Background: ISO certification is widely implemented as a quality assurance tool in healthcare services; however, its impact on patient safety culture (PSC) in public hospitals remains insufficiently explored. Aim: This study aims to assess the effect of ISO certification procedures on different dimensions of PSC in public hospital departments by comparing ISO-certified and non-certified departments across two phases (Phase A: pre-certification; Phase B: 18 months post-certification). Methods: A two-phase cross-sectional study was conducted in a tertiary public hospital in Greece. Healthcare professionals from both ISO-certified and non-certified departments participated. The Hospital Survey on Patient Safety Culture (HSOPSC v1.0) was administered at two time points (Phase A: baseline, pre-certification; Phase B: 18 months post-certification). A repeated measures analysis was performed to assess the changes over time and differences between the two groups. Results: The findings suggest that ISO certification has a mixed impact on the PSC dimensions. A significant improvement was observed in “Supervisor’s/Manager’s Expectations and Actions Promoting Safety” (p = 0.012), while “Teamwork Within Units” (p = 0.026) and “Handoffs and Transitions” (p = 0.037) showed statistically significant changes. These results indicate that certification may enhance structured managerial oversight and interdepartmental collaboration, but at the same time, may negatively impact the teamwork within hospital units. However, no statistically significant changes were observed in “Overall Perception of Safety” (p = 0.135) and “Non-Punitive Response to Error” (p = 0.101), suggesting that while there was a trend towards a stricter safety evaluation, this was not statistically confirmed. Additionally, the staffing perceptions remained unchanged (p = 0.745). Conclusions: ISO certification appears to reinforce managerial safety expectations and interdepartmental teamwork, yet does not significantly improve the overall perceptions of patient safety or non-punitive error responses. The results indicate the need for targeted interventions to ensure that certification processes do not increase administrative burdens or negatively impact staff perceptions. Future research should explore whether these effects persist over time and how hospitals can optimize certification processes to strengthen PSC without unintended consequences.

Patient safety is often discussed through the language of clinical error, adverse events, protocols, and quality improvement. Yet many conditions that make harm more or less likely are created before the clinical encounter itself, through leadership decisions that shape priorities, staffing, communication, accountability, role clarity, and team capacity to respond to risk. This chapter examines leadership as an active patient safety intervention rather than as a background managerial function. It argues that just, responsive, and resilient healthcare organizations are built when leaders create conditions in which professionals can speak up, report unsafe conditions, learn from weak signals, and act before preventable harm reaches patients. Particular attention is given to administrative harm, psychological safety, leadership visibility, accountable decision-making, workforce engagement, and competency-sensitive staffing. The chapter highlights the patient safety implications of failing to use specialized nurses according to their expertise, especially when professionals are redeployed to unfamiliar clinical environments without adequate preparation, supervision, or competency alignment. It also links safe workforce deployment with just culture, speaking up, and organizational learning, showing how leadership choices can either expose patients and staff to avoidable risk or create protective barriers. A leadership-oriented patient safety framework is proposed to support healthcare leaders in translating safety intentions into everyday organizational practice and in aligning culture, competence, voice, and learning. The chapter concludes that leadership should be judged by the safety conditions it creates, not only by the intentions it declares, for healthcare organizations working under pressure and seeking safer, fairer, and more resilient models of care.

Standardization procedures have emerged as fundamental components in healthcare quality and patient safety strategies. This chapter examines the impact of certified quality systems—specifically ISO 9001:2015 and ΕΝ 15224:2017—on healthcare professionals’ perceptions of safety culture and institutional trust within a large public hospital in Greece. The study utilized the validated Greek version of the Hospital Survey on Patient Safety Culture (HSOPSC v1.0) and included a total of 877 participants across two phases: before (n = 441) and after (n = 436) the implementation of standardization protocols. Descriptive and inferential statistical analyses were conducted to assess perceptions across key safety dimensions, including communication openness, teamwork, nonpunitive response to error, leadership support, and staffing adequacy. The results indicated statistically significant improvements in several safety culture domains following the implementation of certified quality systems. In particular, enhancements were observed in feedback and communication about errors, teamwork across units, and supervisor support for safety. However, persistent challenges were identified in areas such as staffing and event reporting. Regression analysis highlighted organizational learning, leadership expectations, and communication climate as key predictors of trust in safety systems. The findings support the view that standardization, when embedded in a supportive and learning-oriented culture, can foster not only operational improvements but also deep-seated cultural transformation. The study underscores the need for healthcare policy to integrate certification frameworks with human-centered interventions that promote staff engagement, transparency, and trust. These elements are critical for cultivating resilient and trustworthy public healthcare systems, particularly in resource-limited settings.

Background/Objectives: Patient safety incidents can adversely affect healthcare professionals, but relationships between leadership and organizational responses, clinician recovery, professional consequences, and safety-related outcomes remain incompletely synthesized. This review examined contemporary quantitative evidence on these relationships and the extent to which directly measured safety behaviors and patient-safety outcomes have been evaluated. Methods: This PROSPERO-registered systematic review (CRD420261453278) followed PRISMA 2020 and PRISMA-S. PubMed and Scopus were searched as the primary bibliographic databases, supplemented by Europe PMC and OpenAlex and by forward citation searching in Scopus and the Web of Science Core Collection, for English-language studies published from January 2021 through July 2026. Two reviewers independently screened records and extracted data; design-specific JBI appraisal judgments were agreed by two reviewers. Heterogeneity precluded meta-analysis, and findings were synthesized narratively using SWiM-informed structured reporting. Results: Of 6838 records, 44 studies were included. Distress/recovery was assessed in 40 studies (90.9%), professional consequences in 21 (47.7%), other safety-related outcomes or indicators in five (11.4%), and disclosure-related behavior in one (2.3%). No study prospectively evaluated incident or near-miss reporting or speaking up as a principal exposure-linked outcome. Supportive organizational responses, just and non-punitive cultures, learning-oriented safety climates, and structured support were generally associated with less distress, more favorable recovery, and fewer negative professional outcomes. Structured-support evaluations suggested feasibility, acceptability, and favorable short-term signals but did not establish intervention effectiveness. Conclusions: Contemporary evidence is substantially stronger for clinician recovery and professional functioning than for safety behavior or patient outcomes. Predominantly cross-sectional, self-reported, and uncontrolled evidence precludes causal conclusions. Direct evaluation of reporting, disclosure, speaking up, verified workforce outcomes, and patient-safety effects remains a major research priority.