Integrating ISO 9001 and Industry 4.0. An implementation guideline and PDCA model for manufacturing sector

The main purpose of this paper is to develop an implementation guideline for manufacturing companies integrating ISO 9001 requirements and Industry 4.0 technologies. The implementation guideline follows the Plan-Do-Check-Act model of ISO 9001 standard. We interviewed 25 experts and observed the quality management documentation of seven European manufacturing companies. Results emerged using thematic content analysis and we gained further insights from interviewees, allowing us to propose suggestions garnered from the interviews. The guideline demonstrates how requirements can be integrated with Industry 4.0 technologies such as radiofrequency identification tags, smart sensors, the internet of things, smart human interface, enterprise resource planning modules, artificial intelligence to improve a typical ISO 9001 quality management system. Some issues emerged relating to the fear of losing jobs, validation of quality control equipment based on artificial intelligence, and decision-making and problem-solving processes. The implications of this research are mainly related to the opening of a new debate concerning the integration between ISO 9001 and Industry 4.0 as well as the proposal, to our knowledge, of the first tentative integration. Manufacturing companies can use the guideline for integrating their quality management system with Industry 4.0 technologies while considering also the practical suggestions provided by the experts.