Standard EN 15224 is recommended to all providers of healthcare services, regardless of their size and position in the healthcare system.

EN 15224 defines a Europe-wide standard for quality management in the healthcare sector. The standard is based on the requirements of ISO 9001 and transfers these to the specific quality requirements for healthcare. It also contains additional requirements, specifications and interpretations as well as aspects for the management of clinical risks.


EN 15224 requires comprehensive clinical risk management and thus much more than risk-based thinking. Clinical risk management is a key component within the quality management system. The risk requirements are based on the high level of ISO 31000 - an ideal combination for more patient safety.

The 11 central features of 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

Requirements of the standard are:

Systematic risk analysis and taking appropriate measures in all phases of health service provision: includes the written, based on recognized methodology identification, assessment and categorization of potential risks that may arise during the provision of the service, their rational management and reassessment periodically.
Clinical Governance: in combination with the previous requirement, includes the selection and implementation of medical and nursing protocols, which ensure the quality of services provided and patient safety.
Determine KPIs, setting goals and monitoring performance in 11 areas such as evidence-based treatment, availability, continuity of care, effectiveness, efficiency, etc.
Systematic recording, treatment and evaluation of events that directly affect the patient: incidents, adverse events, near-events.
Evaluation of staff and confirmation of their competence
Ongoing staff training
Clinical staff examination
Traceability of actions, materials, persons.

All legislation within the scope of this standard, within the scope of all legal regulations, provides benefits to institutions that want to show their skills so that the demands of customers who apply to the health institution can be met, and the quality requirements are covered by the  EN 14224 standard.


This standard provides your company with a systematic approach in areas such as compliance, correct care services, information-based care services, continuity of care, efficiency, efficient service, right to equality, patient participation, patient safety and accessibility.

A stand-alone EN 15224 quality management system can be established for health institutions, but the integration of the system will be much easier with the ISO 9001 certificate that should be in each of these institutions.

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Benefits of EN 15224 Health Services Quality Management System to the Health Sector


In EN 15224, which has many benefits for businesses in health services, primarily the planning and control of the health services of the institution is provided.
Thanks to this standard, which allows better management of processes in health institutions, many errors are reduced and the costs of the institution are reduced.

Since EN 15224 Health Services Quality Management System is known as a completely risk-based system, controls and risk managements in institutions providing health services will be achieved and some conditions will be completed in order to reach new corporate customers in those who have this certificate.
At the same time, thanks to EN 15224, you will be able to open your doors to new customers in the field of health tourism, and you will create trust for your customers, especially from abroad.

Another detail within the scope of the Benefits of the EN 15224 Health Services Quality Management System for the Organization is the increase in the productivity of your staff and the doctors in charge, and the increase in their motivation.
This standard will be a big step forward for you to prevent legal proceedings and sanctions. In terms of high prestige and corporate prestige, you should be included in EN 15224 Health Services Quality Management systems.