DIN EN 15224

Health care services - Quality management systems

The quality management standard EN 15224 was specifically developed for the healthcare system. For the first time since the publication in December 2012, there is a single European and sector-specific standard for the healthcare system. It is aimed at medical practitioners, hospitals, and any institutions engaged in nursing or other health care. The focus of the standard is on clinical process and risk management. Both components are strong indicators of the degree of quality care in your institution.

Essentially, the requirements of EN 15224 coincide with those of ISO 9001. However, the EN 15224 demands a lot more. With its focus on risk management and patient safety, this standard goes much further than other quality management systems. It defines a total of 11 quality characteristics for healthcare system and emphasises that the management of clinical risks is involved in all planning, execution and control processes. A clinical risk is defined as a risk that could have a negative impact on at least one of the 11 quality characteristics.

The quality characteristics have been defined as: adequate and proper supply, availability, effectiveness, efficiency, equity, evidence (knowledge)-based care, focused on the patient care (including physical and mental integrity), patient involvement, patient safety, timeliness and accessibility. Each of your processes must be based on these 11 quality characteristics.

For an initial assessment DQS MED offers you a pre-audit. It will be determined what has already been implemented in your institution with regards to the requirements and what needs to be done. An existing alignment with KTQ facilitates the introduction and implementation of the EN 15224 requirements. The certification audit itself documents the successful implementation of your quality management system according to EN 15224. An annual surveillance assessment is used for process stability and risk minimization.

The realised audits are helping to ensure the implementation of quality characteristics. The advantages for you are that the patient safety in your facility is increased; error and safety culture are promoted and improvement potentials are revealed.

With the certification of your health facility corresponding to EN 15224, you

  • establish a clinical process and risk management according to the state of knowledge and technology,
  • create an extensive risk assessment,
  • gain conclusive arguments for your marketing,
  • improve internal and external processes and provide more transparency,
  • lower your costs through more effective processes and
  • strengthen the confidence of the patient in the work of your clinic or practice.