The importance of ISO certification

By Kelly Huckabone

July 2018

Quality Management Systems have been around for many decades. Toyota made them famous by running their businesses using lean manufacturing and having procedures and training programs in place to ensure a standardized approach to building cars that were of extreme high quality with a focus on eliminating waste and driving process improvements.

People from all over the world have studied how Toyota built a culture of quality and many companies in turn have modelled their quality programs around the philosophy that “quality should be built into everything you do.”

Many of our customers require us to have a quality program in place especially pharma, health care, testing laboratories, and production customers. They need to have evidence that they are working with companies that understand quality and have training programs in place to ensure a consistent approach when delivering products or services.

In particular for our customers, many of them require compliance with the FDA and we are on their critical supplier list because we are doing installs, repairs, and calibrations on equipment that could have a direct impact to patients and their products.

Having a quality system in place provides our customers with a high degree of trust and confidence in the services we are delivering.

We have been recommended by our ISO Registrar and have received our ISO 9001:2015 certificate. This new version of the ISO Standard helps us adopt a risk-based approach to understanding and tackling high risk issues within our business.

Stay tuned for future updates!

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About the Author

Kelly Huckabone is the North American Audit Program Manager who oversees the Unity Lab Services internal and external customer and supplier audit programs. Kelly is a certified risk manager, lead auditor with the American Society for Quality (ASQ), and has been conducting audits for over 25 years for different quality systems, including ISO 9001, 13485, and 17025, as well as Health Canada and the FDA.

Contact me at kelly.huckabone@thermofisher.com if you have any questions.