When commercial fitness equipment company, Cybex International, decided to move into the physical therapy market, management realized that ISO certification would be a real benefit to the business.
What they did not realize was the scope of the task as they struggled to bring two domestic and one international manufacturing site into compliance with ISO 9001 standards. The organization was unfamiliar with ISO terminology and definitions, and bringing in a consultant only muddied the water further. That is, until they brought the ISO-muscle of simpleQuE to the table.
“SimpleQuE’s methodology was the key to successfully getting started and moving,” said Pete Sturmfels, Director of Quality at Cybex.
SimpleQuE’s experience in quality and manufacturing, combined with their expertise working for registrars, allowed them to quickly assess the situation at Cybex and offer the most simple and efficient ways to place them on the path toward certification.
During the internal audit, simpleQuE uncovered gaps in Cybex’s quality system standards and helped establish sustainable systems that managers could understand. They also identified aspects of the plant’s product development system that already met certification requirements but were not documented by the company, moving the certification along more swiftly.
SimpleQuE consultant Jim Lee said, “They felt they needed to do so much more to meet ISO requirements. I helped them step back and see how their existing process met each of the ISO design requirements. If Cybex wanted to do more, that is a business decision, but they needed to understand that it wasn’t required for ISO.”
Most importantly, however, simpleQuE helped Cybex strip away waste, especially on the documentation side – helping reduce the company’s ISO manual from 40 to a sustainable 10 pages.
The key is simpleQuE’s knowledge of what defines a quality system – what needs to exist and what is not required.
Cybex began working with simpleQuE in October 2005, and in 9 months, the Minnesota plant was ISO 9001 certified. The company’s plants in Medway, MA and Derbyshire, UK followed, both obtaining 9001 certification on the first attempt.
For these reasons, Cybex continues to use simpleQuE for ISO 14001 and ISO 13485 certifications as well as for periodic training.
For more information on how simpleQuE’s methods helped Cybex gain ISO certification, or to contact simpleQuE, visit our website.