The organization sets up, runs, keeps up and continually improves its QMS and the processes within it, deciding for each process its inputs and outputs, sequence and interactions, criteria and methods, resources, responsibilities and authorities, risks and opportunities, and how it will be evaluated and improved, and it keeps and retains the documented information needed. Under 9100 the system must also deal with customer QMS requirements and with statutory and regulatory QMS requirements that apply, and there must be documented information giving: an overall description of the relevant interested parties; the scope, with its boundaries and applicability; a description of each process and how they apply across the organization; and how the processes follow and interact with one another. This material may be brought together as a quality manual.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.