3rd party auditor for ISO 13485:2016

Hi All,
I just wondering that if somebody can advise that what is the process of being as a certified 3rd party auditor for the ISO 13485:2016 (Medical Devices Quality Management Systems)?
Thanks in advance

Jen Kirley

Quality and Auditing Expert
Good day Khalil,

ASQ has a certification and a course for ISO 13485 Lead Auditor, but this may or may not help you professionally. If you want to audit for a registrar, you may be expected to have passed an accredited Lead Auditor course for ISO 13485. Registrars may additionally expect a certain amount of time working in the Medical Device field, in a capacity other than that of Auditor. The registrars set their requirements. Please review these requirements as posted in job openings.

I hope this helps.


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If you have at least 4 years in R&D in medical devices you can speak to a notified body, they bring people in and train them. Certain notified bodies are known for training people and having them spread out into industry and other NBs, Registrars etc...
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