Quality
Quality Systems
- ISO 9001-2000 and ISO 13485-2003 certified, FDA compliant contract manufacturer and component supplier
- GMP compliant
- Registrar: Orion Registrar, Inc.
- Closed-loop information systems
- Quality and manufacturing integration
- In-process and final inspection SPC data available
- Emphasis on process improvements and problem prevention
- Management drives and measures process improvements
- Defined self-audit system
- Continual quality and on-time delivery improvements
Inspection Capabilities
- State-of-the-art equipment
- Video inspection systems
- Hybrid CMM, video, rotational systems
- Resolution — 0.000004"
- Repeatability and accuracy — 0.000010"
- Gage calibration system: Gage InSite
- Calibration traceable to National Institute for Standards and Technology (NIST)
Process Capabilities
- Statistical data
- Team-based SPC
- Real time data entry during manufacturing
- Calculates CPK, CR, CP, CPU and CPI at point of manufacture using dedicated terminals
- Certified process control
- Vertical integration
- Preproduction planning:
All orders are reviewed by Quality, Engineering, Manufacturing and Customer Service Improvements for manufacturability are reviewed with the customer - Manufacturing inspection procedure
- Quality assurance determines the inspection method for each stage of manufacturing
- First article
- At each stage of manufacturing, a first article inspection is performed and signed off
- Process capability study
- SPC is used to analyze process variability and CPK to maintain optimum capability
- Certified supplier program
Validation and Traceability
Quality systems integrate validation, lot control, certifications and record retention. every detail of a project is monitored, controlled and captured through Stellar Technologies’ management system.