The organization documents requirements for cleanliness of product or contamination control of product where product is cleaned by the organization before sterilization or use; where product is supplied non-sterile for cleaning before sterilization or use; where product cannot be cleaned before sterilization or use and its cleanliness is significant in use; where product is supplied for non-sterile use and its cleanliness is significant in use; or where process agents are to be removed during manufacture. Where product is cleaned before sterilization or use under the first two cases, the work environment requirements of 6.4.1 do not apply before the cleaning process.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.