I'm pretty sure that the casual understanding of ISO 9001 on the part of most non-specialists across the business world is summed up by Scott Adams in his multiple Dilbert cartoons about the subject. Back in the early years of the standard someone tried to summarize the ISO 9001 standard by saying, "Document what you do, and then do what you documented." No doubt the original intention was de-mystify the standard, to show how close it came to basic common sense. But the consequence of this slogan was that everyone focused on documentation. The word went out that ISO 9001 was about documentation. If you have to implement ISO 9001, your first step should be to document everything!
If I had to pick two cartoons that exemplified this point of view, it would be the following. (I'm not sure of the exact limits of fair use, so I will post only links to the cartoons and not copies of them.) The first one shows Dilbert explaining how all the company's ISO 9001 documentation will be collected in "one big honkin' binder." The second shows someone labeling everything because he thinks it's a requirement.
Of course the real requirement says no such thing. In fact, the 2015 edition of the ISO 9001 standard removed all requirements for specific documents. But let me draw a distinction. There are still plenty of requirements that you write things down; what no longer exists is a requirement that you specifically write a Quality Manual, or a documented procedure for records control. Instead of focusing on specific document titles and formats, the requirements now say – in effect – "If you need to write it down, write it down." And then there are a lot of specific paragraphs where they remind you that if your business involves doing this or that, … that's something you need to write down.
So when someone asks me, "Does ISO 9001 require me to document X?" my first step is not to check the standard. My first step is to ask back, "I don't know … would you need to document it in the Real World, even if there were no such thing as ISO 9001?" Nine times out of ten, the answer is, "Yeah, I guess so. Never mind." Then in the rare case where the answer is "No," we can talk about it a little more, check our local company directives, and – yes – look at the standard. But invariably, if the rules finally say "Document it," there's a reason why.
Now that I've made this point – I mean, that ISO 9001 doesn't require you to document everything blindly – maybe it is worth talking in a little more detail about some of the kinds of documentation that auditors often ask for, and why they matter.
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