Health care services - Quality management systems - Requirements based on EN ISO 9001
The quality management standard EN 15224 was specifically developed for the healthcare system. For the first time since the publication in December 2012, there is a single European and sector-specific standard for the healthcare system.
It is aimed at medical practitioners, hospitals, and any institutions engaged in nursing or other health care.
Essentially, the requirements of EN 15224 coincide with those of ISO 9001. However, the EN 15224 demands a lot more. With its focus on risk management and patient safety, this standard goes much further than other quality management systems. It defines a total of 11 quality characteristics for healthcare system and emphasises that the management of clinical risks is involved in all planning, execution and control processes.