TS EN 15224

TS EN 15224 is a quality management systems standard for healthcare organizations that builds on ISO 9001:2015 and adds healthcare-specific quality aspects. Its core purpose is to help an organization demonstrate that it can consistently provide healthcare services in line with customer needs, quality objectives, and applicable statutory and regulatory requirements.

Quality dimensions specific to healthcare

What makes this standard distinctive is the way it connects general quality management principles to the realities of healthcare delivery. Continuity, accessibility, timeliness, effectiveness, efficiency, equity, evidence-based care, patient involvement, and patient safety are treated as essential dimensions of quality in healthcare. The emphasis on patient-centred care, including physical, psychological and social well-being, shows that quality in this field is judged not only by outcomes, but also by how care is organised and delivered.

Why it matters in practice

• Consistent and controlled delivery of healthcare processes and services
• Joint consideration of patient requirements and applicable legal/regulatory obligations
• Management of care continuity, correct care, access and timeliness as quality goals
• Use of improvement processes and customer satisfaction within the quality system

In general technical terms, an ISO 9001-based management system is built around process approach, leadership, resource management, monitoring and measurement, and continual improvement. TS EN 15224 applies that framework to the clinical and organisational context of healthcare, linking quality management directly to the characteristics of patient care rather than treating it as a purely administrative exercise.