The article titled “The Impact of ISO Certification Procedures on Patient Safety Culture in Public Hospital Departments”, authored by Georgia Kyriakeli, Anastasia Georgiadou, Maria Lithoxopoulou, Zoi Tsimtsiou, and Vasilios Kotsis, offers a timely examination of the relationship between ISO certification and patient safety culture (PSC) in public healthcare settings. Published in Healthcare (2025, Vol. 13, p. 661), the study is grounded in the growing recognition of PSC as a cornerstone of high-quality healthcare delivery, aligning with global priorities set by the World Health Organization (WHO). While ISO certification—particularly ISO EN 15224:2017, an adaptation of ISO 9001:2015—has been promoted as a tool for enhancing clinical quality and safety, empirical evidence on its impact remains inconclusive. This study seeks to address this gap by empirically evaluating how ISO certification affects different dimensions of PSC in the context of Greek public hospital departments.
The researchers employed a two-phase cross-sectional design involving healthcare professionals from both ISO-certified and non-certified departments within a tertiary public hospital. Data were collected using the validated Hospital Survey on Patient Safety Culture (HSOPSC v1.0) at two points in time: Phase A (pre-certification baseline) and Phase B (18 months post-certification). The study utilized repeated measures analysis of variance (RM-ANOVA) to identify temporal changes and intergroup differences across PSC dimensions.
Findings indicate that ISO certification yielded statistically significant improvements in select PSC dimensions. Notably, the dimension “Supervisor’s/Manager’s Expectations and Actions Promoting Safety” improved (p = 0.012), reflecting a heightened role of leadership in promoting safety practices. Likewise, “Handoffs and Transitions” showed improvement (p = 0.037), suggesting that ISO-driven standardization facilitated better communication across departments. However, the effect on “Teamwork Within Units” (p = 0.026) was more nuanced; while teamwork perceptions remained stable in certified departments, a decline was observed in non-certified ones.
Importantly, several critical dimensions did not exhibit statistically significant changes. These included “Overall Perception of Safety” (p = 0.135), “Non-Punitive Response to Error” (p = 0.101), and perceptions of staffing adequacy (p = 0.745). These results underscore that while procedural enhancements and managerial oversight may improve, frontline perceptions and the underlying culture of safety—particularly in terms of error reporting and psychological safety—require additional attention.
The authors conclude that ISO certification, while beneficial in structuring managerial practices and enhancing interdepartmental processes, is not sufficient on its own to transform the deeper layers of PSC. They recommend integrating ISO procedures with leadership-focused safety initiatives, comprehensive training programs, and non-punitive reporting policies. Such combined strategies may help bridge the gap between formal certification and meaningful cultural transformation. Future research is encouraged to explore the long-term sustainability of ISO’s impact on PSC and to develop frameworks that mitigate unintended consequences, such as increased administrative burden or disengagement among clinical staff.
Reference: Kyriakeli, G., Georgiadou, A., Lithoxopoulou, M., Tsimtsiou, Z., & Kotsis, V. (2025). The Impact of ISO Certification Procedures on Patient Safety Culture in Public Hospital Departments. Healthcare, 13(661). https://doi.org/10.3390/healthcare13060661
