Firstronic announced that its facility in Juarez, Mexico has been certified to ISO 13485:2003, effective Aug. 6. Its registrar is Intertek, the company revealed in a press release.
"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 & 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.
Tony Bellitto, Director of Quality added on the subject: "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 Bellitto.