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Quality Systems

Ensuring Quality Built in Every Part

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Quality Policy

  • Quality Excellence
  • Customer Satisfaction
  • Long-term Business

At INTAI, we understand any compromise in quality can result in recalls, loss profits and even disastrous business issues to our partners. Our approach is to fully integrate quality into each step from design, development, to manufacture of a product and systematically broaden this mindset to our supplier chain. Our devotion in seeking excellence is embedded in our employees from top management, project leads to junior engineers and line operators.

Since the company began in 1988, INTAI has established stringent processes and monitoring practices for consistent quality. As an ISO-certified and FDA-registered company, we continue our legacy in providing the outstanding products and services.
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Certification

We widely utilize Six Sigma tool with computerized inspection equipment, the supervision of on-line SPC system, and the real time data feedback to make sure out-of-controls and out-of-spec are detected in time. Our ultimate goal is to effectively mitigate our partners' risks and assure consistent quality output.

  • ISO 9001
  • AS 9100
  • ISO 14001
  • FDA 21 CFR 820 Compliant
  • ISO 13485
  • cGMP-QSR Compliant
  • TS 16949
Company-wide Quality Systems
  • DESIGN CONTROLS
    • – Design input, review, output, verification and validation, transfer and design history files (DHF)
  • PROCESS VALIDATION
    • – Installation qualification (IQ), operation qualification (OQ), performance qualification (PQ) and process capability assessment (short-term, on-going and long-term)
  • EQUIPMENT and CALIBRATIONS
    • – Preventive equipment maintenance, measuring equipment calibration and measurement system analysis
  • DOCUMENTATION and CONTROL
    • – Revision level control, validation and communication
  • SYSTEM AUDIT
    • – Management review, scheduled internal audit, 3rd party audit and corrective action and preventive action (CAPA)
  • RISK MANAGEMENT
    • – Failure mode and effects analysis (FMEA), Pokayoke or mistakeproofing
  • CONTINUOUS IMPROVEMENT
    • – Six Sigma (DMAI2C), statistical process control (SPC), design of experiment (DOE)