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Harmac’s Quality Management System Becomes Point of Distinction

January 25, 2022

Harmac’s Quality Management System Becomes Point of Distinction

As a medical device contract manufacturer, Harmac is required to follow regulations of various agencies which hold high standards for safety, quality, efficiency and many other attributes. Whether it’s the U.S. Food & Drug Administration, Japanese Pharmaceuticals and Medical Devices Agency, or International Organization for Standardization, all have requirements for standard operating procedures which must be documented and available to view.

Harmac’s culture of continual improvement led us to realize these requirements present opportunities to make numerous areas of our company stronger, which benefits not only our employees, but also our customers and their patients.

Thus, we’ve made a long-term commitment to creating and supporting a single, companywide, customized, proprietary, 21 CFR Part 11-compliant, quality management system (QMS). The fully digital, standardized system provides all three Harmac facilities with access – simultaneously, if needed – to any documentation required, with uniform processes, formats and sets of requirements. This adds to our customers’ peace of mind, knowing their products will be manufactured using the same processes, regardless of whether they are working with one or multiple divisions.

“Wherever you are in the world, you can touch the document where you stand, when you need it,” says Nate Monin, Harmac’s Associate Director of Corporate Quality, based in our Buffalo, N.Y. headquarters. “It has not only impressed our customers, external partners and regulatory bodies, but it streamlines investigations, paperwork and other administrative functions.”

Examples include corrective and preventive action reports, maintenance scheduling and records, calibration controls and investigations such as root-cause analyses or nonconformity reports. The QMS also captures electronic signatures and provides instant access to documents and records when needed, such as in a routine audit or for investigatory purposes, to ensure quality and process criteria are properly met.

“It has gained us accolades from many external auditors,” says Mary Woolley, Harmac’s Quality Assurance Manager at our Castlerea, Ireland facility. “They’ve commented on how robust our systems are, how well they work, and how easy documents are to retrieve, whether they’re onsite or virtual.”

Not surprisingly, Harmac has experienced no major findings, companywide, during its audits for years, and much of that is attributable to our digital QMS and broad capabilities.

“From a customer perspective, especially as we have more shared customers across our facilities, it makes it easier, because they don't have to learn a separate system for each site,” Monin adds. “They can operate in essentially the same way, regardless of who they're working with across Harmac.”

However, its greatest value is perhaps found in the fast and far-reaching knowledge-sharing it provides to Harmac’s roughly 1,250-member global workforce.

“The QMS is a digital information network that is accessible by all employees across all sites,” Woolley attests. “Whether it be standard processes or a new finding one facility uncovers which needs to be quickly shared, it truly helps to facilitate collaboration.”

The stakes are very high at Harmac, in that everything we produce is being created to improve and even save the lives of patients. Our culture of continual improvement is what truly sets us apart from our competition; thus, with patient and employee safety at the forefront of our work, the feedback we receive from outside partners is always welcome.

“We take comments from our customers and all auditors to heart,” Woolley insists. “If they see an area for us to improve, we actively work on that because it’s an opportunity to become better. We’re manufacturing finished products that are going directly to the customer. There isn’t another control step. It’s a huge responsibility that we take very seriously, so we have a high level of self-scrutiny.”

“Our QMS is not typical of a company our size,” Monin concludes. “It’s robust, fast, accurate and easy to use – because it’s been developed by our users, the people who work most closely with them.”

If you’d like to work with a company that has such forward-thinking team members at your side, reach out to us at or 716-897-4500, ext. 200. We’d welcome the chance to learn more about your business.