ThermoFab Achieves ISO 13485:2016 Certification

ThermoFab, a trusted leader in thermoforming and injection molding heavy gauge plastic enclosures, has achieved ISO 13485:2016 certification, an international benchmark for quality management systems in the medical device industry. With this certification, ThermoFab demonstrates its commitment to excellence in quality management, with a comprehensive system encompassing all facets of design, development, production, and customer service in the manufacture of medical devices.
 
The quality team, led by Melissa Wright, a seasoned expert with extensive experience in quality assurance, was instrumental in driving these initiatives. Supporting her in these efforts are Arti Jivanani and Nicole Rodriguez, both dedicated Quality Inspectors, who contributed to refining ThermoFab’s quality inspection processes. The team was instrumental in transitioning from visual-only inspections to precise measurement-based checks for every component, increasing the reliability and precision of ThermoFab’s products.
 
Wright transitioned from a role in thermoforming to Quality Lead, has brought invaluable insights into ThermoFab’s quality control processes, and instituted new measures and procedures to foster a culture of quality awareness throughout the organization.
 
The attainment of ISO 13485:2016 certification positions ThermoFab to better serve its customers by adhering to stringent regulatory requirements and demonstrating a commitment to continuous improvement. This not only optimizes current production but also positions ThermoFab to expand its market reach, appealing to new customers seeking certified manufacturing partners.
 
Integrating new Keyence WM6210 technology will enable a more detailed analysis of components, further improving measurement accuracy and helping reduce defects. Additionally, ThermoFab’s strengthened documentation practices ensure that all processes are traceable and compliant with medical industry standards.