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Quality management system audits and certification guidance

Guidance

This guidance provides information for medical devices manufacturers on how we conduct Quality Management System (QMS) audits, roles and responsibilities for audits, aspects of conformity assessment certification relating to auditing and post-audit activities.

Last updated

We perform audits of both domestic and overseas medical device manufacturers. 

This is to make sure they follow: 

The Act requires manufacturers of medical devices to show conformity assessment procedures have been applied.

A manufacturer generally must implement a quality management system (QMS) based on recognised standards and the regulatory requirements and have the QMS assessed by us or a recognised conformity assessment body. 

Sponsors must: 

  • declare that manufacturers have met their obligations
  • be able to provide us with the technical and QMS documentation to support this claim.
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