Quality Systems
C-Axis maintains robust quality systems designed to meet the strict regulatory and performance requirements of medical device manufacturing. Our facilities operate under ISO 9001 and ISO 13485 certifications and are fully FDA registered, ensuring every component is produced with consistent accuracy, traceability, and process control. Through advanced inspection technologies and disciplined quality practices, we deliver confidence in every part we ship.
C-Axis integrates quality into every stage of development and production, from incoming materials through final inspection. Our dedicated quality teams work closely with engineering and manufacturing to ensure validation readiness, process repeatability, and compliance with customer-specific standards. With comprehensive documentation, real-time data collection, and a culture grounded in continuous improvement, we help customers reduce risk, strengthen reliability, and meet the highest regulatory expectations.
Advantages:
- ISO 9001 and ISO 13485 certified with full FDA registration
- Advanced inspection and metrology equipment including CMMs, vision systems, and laser measurement technologies
- Robust documentation and traceability from raw material to final component
- Statistical process control (SPC) to maintain consistency and identify trends
- Incoming, in-process, and final inspection to ensure full lifecycle quality control
- Nonconformance and CAPA management for structured problem resolution
- Validation readiness with support for IQ, OQ, PQ, and process capability studies
- Continuous improvement culture aligned with Lean practices and customer expectations
Examples of Quality System Activities
- Dimensional and geometric inspection using CMM, optical, and high-resolution metrology tools
- Surface finish and material verification for implantable and surgical components
- First Article Inspections (FAI) for new product introduction
- Lot traceability documentation including material certs and process records
- Process monitoring and SPC tracking for critical machining parameters
- Risk assessments including PFMEA and process audits
- Calibration and equipment verification to ensure ongoing measurement accuracy
- Final quality release for shipment of validated, compliant components
Other Capabilities
Precision Machining
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We look at C-Axis 360 as an opportunity for our customers to save weeks of development time by having their project team come into our facility. Here they are assigned a C-Axis team (an Engineer, Technician, and Machinist) to work with to complete multiple iterations in one sitting, helping to improve the R&D timeline. Instead of doing things in series, our customers can do multiple potential design iterations in parallel and save six or seven weeks in their NPD cycles. — Olson