Zum Inhalt

ÖNORM EN 15224 Services in Healthcare — Quality Management Systems — Requirements based on ISO 9001:2015


In march 2017 the update of EN 15224 was completed. This standard is a sector specific quality management standard for health care organizations and has incorporated the complete ISO 9001:2015 and some specific requirements, like clinical risk management. In order to promote high-quality health care, elements of ISO 9001 are extended by the addition of further aspects.


First and foremost these are the eleven quality features which should be a reference point in quality policy, quality planning and quality objectives. In addition to risk management the clinical risk management is highlighted explicitly, since risks in the core process and the security of patients have been becoming an increasingly important issue in the health care sector. The diffusion of the EN 15224 standard in the health care system has increased significantly. Especially regarding newly implemented quality management systems this standard is starting to get ahead of ISO 9001 certifications.

In the center of interest are clinical risk management, compliance with additional legal/regulatory burdens and the eleven quality features:

  • adequate and correct health care
  • availability
  • continuity of health care
  • effectiveness
  • efficiency
  • equality
  • health care based on evidence/knowledge
  • health care focusing on the patient, including the physical,
  • psychological and social integrity
  • involvement of the patient
  • patient safety and security
  • timeliness/accessibility

In principle, the standard is applicable for all service providers active in this sector as well as for doctors’ offices, hospitals, nursing homes, hospices, health care institutions, psychiatric nursing institutions, dentists’ offices, physiotherapeutic institutions, institutions providing labour protection services and pharmacies.

ISO 9001, ISO 13485, ISO 14001, ISO 27799, ISO 31000


If you are interested in our service, we will be pleased to contact you. Please complete the inquiry form below. An employee will deal with your concern as soon as possible.


As for information given on the phone, our Customer Service Center will be pleased to be at your disposal at +43 732 34 23 22.



Please note:
austria clients will receive information about services of Quality Austria. This information will be provided for marketing purposes and in accordance with the legal basis of legitimate interest. qualityaustria clients have the right to object at any time to this processing of data.

For further information, please read the qualityaustria PRIVACY POLICY.

Note that fields marked with an asterisk (*) have to be filled out!

Information for offers

In order to enable us to make a detailed and complete offer for certification/assessment of your organization, you are requested to complete this questionnaire and return it to us via fax: +43 732 34 23 23
e-mail: office@qualityaustria.com.

If you have questions, our
Customer Service Center will be pleased
to be at your disposal at
+43 732 34 23 22.


Information offer making