There is a QMS requirement that internal audits "shall ensure objectivity and impartiality", and that "auditors shall not audit their own work".
Here's the situation: Years ago, I authored procedures for purchasing & supplier control based on our input quality system standard requirements (ISO 13485), and our own internal needs. I developed all supplementary training work instructions and forms, and was one of the persons responsible for authorising the documents for use.
I then delegated persons to train and implement so, for the last few years, I've not been involved with the process, with the exception of monitoring vis-a-vis internal audit outputs and management reviews.
Question: Can I justify performing an internal audit, given that I'm not involved in any of the actual activities at this point, but despite the fact that I am the original author of the current documents being used? Would this be a violation of the "objectivity and impartiality" or "not audit own work" requirements?
According to our ISO requirements, internal audits are intended to (paraphrased) (a) check conformity to the QMS standard, and internal & regulatory requirements; and (b) confirm effective implementation and maintenance. Perhaps I could do (b), but not (a)?
Here's the situation: Years ago, I authored procedures for purchasing & supplier control based on our input quality system standard requirements (ISO 13485), and our own internal needs. I developed all supplementary training work instructions and forms, and was one of the persons responsible for authorising the documents for use.
I then delegated persons to train and implement so, for the last few years, I've not been involved with the process, with the exception of monitoring vis-a-vis internal audit outputs and management reviews.
Question: Can I justify performing an internal audit, given that I'm not involved in any of the actual activities at this point, but despite the fact that I am the original author of the current documents being used? Would this be a violation of the "objectivity and impartiality" or "not audit own work" requirements?
According to our ISO requirements, internal audits are intended to (paraphrased) (a) check conformity to the QMS standard, and internal & regulatory requirements; and (b) confirm effective implementation and maintenance. Perhaps I could do (b), but not (a)?