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DQS SLOVAKIA s.r.o. - certifikačné služby ISO 9001, ISO 45001, ISO 14001:2015, TISAX, IATF 16949:2016.| dqs-slovakia.sk

Quality management


Companies around the world, ranging from all business sectors, see DQS as their trusted partner management systems certification. Find out what we have to offer via the overview below, or contact us to see how we can be of service.

DIN EN 15224

Quality meets health

Quality management standard EN 15224 was developed specifically for the health sector. It is aimed at medical practitioners, hospitals, and any institutions engaged in nursing or other health care. The emphasis of this standard is on hospital process and risk management. Both components are strong indicators of the degree of quality care in your institution. The best way to find out what you need to implement EN

15224 is to talk to us. DQS offers process audits that have at their core the integration of risk management according to EN 15224 into an existing quality management system according to ISO 9001. 


Basically, the requirements of EN 15224 agree with those of ISO 9001. However, EN 15224 requires more: it defines a total of eleven quality characteristics for health care, and emphasizes that the management of clinical risk is included in all processes for planning, execution, and control.

A clinical risk is understood to be any risk that may have adverse effects on at least one of the eleven quality characteristics.

The quality characteristics have been defined as follows: adequate and correct care, availability, effectiveness, efficiency, equality, evidence-based (scientific) care, care that is focused on the patient (to include physical and mental inviolacy), patient integration, patient safety, timeliness, and accessibility.

Each of your processes needs to be focused on all of these eleven quality characteristics. Our process audit contributes to ensure that it

does. The advantages for you are increased patient safety in your institution, the promotion of an error- and safety awareness culture, and the identification of improvement potential. 


DQS offers you a pre- audit to determine where you stand (initial localization).  We identify what has already been done in your organization regarding implementation of the requirements, and what still needs to be done. An existing focus on KTQ facilitates introduction and implementation of the requirements of EN 15224.

Subsequently, we support you by conducting process audits that show to what extent your processes are described in a structured manner, and if they are suited to achieving objectives. At the same time, we conduct moderated risk analyses and risk evaluations. The certification audit itself documents the successful implementation of your quality management system according to EN 15224. Annual surveillance serves to provide process stability and minimize risk.