We often talk about the value of continuous improvement, as it’s one of the foundations of Enterprise Minnesota’s consulting services.
While we are experts at helping others improve and become more profitable, we also focus on continually improving our own skills and credentials to remain competitive in the manufacturing marketplace.
In Keith’s case, he’s shrewdly leveraging his real-world experience within ISO to grow his ability to help clients.
Prior to joining us, Keith worked for a medical device company, so it seemed natural for him to pursue credentials in ISO 13485, the standard that pertains to medical device manufacturers. (He’s also updating his credentials in ISO 9100, the standard for aerospace manufacturers.) He’s now certified as a lead auditor in both, which means he can guide a manufacturer through the certification process in those standards.
Many medical device manufacturers are already ISO 9001 certified. Upgrading to ISO 13485, which is specific to their industry, can give them a strategic advantage.
Enterprise Minnesota can help your company with ISO certification or audit support. Learn more.
“I’ll quote my cousin CJ who works at Polaris: ‘The supplier should know how they’re doing. I shouldn’t have to tell them with a scorecard. If I need to tell them with a scorecard, they’re not the supplier for me.”
In other words, it’s better to take the initiative with a business management system certification that not only helps manufacturers zero in on mission and profitability, but also sends out a specific signal of credibility.
When a manufacturer asks its supplier to obtain a specific ISO certification, Gadacz says, it helps that supplier take ownership of their role, and get them thinking about things such as customer satisfaction, delivery and performance metrics.
ISO 9001 puts a stiff focus on business risk. Every aspect of the standard serves the larger goal of unifying a business’ parts for the betterment of the whole: optimize quality and efficiency to maximize profit.
ISO 13485 requires a shift from that mindset.
“In ISO 13485, it’s all about safety for the patient,” Gadacz says. “Which makes sense, right? We’re dealing with medical issues and dealing with people’s lives.”
Medical device manufacturing thrives in Minnesota. According to the Minnesota Department of Employment and Economic Development:
- Medical device manufacturing employs nearly 32,700 workers in Minnesota, ranking second nationwide. (Only California employs more.)
- The state ranks first nationwide in the concentration of medical device manufacturing employment.
- Minnesota ranks among the top states in medical devices patents per 1 million people.
Of course, many of those medical device manufacturing employees work for large companies such as Medtronic, which employs 10,000 workers alone. And Medtronic doesn’t have to worry about ISO 13485 because it’s regulated directly by the Food and Drug Administration.
But any manufacturer within Medtronic’s supply chain — or, more importantly, any manufacturer that wants to be in Medtronic’s supply chain — will likely need to strongly consider an upgrade to ISO 13485.
Gadacz says that, by his rough estimate, there are between 200 and 400 medical device manufacturers in Minnesota right now that could benefit from a shift from ISO 9001 to ISO 13485.
The credential upgrades aren’t stopping at medical devices manufacturers. Both Gadacz and Ahlquist are also upgrading their credentials to become lead auditors in the AS 9100 standard utilized by the aerospace industry. Like medical manufacturing, aerospace and defense manufacturing thrives in Minnesota with roughly 6,700 workers, according to DEED, helping manufacture everything from small arms ammunition, aircraft and navigation systems.
Look for the full story in the Spring 2021 issue of Enterprise Minnesota® magazine.
January 28 – Executive Manufacturing Forum: Thriving in a State of Change
This Executive Forum is for manufacturing executives who want to grow and innovate to work through the COVID-19 recovery. Three of our expert consultants will show you how to identify gaps that may exist within your purpose, processes, and people and help you create a step-by-step action plan to achieve a clear company direction, optimize process improvements, and more readily navigate change. Online via Zoom Learn more and register
February 4 – A Model for Manufacturing Excellence Using ISO 9001
ISO Certification expert Keith Gadacz will show you the value of the ISO and how it can help your company grow. Online via Zoom Learn more and register
February 25 – Strategically Navigating an Uncertain Future
Our strategy and revenue growth expert Steve Haarstad will show you how to shorten your strategic outlook to help navigate uncertainty and plot a course for your company’s continued success. Online via Zoom Learn more and register
Protolabs to acquire 3D Hubs in $320M deal
Maple Plan, MN-based Proto Labs, Inc. has entered into an agreement to acquire 3D Hubs, Inc., an online platform that provides engineers with on-demand access to manufacturing partners. Jan. 20, Metal-Am.com Read more
Brooklyn Park development along Highway 610 continues to flourish
Several medical device and manufacturing companies have set up shop in the area, including Juno Pacific, Cirtec Medical and Databank, and are expected to create hundreds of jobs in the next two years. Jan. 17, CCX Media Read more
Pet treat manufacturer purchases former Del Monte facility in Sleepy Eye
Chasing Our Tails, Inc., a pet treat manufacturer in rural Minnesota has reached an agreement with Seneca Foods Corporation to purchase a former Del Monte packing plant in Sleepy Eye. Jan. 14, PetFoodProcessing.net Read More
Nonprofit manufacturer MDI announces new CEO, Eric Black
Eric Black will be taking over for current President and CEO Peter McDermott, who is retiring on April 1 after 12 years with MDI. MDI is a nonprofit corrugated plastic manufacturer and assembly service provider headquartered in Minneapolis with locations throughout the state. Jan. 14, MDI.org Read more
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