Internal Audits Prior to CB Audit

I am currently going through the CB audits to transition to the 9001:2015 standard at our three main US facilities and one of the issues that came up at our CA facility has me a bit worried about what will happen this week at our OH facility. We had some non-conformance issues regarding our internal audit process, which admittedly had a lot of gaps. We had been without quality representatives (myself included - I'm new to the company) until about three months before the CB audit, so we didn't have much time to get familiar with the company, products, and state of the QMS. That being said, we did not complete many of the internal audits during that time to close the gap. At CA, there was an approved audit schedule with some of the audits completed, but not all. Because not all of the internal audits were completed against the 2015 standard, and thus they did not yet have the Management Review completed, they were given a non-conformance and a timetable to complete the internal audits and Management Review. I guess what baffles me about this is that the standard does not state that these items have to be completed prior to the CB audit. It only states that they must be done periodically. If our CA facility had a schedule to complete the audits and the MR, where are they in violation of the standard?

 

I haven’t seen the actual audit report yet, so I’m not exactly sure how it’s worded. I’ll come back when I’ve seen the actual report. At any rate, I finished all of the internal audits and management review at my facility today to prepare for the start of CB audits tomorrow. I’ll let you know how things go.