QUALITY

Making it right, even when no one is looking.

Biosonix manufactures products that exceed expectations. As a team, we continually strive to perfect our processes and products and provide superior service to our customers.

Biosonix specializes in the design, development, and manufacturing of ultrasonic fluid sensing, surgical, therapeutic and related devices. Our quality management system is ISO-13485 certified.

REGISTRATIONS

  • Biosonix: ISO-13485
  • Biomerics: ISO-13485, ISO-9001, CE Mark & FDA Registered

PROBLEM SOLVING

  • Six Sigma Problem Solving Tools (DMAIC, 8D)
  • Lean Manufacturing Tools (5S, SMED, 7 Wastes)
  • Value Stream Mapping/Work Flow Diagrams/Process Mapping
  • Visual Management Systems (VFM)
  • 5 Why’s, Ishikawa Diagrams, Root Cause Analysis

PRODUCT & PROCESS VALIDATION

  • Standard Work Documentation
  • DFMEA / PFMEA / Control Plans
  • First Article Layouts and Approvals
  • Process Capability Studies (CpK)
  • Real-time Monitoring Systems
  • IQ, OQ, PQ Validations
  • Lab testing for Analysis and Compliance
  • Risk Analysis and Risk Assessment

    OPERATIONAL TOOLS

    • Preventative Maintenance Program
    • Mold Maintenance Program
    • Clean Room Process
    • Calibration Program
    • Regular Internal Audits