Using external FDA and ISO 13485 audit as internal audit

bolesen

Starting to get Involved
#1
We are scheduled for our annual internal audit in Q3 but have went through both a full FDA Audit and ISO 13485:2016 stage 1 and stage 2 certification audit earlier in the year.

Can we use these full audits to satisfy our Internal Audit schedule or do we still need to conduct a internal audit?
 
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blackholequasar

Involved In Discussions
#3
I agree with @Marc - internal audits are your organizations continued responsibility. To be fair, a lot of times we've all sat through an ISO audit and have sighed some relief they didn't find a 'problem' with something we may have known internally to be an issue. Internal auditing is how you fix those issues, take responsibility for continued improvement, and grow the maturity of your quality systems. I wouldn't try to skimp on them, even IF you could use these to satisfy the responsibility. They're only of help to you and your organization. (Even if they're a bit tedious and sometimes difficult to find people to do! Haha)
 

bolesen

Starting to get Involved
#4
I am new to quality management and I understand and agree, with the purpose and responsibility of internal audits and differences going forward.

But as a small PACS imaging software company the resources responsible for conducting our internal audits are the same resources involved in the external audits so ultimately we conducted internal audits in parallel with both the FDA and ISO audits.

So really wanted to know if there are any FDA or ISO requirements that we are not conforming to by using these audits as for our Quality Systems Internal Audit Schedule.
 

blackholequasar

Involved In Discussions
#5
Per ISO 13485 8.2.4 - The organization shall conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to planned and documented arrangements, requirements of this International Standard, quality management system requirements established by the organization, and applicable regulatory requirements; b) is effectively implemented and maintained

That is the responsibility of the organization, per ISO. If it was the responsibility of ISO to do that action, it would allow for it in the standard. But it does not. That's my take on it, anyway! I can respect what a pain it can be - especially in small organizations. But it would be an NC if the scheduled internal audits weren't done. If the company is too small and there is too much conflict, the other alternative is to hire someone from the outside to perform your internal audit. I've been at a company where this had to be done (we were only about 10 people strong at that time) and it was actually a tremendous help in assisting our QMS to mature further.
 

Watchcat

Trusted Information Resource
#6
A key difference between external and internal auditors is that external auditors are auditing to serve someone else's needs; internal auditors are auditing to serve your needs.
 

bolesen

Starting to get Involved
#7
Per ISO 13485 8.2.4 - The organization shall conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to planned and documented arrangements, requirements of this International Standard, quality management system requirements established by the organization, and applicable regulatory requirements; b) is effectively implemented and maintained

That is the responsibility of the organization, per ISO. If it was the responsibility of ISO to do that action, it would allow for it in the standard. But it does not. That's my take on it, anyway! I can respect what a pain it can be - especially in small organizations. But it would be an NC if the scheduled internal audits weren't done. If the company is too small and there is too much conflict, the other alternative is to hire someone from the outside to perform your internal audit. I've been at a company where this had to be done (we were only about 10 people strong at that time) and it was actually a tremendous help in assisting our QMS to mature further.
Can you provide me with the contact info for the outside auditor you used? Or do you know of outside auditors you would recommend?
 
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