ISO Consulting Services is the trusted adviser for many of Australian businesses in the medical device industry for ISO 13485 Quality Management Certification. We provide expert advice, in-depth guidance, and tailored support to assist in the development, implementation, certification and maintenance of your Quality Management System (QMS), in order to meet the regulatory requirements and processes for the ISO 13485 certification.
Submit the Application Form today for more information on our ISO 13485 advisory services.
What is ISO 13485?
ISO 13485:2016 is the current, internationally recognised standard for a business operating in the design and development, production, storage and distribution, installation, or servicing of a medical device and or provision of associated activities or services (e.g. technical support).
Why is ISO 13485 certification important?
Australian Government Regulations
With regards to ISO 13485:2016, the Australian Business Licence and Information Service (ABLIS) government website states:
“You may be required 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 (ARTG), it must be manufactured according to the requirements of this standard.”
The Therapeutic Goods Administration (TGA) is the Australian Government body (as part of the Department of Health) responsible for making decisions regarding market authorisation of therapeutic goods in Australia, such as medical devices, and assess applications for conformity assessment certificates (specified in a Conformity Assessments Standards Order) for some devices and for the inclusion of medical devices in the ARTG. The TGA also recognises matching standards in jurisdictions where ISO 13485:2016 has been adopted, including Europe, Canada, and the US.
From 1 March 2019, TGA applications must be supported by evidence that a quality management system has been implemented in accordance with the 2016 revision of the standard.
International Trade Opportunities
For Australian businesses within the medical device industry (regardless of their size and type), implementation of the highly stringent requirements of the ISO 13485 certification into their quality management system will validate their consumer, services, and regulatory compliance with globally accepted requirements for medical devices.
If you require additional information on the requirements for ISO 13485, submit the Application Form today.
How do I become ISO 13485 certified?
The experienced team at ISO Consulting Services works closely with medical device manufacturers and service providers to conduct a gap assessment and to design and implement a QMS to attain ISO 13485 certification.
To discuss your ISO 13485 certification requirements in further detail, submit the Application Form today.