Managerial and organizational determinants of quality 4.0 implementation: Evidence from ISO 9001:2015 certified companies

Abstract

Successful implementation of Quality 4.0 requires managerial and organizational conditions that extend beyond the mere adoption of digital technologies. This study examines the key determinants of Quality 4.0 implementation in companies certified to the ISO 9001:2015 standard. The research was conducted in the Republic of Serbia using a structured questionnaire survey. Correlation and multiple regression analyses were employed to examine the effects of top management support, leadership, vision and strategy, organizational culture, managerial competencies, and employee training on the implementation of Quality 4.0. The results indicate that all examined determinants are significantly associated with successful Quality 4.0 implementation, while vision and strategy and employee training remain statistically significant independent predictors in the full regression model. The findings confirm that successful Quality 4.0 implementation depends on the alignment of managerial and organizational capabilities rather than solely on technological factors. This study contributes to the existing literature by shifting the focus from assessing organizational readiness to identifying the determinants that support successful Quality 4.0 implementation, while also providing practical guidance for managers planning digital transformation initiatives.