NA 063-01-10 AA "Qualitätsmanagementsysteme im Gesundheitswesen" ("Quality management systems in health care facilities") of the Medical Standards Committee (NAMed) is responsible at DIN, the German Institute for Standardization e. V.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-01-01 AA - Quality management systems in health care facilities  

Responsible european committee

CEN/TC 362 - Healthcare services - Quality management systems