不適合及び是正処置

Clause 10.2

When a nonconformity occurs, the organization shall: a) react to the nonconformity and as applicable: 1) take action to control and correct it; 2) deal with the consequences; b) evaluate the need for action to eliminate the cause(s) of the nonconformity, so that it does not recur or occur elsewhere, by: 1) reviewing the nonconformity; 2) determining the causes of the nonconformity; 3) determining if similar nonconformities exist or can potentially occur; c) implement any action needed; d) review the effectiveness of any corrective action taken; e) make changes to the AI management system, if necessary. Corrective actions shall be appropriate to the effects of the nonconformities encountered. Documented information shall be available as evidence of: — the nature of the nonconformities and any subsequent actions taken; — the results of any corrective action.