What Tolerance is Built Into Your ISO9001-2008 quality system?

Anyone in manufacturing knows that every product is built within a specified set of tolerances. That bit of hardware is 8 millimeters wide, plus or minus a tolerance of, say, .001 mm. This plastic tank is 2 mm thick, with a tolerance of .1 mm in either direction.

Have you built any tolerances into your quality management system? For example, do you state in your quality manual that management review must be done in, say, the first week of February each year? If so, what is the reason for such precision? Is it really necessary? Or could you say management review must be done in the first quarter of each calendar year?

Companies new to ISO9001-2008 tend to err on the side of being too precise, and it can get them into trouble. If your manual says that all internal audits are to be done during the month of January each year, but then unexpectedly you get very busy in January, your manual doesn’t give you the flexibility to move your internal audits to February.

One company I work with has many, many measuring devices that need to be calibrated. They’re old hands at ISO9001-2008, and over the years they’ve learned more about what works best for them. In the early days they had every calipers and micrometer calibrated every 90 days. After a while they started to ask themselves if this was really necessary. There were some measuring tools that were rarely used, and when they were used, it was for non-critical measurements. They decided that certain non-critical, rarely used measuring devices could go one year between calibrations. This new calibration schedule works fine for the company, and who can argue with what works best?

ISO9001-2008 requires that such tools be calibrated at specified intervals, but it’s up to you to decide what interval is right for your company. Now, going for 5 years on a tool that’s used every day might not seem reasonable to your auditor, so there are limits between what’s required and what’s reasonable.

Whether its your calibration schedule, your internal audit schedule, frequency of management review, number of corrective actions written, etc, you might want to give some thought to how much work you’re doing, and whether its necessary.

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One Response to “What Tolerance is Built Into Your ISO9001-2008 quality system?”

  1. Shannon says:

    I really like your blog! It’s very informative and I’ve been looking for something that could help us out. I have a very small business, there are only 5 of us, and we are trying to implement our Quality Management system, but I was wondering if I could talk to you about some questions I have about our quality manual, revisions, records, and non-conformances. For instance, I have a really hard time not writing out an NCR for every little thing that goes on in the shop, but if we are running late on production then I would definitely need to write an NCR for that, right?
    Please get back to me, I could really do with some consulting and I think I would like to talk with you about implementing our program.

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