Congratulations to Filtech Testing Division on ISO 9001:2015 Certification!

Jen Briese, simpleQuE consultant, presents a plaque to the quality team at Filtech Inc. for achieving and maintaining ISO 9001 certification. Based in Western Pennsylvania, Filtech has been servicing, testing, and providing certifications for hoods, cleanrooms, and containment systems for more than 50 years. 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.

Filtech’s 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. 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.”

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, Jen worked with the 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.  Control of changes and document control was a key area that they worked to improve. The team identified a need to increase the document control on customer reports.   They also implemented a new program for organizing the calibration of equipment for Field Technicians.  “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.

In 2022 Filtech Testing Division achieved ISO 9001:2015 certification from certification body, PRI, with no audit findings. When 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 increased their organizational performance metrics from 70% to 96%. With such a strong focus on quality, improvement and customer satisfaction, Filtech Testing Division also passed their 2023 surveillance audit with no findings.

“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

For an in-depth look at the challenges faced, the solutions implemented, and the strong measurable results, Read the entire case study on Filtech Testing Division.