| 8.4.1 | Supplier selection and approval | Confirm selection criteria consider the supplier’s ability to meet drawing, material, dimensional, delivery, and applicable regulatory requirements. | Approved supplier criteria, initial evaluation records, technical capability review, and approval status for the relevant component category. | Acceptable when documented criteria are applied before purchase and approval is traceable to the supplier and scope of supply. |
| 8.4.1 | Monitoring and re-evaluation | Check that supplier performance is monitored and re-evaluation is performed at planned intervals or when performance issues arise. | Incoming inspection results, delivery performance records, nonconformity and corrective-action history, and dated re-evaluation records. | Acceptable when monitoring results inform decisions and action is taken when performance does not meet requirements. |
| 8.4.2 | Type and extent of control | Verify controls are proportionate to the component’s impact on conformity and to the effectiveness of the supplier’s own controls. | Risk-based inspection plans, supplier process assessments, receiving inspection records, and defined verification or testing activities. | Acceptable when higher-risk or critical characteristics receive appropriate verification and control methods are defined. |
| 8.4.2 | Verification of purchased components | Check that verification confirms conformity to the current specification, including applicable dimensions, material, hardness, surface finish, and heat-treatment requirements. | Inspection reports, certificates or test reports when specified, calibrated measurement equipment records, and links to the applicable drawing revision. | Acceptable when verification methods and acceptance criteria are established and records identify the inspected lot or part. |
| 8.4.2 | Control of changes | Determine whether changes affecting supplied components, processes, materials, or manufacturing location are reviewed and authorized as required. | Change notifications, customer or internal approvals where required, revised specifications, and records showing implementation dates or affected lots. | Acceptable when relevant changes are controlled and the organization can assess their effect before use. |
| 8.4.3 | Clarity of purchasing requirements | Confirm purchase information adequately describes the component and applicable requirements, including drawing revision, material specification, quantity, and acceptance criteria. | Purchase orders, technical specifications, controlled drawings, quality clauses, and records showing requirements were reviewed before communication to the supplier. | Acceptable when requirements are complete, current, and communicated before the supplier accepts the order. |
| 8.4.3 | Competence and external provider interactions | Where relevant, communicate competence requirements, required interactions, inspection or approval activities, and any intended verification at the supplier’s premises. | Order requirements, supplier instructions, inspection arrangements, approval records, and agreed access or verification provisions. | Acceptable when applicable requirements are communicated and agreed arrangements are documented. |
| 8.4.3 | Nonconformity communication and response | Verify that nonconforming supplied components are identified, contained, and communicated, with corrective action requested when appropriate. | Nonconformity reports, containment records, supplier responses, corrective-action evidence, and disposition approvals. | Acceptable when affected product is controlled and actions are followed through to a documented disposition and effectiveness review when required. |