FMI’s Quality Standards

FMI believes in quality.

Quality is the foremost goal of every FMI employee.

While striving for zero defects, we are also committed to improving the quality of our parts through a process of continuous improvement.

We achieve quality by applying Six Sigma methodolgy to our unique manufacturing process, drawing upon our decades of experience as a quality leader in the silicone rubber industry.

As we work towards higher quality products and services, our customers will benefit by receiving the best products attainable in our industry. We maintain a leadership position in our industry by producing the highest quality products.

FMI's Quality Policy

We are committed to satisfying our customers by supplying quality parts in a timely manner, exceeding customer requirements, and continuing to improve the effectiveness of our quality management system.

ISO Medical Devices

FMI is an ISO 9001:2008 registered company. Click here to see our registration (pdf).

We use quality tools such as APQP, Control Plans, PFMEAs, and others to produce a quality plan that help exceed customer expectations.

We use the tightest process controls and believe this is reflected in the quality of our parts. We have the capability of validating both parts and processes, using extensive IQ/OQ/PQ qualification processes.

FMI inspectors are highly trained and qualified to work on micro-precision parts under 10x – 40x magnification. We have state of the art measuring equipment such as a fully automated vision system that increases productivity, and produces the best gage repeatability and reproducibility (GR&R).

Our goal is to relentlessly improve quality, performance, delivery, and service to our customers and be a world leader in our industry.

Get To Market With Quality Assurance

FMI has extensive experience with ultra clean silicone medical products. Let FMI create turnkey solutions for your medical device components.

Call (847) 350-1535 or Contact FMI to discuss your next medical silicone project.