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Targeting booming medical industry, family-owned electronics company takes standards to ‘another level’
Since 1986, Scott Electronics, a family-run and certified woman-owned small business, has been a local leader in Electronics Manufacturing Services (EMS). The still-growing company of roughly 100 employees specializes in cable, electro-mechanical and fiber optic assemblies, including homeland security products used in airports, advanced medical devises and much more.
The company, which generates about $15 million annually in revenue, is structured around lean practices, and is ITAR and ISO 9001:2008 registered, RoHS compliant and has IPC-620 and J-STD-0001 certifications. Yet the decision makers at Scott Electronics embrace a guiding philosophy of continuous improvement throughout the company, from its 25,000 sq. ft. central headquarters in Salem, New Hampshire, to its facility in Mexico and sales office in Nevada.
Recognizing the need to stay ahead of the curve in terms of best practices and procedures, specifically when considering current and potential customers in the ever-expanding medical market, decision makers at Scott Electronics decided to seek ISO 13485:2008 certification, which reflects current FDA medical standards.
“In this instance, where we’re talking about the ISO 13485, related to the medical standard, we saw there was a need for it. Not that there was a demand for it by a customer, but there was that need for it to give you that opportunity in the market to tap into new customers,” said Scott Metzemaekers, Senior Corporate Officer and Director of Quality Assurance at Scott Electronics. “A lot of them will require that you have this standard to be able to do business with them.”
Having worked with New Hampshire MEP on employing lean efficiencies in the mid- to late-90s, and having doubled its employee base in the time since, Scott Electronics reached out to NH MEP for additional assistance.
v “I think we knew from previous projects the attention to detail, the success that we had and the trust we had in NH MEP to provide us with a service and a product at the end that would give us the result we are looking for,” said David Metzemaekers, Vice President at Scott Electronics. “Having this ISO (13485:2008) certificate will hopefully take us to another level. We definitely think this is going to increase our employee base in New Hampshire and it’s going to increase our employee base in Mexico.”
NH MEP partnered with Exolytic Inc. to provide fifteen days of assistance in training and coaching Scott Electronics’ employees to comply with the ISO 13485:2008 standard for registration. Working with process owners, NH MEP and Exolytic reviewed and assisted with the creation of a quality manual, Level 2 procedures required by the ISO 13485:2008 standard, and Level 2 procedures needed by Scott Electronics.
As a result, Scott Electronics completely restructured its quality management system to ISO 13485:2008 standards including the installation of a flow-diagram procedural approach, the creation of a central database for all forms and work instructions, and the establishment of a more process-based self-audit procedure.
“Everything is much more accessible and centralized now,” said Scott Metzemaekers. “(NH MEP and Exolytic) didn’t come in here with their generic design and generic plan and say ‘this fits for everyone.’ They took what they knew is a model that works in the industry, and they adapted it to our company, so we weren’t working toward something we weren’t used to … they said, ‘you’re already doing the right things, but let’s make the system better,’ so it’s much more user friendly and adaptable to every new procedure that you implement.”
“These guys hit a home run,” said David Metzemaekers.
Thanks to the aforementioned improvements and certification, Scott Electronics projects adding 8-12 new employees, an 8% increase; $600,000 to $960,000 in additional revenue, a 4-8% increase; $100,000 to $180,000 in technology and equipment investments; a 5,000- to 9,000 sq. ft. facility expansion; and widespread increases in employee salary and compensation.
“(NH MEP and its partners) did a tremendous job of coming in here and presenting what (ISO 13485:2008) is all about. They educated the core group that was going to be involved initially, and then worked with us on a daily, weekly, monthly basis until we understood it and as we incorporated the new design, the new layout, the new processes and procedures, the training … you know, whatever was involved, they were always there hand-in-hand with us.”
- Scott Metzemaekers, Senior Corporate Officer and Director of Quality Assurance