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Quality

Solutions

All Valtronic sites are ISO 13485 and ISO 9001 certified. Our production facilities are also FDA registered. With over 30 years of experience and state-of-the-art inspection methods and equipment, Valtronic is thus equipped to handle all quality aspects related to medical and advanced industrial devices. Whether it is the design, development, industrialization or manufacturing phase, our Group Quality Management System incorporates standards recognized by the FDA, European Medical Device Regulations, Norm IEC 60601, 21CFR 820, and more. Our team has the certifications and industry experience to bring your quality product to market quickly.

Through the development and implementation of a risk-based test strategy founded on an individually developed process map, our team is able to ensure quality control through strategically designed tests for each project.

Our seamless quality process is controlled and executed by the following practices:
  • Inspection by quality department before delivery
  • Quality control based on sampling plan or customer requirements
  • Quality control with standard measurement tools and 3D machine (Zeiss), optical machine (2D), Contour tracer, Height gauges, electrical test, binocular, and more
  • Gage R&R and FAI approach
  • Supplier selection and homologation
  • Auto control for each manufacturing process
  • Change control management
  • Full traceability upon request
  • Preventive maintenance program
  • Transfer management
  • Environmental control with certified ISO 14644 clean room
  • Quality engineering and quality control fully independent operations
  • Process validation according IQ/OQ/PQ methodology
  • Non-conformity and CAPA management
  • DHR management
  • IPC Trainer and IPC specialist (IPC A610) for electronic assemblies
  • Document retention with external partner according to customer requirements
Further Engineering and Design Quality Support:
  • State-of-the-art standard measurement instruments
  • ESD equipment
  • 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)
Further Manufacturing Quality Support:
  • 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

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