EN 15224 Quality management systems – EN ISO 9001:2015 for Healthcare

By: | Tags: | Comments: 0 | July 4th, 2022

What is standard EN 15224?

This European Standard specifies requirements for a quality management system of healthcare organization. It brings together the advantages of ISO 9001 with comprehensive healthcare quality requirements, focusing on patient safety and management of clinical processes and risks. The term “clinical” refers to all means of interaction between patients and health care staff.


Like other management standards, this standard focuses on processes, where requirements related to material outputs such as tissue, blood products, pharmaceuticals or medical devices have not been focused in the scope of this standard as they are regulated elsewhere. This standard aims to adjust and expand EN ISO 9001:2015 requirements, maintaining the ISO “product and service” concept and focus on customer to the specific conditions of healthcare services considering patients as customers.

Aimed users?

The Standard is directed towards all healthcare providers such as hospitals, outpatient clinics, nursing homes, healthcare centers, diagnostic centers, private surgeries, dental practices, pharmacies, IVF centers, rehabilitation centers, post-treatment facilities, etc.


In EN 15224, there are eleven central aspects which characterize the quality of healthcare:

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

Latest edition (EN 15224: 2017) follows the basic structure of the quality management standards (High Level Structure), adopts all changes to ISO 9001 and adds interpretations, explanations, examples and additional requirements for healthcare.

What are the benefits of compliance with this Standard?

There are numerous benefits to complying with EN 15224 and all of them aim for long-term improvement of healthcare services. Also, full and smart implementation of the requirements:

  • ensures compliance with the applicable healthcare legislation
  • enhance organization credibility among patients
  • improve functionality of processes and boost productivity
  • reduces complaints from patients and/or their escorts
  • reduces operating costs
  • ensures management and prevention of clinical risks
  • enables more flexible response to changes and market requirements

Can organizations get certification according to this standard?

Yes. All above mentioned healthcare providers can be certified according to EN 15224. Generally, certification is not mandatory, however healthcare organizations who want to prove they operating in accordance with this Standard, may request a certification by accredited certification body.



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