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.