Light Fabrications, a leading supplier to the medical and electronics industry, has achieved ISO 13485 certification at its manufacturing facility in Rochester, NY. The new certification adds to the current TS 16949 and ISO 14001 certifications that it has maintained for many years.

"A growing segment of Light Fab's business comes from the medical electronics market. This certification strengthens our position in that marketplace and shows our commitment to process and quality improvement for all other markets and customers we serve," commented Jim Cucinelli, President.

ISO 13485 is a standard specific to medical device quality systems that supplements the ISO 9001 standard. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention and regulatory actions that are critical to the medical electronics device industry.

This achievement allows Light Fab export globally and offer traceability down to component levels as an important part of end-iem product tracking and history.