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Quality

Quality Overview

  • Professional Quality Management, experience with:
    • ISO 13485 Quality Management System Requirements
    • Internal and external auditing
    • Risk Assessment
    • First Article Inspection Reports
    • Certificates of Compliance
    • Dock-to-stock
    • Gauge R&R
    • Dimensional Measurement Tools
    • Capability Analysis (Cpk)

ISO Registration

Welch Fluorocarbon, Inc. became registered to the ISO 9001:2008 international quality standard on January 7, 2011.  In 2018, Welch decided to transition its Quality Management System to the medical device standard, ISO 13485:2016.  Welch Fluorocarbon, Inc. became registered to the ISO 13485:2016 standard on December 17, 2018.

Quality Policy

Welch Fluorocarbon, Inc. is committed to meeting customer needs and expectations.