ISO 13485:2016

Argonaut Announces ISO 13485:2016 Quality Certification Achievement

Argonaut Manufacturing Services, a contract manufacturing organization (CMO) dedicated to serving the life science and molecular diagnostics markets, announced today that it has received ISO 13485:2016 certification following a successful inspection conducted by the British Standards Institute (bsi).

This achievement indicates that Argonaut Manufacturing Services meets the highest standards required of quality management in the medical devices and life science industries.

“Achieving this ISO certification is a great accomplishment by our team and an excellent example of Argonaut’s commitment to delivering the highest levels of quality and regulatory compliance to our clients,” said Wayne Woodard, Argonaut’s CEO. “By achieving ISO 13485:2016 we are holding ourselves accountable to the highest and most current industry standards of excellence.”

About Argonaut Manufacturing Services

Argonaut is an independent contract manufacturing organization dedicated to providing manufacturing and supply chain solutions for life science, MedTech and molecular diagnostic companies. With the recent completion of 11 state-of-the-art manufacturing cleanroom suites located within their 31,000 square foot facility, Argonaut is providing flexible solutions for their clients diverse outsourcing needs.


Prioritizing quality from day one, the Argonaut Quality Management System is the overarching structure that houses all other systems, including ERP. Argonaut’s Quality Management System is compliant to ISO 13485:2016, cGMP, and quality system regulations 21 CFR 820, 21 CFR 210, 21 CFR 211, and Argonaut is FDA registered and CA FDB audited (link to certificates).

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