Certifying 3 sites on first attempt
Cybex began to explore the possibility of selling products in the physical therapy market, especially in Europe, and quickly realized getting its three sites—Owatonna, Minn., Medway, Mass., and Derbyshire, U.K.—certified to ISO 9001 would be very beneficial in that endeavor.
The first step was to get the Minnesota plant ISO 9001certified. The process seemed daunting, however, as Cybex tried to familiarize itself with ISO terminology and definitions. Even bringing in a consultant did not help the company overcome the inertia of not knowing where to start. It wasn’t until Cybex hired simpleQuE as a new consultant that the certification plan really began to find direction.
“We struggled getting off the ground by approaching ISO requirements first, not looking at our processes and then ISO requirements,” said Pete Sturmfels, Director of Quality at Cybex. “simpleQuE’s methodology was the key to successfully getting started and moving.”
simpleQuE’s experience in quality and manufacturing, combined with its expertise working for registrars, allowed it to quickly assess the situation at Cybex and offer the most simple and efficient ways to place it on the path toward certification. According to Sturmfels, the company brought in a full understanding of ISO. “There is too much room left for interpretation in the ISO 9001 standard,” said Sturmfels. “simpleQuE brought clarity and confidence to the actions Cybex was taking to assess our current system and improve the system to meet ISO 9001.”
During the internal audit, simpleQuE identified gaps in Cybex’s quality system standards and helped establish sustainable systems that managers could understand. The company also brought to light aspects of the plant’s product development system that the company was not taking credit for but already met certification requirements.
“Cybex already had a very detailed product design process with documented risk analysis and defined phases,” said Jim Lee, one of the consultants. “Yet, the company felt it needed to do so much more to meet ISO requirements. I helped its people step back and see how the 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.”
Perhaps most importantly, however, simpleQuE helped Cybex strip away waste, especially on the documentation side. In a specific example, simpleQuE found Cybex’s quality manual and procedures to be overly extensive and not sustainable.
“My initial manual was over 40 pages,” admitted Sturmfels. “By the time simpleQuE got done asking questions and giving direction, it was less than 10. The key was the company’s knowledge of what defines a quality system and what needs to exist and what was fluff and not required.”
“Cybex had a procedure for almost every clause and sub-clause of the ISO standard,” said Lee. “We reduced that significantly to the necessary documents the company needed and would use, focusing more on their important business processes for simple and sustainable systems.
While Cybex has a very robust engineering change process, Lee said that the document control process was weak. “We ended up putting the quality management system documentation under the same engineering change process because that is what works for Cybex. It was a simple way to have an assured, sustainable system that didn’t require the development of a new process.”
simpleQuE began working with Cybex in October 2005, and by July 2006 the Minnesota plant was ISO 9001 certified. All three sites successfully achieved certification on their first attempt.
“simpleQuE brings everything to the table for its customers,” said Sturmfels. “First, simpleQuE is committed and always available for questions and support. This was a significant help. Second, its experience allows you to do things right the first time and not waste time. simpleQuE does not allow you to keep trying without providing you effective feedback to make good decisions. The company brings all the technical knowledge you need, experience you expect and—most importantly—uses both to provide simple solutions to very complicated problems.”
After initial anxiety about the certification process – before hiring the services of simpleQuE Inc. – Sturmfels now considers the certification process a very positive experience for Cybex International. “People really do see ISO 9001 as ‘what does ISO tell us to do,’ instead of what are we already doing to meet ISO and what gaps need to be filled,” he said. “Jim’s approach is not only a good one, but it removes any apprehension a company may have over ISO.”
Sturmfels has also recommended simpleQuE for international work at one of the company’s top suppliers, saying “it is very adaptable to any environment or business. simpleQuE has developed the right approach to ISO and quality consulting.”
It is for these reasons that Cybex continues to use simpleQuE for ISO 14001 and ISO 13485 certifications at two of their US locations and one UK site, as well as for periodic training.
“simpleQuE Auditors have proven to be knowledgeable, thorough, insightful and pragmatic in their auditing approach.”
Barry Rowley, NOSHOK, Inc.