Structural, Normative and Clinical Positioning of Healthcare Quality Management Systems: A Comparative Analysis of ISO, EFQM, JCI, AND TÜSKA

Abstract

Purpose: Quality management systems in healthcare are evolving within a multi-layered structure that includes general management standards, sector-specific adaptations, and accreditation frameworks. This study examines International Organization for Standardization standards (ISO 9001, ISO 15224, and ISO 7101), the European Foundation for Quality Management (EFQM) model, Joint Commission International (JCI), and Türkiye Sağlık Hizmetleri Kalite ve Akreditasyon Enstitüsü (TÜSKA) in terms of scope, conceptual orientation, clinical risk management, performance measurement, and external evaluation mechanisms. Material and Methods: The research used the qualitative document analysis method. Relevant standard texts and official documents were evaluated through thematic content analysis. Results:The results show that ISO 9001 provides a process architecture for quality management independent of the sector; ISO 7101 is a quality management system for healthcare organizations; ISO 15224 integrates clinical risk management into the core of the system; and accreditation systems in healthcare contain more detailed and operational clinical requirements. The EFQM model, on the other hand, offers a governance framework that provides a perspective on organizational maturity and sustainable performance rather than being a compliance-based certification standard. Conclusion:The study demonstrates that these systems are complementary, not contradictory, and that they create a layered quality architecture in healthcare organizations.

Keywords

• International Organization for Standardization
• European Foundation for Quality Management
• Accreditation
• Quality Improvement
• Quality Assurance
• Health Care.

Structural, Normative and Clinical Positioning of Healthcare Quality Management Systems: A Comparative Analysis of ISO, EFQM, JCI, AND TÜSKA

Abstract

Sağlık hizmetlerinde kalite yönetim sistemleri; genel yönetim standartları, sektöre özgü uyarlamalar ve akreditasyon çerçevelerini içeren çok katmanlı bir yapı içerisinde gelişmektedir. Bu çalışma, International Organization for Standardization tarafından yayımlanan ISO 9001, ISO 15224 ve ISO 7101 standartları ile European Foundation for Quality Management (EFQM) modeli, Joint Commission International (JCI) ve Türkiye Sağlık Hizmetleri Kalite ve Akreditasyon Enstitüsü (TÜSKA) tarafından geliştirilen sistemleri kapsam, kavramsal yönelim, klinik risk yönetimi, performans ölçümü ve dış değerlendirme mekanizmaları açısından incelemektedir. Gereç ve Yöntem: Araştırmada nitel doküman analizi yöntemi kullanılmıştır. İlgili standart metinleri ve resmi dokümanlar tematik içerik analizi yoluyla değerlendirilmiştir. Bulgular: Bulgular, ISO 9001’in kalite yönetimi için sektörden bağımsız bir süreç mimarisi sunduğunu; ISO 7101’in sağlık kuruluşlarına özgü bir kalite yönetim sistemi oluşturduğunu; ISO 15224’ün ise klinik risk yönetimini sistemin çekirdeğine entegre ettiğini göstermektedir. Sağlık hizmetlerinde akreditasyon sistemleri (JCI ve TÜSKA) daha ayrıntılı ve operasyonel klinik gereklilikler içermektedir. Buna karşılık EFQM modeli, uyum temelli bir belgelendirme standardı olmaktan ziyade, kurumsal olgunluk ve sürdürülebilir performansa odaklanan yönetişim temelli bir çerçeve sunmaktadır. Sonuç: Çalışma, söz konusu sistemlerin birbirleriyle çelişen değil tamamlayıcı nitelikte olduğunu ve sağlık kuruluşlarında katmanlı bir kalite mimarisi oluşturduğunu göstermektedir.

Keywords

• Uluslararası Standardizasyon Örgütü
• Avrupa Kalite Yönetimi Vakfı
• Akreditasyon
• Kalite İyileştirme
• Kalite Güvencesi
• Sağlık Hizmetleri.

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