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Milwaukee Electronics' Portland Facility Completes Transition to ISO 13485:2016
December 31, 2018 | Milwaukee ElectronicsEstimated reading time: 1 minute
Milwaukee Electronics' Portland facility completed its audit for the transition to ISO 13485:2016 and recertification to ISO 9001:2015 in October.
"We completed the audit with only three minor findings which were quickly corrected. Our team did a great job supporting this transition," said Bob Willenbring, Milwaukee Electronics' Corporate Quality Director.
The quality team began their transition efforts to ISO 13485 revision in 2017, shortly after the facility completed certification to the latest revision of ISO 9001. While some of the work supporting revision of ISO 9001 quality management system (QMS) procedures did benefit the ISO 13485 revision, the two standards are no longer as closely aligned, which drove some additional procedural modifications. For example, the transition to the new standard more closely aligns the facility’s processes with FDA requirements in the areas of complaint handling, process validation and risk management.
"Jack Tanz, our Quality Engineer, did a great job updating procedures to comply with the new standard, then working with the Quality team to perform a full internal audit to identify any areas we needed to enhance. They completed over 90% of the work prior to my joining the company. The only area I felt we needed to add was employee training on the intent of the standards," added Willenbring.
While employees were already fully trained on the procedures, the additional training was designed to better ensure they understood the intent of both standards in terms of mitigating risk and driving better understanding of the impact of each employee’s efforts on product quality and overall customer satisfaction.
"Both standards drive more risk analysis across the organization and require employees to understand the specific impact of their roles in process of product realization at a much deeper level than in previous iterations. Our training was designed to
ensure they fully understood that new level of responsibility," said Willenbring. At a corporate level, Willenbring is working to better standardize procedures across the company.
"Our quality procedures vary slightly by facility. While we serve distinctly different customer bases in each facility, we will be focusing on standardizing key processes, such as corrective action, and the look and feel of documentation going forward. While certificates demonstrate third-party oversight of our QMS at each facility, it is equally important that we internally maintain a vision that unifies our approach to quality documentation across our company," said Willenbring.
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ASC Sunstone Circuits Appoints Ron Morelli as Senior Production Manager
07/21/2025 | ASC SunstoneASC Sunstone Circuits is proud to announce the appointment of Ron Morelli as Production Manager. With over 30 years of experience in production management and planning, Ron brings a wealth of operational expertise and team leadership to ASC Sunstone’s manufacturing operations.
NEOTech’s Agave 1 Facility Earns AS9100 Certification for Commercial Aerospace Manufacturing Excellence
07/17/2025 | NEOTechNEOTech, a premier provider of electronic manufacturing services (EMS), integrated design engineering, and advanced supply chain solutions for the aerospace and defense, medical device, and high-tech industrial markets, proudly announces that its Agave 1 manufacturing facility in Juarez, Mexico has officially received AS9100 certification.
Inside Aimtron’s Cross-border EMS Strategy
07/08/2025 | Nolan Johnson, SMT007 MagazineMukesh Vasani immigrated from a very small farming village in India to the U.S. in 1995 as a civil engineer. After shifting into electronics, Mukesh built his Chicago-based company, Aimtron, into a successful enterprise by combining quality with competitive pricing. He leveraged his roots in India to expand manufacturing without compromising on quality.
Trouble in Your Tank: Can You Drill the Perfect Hole?
07/07/2025 | Michael Carano -- Column: Trouble in Your TankIn the movie “Friday Night Lights,” the head football coach (played by Billy Bob Thornton) addresses his high school football team on a hot day in August in West Texas. He asks his players one question: “Can you be perfect?” That is an interesting question, in football and the printed circuit board fabrication world, where being perfect is somewhat elusive. When it comes to mechanical drilling and via formation, can you drill the perfect hole time after time?
Driving Innovation: Direct Imaging vs. Conventional Exposure
07/01/2025 | Simon Khesin -- Column: Driving InnovationMy first camera used Kodak film. I even experimented with developing photos in the bathroom, though I usually dropped the film off at a Kodak center and received the prints two weeks later, only to discover that some images were out of focus or poorly framed. Today, every smartphone contains a high-quality camera capable of producing stunning images instantly.