At GC MOLD we realize that quality is of the highest importance to our customers, due to the patient-critical and highly regulated nature of the plastic molding parts and services. GC MOLD continues to provide a quality system that meets or exceeds our customers’ stringent requirements.

GC MOLD’s Plastic Molds are made according to American and Europe mold standard, 21 CFR Part 820, and has been certified to meet the requirements of ISO13485: 2003. These requirements have been developed as a globally harmonized approach to quality system management for medical devices.

ISO13485:2003 is a stand-alone international standard using a format similar to ISO9001:2000, but focused toward the design and manufacture of medical devices. Like ISO9001:2000, ISO13485:2003 is based on a process approach to quality management. For an organization to function effectively, it must identify and manage numerous linked processes. The quality system must interact within these processes.

GC MOLD maintains this quality system focused on continual improvement and compliance with customer and regulatory requirements. We continue to deploy a world-class quality program throughout GC MOLD and strive to continuously improve by utilizing Six Sigma principles to eliminate variations and sustain higher levels of quality. These efforts enable GC MOLD to remain committed to:

  • Improve Product Quality and Reliability
  • Monitor Health, Safety and Environmental Protection, and Reduce Waste
  • Provide Greater Compatibility and Interoperability of Goods and Services
  • Increase Distribution Efficiency, and Ease of Maintenance