EN 15224:2012

Health care services - Quality management systems - Requirements based on EN ISO 9001:2008

Publication date:   May 17, 2013

Scope

1.1 General
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 and psychological 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.
1.2 Application
This European Standard
a) gives requirements for systematic approaches for the organization’s ability to produce good quality health care.
b) can be used by management at all levels in the health care 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 those from other customers.
c) is applicable to health care organizations, regardless of structure, organization, owner, size or type of health care services provided.
d) is applicable to e.g. primary health care, pre-hospital and hospital care, tertiary care, nursing homes, hospices, preventive health care, mental health services, dental services, physiotherapy, occupational health services and pharmacies.
e) 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.
Where any requirement(s) of this European Standard cannot be applied due to the nature of a health care organization and its product (including services), this can be considered for exclusion.
Where exclusions are made, claims of conformity to this European Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the health care organization’s ability, or responsibility, to provide products (including services) that meets customer and applicable statutory and regulatory requirements.