GLOSSARYGlobal
CAPA
The paired process of corrective action, which removes the cause of a nonconformity that has occurred, and preventive action, which removes the cause of one that could occur. ISO 13485 requires both under clauses 8.5.2 and 8.5.3 but does not name the pair.
Avoid This Mistake
The old CAPA section, 21 CFR 820.100, is no longer in Part 820. ISO 13485 requires corrective action and preventive action as separate clauses and names no collective term.