ISO 13485 Certified Contract Manufacturer
As an ISO 13485:2016 certified contract manufacturer, Genesis Plastics Welding maintains the following quality standards, registrations, and certifications:
- ISO 13485:2016 Certificate
- Class 7 Clean Room Certification (Room 1)
- Class 7 Clean Room Certification (Room 2)
- Class 8 Gown Room Certification
- Medical Device Quality System Regulation 21 CFR 820
- FDA Registration
Genesis Plastics Welding is affiliated with:
Quality and Excellence in Plastics Manufacturing
A dedication to continuous improvement is at the foundation of Genesis Plastics Welding’s success. Employees at each level of the organization — from machine operators to the CEO —are responsible for contributing to the improvement of the quality system and are empowered and trained as front-line inspectors in each phase of the manufacturing process.
Quality Committee
Our Quality Committee is responsible for managing the overall effectiveness of the Genesis Quality System, including review of critical continuous improvement activities (CAPA), customer complaints and audits. Members of the committee include the president and management representatives from Quality, Operations, Engineering and Production departments.
Quality Audits
If you’re considering our services, we encourage you to inquire about our quality audits. We proudly provide our customers with complete transparency into the manufacturing process.
The single most important question we can ever ask our clients, prospects, friends, and family — “How can I help?”