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Quality Management System - ISO 13485

Valtronic’s quality mission consists of combining creative engineering and advanced manufacturing solutions that meet or exceed our customer's requirements and specifications.

Quality Policy

We support the concept that superior levels of performance result from the deliberate and systematic application of sound management practices. Management that works toward clearly defined goals creates an efficient Quality Management System based on continuous improvement. The quality management system is central to the culture of Valtronic and is imperative to the achievement of our business objectives. At Valtronic, quality is everyone’s responsibility. The quality management system is planned in accordance with the highest quality standards providing all customer’s with medical caliber quality.

Quality Services Include:

Engineering and Design
  • 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

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)