How much can you tailor ISO9001:2008 to your company?

One of the beautiful features of the ISO9001:2008 quality standard is that it gives users a lot of leeway in how to structure your quality system. ISO9001 might say “you shall evaluate training effectiveness”, but it doesn’t tell you how you have to do it. You can try to figure out the best way that works for you.

While its true that an ISO9001 quality system can be and should be tailored to your operation, there is such a thing as carrying it too far.

I recently met a man who read a little bit about ISO9001 and is positive that he can configure his quality system any way he wants, using a very loose interpretation of the quality standard, and still pass an ISO9001 audit. For example, the need to identify product throughout the production process is pretty clear in the standard, but my new friend believes that because his experienced people “just know what those things are”, and have not had any problems, that he can ignore the standard on this issue. And other issues.

The ISO9001:2008 quality standard was created to help businesses standardize and improve their practices. Not every part of the ISO9001 standard will be helpful to every organization out there in the world. Some people might think certain provisions of the standard don’t apply to them because no added value to their organization is perceived. They’d like to pick and choose elements of the standard to suit their needs, add value to their organization, and not create needless busywork.

Of course that’s fine, and I totally understand that way of thinking. If you’re simply trying to create a quality system for your own improvement, then kudos to you for doing so. However if you’re also trying to achieve ISO9001:2008 certification, then I’m afraid you can’t pick and choose which elements of the standard you like. They all apply to you and everyone else who wants to be registered to the ISO9001 quality standard.

There are exceptions, of course. ISO9001:2008 allows you exclusions, as long as you can justify them. For example, if you make pot holders for clients based strictly on customer-supplied drawings, you can probably justify excluding ISO9001 clause 7.3 Design and Development. And if you’re a car wash service, you don’t really have a tangible product that needs to be identified, so you can probably exclude clause 7.5.3.

But if you design products, you can’t exclude 7.3. And if you have products and materials in your shop, you can’t exclude 7.5.3.

It will be interesting to see how far my new friend goes through the ISO9001 registration process, and what things he learns along the way.

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