Systematic quality focus in the healthcare sector
The publication of EN 15224 means that for the first time there is a European Standard for quality management systems in the healthcare sector. EN 15224 is based on the overarching quality management standard ISO 9001, to which fundamental aspects of healthcare have been added. The independent but specific standard EN 15224 is directed towards all healthcare providers, primarily hospitals.
Within the complex and sometimes confusing area of certification service provision, the new standard makes an important contribution to greater clarity and improved comparability. It takes the particular needs of healthcare, with its extensive quality requirements, into consideration; the certification – which is based on the process approach – focuses on patients and in particular on patient safety.
Further development of quality management
In order to achieve certification, a quality management system based on ISO 9001 should already be in place and should be developed further in accordance with EN 15224. The quality management system is then audited taking the special management of clinical processes and their risks into consideration. Following successful completion of the audit, the organisation can provide objective evidence that it systematically places the patients and stringent quality requirements at the core of its activities.