The draft of the EN15224 states:
This is a sector specific quality management system standard for health care organisations. This standard is based on ISO 9001:2008 and replaces EN/TS 15224:2005 Health services – Quality management systems – Guide for the use of EN ISO 9001:2000.
This is a stand alone standard and can be used for certification in health care. The requirements in this standard are based on ISO 9001:2008 with interpretations and specifications for health care. The requirements have been modified and clarified according to the specific health care context.
This quality management system does not include environmental aspects. Therefore it is recommended that organisations that apply a management system also apply an environmental management system according to EN-ISO 14001.
The structure of this quality management system standard is congruent with the structure of the environmental management system standard.
New requirements have been added when considered relevant. This standard also includes aspects related to clinical risk management throughout the planning, operation and control of processes. The congruence and difference between this standard, ISO 9001:2008 and EN/TS 15224: 2005 are explained in this introduction and in cross reference tables (Table 1 and 2).
A practical guide for the implementation of this standard in health care organisations is presented in Annex A.
A preview of the document draft is available here