ISO 13485:2003 – A Critical Standard For The Medical Device Supply Chain

by Todd McDonald on September 13, 2011

If you became aware of a process that could help you discover greater operational efficiencies, improve your risk management and improve the traceability of products, what would you do?

If you learned of a step you could take that would help ensure increased compliance with quality and safety regulations, what would you do?

If you knew of a set of requirements often referred to as “essential for any organization operating at any tier in the medical device supply chain,” what would you do?

The answers seem clear, don’t they? Learn about that process – take that step – and comply with those requirements. And that’s exactly what TEQ did. How? By becoming ISO 13485:2003 Registered.

ISO 13485:2003 is a voluntary quality management system standard for companies that design, manufacture and distribute medical devices, which includes internationally recognized requirements for process validation, risk management and documentation. And TEQ is currently one of the only thermoform manufacturers in the United States that holds this registration.

Why? It’s simple. At TEQ, we are committed to quality, and we’ll do anything we need to do 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 main facility, we have the proven ability and expertise to quickly build an ISO 13485:2003 Registered facility in any location to support the unique needs of our clients.

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

{ 1 comment… read it below or add one }

Andy D'Esposito September 26, 2011 at 11:04 am

Great article Todd.

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