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)
Variety of welch products

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

All Welch Fluorocarbon Team Members are committed to:

  • Meeting customer needs and expectations by strictly following and maintaining the effectiveness of our quality management system.
  • Verifying and implementing team quality objectives.
  • Responding rapidly to customer input.
  • Providing excellent customer service in a safe and environmentally friendly way.

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