Quality management system audits and certification guidance
Information
Type
Guidance
Regulated products
Medical Devices
Topics
In Vitro Diagnostic Medical Devices (IVDs)
Published
December 19, 2023
Last updated
December 19, 2023
Description
Guidance for medical devices manufacturers on how we conduct Quality Management System (QMS) audits, roles and responsibilities for audits, aspects of conformity assessment certification and post-audit activities.
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)