DIN EN 15224:2017-05

This European Standard specifies requirements for a quality management system when a healthcare organization: a) needs to demonstrate its ability to consistently provide healthcare product or service that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer requirements, applicable statutory and regulatory requirements and requirements related to the quality aspects; 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 and timelines/accessibility. The main changes are the inclusion of risk-based thinking in Clauses 4, 5, 6, 8, 9 and 10, as well as the addition of two new subclauses (4.1 and 4.2.) relating to the context of the organization. This European Standard has been prepared by Technical Committee CEN/TC 362 "Health services - Quality management systems", the secretariat of which is held by SIS (Sweden). Working Committee NA 063-01-10 AA "Qualitätsmanagementsysteme im Gesundheitswesen" ("Quality management systems in health care facilities") at DIN Standards Committee Medicine (NAMed) is responsible for the German collaboration.