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Ensure all required inputs are included in management reviews.
Are all required inputs included in management reviews?
9. Management Review
9.1 Review Inputs
Management Review Agendas, Input Data
Verify that management review outputs include decisions and actions related to improvement.
Do management review outputs include decisions and actions for improvement?
9.2 Review Outputs
Management Review Minutes, Action Plans
Ensure the internal audit program covers all areas of the QMS.
Does the internal audit program cover all QMS areas?
10. Internal Audit
10.1 Audit Program
Audit Program, Audit Schedule
Verify that internal audits are planned and conducted as per schedule.
Are internal audits planned and conducted as scheduled?
10.2 Audit Planning
Audit Plans, Audit Reports
Confirm that internal audits are executed
Are internal audits executed according to procedures?
10.3 Audit Execution
Audit Checklists, Execution Records
according to procedures.
Ensure that audit findings and reports are documented and communicated.
Are audit findings and reports documented and communicated?
10.4 Audit Reporting
Audit Reports, Communication Records
Verify that follow-up actions for audit findings are implemented.
Are follow-up actions for audit findings implemented?
10.5 Follow-up Actions
Follow-up Reports, Corrective Action Plans
Ensure nonconforming outputs are identified and controlled to prevent unintended use.
Are nonconforming outputs identified and controlled?
11.1 Identification and Control
Nonconformance Records, Control Procedures
11. Control of Nonconforming Outputs
11.2 Disposition of Nonconforming Outputs
Verify the disposition of nonconforming outputs is documented.
Is the disposition of nonconforming outputs documented?
Disposition Records, Nonconformance Logs
Confirm that dispositions of nonconforming outputs are reviewed and approved.
Are dispositions of nonconforming outputs reviewed and approved?
11.3 Review and Approval of Dispositions
Approval Records, Review Logs
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