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 is ISO-13485 certified specializing in the design, development, and manufacturing of ultrasonic fluid sensing, surgical, therapeutic and related devices.

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