To add to this discussion, I think its important to note that an internal audit does not mean that it has to be performed by the company employees. For example where I work we do our own internal quality audits where we hire an external third party to perform the audit and that is basically us auditing ourself where we can find the problem or issue. Then we can be prepared and can make any corrections we need before ISO or FDA does or they can see that we have found the issue and we are working to rectify it. This common practice not just in quality controls but with finance as well. I personally think that internal auditing is very helpful and useful way to ensure processes are working effectively and that proper documentation is in place. I think its also helpful to note that when you are working on negotiating contracts where maybe you are licensing a product, or contract service out etc you will come across language in the contract regarding auditing.