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Harmac Earns ISO 13485 Audit with Zero Nonconformities for Second Straight Year

October 25, 2022

Harmac has earned its annual, all-facility ISO 13485 audit with zero nonconformities for the second year in a row! This is particularly impressive given the worldwide challenges over the past two years.

As our vision states, we’re changing the lives of patients, employees and the communities in which we work – and we achieve this in large part through our robust quality management system (QMS) shared across our facilities. It’s designed and implemented to assure the highest levels of product quality, as well as compliance with all applicable regulatory and industry standard requirements.

Evaluating and continually monitoring our QMS is important in validating its effectiveness. Audits help companies ensure the decisions they make, the processes they use, and their documented information are in line with applicable requirements and their organization’s purpose. Established procedures and processes are better monitored through audits – internal or external – although external audits from accredited bodies add higher levels of expertise and objectivity.

"It really demonstrates the strength of our QMS, along with the dedication and competence of our employees," said Harmac Associate Director of Corporate Quality Nathan Monin. "It's a comfort to know that, even through the difficulties presented by COVID-19, our system was up to the challenge."

This was further validated during our recertification audit last year, and by this year's surveillance audit. Our customers can be confident that the products and services we provide not only meet, but exceed, all requirements. Our employees are proud of and dedicated to our QMS, as well as the commitment to provide world-class medical products and services. Contact us to learn how we can help you!