How to satisfy section 8.4 Analysis of Data in ISO9001:2000

Your ISO9001:2000 quality management system requires you to gather certain kinds of data, and periodically analyze this data to see how you’re doing. ISO9001:2000 is all about “continuous improvement”, after all. In order to show that you’re continually improving, you have to be able to measure certain objective parameters.

You must be able to show, through your data, that your quality management system is effective, and you also must be able to evaluate where improvements can be made. Data used for these purposes can be gathered from within your organization, and also from external sources. Every company is, of course, different, and the data you gather will be unique to your situation.

ISO does give some specific guidelines about what kind of data you must gather.

First of all, you have to gather information that allows you to objectively measure customer satisfaction. How you do this is up to you. Some people use customer surveys. You might have your outside salespeople fill out a report every time they visit a customer. You can have your inside sales or customer service people keep a log of customer comments, both good and bad. Keep in mind that you have to come up with some kind of objective measurement, so however you do it, it’ll be easier to deal with if you can turn your data into numbers.

You have to gather data that shows conformity to product requirements. This might take the form of inspection records, testing reports, rejection reports, etc. Nonconforming material reports might be used to keep track of how many rejections occur. Maybe you will compare the number of rejections versus the number of parts that pass, and come up with a percentage. Maybe one of your quality objectives is to have 99.9 percent of products pass inspection, and you currently have 99.2 percent. Now you have a concrete objective to work towards. Hopefully you can come up with ways to improve your product and/or processes so that over the next year you’ll reach 99.3 percent of products that pass inspection. It’s not much, but its improvement, and this is what your ISO auditor will be looking for. Quality objectives should be, in my opinion, slightly out of reach. You always want to be able to show improvement, but the moment you actually hit your goals, well now you’ve got to set your goals higher!

ISO9001:2000 requires you to gather data that show characteristics and trends of your processes and products, including opportunities for preventive action. This requirement has always seemed a little vague to me, and I’ve never heard a great way to accomplish this. Fortunately most auditors I’ve worked with apparently also think it’s vague, as I’ve never had to deal with this during an audit. As long as you have documented a system that includes preventive action, and you keep track of trends in your processes, you should be fine.

The last bit of data that ISO requires you to monitor is your suppliers. You must maintain records on your suppliers, showing their performance. Again, how you do this is up to you. Keep records of each supplier, and go thru and approve them at least once per year to show that you monitor their performance. If possible, keep track of your suppliers’ delivery and quality performance.

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5 Responses to “How to satisfy section 8.4 Analysis of Data in ISO9001:2000”

  1. Gajanana says:

    Can I have few examples of Quality Objectives for various departments within the organisation?

  2. Alina says:


    Do we need to mantion statical method such as histogram in our data analysis procedure? Thank you in advance.

  3. Timothy says:

    It is not necessary to mention statistical methods used. You may if you wish, but it is not required.

    Some examples of department level quality objectives are:
    – Percentage of returns due to packaging error.
    – Percentage of returns due to painting department errors.
    – Number of customer complaints due to clerical errors.

  4. Baskaran says:

    Department specific Quality Objective should be derived from the Organizations quality objective.

    An Objective should addres the points as below ..
    what is the current status ?
    where we want to reach from the current level ?
    what is the duration to achieve the goal ?
    and it should practical also ………….

  5. SANJEET MISRA says:

    can i have few examples of quality objectives of store dept & how to achieve them.

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