DIN EN 15224:2016-04

This is a sector specific quality management system standard for healthcare. This standard incorporates EN ISO 9001:2015 and replaces EN 15224:2012 Health services - Quality management systems - Requirements based on EN ISO 9001:2008. This is a standalone standard and can be used for certification of healthcare organizations. The requirements in this standard comprehensively incorporate those from EN ISO 9001:2015 with additional requirements, specifications and interpretations for healthcare. Requirements have been added when considered relevant and existing clarified according to the specific healthcare context. This standard also includes aspects related to clinical risk management throughout the planning, operation and control of processes. This standard includes requirements for quality management but does not specify requirements for specific healthcare services. The quality management system requirements specified in this standard are complementary to requirements for healthcare products and services.