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