ISO 15224 – Quality Management System for Healthcare Services

Scope:
ISO 15224 is a quality management system standard for healthcare organizations that enables the systematic management of services based on patient safety and clinical process quality. The system infrastructure established within this scope includes clinical risk management, patient safety practices, process performance monitoring, data analysis, and continuous improvement activities. In this way, healthcare services are structured to be safe, effective, and patient-centered.

Benefits:
It improves patient safety and service quality. Clinical errors and risks are minimized. Standardization in healthcare services is achieved, and processes are managed more effectively. Internal coordination is strengthened, patient satisfaction increases, and compliance with international healthcare standards is ensured.

Regulations:
The system infrastructure established under ISO 15224 supports compliance with healthcare service and patient safety regulations in Türkiye and the European Union. In Türkiye, key frameworks include the Basic Law on Healthcare Services, the Patient Rights Regulation, and Healthcare Quality Standards, which regulate patient safety, service quality, and healthcare process management. In addition, ethical principles in healthcare services are defined under the Medical Deontology Regulation. In the European Union, patient safety, data privacy, and healthcare quality requirements are regulated under the Directive on Patients’ Rights in Cross-Border Healthcare, the Medical Device Regulation, and the General Data Protection Regulation (GDPR).

Through the ISO 15224 system infrastructure, organizations standardize clinical processes, systematically manage patient safety risks, measure service quality, and implement continuous improvement activities. This structure ensures compliance with national and international requirements for quality, safety, and patient rights while establishing a sustainable and reliable healthcare management system for audit processes.