For an initial audit (stage 1 plus stage 2) the starting audit time comes from Table D.1 by effective number of personnel, from 3 days for 1 to 5 people, 4 days for 6 to 10, rising through 10 days for 86 to 125 and 20 days for 2,676 to 3,450, to 25 days for 8,501 to 10,700 and the same progression above. Time may increase for more than one main technical area, device complexity, suppliers of critical processes or parts including own-label products where the manufacturer's evidence is insufficient, installation at customer premises, poor regulatory compliance, or multiple shifts and production lines; it may be reduced by at most 20 percent where the scope excludes manufacturing (wholesale, retail, transport or maintenance), or where product range or design and production processes have shrunk since the last audit; an audit covering only distribution or transport services may be cut by as much as 50 percent. When ISO 9001 and ISO 13485 are audited together, whether integrated or combined, at least 25 percent is added to the Annex D minimum.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.