ISO 13485 Certified Contract Manufacturer
Genesis maintains the following quality standards, registrations and certifications:
- ISO 13485 Certificate
- Class 7 Clean Room Certification (Room 1)
- Class 7 Clean Room Certification (Room 2)
- ISO 1Class 7 Clean Room Certification (Room 3)
- Class 8 Gown Room Certification
- Quality Control Lab Certification
- Medical Device Quality System Regulation 21 CFR 820
- FDA Registration
Genesis is affiliated with:
- Industrial Fabrics Association International (IFAI)
- Society of Plastics Engineers (SPE)
- Indiana Manufacturers Association (IMA)
- Indiana Medical Device Manufacturing Council (IMDMC)
- The American Freedom Foundation, Inc.
- Purdue University Manufacturing Partnership Exchange
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.
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.