Compliance, auditability and the future of autonomous quality

Joanna Rosak-Szyrocka and Radoslaw Wolniak

Chapter 10 in Quality 4.0 and Artificial Intelligence, 2026, pp 166-178 from Edward Elgar Publishing

Abstract: This chapter discusses the convergence of quality management and artificial intelligence in areas of ethical regulation, compliance and audibility. It observes how adaptive and autonomous systems push the traditional paradigms of regulation such as ISO standards, FDA guidance, and GxP directives through imposing traceability, explainability and secure logging of information at all levels of system activity. The argument enters audit-proofed systems with blockchain transparency, real-time monitoring, and human-in-the-loop governance. It also discusses the governance and ethics issues of introducing fairness, accountability and sustainability to autonomous quality systems. Examples drawn from industries such as pharmaceuticals, medical devices and semiconductors are employed to put into perspective what tensions and opportunities exist between regulation and to provide a road map for how AI-based quality can be a source of trust, legitimacy and competitiveness in highly regulated, high-risk sectors.

Keywords: Autonomous quality; Regulatory compliance; ISO standards; Artificial intelligence; Traceability; Ethical AI; Data integrity; Quality 4.0; FDA regulations (search for similar items in EconPapers)
Date: 2026
ISBN: 9781035397068
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