scope:

1.1 Main purpose This standard aims to adjust and specify the requirements, as well as the "product" concept and customer perspectives in ISO 9001 to the specific conditions for health care where products are mainly services and customers are mainly patients. The focus of this standard is the health care processes and clinical processes and their risk management in order to promote good quality care. This standard is focused on requirements for health care processes and clinical processes. Organisations that also include research and/or education as core processes could use the requirements in this standard where applicable. This standard specifies requirements for a quality management system where an organisation: 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 health care processes and clinical processes and the assurance of conformity to requirements related to the quality characteristics (3.11); appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical and psychological integrity; patient involvement; patient safety and timelines/accessibility. Material products such as tissue, blood products, pharmaceuticals, cell culture products have not been focused in the scope of the standard as they are regulated elsewhere; for example, ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.