DIN EN 15224

DIN EN 15224

Quality Management System in Healthcare

Quality Management System in Healthcare

Demonstrate your commitment to improving healthcare quality

Healthcare providers today rely on the ISO 9001 quality management system as a framework for success. However, in order to truly achieve organisational efficiency, drive productivity and profitability, the continued reliance on ISO 9001 is insufficient. Healthcare providers seeking to differentiate themselves have to ensure that the core health-related issues such as patient safety and management of clinical risks are addressed and properly handled as well. This particular point is not covered under the ISO 9001 standards.

What is DIN EN 15224?

The DIN EN 15224 Quality Management System is a sector specific standard of quality management for healthcare organisations. It is based on the ISO 9001 standard and it includes tangible requirements for patient safety and management of clinical risks in the planning, realisation and management processes.

The DIN EN 15224 system brings together the advantages of ISO 9001 with comprehensive healthcare quality requirements. It defines issues ranging from the effectiveness and suitability of care, to the safety and reliability of care processes. In DIN EN 15524, there are 11 quality features which characterise the quality of healthcare and must be verified as part of a certification.

The 11 central features of DIN EN 15224 are:

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

Why is it important?

Compliance with the DIN EN 15224 Quality Management System allows your business to commit to a long-term goal of providing the best in healthcare services. By adhering to the requirements for the certification, not only do you increase organisational efficiency and product quality, you also minimise waste and mistakes made, thereby increasing overall productivity.

Our services at a glance

  • In-depth assessment - TÜV SÜD will conduct a qualitative and quantitative analysis after the audit. A detailed report and analysis of your company’s processes will be produced at its conclusion. By assessing your strengths and weaknesses, you will drive your service excellence levels and, in turn, increase your profitability.
  • One-stop solution - In addition to DIN EN 15224 certification, TÜV SÜD is also a one-stop provider for other certifications and management systems such as the ISO 9001 standard.

Your benefits at a glance

  • Improve marketability - Your business gains global visibility and consumer trust through your commitment to delivering consistently high levels of service excellence with TÜV SÜD’s DIN EN 15224 certification programme.
  • Boost productivity - By following the standards set out in DIN EN 15224, you eliminate redundant services from your processes, increase productivity, and maximise efficiency levels.
  • Global presence - TÜV SÜD’s international network of subsidiaries enables us to serve organisations worldwide and certify their compliance to DIN EN 15224 on a global scale.


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