| Material Grade and Traceability | 20% | Confirm the specified stainless steel grade, such as 304 or 316L, according to the product application. Require heat or lot identification for each production batch. | Material certificate, chemical composition report, mechanical-property report, lot number, and certificate traceability to the delivered goods. | 5 points: grade and lot are fully traceable; 3 points: grade is stated but traceability is incomplete; 0 points: no objective material documentation. |
| Dimensional Accuracy | 15% | Define critical dimensions before quotation, including barrel or body diameter, wall thickness, plunger fit, nozzle dimensions, and overall length. | Approved engineering drawing, tolerance table, inspection report, calibrated measuring equipment record, and first-article inspection sample. | 5 points: all critical dimensions meet the approved drawing; 3 points: minor deviations require approval; 0 points: no controlled drawing or inspection record. |
| Surface Finish and Corrosion Resistance | 15% | Specify surface condition, polishing requirements, weld or joint finish, burr limits, and resistance requirements for the intended fluid or environment. | Surface-finish specification, visual inspection standard, passivation or electropolishing records where applicable, and corrosion-test results when required. | 5 points: documented finish and verification method; 3 points: visual inspection only; 0 points: uncontrolled surface condition. |
| Leakage and Functional Performance | 15% | Establish acceptance limits for leakage, plunger force, pressure resistance, dispensing accuracy, and repeated-use cycles when the syringe is reusable. | Product-specific test method, test equipment details, batch inspection records, sample test results, and nonconformance procedure. | 5 points: requirements are quantified and batch-tested; 3 points: testing is performed but limits are unclear; 0 points: no functional validation. |
| Quality Management System | 12% | Use a documented quality system covering incoming inspection, process control, final inspection, calibration, corrective action, and complaint handling. | Current ISO 9001 or ISO 13485 certificate when applicable, certificate scope, audit reports, quality manual, and corrective-action records. | 5 points: valid certificate matches the manufacturing scope; 3 points: documented system without independently verified certification; 0 points: no formal quality system. |
| Regulatory and Product Documentation | 10% | Match documentation to the intended market and product use. Do not treat a general factory certificate as proof of medical-device compliance. | Technical file, declaration or certificate required by the target market, risk documentation, labeling information, and applicable test reports. | 5 points: documentation is complete and product-specific; 3 points: partial documentation; 0 points: unsupported regulatory claims. |
| Production Capacity and Lead Time | 8% | Compare capacity against the required monthly quantity, tooling needs, sampling schedule, production lead time, and peak-season contingency. | Capacity statement, production schedule, sample lead-time commitment, tooling plan, and evidence of production-site control. | 5 points: capacity and delivery plan are demonstrated; 3 points: capacity is claimed but not verified; 0 points: no reliable schedule. |
| Packaging, Cleanliness, and Shipping Protection | 5% | Define individual protection, moisture control, carton strength, identification labels, and cleanliness requirements based on the product application. | Packaging specification, packing photos, carton test information, cleanliness controls, and completed pre-shipment inspection report. | 5 points: packaging is validated for transport; 3 points: standard packaging only; 0 points: frequent damage or unclear packing controls. |