This certification also allows the company to keep moving forward in improving its processes and to be able to branch out markets.
ThermoFab, a trusted leader in thermoforming and injection molding heavy gauge plastic enclosures, has achieved ISO 13485:2016 status of being certified with an international standard of quality management systems in medical device business. This certification confirms ThermoFab’s proactive approach to quality management thereof with its approach being holistic touching on aspects of design, development, manufacture and customer relations in the Medical Device Industry.
These initiatives were initiated by a quality team of the organization led by Melissa Wright who is profoundly experienced in quality assurance. Standing with her in these endeavours are Arti Jivanani and Nicole Rodriguez, Quality Inspectors who participated in enhancing the quality inspection procedures of ThermoFab. The team was also very successful in changing from subjective visual inspections to actual measurement specifications on each part for improved accuracy in ThermoFab’s finished products.
Wright has moved from thermoforming to Quality Lead position which has provided a range of ideas and skills in thinking about quality control needs of ThermoFab and put into practice new measures and procedures to enhance the ThermoFab’s culture of the qc awareness across the full organization.
The attainment of ISO 13485:2016 certification will provide ThermoFab with an improved competitive advantage and customer satisfaction by meeting and exceeding high regulatory standards and by showing the customer dedication in improvement. This not only increases current production rates but also puts ThermoFab in a better place to target a wider range of customers that may be seeking certified manufacturing companies.
The new technology of Keyence WM6210 in the production field will allow to enhance the analysis of the components, which will lead to the improvement of measurement accuracy and, thus, a reduction in the level of defects. Also, ThermoFab has upheld improvements that make nearly all the operational procedures traceable and conform to healthcare requirements.
SOURCE – https://www.mpo-mag.com/contents/view_breaking-news/2024-10-04/thermofab-achieves-iso-134852016-certification/
