Filtech Testing Division ISO 9001 Case Study
Filtech Inc., based in Western Pennsylvania, has been servicing, testing, and providing certifications for hoods, cleanrooms, and containment systems since 1969. Founded by Harry Elinsky Sr., Filtech provides a complete line of filtration systems and replacement filters for HVAC, liquid, gas, oil, dust collection, hydraulic, and compressed air and gas applications.
The Filtech Testing Division provides certification and testing of HEPA filtration equipment used in critical environments such as sterile compounding cleanroom pharmacies, academic research facilities, and medical device manufacturing. The division currently employs a total of 21 employees comprising of field technicians, office operations, management, and quality with specialized in-house training and required industry association training.
The job of the technicians entailed certification of equipment with very strict guidelines and parameters. If a minor mistake with reporting and documentation was made, it could result in a missed failure that could raise a potential safety issue with the customer. Therefore, document control was a major challenge that had to be addressed to provide the same consistency to all of their customers.
When a customer required ISO 9001:2015 certification, Nick Karlowsky, Vice President of the Testing Division, selected SimpleQuE to guide them through implementation. “In the early stages of our certification, SimpleQue demonstrated its power of consultation and collaboration where we quickly realized that this certification is tangible and necessary in developing a quality system within our company.”
In January 2021 SimpleQuE’s consultant, Jen Briese, began with a gap analysis to evaluate any current quality system procedures, documentation, and overall identification and implementation of key processes against ISO 9001:2015 requirements and other best practices. In addition, current methods were evaluated to determine what worked within their current processes. Working with Nick and the Filtech team, an action plan and overall implementation strategy was created and action items assigned.
Through 2021, the consultant worked with Filtech Testing Division to streamline processes, implement actions to address gaps identified against the standard and increase document control practices. The Filtech division worked together to modify many of the processes within the organization during the ISO 9001 system implementation.
“SimpleQue was needed to help get a program off the ground. From helping to identify gaps to writing procedures and even understanding the standard, we needed their guidance every step of the way,” said Mary Csorba, Testing Division Operations Administrator.
Control of changes and document control was key area that they worked to improve. The team identified a need to increase document control on customer reports. They also implemented a new program for organizing the calibration of equipment for Field Technicians. Mary Csorba noted of the changes, “There are now written procedures for each process within the testing division. It takes the guesswork out of ‘what to do’ and directs you on how to proceed.”
At the end of 2021, Jen performed an ISO 9001 internal audit to be sure the testing division was compliant with the standard. They had a few more consulting sessions with her to be sure their system was on track and so that they would be ready for the certification audits by their certification body, PRI, which took place in March and April 2022. Filtech Testing Division achieved ISO 9001 certification with no audit findings.
SimpleQuE returned in 2022 to evaluate the entire QMS requirements for ISO 9001:2015 and for evidence of improvement over the year. Filtech was able to show significant improvement using trend data in quality objectives and process measures. The goal of building a robust and effective quality management system combined with the desire to achieve ISO 9001 certification successfully increased their organizational performance metrics from 70% to 96%.
“SimpleQue laid the foundation of an understanding and processes we needed to implement to achieve our goals. SimpleQue also helped us develop guidelines and proper documentation to implement our processes for our day-to-day operations,” stated Mark Bennett, Field Operations Manager. “Some of the benefits I believe the company has achieved is an overall organizational understanding of business flow and improved document control of each department. With the systems we have implemented now, all facets of our department can be broken down for all team members to not only understand but also implement with our customers. This not only gives us better team member-to-team member communication but to each of our customers as well.”
“In my experience, becoming ISO 9001 certified has helped our business by providing a framework for continuous improvement and a commitment to quality that is now embedded in our culture. It has also helped us to better understand and meet the needs and expectations of our customers. Additionally, our certification has given us a competitive edge by demonstrating our commitment to quality and providing a level of assurance to our customers that we take quality seriously.” – Nick Karlowsky, Vice President, Testing Division.
With such a strong focus on quality, improvement and customer satisfaction, it is not surprising that Filtech Testing Division also passed its 2023 surveillance audit with no findings. Encouraged by the benefits and results of ISO 9001 certification, Filtech Inc. is considering following in the footsteps of its testing division and adopting ISO 9001 for its own quality management system.