EN 15224. Quality in healthcare

EN 15224:2016 is an European standard that defines the requirements for a quality management in healthcare services. The standard is applicable for state or private medical facilities and uses as a basis the requirements of ISO 9001:2015 with particular aspects and additional requirements specific for healthcare services.


RIGCERT provides certification to EN 15224:2016 to help demonstrate your performance in healthcare and your efforts to fulfill requirements of interested parties (e.g. patients, next of kin, relatives, authorities).

EN 15224 and the relation to ISO 9001

Although it uses the principles and concepts of quality management developed by the ISO 9000 series of standards and the structure of ISO 9001:2015, EN 15224:2016 addresses the aspects related to the quality of medical services (including clinical processes, research and educational services).

EN 15224 standard identifies eleven basic quality aspects that by clinical experience are known to be relevant in healthcare organizations: appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/ knowledge based care; patient centered care; patient involvement; patient safety; timeliness/ accessibility


Great emphasis is given to the management of clinical risk aiming to identify and treat situations that may lead to negative impacts on the patients’ health.

Certification to EN 15224

EN 15224 certification is applicable to any kind of organization involved in the provision of healthcare services including medical research and education.

The existence of a quality management system according to ISO 9001 represents a starting point to build on in achieving conformity to EN 15224.


Interested in this certification? Contact us at office@rigcert.org!

Get in touch with us!

Welcome to your {38e5eebb5c1380f7017bb98b6adfe22a76404ca792267d725b8f2bdb580a7de4}QUIZ_NAME{38e5eebb5c1380f7017bb98b6adfe22a76404ca792267d725b8f2bdb580a7de4}

Which are the components of the P-D-C-A cycle?
What represents a requirement determined as not applicable to the QMS as per ISO 9001:2015?
Which of the following can be considered post-delivery activities according to ISO 9001:2015?
What is the frequency for internal audits required by ISO 9001:2015?
Which of the following statements is true?

Welcome to your {38e5eebb5c1380f7017bb98b6adfe22a76404ca792267d725b8f2bdb580a7de4}QUIZ_NAME{38e5eebb5c1380f7017bb98b6adfe22a76404ca792267d725b8f2bdb580a7de4}

1. What is the relation between environmental aspects and impacts?
2. Which statement is true according to ISO 14001:2015?
3. The corrective action is?
4. As per ISO 14001:2015 compliance obligations refer to:
5. For determining environmental aspects purposes, the life cycle of a product may include stages like:

Welcome to your {38e5eebb5c1380f7017bb98b6adfe22a76404ca792267d725b8f2bdb580a7de4}QUIZ_NAME{38e5eebb5c1380f7017bb98b6adfe22a76404ca792267d725b8f2bdb580a7de4}

1. The occupational health and safety policy
2. What represents a “near-miss”?
2. OHSAS 18001 requires:
4. Which of the following statements is false?
5. As per OHSAS 18001 the health and safety of visitors to the workplace represents the responsibility of the organization?

Welcome to your {38e5eebb5c1380f7017bb98b6adfe22a76404ca792267d725b8f2bdb580a7de4}QUIZ_NAME{38e5eebb5c1380f7017bb98b6adfe22a76404ca792267d725b8f2bdb580a7de4}

1. What represents the Statement of Applicability?
2. In case the same person is responsible for both initiating and approving specific transactions, what information security control is not respected?
3. In case the organization decides to outsource software development does it have any responsibility to monitor the activity of its subcontractor(s) in terms of information security?
4. The decision to accept a security risk represents an option for treatment?
5. What is the principle of independence related to internal audits referring to?