Quality 4.0: a systematic literature review and future research agenda for the digital transformation of quality management

Purpose The integration of digital technologies into quality management systems has led to the emergence of Quality 4.0 (Q4.0), a transformative paradigm aligned with the principles of Industry 4.0. This study presents a systematic literature review of 102 peer-reviewed articles indexed in the Scopus database between 1993 and 2025, offering a comprehensive and structured overview of the field. Design/methodology/approach By employing a systematic review as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework and a cluster analysis, the research identifies four key thematic areas: (1) integration of total quality management and Quality 4.0; (2) digital transformation of Quality 4.0 processes; (3) practical and theoretical applications of Quality 4.0 and (4) implementation readiness, success factors and barriers to Quality 4.0 implementation. Findings Despite Quality 4.0’s growing relevance, the findings reveal significant research gaps, including limited empirical validations, an overemphasis on technological tools at the expense of organizational and human factors, scarce sector-specific applications and an emergent shift toward Q5.0, highlighting a nascent move toward human-centric and proactive quality control. This paper contributes to both academia and industry by synthesizing fragmented knowledge, proposing a future research agenda and offering actionable insights for the successful implementation of Quality 4.0. Originality/value This review offers substantial contributions to both academia and industry. For researchers, it synthesizes fragmented knowledge and provides a clear roadmap for future research, urging a shift towards empirical studies and a more holistic view of Q4.0. For practitioners and policymakers, the paper presents actionable insights and a strategic guide to navigate the challenges of digital transformation, emphasizing the importance of human capital development, organizational culture and risk management in achieving successful Q4.0 implementation. This work bridges the gap between theoretical frameworks and practical application, serving as a critical resource for all stakeholders.