AS ISO 13485:2017
Medical devices — Quality management systems — Requirements for regulatory processes

Standard No.

AS ISO 13485:2017

Release Date

2017

Published By

Standard Association of Australia （SAA）

Latest

AS ISO 13485:2017

Scope

Adopts ISO 13485:2016 to specify requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

AS ISO 13485:2017 history

• 2017 AS ISO 13485:2017 Medical devices — Quality management systems — Requirements for regulatory processes
• 2003 AS ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
• 2002 AS ISO 13488:2002 Quality systems-Medical devices-Particular requirements for the application of ISO 9002