| 1 | Application and optical configuration | 10% | Confirm whether the lens is intended for rigid endoscopes, flexible endoscopes, imaging modules, illumination paths, or custom optical assemblies. | The supplier should provide a design proposal matching the required field of view, working distance, image circle, and mechanical envelope. | Optical drawing, application questionnaire, preliminary tolerance analysis, and sample design. |
| 2 | Optical performance | 20% | Review resolution, distortion, relative illumination, chromatic aberration, transmission, numerical aperture, and field of view. | Use application-specific acceptance limits; do not compare suppliers using field of view alone. Performance should be confirmed across the specified wavelength range and temperature range. | Measured optical test report, MTF data where applicable, spectral transmission curve, and inspection method. |
| 3 | Dimensional and mechanical compatibility | 12% | Check outer diameter, lens length, clear aperture, thread or bonding interface, concentricity, angular alignment, and allowable assembly tolerance. | All critical dimensions must be listed on a controlled drawing with explicit tolerances and an agreed inspection datum. | 2D/3D drawings, tolerance stack-up, first-article inspection report, and compatibility sample. |
| 4 | Material and coating selection | 10% | Verify optical glass or polymer grade, coating type, coating durability, chemical resistance, and compatibility with cleaning or sterilization procedures. | The selected materials and coatings must withstand the endoscope’s documented cleaning, disinfection, or sterilization process without unacceptable optical or mechanical degradation. | Material certificates, coating specification, chemical-resistance data, and sterilization compatibility test results. |
| 5 | Quality management system | 12% | Assess process control, document control, nonconformance handling, corrective action, traceability, calibration, and internal audits. | For medical-device supply chains, ISO 13485 certification is a strong qualification signal when the supplier’s certified scope covers the relevant activity. Certification should be independently verified. | Current certificate, certification scope, audit summary, quality manual index, and corrective-action procedure. |
| 6 | Prototype and sample validation | 10% | Review the supplier’s ability to produce engineering samples, pilot batches, and production-equivalent prototypes. | Approve samples only after testing the same critical characteristics required for mass production, including optical, dimensional, cosmetic, and environmental performance. | Sample approval record, inspection report, test fixtures, and signed acceptance criteria. |
| 7 | Manufacturing capability and capacity | 8% | Evaluate polishing, centering, coating, bonding, alignment, cleaning, assembly, inspection, and packaging capabilities. | The supplier should have controlled processes for every critical operation and sufficient equipment capacity for the forecast volume, including planned maintenance. | Process flow chart, equipment list, capacity plan, maintenance records, and facility audit findings. |
| 8 | Inspection and measurement systems | 8% | Confirm the availability of calibrated equipment for dimensional, optical, surface, coating, cleanliness, and alignment inspection. | Critical measuring equipment should have current calibration records and a defined measurement method. Measurement-system suitability should be demonstrated for critical characteristics. | Calibration certificates, inspection standards, test-method documents, and measurement-system study where applicable. |
| 9 | Regulatory and product documentation support | 5% | Determine whether the supplier can provide technical files, change notifications, material declarations, risk-related information, and traceability records. | Documentation must be available in a controlled format and remain consistent with the approved drawing, bill of materials, process, and inspection plan. | Document register, change-control procedure, lot-traceability example, and supplier questionnaire. |
| 10 | Commercial, logistics, and after-sales support | 5% | Compare quotation structure, minimum order quantity, lead time, packaging, export experience, payment terms, warranty handling, and communication response time. | Choose the supplier with the best total cost and supply reliability, not simply the lowest unit price. Lead times and quality responsibilities should be written into the purchase agreement. | Formal quotation, delivery schedule, packaging specification, warranty terms, and quality agreement. |