I am a registered RABQSA QMS and AS9100 Auditor. Can I audit an ISO13485 program if a register provides me with training and qualifies me as an auditor? I have not taken the ISO 13485 Lead Auditor class. The company I am auditing does not perform sterilization. The registrar does have an expert to perform this function, if needed. So without formal training (ISO13485 LA class), am I qualified to perform ISO13485 audit all by myself, if a registrar provide me with training.

TY

Being an AS9100 and ISO 9001 lead auditor does not make you a medical device auditor.

Do you have any experience with medical devices?

Are you aware of regulatory requirements for the medical device system that you will be auditing?

It is important that auditors follow a qualification scheme, to ensure that customers receiving an ISO 13485 certification have been properly assessed.

There are no shortcuts.

If you know a registrar that permits you to audit medical devices, I would avoid using that registrar.

Being an AS9100 and ISO 9001 lead auditor does not make you a medical device auditor.

Do you have any experience with medical devices?

Are you aware of regulatory requirements for the medical device system that you will be auditing?

It is important that auditors follow a qualification scheme, to ensure that customers receiving an ISO 13485 certification have been properly assessed.

There are no shortcuts.

If you know a registrar that permits you to audit medical devices, I would avoid using that registrar.
Adding further ... your products classification knowledge and medical devices background would permit you to audit only specific customers matching auditors competency. Please be aware that globally ISO 13485 lead auditors are in shortage and there is a need for more good competant auditors......

I have 2 years of medical device experience. I certified this company to ISO 9001 already. This company build circuit cards, through hole and SMT. They have one production line that is medical related. They assemble the circuit card to a device and test it. The user attach it to somthing else that is more complicated and perform more testing.

I read the ISO13485 and basically it follows the ISO9001 framework, with some exceptions. There is really little difference. I can understand taking a 1-day class just to fill the gap, but not the 5-day class. I did take the ISO 14001 Lead Auditor class and received additional training from this registrar before I got qualified and started conducting ISO14001 audits for them. It is quite different from ISO9001.

Thanks for the input.

TY