| Engineering Team Capability | Electrical, mechanical, firmware, software, and reliability engineering resources relevant to the product. | Organization chart, engineer qualifications, design-responsibility matrix, and examples of completed projects. | Documented engineering ownership and formal design-review procedures. | 15% |
| Product Design and Development | Ability to convert specifications into controlled hardware, firmware, enclosure, thermal, and safety designs. | Design inputs and outputs, risk analysis, verification plans, engineering-change records, and prototype history. | ISO 9001 design-control principles; IEC 61010, IEC 62368-1, or IEC 60601-1 where applicable. | 15% |
| Electrical and Functional Performance | Rated voltage, current, power, efficiency, operating temperature, load behavior, accuracy, and functional limits. | Datasheets, test reports, tolerance limits, calibration records, and samples tested against the approved specification. | Applicable IEC, UL, EN, or national electrical requirements stated in the product specification. | 12% |
| Safety and Regulatory Compliance | Protection against electric shock, overcurrent, overheating, fire, abnormal operation, and electromagnetic hazards. | Valid certificates, declarations of conformity, construction files, safety test reports, and component approvals. | Applicable requirements may include IEC 61010-1, IEC 62368-1, IEC 60601-1, IEC 60204-1, CE, UKCA, or UL requirements. | 15% |
| EMC and Environmental Testing | Immunity, emissions, vibration, shock, humidity, temperature cycling, ingress protection, and corrosion resistance when required. | Laboratory reports, test conditions, pass/fail results, corrective-action records, and pre-compliance test data. | IEC 61000 series for EMC; IEC 60068 series for environmental testing; IEC 60529 for IP ratings. | 10% |
| Manufacturing Process Capability | Control of PCB assembly, wiring, soldering, enclosure fabrication, firmware loading, calibration, and final assembly. | Process flow charts, work instructions, equipment lists, operator training records, and first-article inspection reports. | IPC-A-610 for electronic assemblies and IPC/WHMA-A-620 for cable and wire harness assemblies where applicable. | 10% |
| Quality Management System | Control of nonconforming products, corrective actions, supplier quality, traceability, audits, and continuous improvement. | Quality certificate, audit results, defect-rate trends, CAPA records, inspection plans, and traceability samples. | ISO 9001; ISO 13485 for applicable medical devices; IATF 16949 for applicable automotive production. | 10% |
| Testing and Measurement Resources | Availability and suitability of electrical, safety, EMC, thermal, mechanical, and reliability test equipment. | Equipment inventory, calibration certificates, test-method documents, laboratory scope, and sample test records. | ISO/IEC 17025 for competent testing and calibration laboratories, where certification or independent testing is required. | 8% |
| Customization and Scalability | Ability to support custom specifications, firmware changes, tooling, pilot production, and volume ramp-up without reducing quality. | Prototype-to-production plan, capacity report, tooling schedule, engineering-change workflow, and ramp-up performance data. | Defined acceptance criteria for prototype, pilot, and mass-production stages. | 3% |
| Technical Support and Lifecycle Management | Responsiveness for troubleshooting, spare parts, firmware updates, obsolescence management, warranty, and field failures. | Service-level agreement, escalation process, failure-analysis reports, spare-parts policy, and product-change notifications. | Documented response times, repair procedures, and end-of-life notification practices. | 2% |