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

Certificates:

Swiss_ISO_13485_2003.pdf

Swiss_ISO_9001_2008.pdf

USA_ISO_13485_2003.pdf

USA_ISO_9001_2008.pdf

Morocco_ISO_13485_2003.pdf

Morocco_ISO_9001_2008.pdf

Romania_ISO_13485_2003.pdf

Romania_ISO_9001_2008.pdf

We are a niche “mechatronics” manufacturing solutions company. We produce integrated electronic and mechanical products. Our customers are leading global suppliers of medical implants and devices, diagnostic imaging equipment and sensitive aerospace and industrial assemblies. For over 30 years we have helped hundreds of companies develop and produce Class II & III medical devices and advanced miniaturized electronic assemblies from our worldwide facilities.

ISO 13485 and FDA registered