Firstronic's Juarez Facility Achieves ISO 13485 Certification


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Firstronic has announced that its facility in Juarez, Mexico is now certified to ISO 13485:2003. Its registrar is Intertek.

“I am very pleased that our team in Juarez has achieved this milestone. We have several medical customers in our pipeline and have made the investment in this additional certification to ensure we meet their rigorous requirements,” said John Sammut, Firstronic’s president and CEO.

Firstronic established the greenfield facility in Mexico in 2014. Today, it operates four SMT lines as well as higher level assembly lines. It is also certified to ISO 9001:2008 and ISO/TS16949. In addition to medical customers, the facility serves a growing customer base in the automotive, consumer and industrial market sectors.

“While our systems were set up well for our automotive, industrial and consumer customers, we needed to make some changes to best serve medical customers. To that end we have implemented an Installation, Operation, Performance Qualification (IOPQ) process to provide a standardized approach to equipment and software validation. We’ve also enhanced our management review process to define specific strategic, operational and tactical deliverables. Finally, we made some adjustments to document control within our Plex ERP system to link current versions of Level II customer specific documents to the Part List/Control panel for ease of access by employees. These changes ultimately benefit all of our customers because they all contribute to more efficient, operations,” said Tony Bellitto, Director of Quality.

Firstronic’s facility in Grand Rapids, Michigan is also in the process of pursuing ISO 13485:2003 certification and has adopted all of the same quality system enhancements.

About Firstronic LLC

Firstronic LLC (www.firstronic.com) provides advanced electronics manufacturing services and optimized supply chain solutions for companies in a wide range of industries including automotive, industrial and medical device. Headquartered in Grand Rapids, MI, Firstronic has a 35,000 square foot facility, state-of-the-art equipment and a seasoned management team with an average tenure of 20 years and a 70,000 square foot facility in Juarez, Mexico. It also supports companies needing access to global manufacturing locations via operations in China, India and the Czech Republic.

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