ISO 13485 Internal Audit


Trusted Information Resource
It's best to check with your ISO certification body.
From common sense prospective, it's better to make sure you are ready internally before the external auditor comes.

Good luck.

Philip B

Quite Involved in Discussions
I don't think it is mandatory but it is definitely good practice and shows a proactive approach.

Ed Panek

QA RA Small Med Dev Company
Super Moderator
I think it’s good practice. For example our MDSAP stage 1 audit expected us to audit to MDSAP for the countries we want clearance in.


Involved In Discussions
I have received 9001 and 13485 stage 1 audits from TUV and DEKRA. Both required an internal audit before the stage 1 audit.


Trusted Information Resource
Most certification bodies have a provision in their contract that obliges customers to perform a full internal audit before their stage one and two audits.


Personally I would. As mentioned above, it shows a proactive approach. Plus if you find a non-conformance, the external auditor can see how you handled the NCR process. Win win for everyone. Audit's are there to make you better.


Trusted Information Resource
ISO/IEC 17021-1:2015, section g) lists the stage 1 audit objective to "evaluate if the internal audits and management reviews are bing planned and performed, and that the level of implementation of the management system substantiates that the client is ready for stage 2."
Likewise section e) lists "auditing of at least the following: ... internal auditing and management review".

Thus for any accredited ISO 13485 certification it is needed. You might get away at stage 1 with a finding against them which you need to fix by stage 2, but to be honest going in with that attitude is a recipe for disaster somewhere down the line.


Super Moderator
How is the effectiveness of the internal audit process to be audited and verified if there has been no internal audit? YOU WILL NOT GET A CERTIFICATE! You will be wasting your time and money even if you try to blow smoke up the auditor's &&& without one.
Top Bottom