ELOT EN 15224:2017
Quality Management Systems for Healthcare

WHAT IS ELOT EN 15224:2017?

This standard incorporates EN ISO 9001:2015 and adds interpretations, explanations, examples and additional requirements for healthcare organizations. The standard also includes aspects related to clinical risk management throughout the planning, operation and control of processes the standard identifies eleven basic quality aspects that by clinical experience are known to be relevant in healthcare organizations. To assess fulfilment of quality requirements the organization need to specify quality characteristics related to these requirements.

These aspects are:

  • appropriate, correct care.
  • availability.
  • continuity of care.
  • effectiveness.
  • efficiency.
  • equity.
  • evidence/knowledge based care.
  • patient centred care including physical, psychological and social integrity (ICF).
  • patient involvement.
  • patient safety.
  • timeliness/accessibility.


ELOT EN 15224:2017 is applicable to healthcare organizations, regardless of structure, organization, owner, size or types of healthcare services provided.


The basic benefits from setting and implementing a Quality Management System according to the requirements of this standard are the following:
  • Continuous improvement of the quality of healthcare services to the clients
  • Conformance with legal and regulatory requirements
  • Substantial contribution to the development and sustainability of the organization
  • It provides the organization with a competitive advantage as regards the provision of high quality of healthcare services

How to Apply?

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