by Dianna Brodine, vice president, editorial, The American Mold Builder

ISO 9001 is the international certification for quality management systems. Available in over 170 countries and built to benefit any size of organization, certification proves that the company has a strong customer focus, motivation, managerial skills and an emphasis on continuous improvement, according to the ISO website (www.iso.org). However, ISO certification is a time-intensive process – and isn’t required by most customers. Is the return on investment worth it? Two mold building companies provided insight on their experiences in obtaining ISO 9001:2015 certification, including the process, challenges and ultimate payoff.

THE PROCESS
Concept Molds, Schoolcraft, Michigan, builds custom tooling for the automotive, medical and industrial markets. The company is ISO 9001:2015 certified, which Program and Quality Manager Michael Rochholz called, “the ground level of certification for ISO.” Rochholz has been involved in all facets of certification, from initiation and evaluation through to auditing and maintenance – “basically start to finish,” he said, “and it’s never finished!”

Concept Molds chose ISO 9001:2015 because it’s geared toward tool shops. “There are other certifications that are more appropriate for medical and aerospace manufacturers, but the basic certification of 9001:2015 fits Concept Molds very well,” Rochholz said. The company’s first attempt at certification was in 2003, although it didn’t reach full implementation. “That certification was geared toward the needs of customers – the intended purpose was sales, rather than quality,” he said. “It didn’t have true buy-in from employees because it wasn’t geared toward our needs internally. Eventually, it was dropped.”

Then, ISO certification was reinitiated as a quality management system (QMS). “The purpose changed – to help us grow, do the right things and meet the values our customers expect,” Rochholz explained. “Since then, we have buy-in internally because the certification has meaning to it. The people who are involved in maintaining the system see the opportunities.” These opportunities include workplace autonomy, as employees can go through processes on their own – such as corrective action responses – and take ownership of the issues they see and the solutions they implement.

At Legacy Precision Molds, a Grandville, Michigan-based company specializing in building high-precision plastic injection molds up to 500 ton, the ISO certification process began in June of 2020. “The first step involved meeting with consultants, asking for quotes, and doing our research” said Tyler VanRee, team leader. “From there, we overlapped that with the planning stage.” This included asking questions, such as: What should the QMS look like? How should it be structured? What are the objectives to be achieved?

“Then we moved into implementation,” said VanRee, “which involved clarifying documentation, procedures and processes – and then implementing necessary changes in our organization and preparing for certification.” During the review process, Legacy Precision Molds received outside, third-party input before moving into the certification stage. “It was a 10-month process for us.”

FACING THE CHALLENGES
Any new or changed process will be met with some resistance or unforeseen complications.

Employee Buy-In
At Concept Molds, getting the employees to see the benefit of ISO implementation – especially when some of them had been around for the first attempt – was the biggest challenge. “It was originally viewed as ‘not meaningful to me’ and ‘more work for me’,” said Rochholz. “But, without employee buy-in, it’s difficult to have a meaningful quality management system because the system is everyone, not just one or two individuals.”

The results changed their minds. “The primary thing we learned was that it was important to be sure our procedures were stated in a way that ensures we can fulfill our key performance indicators (KPIs),” he explained. “If the correct standards are in place and we’re meeting our goals, we are able to achieve the outcome we’re expecting.”

VanRee experienced a similar resistance at Legacy Precision Molds. “We knew right away we had to get buy-in from everyone and keep them involved in the process,” he said. To that end, the company included information in its scheduled Monday shop meetings, where all employees would be updated as the processes rolled out. “Step-by-step implementation also was important, because it gave employees a chance to digest the changes and the impacts each step would have on their jobs.”

Document Management
Nick VanderZwaag, purchaser at Legacy, pointed to another challenge – document control. “It was important to train our employees on how to keep track of documents, including making sure they’re using the right version,” he said. “Documents should be simple as possible – keep forms to one page and consolidate as much as possible.” Although there are document control compliance systems available for purchase, Legacy chose to utilize a combination of self-management tools, including Google Forms, Excel and the company’s own database.

Plan can make a difference in another paperwork challenge – change management. “If a customer approves a job and it’s sent to the floor, but then changes are requested, ISO requires you to keep track of those changes,” said VanderZwaag. “When did the change happen? Who approved it? It’s easy to overlook a revision history for production records.” He recommended simply describing the change with a note on the order document itself, and then dating and initialing the change. “It keeps all of the documentation on one page rather than having a
separate log.”

MAINTAINING CERTIFICATION
After acquiring the ISO certification, the work toward recertification begins. At Concept Molds, the company performs scheduled internal quality audits on a semi-annual basis. “We choose to break it up and do part of our quality management review and part of our internal quality audit each half of the year,” said Rochholz. “We also have surveillance and recertification audits from a third party, and the quality management system is evaluated against customer surveys and corrective actions both internally and externally.” The use of a third-party for evaluation is valuable to Rochholz. “Even though I need to stay current on ISO, I have other roles to play here,” he said, “so I rely on that professional to oversee what we’re doing and make sure we’re meeting our expectations.”

At Legacy Precision Molds, “Our internal maintenance process includes quarterly internal meetings to review and update things as necessary,” VanRee said. “We also have yearly audits done by an outside firm to confirm the ISO system is effective and up to date.”

RETURN ON INVESTMENT
“For us, our return on investment is seeing our customers coming back to us because they value what we do,” said Rochholz. “We can see that the quality and documentation we’re providing is paramount to them, as shown by the surveys they return to us.” Having ISO certification also minimizes individual customer audits. “We can provide our ISO certificate, and customers know we have systems and standards in place, If we didn’t have certification, customers might want to come in and do an audit to see if we meet their criteria – and other customers may have different criteria. That could be a challenge to handle. He also pointed to a more structured flow of design and build, reduced quoting time and standardized training for new and existing employees as benefits realized.

VanRee said, “ISO is really a structured improvement program. It adds a framework around which to execute and do things well.” Benefits at Legacy have included enhanced performance data management, improved data management, external accountability and recognition from customers. However, “The biggest return on investment is inside your own four walls,” VanderZwaag said.

VanRee added, “One of the biggest misunderstandings with ISO is that ISO is going to transform my business into something I don’t want it to be,” he said. “But the opposite is true. We are the ones setting the quality objectives we want to achieve – the things important to our business. ISO provides a framework, and it tells our customers that this company is intentional in the way we handle quality.”

Rochholz didn’t downplay the work that went into certification. “But I’ll tell you it’s valuable work,” he said. “We recently passed our recertification audit, which is a three-year cycle. Our system is mature, and it works very well. Some say the ISO program is too expensive, but customers say that to us as mold builders, too – and we expect them to look at us with the value we provide in mind. I would say you need to look at this system for the value it can provide to help your company be successful.”

And there’s no reason to worry about perfection. “ISO 9001 is about continuous improvement,” VanRee said. “You don’t need to get everything right the first
time around.”