Continual improvement of a QMS based on ISO 9001
Domain 6 is clause 10. The exam tests the distinction between correction, corrective action and improvement, and whether the organization can show that actions worked.
The three layers (10.1, 10.2, 10.3)
A correction removes the detected nonconformity; a corrective action eliminates the cause so it does not recur. 10.2 requires reacting to the nonconformity, evaluating the need for action, determining and implementing it, reviewing its effectiveness, updating the risks and opportunities determined in 6.1, and making changes to the QMS if necessary. Documented information must be retained as evidence of the nature of the nonconformities and the results of any action. 10.3 requires improving the suitability, adequacy and effectiveness of the QMS by identifying opportunities and implementing actions, using data from 9.1 and 9.3.
Note the 2015 edition removed the standalone preventive action clause. Risks and opportunities under 6.1 now carry that intent, and an answer recommending a preventive action procedure is wrong.
Root cause and effectiveness
Containment is not root cause analysis. Tools such as 5 Whys and cause-and-effect diagrams support it, but the test is whether the identified cause explains the specific nonconformity and whether the action would prevent recurrence.
Worked example
Three late deliveries occur in one quarter. The correction is expediting the affected orders. Root cause analysis shows scheduling assumed a two-day production lead time while the work instruction states three. Production planning is corrected, the work instruction aligned, and the scheduler retrained. Effectiveness is verified against on-time delivery data for the next three months, and the 6.1 risk entry on planning assumptions is updated.
Traps
- Closing a corrective action at the containment stage.
- Accepting a completed form as evidence of effectiveness instead of outcome data.
- Improvement projects with no baseline measurement, so no improvement can be demonstrated.