Examples of major nonconformities, which call for the correction and corrective action to be accepted and their effectiveness verified, are failing to address the applicable requirements in full and to implement a whole QMS process such as complaint handling or training; failing to implement applicable QMS requirements; failing to take appropriate corrective and preventive action when post-market data shows a pattern of product defects; marketed products that pose undue risk to patients or users when used as labelled; products that clearly do not meet the client's specifications or the regulatory requirements; and nonconformities repeated from previous audits.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.