We've spent the last year trying to get our quality system up and running. We had a few internal (contracted) audits and then a pre-audit with an ISO auditor. I was impressed/embarrassed about how the pre-audit person was simply looking at each line of the ISO 13485:2016 standard and wanted us to show evidence/records. It was simple, yet complete at the same time. Such an eye opener. I then wrote each requirement on a index card and on the back listed areas where I thought we demonstrated compliance. This was a great exercise in realizing areas where we needed to focus our attention.