Quality management system audits and certification guidance

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

This is to make sure they follow: 

• QMS standards
• the Therapeutic Goods Act 1989 
• Therapeutic Goods (Medical Devices) Regulations 2002.

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.