If the applicable regulatory requirements call for the organization to notify complaints meeting set reporting criteria for adverse events, or to issue advisory notices, the organization documents procedures for notifying the relevant regulatory authorities. Records of such reporting are kept.
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.