What is EN 15224?
EN 15224:2017 - Quality Management Systems. Application of EN ISO 9001:2015 in Healthcare.
The standard is specific to the healthcare services sector. It aims to ensure patient safety and risk management in healthcare organisations, adding value to the quality management system in health services.
Quality management in healthcare ensures organised, transparent and reliable management of medical activities, earning the trust of the general public.
EN 15224 is a standalone standard that can be used for certification of healthcare activities. It includes ISO 9001 requirements with additional interpretations and healthcare-specific provisions, emphasising clinical processes and risk management.
Who is it for: EN 15224 includes ISO 9001 requirements with additional healthcare-specific provisions. ISO 9001 can support and facilitate the establishment of procedures in healthcare.
Key Principles
Certification Benefits
Increased trust in the healthcare institution
Reduced risk of clinical errors
Enhanced patient satisfaction
Improved competitive position
Identified and optimised processes
Reduced costs and well-managed documentation
Integration: EN 15224 is a standalone standard based on ISO 9001 with healthcare-specific enhancements.
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