scope:

This international standard specifies requirements for a quality management system when a healthcare organization:

a) needs to demonstrate its ability to consistently provide healthcare product or service that meets customer and applicable statutory and regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer requirements, applicable statutory and regulatory requirements and requirements related to the quality aspects; 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.

All the requirements of this International Standard are generic and are intended to be applicable to any health care organization, regardless of its type or size, or the products and services it provides.

NOTE 1 In this standard the terms "product" or "service" only apply to products and services intended for, or required by, a customer.

NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

Requirements related to material outputs such as tissue, blood products, pharmaceuticals, cell culture products and medical devices are not the focus of the scope of this standard as they are regulated elsewhere.

This standard is focused on requirements for management of clinical processes. Organizations that also include research or education processes in their quality management system could use the requirements in this standard where applicable.

This standard aims to specify and complement the requirements in EN ISO 9001:2015 to the specific conditions for healthcare providing mainly services and where customers are mainly patients.

Application

This standard:

a) gives requirements for systematic approaches for the organization's ability to produce good quality healthcare services;

b) can be used at all levels in the healthcare organization to implement and maintain a quality management system or by internal and external parties, including certification bodies, to assess the organization's ability to meet patients' needs and expectations as well as those from other customers;

c) is applicable to healthcare organizations, regardless of structure, organization, owner, size or types of healthcare services provided;

d) is focused on requirements for clinical processes. Organizations that also include research or education processes, in the scope of their quality management system could use the requirements in this standard where applicable.