I agree with hc225 that most countries adapt the structure of their plans from the standards written in ISO13485:2016. Medical products need to be of highest quality to deliver confidence and reliability for the health care professionals and patients using the product. Being said, the project quality plan and its trace matrix are essentially the backbone to the project. These documents restate the project scope/plan from the DDP, define the quality criteria, and the list of procedures based from regulatory requirements to manufacture a product of high quality demands. The project quality plan and its traceability to other relating plans and reports are live documents that are updated from project inception to product launch. The Quality Plan incorporates cross-functional input, intertwining plans such as the project management plan, market strategy plan, product development plan, systems and software plans, regulatory plan, operations plan, reliability plan, etc.