- QMS - ISO 13485 (SYD-14-11-18)
9:00 am - 4:00 pm
Sydney Quality Management Systems – ISO 13485 training course
This one day ISO 13485 training course covers the requirements of ISO 13485 and its implications within a medical device manufacturing company. PharmOut’s consultants regularly design and write Quality Management Systems for companies, from the smallest to the large blue chip companies. They have many practical suggestions on how to apply the ISO 13485 standard and with ready access to ex TGA inspectors can answer the more difficult questions too. We will include updates from the pending 2016 updates.
As the ISO Standard 13485:2016 Medical Devices states;
“All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization.”
Read the full course outline here.