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.