DIN EN 15224 - Quality Management System for Healthcare Services

What is DIN EN 15224?

DIN EN 15224 is the quality management standard addressed specifically to healthcare service providers. It applies the logic of ISO 9001 to the clinical environment, with emphasis on defined quality characteristics of care and on the systematic management of clinical risk.

Who is DIN EN 15224 for?

It applies to private clinics, diagnostic centres, rehabilitation centres, elderly care units, dental and medical practices, day surgery units, and primary healthcare providers.

Benefits of DIN EN 15224

1. Quality defined by clinical criteria, not administrative ones alone
2. Systematic management of clinical risk
3. Fewer adverse events and recurring errors
4. Documented patient safety
5. Clear clinical processes and protocols
6. An improved patient experience and better patient information
7. An advantage in contracts with insurance providers
8. Full compatibility with ISO 9001

Certification Requirements

The DIN EN 15224 management system must meet the applicable legal requirements concerning the unit, such as licensing and operating conditions, protection of health data and medical waste management, as well as the requirements of the standard. A record of clinical processes and indicators monitoring the quality of care are required.