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ISO 9001:2015 Supplier Audit Checklist - Manufacturing
Section 1: ISO 9001:2015 Supplier Audit Checklist - Manufacturing
1. 1. Review the documents that describe and control the process.
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No
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2. 2. Review all the important steps and activities of the process being audited.
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3. 3. This info must be documented within the QMS.
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No
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4. 4. Evaluate how effectively the process flows through the steps.
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5. 5. Do you see roadblocks or issues?
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No
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6. 6. Audit Question: Are areas around the facility clean and orderly and are tools and equipment properly stored and readily available for use and is lighting and air quality are adequate?
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No
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7. 7. Audit Evidence: Observe production, office & product storage areas. (Sort, Set-in-order, Shine, Standardize, Sustain + Safety)
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8. 8. Audit Question: Are documented procedures followed to ensure proper control and preservation of handling, storage (FIFO), packaging, and delivery of product?
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9. 9. Audit Evidence: FIFO practices are defined, packaging specifications, test results, handling and storage procedures.
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10. 10. Audit Question: Is the suitability of product packaging reviewed and concerns communicated to the customer prior to initial production shipment?
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No
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11. 11. Audit Evidence: Technical review, packaging/shipping tests, packaging work instructions, carton strength tests
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No
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12. 12. Audit Question: Is stored product/material periodically inspected, and where applicable, actions are taken to prevent deterioration per documented procedures?
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13. 13. Audit Evidence: Lists of shelf-life sensitive materials. Look for poor storage conditions and damage. Handling procedures
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14. 14. Audit Question: Have contingency plans been developed that describe actions to be taken in the event of a major interruption of the manufacturing process?
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No
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15. 15. Audit Evidence: Process covering utility interruptions, labour shortages, key equipment failures, major production issues
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No
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