Quality Management Systems in Healthcare Facilities: Between Rules, Standards, and Business Excellence

Purpose: This paper explores the role of quality management systems (QMS) in Croatian healthcare institutions, emphasizing their regulatory foundations, the implementation of international standards (ISO 9001, EN 15224, ISO 7101), and their potential to enhance safety, performance, and organizational excellence. Design/Methodology: A thematic literature review was conducted using sources from PubMed, Web of Science, Scopus, Google Scholar, and Hrčak, covering the period from 2015 to 2025. Inclusion criteria focused on peer-reviewed studies and official regulations related to healthcare QMS, international certification models, and performance monitoring practices. Selected examples of good practice from Croatian hospitals were also analyzed. Findings: The implementation of QMS in Croatian healthcare institutions has advanced considerably, driven by legislation and the support of national bodies such as the Ministry of Health and the Croatian Health Insurance Fund. Institutions that adopt ISO standards report improvements in documentation, communication, risk management, and patient satisfaction. Case studies, such as those from the Special Hospital Medico and General Hospital Pula, demonstrate that multi-standard certification fosters a strong safety culture and strategic excellence. Nonetheless, challenges remain, including uneven implementation, limited human and financial resources, and the absence of a unified national accreditation framework. Practical Implications: To ensure sustainable quality improvement, healthcare institutions must embed QMS into everyday management, invest in continuous staff education, strengthen leadership engagement, and adopt digital solutions. QMS should not be viewed solely as a regulatory obligation but as a strategic imperative involving all stakeholders. Originality/Value: This paper offers a comprehensive overview of QMS development in Croatian healthcare and demonstrates how alignment with international standards can significantly elevate both patient care quality and institutional effectiveness.