Quality Systems

At C-Axis we are committed to exceed our customers expectations in all aspects of our business. C-Axis has developed and implemented a Quality Management System (QMS) that encompasses both the Minnesota and Puerto Rico facilities and conforms to the exacting standards expected by today’s medical device industry. Our QMS assures we provide the highest-quality products and services to meet your requirements.  C-Axis achieves this by using advanced metrology and measurement techniques. Not only does this help ensure conformance with each specification but supports our continuous improvement process as well. Combine this with our robust training programs and you can be assured that you are working with the highest skilled people in the industry, using the best technology available.

C-Axis provides high-level project quality support beginning at the development and design phase of the project.  We offer:

  • Certified and registered QMS
  • Advanced Product Quality Planning (APQP)
  • Process Validations
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)
    • Special processes
  • Production Part Approval Process (PPAP)
  • Process Failure, Modes and Effects Analysis (PFMEA)
  • Gauge Repeatability and Reproducibility (GR&R)
  • Capability analysis
  • Statistical support for validation planning and execution