A Voluntary Standard We Can’t Do Without

by Todd McDonald on February 27, 2014

Wouldn’t it be wonderful if a certification existed that could help you identify which medical thermoformers have systems in place to help you discover greater operational efficiencies, improve your risk management and increase compliance with quality and safety regulations? Well, you’re in luck.

ISO 13485:2003 is a voluntary quality management system standard for companies that design, manufacture and distribute medical devices – one that includes internationally recognized requirements for process validation, risk management and documentation – and one that only a handful of thermoformers in the United States hold.

In order to achieve ISO 13485 certification, companies must develop written policies for a variety of functions from process and design controls to accountability and traceability. Companies must also have a fully operative quality management system and be subject to a full cycle of audits.

TEQ not only holds this registration, but was actually one of the first thermoform manufacturers in North America to do so.

Why? It’s simple. At TEQ we are committed to quality, and we’ll do anything we need to do to ensure the safe and efficient manufacturing and packaging of medical devices. In fact, not only do we have an ISO 13485:2003 Registered facility near our ISO 9001:2008 Registered main facility, we have the proven ability and expertise to quickly build an ISO 13485:2003 Registered facility in virtually any location to support the unique needs of our clients.

We also hold several other preferred certifications including being ISO 11607:2006 Compliant and FDA Registered.

As you can tell, this expertise is an accomplishment we are extremely proud of. What certifications or achievements are you most proud of?

Learn More About Our Medical Device and Packaging Certifications

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