ISO9001:2000 Section 4.1 General Requirements Part 2

This is the second part of an occasional series on ISO9001:2000 Section 4.1, General Requirements.

Keep in mind that when the ISO9001:2000 quality standard uses the word “shall”, then whatever they’re referring to is a requirement, not a suggestion.

We’ve already written about how your company must identify and document all the processes that affect your quality management system. In addition to identifying and documenting them, you must also document how they interrelate with each other, and in what sequence. You’re basically writing an operational manual for how your company works. After all, you want all your people to be “rowing the boat” in the same direction, so its very helpful if they’re all looking at the same map.

You must also determine the criteria and methods needed to make sure that the operation and control of your processes are effective. If you’re turning out small, large, and medium widgets, what is your criteria for determining if they are good widgets? What size constitutes small, medium and large? How do you ensure that your criteria are being met? Who’s responsible for determining what is acceptable and unacceptable?

Another requirement in ISO is that you have available sufficient resources and information needed to support the operation and monitoring of your processes. Do you have adequate machinery? A sufficient quantity of adequately trained personnel? A sufficient quantity and quality of measuring devices?

More on this later.

Your comments are encouraged.

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