TS EN 15224
Quality management systems - EN ISO 9001:2015 for healthcare
This international standard specifies requirements for a quality management system when a healthcare organization:
a) needs to demonstrate its ability to consistently provide healthcare product or service that meets customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer requirements, applicable statutory and regulatory requirements and requirements related to the quality aspects; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical, psychological and social integrity; patient involvement; patient safety and timelines/accessibility.
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- Language: English
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About This Item
TS EN 15224 is a standard for healthcare organizations that need to establish and operate a quality management system. Its focus is not only general management control, but also the quality characteristics that are specific to healthcare delivery, such as patient safety, continuity of care, accessibility, effectiveness, and a patient-centred approach. The standard addresses the ability to consistently provide healthcare products or services while meeting applicable statutory and regulatory requirements.
How healthcare quality dimensions are organised
The quality concepts highlighted here bring together clinical and organisational concerns. Appropriate and correct care, availability, continuity of care, efficiency, and equity are aimed at ensuring that services are not merely delivered on time, but are also clinically consistent and aligned with patient needs. Evidence- and knowledge-based care, together with patient involvement, points to decisions grounded in up-to-date information and the patient’s condition, while patient-centred care encompassing physical, psychological, and social integrity keeps the patient experience at the centre of service design.
In general technical terms, a quality management system is built on process thinking, measurement, monitoring, improvement, and customer satisfaction. In healthcare, that framework is typically supported by clinical process control, risk reduction, continuity of service, and follow-up of care outcomes. TS EN 15224 brings this general quality management model into the healthcare context and aligns it with the terminology and expectations of healthcare services, helping organisations build a consistent and traceable system suited to their delivery model.
- Defines quality management system requirements for healthcare organisations.
- Focuses on meeting customer requirements together with applicable statutory and regulatory requirements.
- Highlights healthcare-specific quality dimensions such as patient safety, continuity of care, and accessibility.
- Provides a healthcare-oriented framework built on the general EN ISO 9001:2015 approach.
- Publication Date: 20.03.2017
- Standard Status: U (Yürürlükteki Standard/Standard)
- Publisher: TSE
- Document Language: en
- ICS Classification: 03.100.70 Yönetim Sistemleri; 03.120.10 Kalite Yönetimi ve Kalite Güvencesi; 11.020.01 Sağlıkta Kalite ve Çevre Yönetimi
- Pages: 86
- Source Standard: EN 15224:2016
- International Equivalents: EN 15224-EQV
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