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Hello,
We are a small Medical Device company certified to ISO 13485 and I am currently putting our 2012 Internal Audit Schedule together. Typically, our internal audits have been covering the entire Quality System on an annual basis, equally divided into 4 quarterly audits. Now, our CEO is trying to push back, saying that we have been doing really well with our NB and internal audits and that we could use the resources elsewehere. I though that it was a requirement that we cover the entire QS every year, but could not find it in the Standard (13485) to show him. Is it a requirement or if we could skip some sections next year?
We are a small Medical Device company certified to ISO 13485 and I am currently putting our 2012 Internal Audit Schedule together. Typically, our internal audits have been covering the entire Quality System on an annual basis, equally divided into 4 quarterly audits. Now, our CEO is trying to push back, saying that we have been doing really well with our NB and internal audits and that we could use the resources elsewehere. I though that it was a requirement that we cover the entire QS every year, but could not find it in the Standard (13485) to show him. Is it a requirement or if we could skip some sections next year?