GMN’s plastics facility becomes ISO 13485 certified

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By Chris Passanante | Jun 23, 2017
ISO 13485

Due to our ongoing commitment to the medical device industry and growing demand, GM Nameplate’s (GMN) Beaverton, OR Division attained ISO 13485:2003 certification. The Beaverton, OR Division, GMN’s dedicated plastics facility, received this certification after auditing and approval by the Orion Registrar on May 9, 2017. This ISO standard is in regard to the quality management system requirements specific to medical device manufacturers. GMN’s Beaverton, OR Division is the third GMN division to obtain this quality certification.

What does this standard mean for GMN customers?

Meeting the strict standards of ISO 13485 assures that GMN can continue to support existing and future customers in the medical industry. ISO 13485 demonstrates that GMN meets regulatory standards and legal requirements to operate in the medical device industry, reduces risk effectively, and has systems in place to consistently yield safe and effective medical device components.

With little room for error in the medical industry, GMN has continually worked to uphold a quality system that meets the highest quality standards in order to produce best-in-class solutions. This certification validates the strength and sustainability of our processes which differentiates us from competitors.

Dedication to quality

For decades, GMN has shown commitment to the medical device industry and a dedication to creating quality products. Compliance with ISO 13485 ensures that the medical device components and sub-assemblies produced by GMN will meet or exceed thoroughly planned specifications every time, without exception.

As a company that supports multiple regulated industries, such as medical, we are committed to ensuring that our Quality Management System is robust and flexible enough to meet the variety of challenges presented by our wide range of customers and industries. With this new recognition, GMN’s Beaverton, OR Division shows its ability to handle increasingly stringent and diverse customer requirements. In addition, the ISO 13485 compliments ISO 9001, another quality standard that GMN has long been in compliance with, which reflects our continual efforts to broaden our quality system to better align with the current Good Manufacturing Practices.