1. What are the requirements of ISO 9001:2015?

The concept of the risk-based approach is omnipresent in this new version of ISO 9001. It is associated with the process approach and customer orientation. It is considered in the planning of the quality management system, in operational control and in the assessment of performance and improvement.

• Chapter 4: In this chapter, the standard specifies the characteristics that determine the company's processes (input, output, methods, resources). It also specifies that the company must determine the risks associated with the processes and the actions required to deal with them.

• Chapter 5: in the section dealing with customer orientation, management is asked to ensure that risks likely to have an impact on the conformity of products and services, as well as on customer satisfaction, are identified and addressed....