4. What are the application risks?

4.1 Dealing with Chapter 8 requirements in an "autarkic" manner

Chapter 8 presents coherent requirements covering the product and service realization cycle. It could appear self-sufficient, and the risk would be to interpret it in isolation. The point here is not to forget the interactions of these requirements with those of the rest of the standard. Operational control is, of course, based on a process and risk-based approach. It also relies on supporting processes and is integrated into the continuous improvement loop (PDCA).