# Quality 4.0 and Cognitive Engineering Applied to Quality Management Systems: A Framework
### Quality Management System  
The policies, procedures, and controls required for an organization to produce and provide high-quality goods or services to clients, and hence raise customer satisfaction, are documented by a quality management system (QMS) [25].  
Growth in globalization supports quality management systems. Only businesses that can match their consumers' expectations will be able to grow as a result of the rising variety and quantity of products, reduced number of essential machines and devices, shorter production times, and shorter product life cycles. Besides testing the quality of products, services and processes to improve them, organizations should also manage systemically if they want to remain competitive [26].  
The ability to manage effectively within an organization is made possible by conforming to the requirements of the ISO standards, such as ISO 9001 and ISO 13485, which are based on the PDCA (Plan-Do-Check-Act) cycle. These standards also specify the requirements that must be met in order to guarantee the quality of the processes. Without a QMS in place while executing the organizations processes, it is frequently impossible to operate as a trustworthy partner on the market, especially when dealing with industries whose functioning may pose an high risk, as is, for example the medical devices field (ISO 13485) [27; 28].  
Risk, which is the impact of uncertainty on the accomplishment of quality objectives, can be identified by a departure from the expected outcome. However, in the same processes, the risk can be established in relation to potential events, their effects, or their combination. As a result, the organization can conduct a qualitative and/or quantitative assessment of risks in the QMS and decide on the best course of action for management [29].  
Regardless of size or industry, organizations must apply the risk-oriented approach in the QMS; however, the complexity of the procedures used depends on the maturity of the organization's QMS and the variables in its external environment. The development of the risk-based approach application in the QMS, depends on the significance of these organizational features [30]. The center of quality management operations is the QMS, in recent years the concept of an Electronic QMS (EQMS) started to emerge. It offers a scalable solution to automate workflows, connect quality processes, enhance data integrity, provide centralized analytics, guarantee compliance, and promote collaboration within a single app. Quality affects every step of the value chain and how it is run, making it a hub [16]. This EQMS already falls into the concept of Quality 4.0 and can be explored to fully embrace the available tools.  
Better supplier oversight, easier resource management, assurance of customer requirements compliance, and product quality control are all made possible by properly defined procedures and instructions, which further lowers production costs [31].  
Although the market has made some strides toward EQMS adoption, many companies remain gravely behind. Organizations put off implementing quality technology in part because their fundamental processes are fragmented; it is difficult to implement technology to automate operations that are fragmented [16].  
During this research, the relationship between quality management practices and Industry 4.0 technologies that improve quality were deeply studied and connected with cognitive engineering practices to develop an advanced framework that makes it easier to overview all the dispersed activities within the manufacturing environment gathered as one, and simplify the application of new technologies to the QMS activities.