BS EN 15224:2016 specifies requirements for a quality management system when a healthcare organization:

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


Cross References:
EN ISO 9000:2015
ISO 9000:2015
EN ISO 9004
ISO 10001
ISO 10002
ISO 10003
ISO 10004
ISO 10005
ISO 10006
ISO 10007
ISO 10008
EN ISO 10012:2003
ISO 10012:2003
ISO/TR 10013
ISO 10014
ISO 10015
ISO/TR 10017
ISO 10018
ISO 10019
EN ISO 14001
EN ISO 19011
ISO 31000
ISO 37500
ISO/IEC 90003
EN 60300-1
IEC 60300-1
EN 61160
IEC 61160
ISO 9001
EN ISO 9001:2015
ISO/IEC 27000:2009
ISO/IEC 27001:2005
EN ISO 13485:2016
ISO 13485:2016
EN ISO 13940:2016
ISO 13940:2015
ISO/TR 20514:2005
ISO Guide 73:2009
ISO 704:2009
ISO 860:2007
EN ISO 9004:2009
ISO 9004:2009


All current amendments available at time of purchase are included with the purchase of this document.