Quality Management System - ISO 13485

The Valtronic Quality Policy is to provide services that meet or exceed industry and regulatory requirements. The Valtronic Quality Management System (“QMS”) applies to activities that affect quality and is implemented throughout Valtronic to ensure that all requirements for our services are met. All Valtronic services are controlled in accordance with the commitments of the QMS. All Valtronic sites are ISO 9001 and 13485 certified and our production facilities are FDA inspected.

Quality Services Include:

 
Engineering and Design
Manufacturing
  • Instruments for measurement of precision, temperature,force, electricity, tension, ESD, cleanliness
  • High accuracy 3D measurement system
  • Execution of stringent quality control measures at entry and exit points
  • Forward and backward traceability
  • Risk assessment (PFMEA & DFMEA)
  • Statistical Process Control (SPC) – for critical wire bonding processes providing Six Sigma performance
  • X-ray - investigating for die placement accuracy, BGA shorts, faulty  components, counterfeit components and trace and wire bonding contacts/connection
  • Complete capability of environmental testing for qualification
  • Mechanical Tests and Control Certified IPC trainers (IPC-A-600, IPC-A-610, J-STD-001)
  • Execution of Customized Quality Plan for Each Project
  • Design Controls and DHF Management
  • Extensive use of quality tools 
  • (Histograms, Ishikawa diagrams, Pareto analysis, etc)
  • Design Verification Planning and Testing
  • Equipment and Process Qualification
  • Process Validation
  • Support for regulatory submission