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Ensure internal audit schedules cover all areas of the QMS.
Do internal audit schedules cover all areas of the QMS?
37. Internal Audit Program
37.1 Audit Schedules
Audit Schedules, Coverage Reports
Verify internal audits are executed according to the schedule.
Are internal audits executed according to the schedule?
37.2 Audit Execution
Audit Reports, Execution Logs
Confirm follow-up actions from audits are tracked and closed.
Are follow-up actions from audits tracked and closed?
37.3 Audit Follow-up
Follow-up Logs, Closure Records
Ensure calibration schedules for measuring equipment are defined and followed.
Are calibration schedules for
38.1 Calibration Schedules
Calibration Schedules, Calibration Certificates
38. Calibration and Testing
measuring equipment defined and followed?
Verify testing procedures for product conformity are documented and followed.
Are testing procedures for product conformity documented and followed?
38.2 Testing Procedures
Test Procedures, Test Records
Ensure supplier qualification criteria are defined and applied.
Are supplier qualification criteria defined and applied?
39.1 Supplier Qualification Criteria
Qualification Criteria, Supplier Evaluation Records
39. Supplier Qualification
39.2 Supplier Re- evaluation
Verify suppliers are re- evaluated periodically.
Are suppliers re- evaluated periodically?
Re-evaluation Records, Performance Reviews
Ensure emergency preparedness plans are defined and communicated.
Are emergency preparedness plans defined and communicated?
40. Emergency Preparedness
40.1 Emergency Plans
Emergency Plans, Communication Records
Verify emergency drills are conducted regularly.
Are emergency drills conducted regularly?
40.2 Emergency Drills
Drill Reports, Attendance Logs
Ensure change control processes are defined and implemented.
Are change control processes defined and implemented?
41.1 Change Control Process
41. Change Management
Change Control Procedures, Change Logs
Verify impact analysis for changes is conducted and documented.
Is impact analysis for changes conducted and documented?
41.2 Change Impact Analysis
Impact Analysis Reports, Change Records
This expanded checklist ensures a thorough and comprehensive audit of the Quality Management System by covering all critical aspects and requirements. Each section includes specific audit checklist items, questions, and required Objective Quality Evidence (OQE) to ensure effective auditing and compliance verification.
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