CHAPTER 17
Quality and Design
What Is Design?
The design requirements in the foundation quality management standard ISO 90011 make it very clear that this whole section is a system within the wider system, or a process or project approach within the wider overall process.
There is a complete commonality of the inner design system or process/project requirements and the wider system or set of process requirements with one major exception—validation. Validation is different from verification—final check or inspection confirming compliance, which is also specified as a requirement. There is also guidance on when a change requirement in the wider organization might be, or become, a design change.2
There is uncertainty about when change becomes a ...
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