Quality Management Systems for Healthcare Services (EN 15224)

Brief description

EN 15224 is a specialized standard that concerns application of a quality management system in the healthcare sector.

Detailed description

This standard covers the requirements of ISO 9001:2015 and, incorporating additional requirements for patient safety and the management of clinical risks, is an excellent choice for organizations that provide healthcare services.
Compliance with this standard enables an organization to aim for long-term improvement of its healthcare services. EN 15224 certification will not only increase an organization’s organizational effectiveness and the quality of its services, but will also avert potential errors. It also improves an organization’s commerciality, giving it global promotion and earning it consumers’ confidence through its commitment to provide consistently high-quality services.

EN 15224 defines eleven quality aspects:

  • Appropriate, correct care
  • Availability
  • Continuity of the care
  • Effectiveness
  • Efficiency
  • Consistency
  • Evidence-based, knowledge-based care
  • Patient care, including the physical and psychological integrity of the care
  • Integration of the patient
  • Patient safety
  • Timeliness and accessibility

What is the certification procedure?

We propose a link to the Regulation and the application for all the standards.

Certification Regulation

Who is it for?

This certification can be applied to all organizations that provide healthcare services, including primary, secondary and tertiary healthcare services, hospitals, clinics, rehabilitation or palliative care services, chronic diseases handling, healthcare centers, diagnostic centers, private surgeries, dental practices, pharmacies, nursing homes, provision of services for people with special needs, etc.

What are the benefits of certification?

The advantages of application and certification of an EN ISO 15224 Quality Management System are as follows:

  • Demonstrating the ability of the Management System to ensure that the company complies with the legislative, regulatory, and contractual requirements concerning its services
  • ensures the healthcare unit’s compliance with the requirements of the applicable national and European legislation
  • improves the services provided for customers/patients
  • reduces complaints from patients and/or their escorts
  • reduces operating costs
  • ensures management and prevention of clinical risks


Who do I contact for certification?

Customer Service Department Contact Person: Ms. Anna Topaltziki, Tel: +30 210 5220920, Ext: 2064

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