A short-notice or unannounced audit may be needed where external factors apply, such as devices in scope indicating a possible significant QMS deficiency or significant safety and performance information becoming known to the body; where significant changes submitted under the regulations or otherwise known could affect the client's compliance status; or where public law or the regulatory authority requires them. Changes that may be significant include new ownership, extension to manufacturing or design control, a new facility or site change, new or changed processes such as moving sterilisation in-house or changing method, changes to the management representative's authority, new products or device categories, and changes in standards, regulations, post-market surveillance or vigilance, though none triggers an audit automatically; justified concerns about corrective action or compliance may also warrant one.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.