You may need to comply with this standard if you intend to supply medical devices and provide related services. If a therapeutic device is required to be listed or registered on the Australian Register of Therapeutic Goods, it must be manufactured according to the requirements of this standard.
The aim of this standard is to specify requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
