The organization acts to remove the causes of nonconformities so they do not happen again. It does this promptly and in proportion to the effects of the nonconformities found. A documented procedure sets the requirements for: reviewing nonconformities, complaints included; finding what caused them; deciding whether action is needed so they do not recur; planning, documenting and carrying out the action required, updating documentation where appropriate; checking that the action does not harm regulatory compliance or the device's safety and performance; and reviewing whether the corrective action worked. Records are kept of investigation results and of the action taken.
This control maps to 3 controls across 3 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 3 it maps to, and the evidence behind each claim, over MCP and REST.