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is a requirement in the world of medical devices. There are many types of
audits, including, but not limited to, first-party, internal, second-party,
supplier, external and agency audits. Regardless of the audit’s nature and
scope, the purpose is basically the same—to assess compliance with the Quality
Management System (QMS) requirements. Typical audit outcomes require manufacturers
to take some sort of action to come into compliance with standards or
regulations and make improvements to quality management systems.
quality system audit is one of the most important good manufacturing practice
(GMP) requirements. The process of auditing medical device quality systems is similar
to quality system audits in other industries, but with a distinct difference.
Whereas other quality systems may focus more on quality as a component of
customer satisfaction, a medical device audit focuses on ensuring compliance
with regulatory agency requirements (e.g., FDA, Health Canada, EMA, TGA, CFDA,
etc.) or other applicable regulations, with the goal of assuring patient safety
and product effectiveness. A quality system audit is performed to determine
whether the company’s QMS meets regulatory requirements and ensures products
meet specifications and customer expectations.
of the nature and scope of an audit, any finding should be addressed with corrective
and preventive actions (CAPAs) to help drive compliance to standards and
continuous improvement(s). Audits often identify areas that need improvement
and offer valuable insight into the proper functioning of a compliant Quality
At A Glance
Upon completion of this course, participants should be able to: