Everyone who works with ISO 9001 has run into That Person—the one who is convinced that the standard requires something crazy. Maybe it's the person who insists you have to document your paper clip usage ... or the one who tells you that auditors can write findings based on their judgement or opinions, or on a hunch that you might be doing something they personally don't like. Maybe it's The Stupid Label Guy. (See also this post here.) Sometimes, regrettably, it can even be your auditor, so that you have to have a long conversation during the Closing Meeting about why this or that topic really has no place in the report.
Yes, someone can. For myself, I spent way too many years in this business before I found out about them. So let me save you a little time, I hope, by telling you about them now.
The authorities in question are a subgroup of the ISO Technical Committee 176, the committee responsible for writing ISO 9001. Their formal designation is ISO/TC 176/SC 2/TG 04, or ISO Technical Committee 176, Subcommittee 2, Task Group 4. And their whole job is to give authoritative answers to questions about what the standard requires.
Note the limitations. They are not there to give advice on how you might best implement the requirements of the standard. They won't analyze your business's special circumstances to suggest what you in particular will find efficient or useful. That's consulting, and there are lots of people willing to do it for a fee. But if you have a straightforward, Yes/No question—something like, "Does ISO 9001 require us to hang a printed copy of our Quality Policy in the lobby, signed by the CEO?"—TG 04 can give you a clear Yes or No that settles what the standard actually means.
There are a few other restrictions. To keep the volume of requests manageable, TG 04 replies only to member bodies—that is, national standards organizations who are themselves members of TC 176. If you or I, as private individuals, have questions of interpretation, our first stop should be our national standards organization. (Since I'm American, for me that means ANSI.) All questions must be phrased so that they can be answered Yes or No. And the website warns questioners not to expect an immediate reply: "As it is an official process, that involves developing consensus among the members of ISO/TC 176/SC 2 to agree on any proposed interpretation, a quick response cannot be expected." You can find a list of detailed guidelines at this link here.
Still, it's nice to know that this group exists. When That Person tries to tie you in knots by insisting on something crazy because they think "ISO 9001 requires it," it's nice to know there's somewhere to turn to get a clear answer.
And it's especially nice to know you don't have to put a label on your coffee maker. 😀
Thanks for the very insightful content. Having read through most of your blog in the past couple of weeks, I wonder what would you say is the purpose of a quality manager?
ReplyDeleteA Quality Manager is an expert in the QMS, who manages the system and helps steer the company through it. (Managing employees is possible in the role, but not required.) Of course there are lots of other ways to express the same basic idea. What did you have in mind?
DeleteYes, your reply covers the essence, I believe. And then there are, like you said, different ways to expand on it. I agree, it is as simple as that, while being essential to any organisation. As a new quality manager, I seem to struggle to make the role visible.
ReplyDelete