Keith Gadacz stands in a manufacturing facility wearing a gray suit.
Keith Gadacz helps manufacturers implement and manage quality management systems as a business growth consultant with Enterprise Minnesota. Photo by Alex Carroll.

When manufacturers seek consulting advice from Enterprise Minnesota, they aren’t looking for insight on how to make better products. They’re already good at production, so we’re not there to explain how to mold plastic better, assemble a lighting fixture better, or cut granite better.

Where they need help is connecting everything else to the operational excellence that already exists within their company. “Everything else” has a name: a quality management system. And most manufacturers don’t have a certified one.

Just 18% of manufacturers have earned ISO certification, according to the last time our State of Manufacturing® survey asked about it. Compare that to what we heard from buyers in last year’s SOM survey: Roughly half of manufacturers say a formal quality program is what they look for when choosing a supplier.

Highlighting that gap isn’t a knock on the other 82% — plenty of them run solid shops. What it means is that companies without a formal quality system in place have a lot of potential for growth by becoming certified to an ISO quality management system.

Manufacturers who pursue certification know that the benefits go well beyond earning more business. Adopting a formal quality system also boosts employee engagement, customer satisfaction, and overall performance.

Some companies fear that ISO certification is too big a lift. I remind them that every manufacturer already has a management system. It might be written down, or it might live entirely in the company’s culture: the way it handles customers, trains new hires, and responds when things go wrong. Whether it’s documented or “just the way we do things,” that’s the management system.

ISO doesn’t create one. It strengthens the one that’s already there, making it durable enough to survive when the leader isn’t in the room.

That’s why the benefits don’t stay in the quality department. They touch the whole company. Here’s the framework I walk manufacturers through to get there.

Who cares

Before I help a company write a single procedure, I ask one question: Who cares about your success? Four groups always show up: customers, the business itself (meaning shareholders and lenders), employees, and management.

Customers want good products, on time and at a fair price, along with easy-to-navigate relationships. The business itself, including owners and the bank holding the company’s line of credit, is looking for cash-flow stability and appropriate growth. Employees want stability, respect, fair wages and benefits, and flexibility. Management expects adequate resources, buy-in to the vision, and team members who are engaged and pulling in the same direction.

Imagine these four stakeholders each hold one corner of a sheet: Pull too hard on any one corner and the others suffer. A company chasing customer satisfaction at all costs can run its employees ragged. A company focused only on the bottom line can let customer relationships and culture go stale.

A mature management system enables leaders to keep that balance on purpose instead of by accident. ISO is the key to maturing the management system companies already have in place. It’s also how companies rise above average. No one raves about average, and average is exactly what happens when one group’s needs crowd out everyone else’s.

Step 1: Plan

Once a manufacturer knows who it’s taking care of, the next question is: How do we do it? That starts with leadership taking real ownership and not handing the whole effort to a quality manager and walking away.

Leaders who take charge realize the value of the system comes from its touching every aspect of the company. It has to be a shared responsibility with leadership driving authentic engagement, not top-down command.

A real plan does three things: It sets objectives, it assesses the risks that could knock the company off course, and it prepares for handling change.

How a manufacturer measures progress toward the objectives matters less than ensuring they’re tracked. Monitoring can be done with a formal scorecard, a whiteboard, a spreadsheet, or a note on somebody’s phone.

It doesn’t matter which method a company uses, as long as the objective and the result both get written down. The result — and accountability — is what enables leaders to make the next decision.

And a good plan cascades: Company strategy turns into a department’s goals, which turn into this week’s production target, which connects to what one person is responsible for today.

Smaller shops with tight resources should focus on foundational versus decorative pieces of the system. Ensuring appropriate training and developing a system for handling nonconformities that is consistently applied are foundational; a polished quality policy plaque is decorative.

And that carefully crafted policy won’t move the needle. Neither will downloading some procedures off the internet and calling it a system. Written procedures alone won’t change behavior.

Engaging employees in the process means that what is said is likely to match what is done. One of the best examples I’ve seen is a company whose core values spell out the word COLOR — communication, ownership, leadership, opportunity, respect. It’s not abstract to those who work there. I once heard a second-shift employee explain what it meant to him: At the end of his shift, he puts his tools away so the guy on the next shift can find them in the morning. That manufacturer’s values are living in real behavior, not framed on a wall.

The second part of a plan, assessing risk, is where a lot of leadership teams get vague. Risk assessment doesn’t have to be elaborate. It can be as concrete as asking whether a company is about to overreach on a growth target, or whether a new customer is actually the right fit for its capabilities.

The last piece, developing a plan to handle change, matters more than people think. I tell manufacturers “the plan is the plan until it changes, and then it’s still the plan.” This happens frequently. If a leadership team sets a quarterly goal to land three new customers, but only knocks on two of the three doors, it has to decide next quarter whether door three is still worth knocking on. That’s not a failed plan. That’s a plan doing its job.

Step 2: Do

This is where the operations come in. It’s not about how a manufacturer makes its products within the value stream. It’s about how the pieces around it connect.

Every task in a business, no matter what it is, runs on the same pattern. There are inputs — people, equipment, information, materials. And there’s a process that turns those inputs into an output — a shipped order, an onboarded supplier, a finished part.

There’s also a way of knowing whether that process is working: a key performance indicator (KPI) that tells a leader if today was a “green day or a red day.” When the output isn’t right, the question is always the same: Which input caused it? Was it the equipment, the documentation, the people? Was the process itself poorly executed?

I worked with Duluth-based Van Technologies during COVID. Our work was entirely remote, which is unusual for this kind of engagement, but was necessary because of the pandemic. The company earned ISO certification in about five months instead of the usual 10 to 12, a remarkably fast turnaround.

Then everything a company would expect improved: predictability, training, the ability to bring a new hire up to speed with documentation instead of tribal knowledge. Would Van Technologies have improved without ISO? Probably. Did they get there faster, more methodically, and as a unified leadership team because of it? No question.

Small fixes compound too. Another company I worked with kept losing time to a stop-ask-go-back cycle. An engineer would finish a project packet, hand it off, and the person receiving it would have questions that sent the whole thing back up the chain before work could start.

By adding a few questions to the order review checklist, the packet answered those questions before anyone had to ask. That one small change cut downtime by roughly 30%. The “Do” aspect of quality isn’t always about bigger systems. Often it’s about making sure the information moves with the part instead of trailing behind it.

The real value of the Do step is making sure the call-to-cash chain — quoting, order entry, purchasing, production, quality, shipping — actually hands off cleanly from one department to the next, instead of leaking time and rework at every seam.

Step 3: Check

Once a system is running, the next question is simple: Is it working? That’s where data comes in.

Most of the manufacturers I work with have fewer than 50 employees, with an owner, a small leadership team, supervisors, and employees. The data they care about is usually close to the floor: machine uptime, attendance, scrap rate.

The leadership team adds items like revenue and on-time delivery to its list of trackable data. If the overall on-time rate comes out to 40%, is that acceptable? Is that risk tolerable for the business? If yes, a leader can choose to do nothing. However, if that on-time rate jeopardizes future business, it’s time to go back and find the cause.

There’s a limit to how many items are genuinely useful for decision making. One leadership team I worked with had built a scorecard with 47 different KPIs. The owner liked having the information — and there’s nothing wrong with that. Still, we wanted to understand which of those KPIs actually drove the next steps. Only seven did. Those seven now run the weekly production meeting; the other 40 stay available for anyone who wants to dig deeper.

Another company I worked with had the opposite problem: barely any data at all, just a production schedule on a spreadsheet. We built a simple scorecard that included on-time delivery, training status, maintenance and calibration status, uptime, and efficiency. Nothing fancy, just enough to know whether today was a good day or a bad one. Their production meeting went from 90 minutes to 15 because they could focus on what was worth talking about.

When it comes to checking the process, every piece of data ultimately leads to one of three choices: Do something now, do something later, or do nothing. Doing nothing gets a bad reputation, and yet sometimes it’s the right call. It’s important, though, to ensure that’s a decision made on purpose and not just the default because nobody checked.

Step 4: Act

This is the step people misunderstand the most. ISO uses the word continual improvement, not “continuous.” The difference matters more than it sounds like it should. Continuous is a straight line, moving all the time. Continual is a staircase, with plateaus. A company builds something, uses it for a while, adjusts, and uses the improved version for a while before changing it again.

That plateau period is where the real gains show up. It’s also, not coincidentally, why the whole ISO certification process tends to take around 10 months from start to finish. That includes five months for building a system, three months living with it and adjusting, and two months for certification audits.

The company with the COLOR values has grown roughly 4X over the past four years. ISO alone isn’t responsible; plenty of factors go into growth like that. A leadership team that formalized its culture and its decision making was in a far better position to handle that growth than one running on instinct.

I’ve also watched this play out in real time at a shop where, early on, an idea would only get traction if someone said “Keith from Enterprise Minnesota said we should try that.” A few years later, nobody needs to invoke my name. They just ask, “Could you try this?”

That shift, from needing outside permission to trusting a team to test and adjust, is what continual improvement looks like within a mature organization.

The value of ISO doesn’t come in one big leap. Every day, teams move a step or two higher, until the next plateau comes into view. Manufacturers earn a real edge taking one landing at a time.

Keith Gadacz is a business growth consultant with Enterprise Minnesota with extensive experience in implementing and managing quality management systems.

A hand marks a green checkbox beside the words ‘ISO 9001 Certified.’
ISO 9001 provides a framework for documenting and improving a manufacturer’s quality management system.

What’s Next for ISO 9001?

If you’re already ISO certified, or thinking about it, there’s a new wrinkle on the horizon. ISO 9001 was just revised this past September, the first revision since 2015. Every certified manufacturer will have roughly three years to upgrade to the new standard.

Two new requirements stand out. The first formalizes something that’s always been implied and never spelled out: quality culture. Leadership teams will need to show, not just claim, how their culture supports the quality system. The same say-do alignment I already push companies toward will now be written into the standard itself.

The second is new territory: business ethics. It’s not about writing a code of conduct and filing it away. Instead, manufacturers will need to show that they did what they documented and documented what they did. A company that logs a maintenance task it never performed has an ethics problem, not just a paperwork problem. The new clause makes that distinction part of the audit.

Neither change should concern companies with a mature system already in place. If your culture and your documentation already match, you’re most of the way there. If they don’t, this is as good a reason as any to close that gap now.

–Keith Gadacz

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