Under production quality assurance (Module D) or product quality assurance (Module E) the manufacturer applies to a notified body for assessment of its quality system, documented in written policies, procedures and instructions covering quality objectives and responsibilities, the manufacturing and quality techniques used, examinations and tests and their frequency, quality records and the means of monitoring effectiveness. It must fulfil and maintain the approved system, keep the body informed of any intended change, give the body access to manufacture, inspection, testing and storage sites and to documents and records, and accept periodic audits and unannounced visits that may include product tests.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.