scope:

This European 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 and timelines/accessibility. Material products such as tissue, blood products, pharmaceuticals, cell culture products and medical devices have not been focused in the scope of the standard as they are regulated elsewhere. This European Standard is focused on requirements for clinical processes. Organizations that also include research or education processes, or both in their quality management system could use the requirements in this European Standard where applicable. This European Standard aims to adjust and specify the requirements, as well as the "product" concept and customer perspectives in EN ISO 9001:2008 to the specific conditions for health care where products are mainly services and customers are mainly patients. The focus of this European Standard is the clinical processes and their risk management in order to promote good quality health care.