The concepts and frameworks behind quality management are evolving. As more companies adopt new technologies, and standards like ISO 9001:2015 begin to shift in focus, there is a concept that is arising out of Industry 4.0, the factory of the future, and the industrial internet of things (IIoT). This concept, known as Quality 4.0 and the digital transformation of quality, combines the elements of technology, process innovation, and risk-based thinking to provide greater visibility and control into quality processes.

There are various ways in which Quality 4.0 has built technology into the overall story of quality, specifically through companies incorporating more data into their processes.

This article will consider where risk-based thinking fits in, and how current quality management system (QMS) processes and concepts feed into the Industry 4.0 story to create a Quality 4.0 dynamic.

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