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UNE 15224 Healthcare Services
Application of Standard ISO 9001 for healthcare services

UNE 15224 Healthcare Services

Application of Standard ISO 9001 regarding healthcare services

The Standard UNE 15224 for Healthcare Services is a standard for the specific quality management system of the healthcare services sector.

The requirements of this standard exhaustively incorporate those of standard ISO 9001:2015 with additional requirements, specifications and interpretations for health services. The requirements have been added whenever this was deemed relevant, and the high requirements have been clarified in accordance with the specific healthcare context. This standard includes aspects related with clinical risk management in planning, operational and control processes.

This standard identifies eleven basic quality aspects that clinical experience demonstrates, and which are adapted to the needs of healthcare organisations.

Implementing this standard allows organisations to understand the quality aspects identified in their healthcare services, processes and systems, to then specify and determine quality characteristics that must be assessed. Using the process-based focus, recommended in the standard ISO 9001:2015, said objective is achieved by the systematic management of the clinical process, with the benefit that this leads to in an efficient and effective health service, and an improvement of the health centre's image among patients, employees and society.


UNE 15224 certification for Healthcare Services can be perfectly integrated with the management system ISO 9001.

Once the Audit process is complete, if the system set up adapts to the requirements of the Lean management scheme, the organisation obtains:

  • The AENOR Certificate for Healthcare Services
  • The licence to use the UNE 15224 Mark for Healthcare Services by AENOR.

Furthermore, organisations with management systems certified by AENOR have free access to the AENORnet and a subscription to the AENOR monthly magazine.


AENOR Certificate for Healthcare Services

AENOR Mark for Healthcare Services


AENOR has extensive experience in specific certifications for the medical-hospital sector.