GW Plastics, Inc. announced that it has obtained ISO 13485 certification at its world headquarters in Bethel, VT. This achievement now places GW within a small group of exceptional companies that can claim it has a quality system certified to three international standards: ISO 9001, ISO/TS 16949, and ISO 13485.
As part of its plan to achieve ISO 13485 certification worldwide, GW has already completed the process at six of its seven locations including its Dongguan, China and Querétaro, Mexico locations. The first GW plant achieved its certification in just four months. According to Sumanesh Agrawal, VP Quality & Continuous Improvement at GW Plastics, “GW has a long history of serving the Healthcare industry, so our systems and practices were already harmonized with the requirements of 13485.” Normally, it can take a plant six to nine months to obtain certification. The company also coordinated with their registrar, UL-DQS, to simultaneously recertify to the 2008 release of the ISO 9001 standard.
In addition to obtaining ISO 13485 certification, GW Plastics has concurrently integrated requirements from 21 CFR Part 820 in order to fully comply with the FDA’s Quality System Regulation. The company was first registered with the FDA for medical device manufacturing in 1979.
About GW Plastics:
GW Plastics is a global, high-precision injection molder, mold builder and contract manufacturer specializing in single-source responsibility for medium-to-high volume, close-tolerance components and assemblies. Ranked among the top 100 molders in North America, GW Plastics’ leading-edge technologies, total quality commitment and pursuit of innovation have driven its steady growth since the company was founded in 1955. The financially strong, closely held organization services a portfolio of Fortune 1000 customers in the Healthcare, Consumer/Industrial and Automotive markets. In addition to the China facility, GW has four U.S. plants (two in Vermont; San Antonio, Texas; and Tucson, Arizona). GW also has a full-service production facility in Queretaro, Mexico.
