A Milestone That Matters
How ASG’S ISO 13485 certification paves the way for innovation
ASG became ISO certified in the United States in November 2025. “The milestone is important, but the way we grew matters just as much,” said Onna Koeneman, ASG’s quality risk manager.
“Going through certification helped us strengthen the quality practices our clients count on every day,” Onna said.
“It shows up in how we work alongside our clients, asking questions, working through problems together and caring about the outcome as much as they do.”
Certification has been much more than a compliance effort. It marked a shift for the organization — and an effort that touched every part of the company. The ASG team achieved the goal by working together. ISO 13485 is a companywide certification, and it required a companywide effort.
“The process began with taking a close look at how we worked,” Onna said. “We asked each other questions: What worked well? What could be improved? Could systems grow as the company grew?”
The work could be demanding. “It took clarity, patience and a willingness to adjust,” Onna said.
Clients may not see every procedural or cultural change, but they’ll feel the difference in steadier executions and clearer communication. “ISO certification builds confidence and trust,” Onna said. “It reinforces that we work both thoughtfully and consistently.”
Read more about ISO certification at ASG and how it benefits our clients.
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