When the certification body has already audited the client under a regulatory scheme whose requirements include or exceed ISO 13485 (the European medical device regulations, for example, and other national regulations adopting ISO 13485), it need not repeat the audit of the ISO 13485 elements already covered, provided it can show that every requirement of this document has been met. For higher-risk devices (GHTF classes C and D, for instance) the stage 1 audit should take place on site.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.