8.7 Corrective Actions (Option A)
The laboratory shall take appropriate corrective actions when a nonconformity occurs, ensuring effective resolution and prevention of recurrence.
8.7.1 Addressing Nonconformities
When a nonconformity occurs, the laboratory shall:
-
React to the nonconformity and, as applicable:
- Take action to control and correct it.
- Address the consequences.
-
Evaluate the need for action to eliminate the cause(s) of the nonconformity, in order to prevent recurrence or occurrence elsewhere, by:
- Reviewing and analyzing the nonconformity.
- Determining the causes of the nonconformity.
- Determining if similar nonconformities exist or could potentially occur.
- Implement any action needed.
- Review the effectiveness of any corrective action taken.
- Update risks and opportunities determined during planning, if necessary.
- Make changes to the management system, if necessary.
8.7.2 Appropriateness of Corrective Actions
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
8.7.3 Retention of Records
The laboratory shall retain records as evidence of:
- The nature of the nonconformities, cause(s), and any subsequent actions taken.
- The results of any corrective action.