Association between the application of ISO 9001:2008 alone or in combination with health-specific standards and quality-related activities in Hungarian hospitals.

Objective: To investigate how International Organization for Standardization (ISO) 9001 and the Hungarian Health Care Standards (HHCS) certifications are associated with quality management, patient safety, patient rights and human resource management activities.

Design: A cross-sectional study was implemented using the 2009 Hungarian hospital survey's database.

Setting: Hungary.

Participants: Fifty-three general hospitals were included in the statistical analysis.

Intervention: No intervention was carried out in the study.

Main Outcome Measures: The outcomes included the percentage of compliance in the dimensions of quality management, patient safety, patient rights, human resource management and the overall score for each hospital, and they were grouped according to the hospitals' certifications.

Results: Sixteen hospitals did not have either ISO 9001 or HHCS certifications, 19 had ISO 9001 certification only and 18 had both. Hospitals with ISO 9001 alone or in combination with the HHCS significantly outperformed hospitals with no certifications in terms of quality management and human resource management activities but not in terms of patient safety or patient rights activities. Combined, the two models provided the highest median levels in all cases. Nevertheless, no significant differences were observed when the hospitals with both certifications were compared with hospitals with ISO 9001 only.

Conclusions: Although the combination of ISO 9001 and the HHCS showed the best results, the benefits were not decisive. Furthermore, although the HHCS include standards addressing patient safety, no direct association was found with regard to compliance. Thus, further investigation is required to understand this enigma.