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Controlling forms for ISO 9001 QMS

Jul 24, 2008
One of the controversial issues with interpretation of ISO 9001:2000 Standard and others is control of forms. Many companies, by some reason, treat forms differently than documents, leaving them not controlled. Per ISO 9001:2000, element 4.2.3, "Documents required by the quality management system shall be controlled." Let's see if a form qualifies to be a "document" that shall be controlled.

Very often, companies use forms as lower-level documents. Frequently, it is not necessary to write a typical, instruction with the purpose, scope and details if a simple table will do the job. Very often companies receive audit non-conformities because their forms are not controlled.

When questioning the validity of a form without a number, I often hear: ?This is just a form.? It always escapes me, why should a form be different from any other instruction? How would we know that we need a form if it is not referenced in our documentation system? After all, if you are not managing forms by assigning document or part number and decide to modify them, how can you be sure that the latest revision is being revised? At best it would be difficult. In practice it would be impossible. Well, exactly what is a form? A quick quiz will help answer this question. If we have a list of directions telling us to:

- draw a two-column table

- enter your company name into the first column

- enter your company?s URL into the second column

Most likely, we all would call this three-line direction an instruction. So, since this is an instruction, it shall be controlled.

Now, what if we were given a two-column table where the first column was titled "You company name" and the second column "Company's URL". We were asked to complete the form. Easy to imagine, we would enter our company's name and our URL in the table. It means that we interpreted this table as an "instruction".

If we agree that our first three-line instruction in English was a ?real? instruction, that needs to be controlled, the second, completed form, resulting in the same output, must also be an instruction!

I think that the confusion regarding forms is based on the fact that forms serve two purposes. Blank forms are concise instructions written in tabular language. After a form is filled out, it becomes a record. Unlike instructions, records are not expected to have a part number or a revision level. Records are managed in a different manner. Let?s remember this and treat our blank forms as instructions letting the documentation management process govern them. There are a couple of simple tests you may take when you are tempted to use a form that has not been assigned a part number:

- If you created a form and found it had been changed, would you like to know who did it and why?

- If you changed your form, would you like personnel to use the most resent revision?

- If you were on vacation, would you like folks to be able to find your form just by finding a reference to it?

If you answered, "yes" at least once, your form should be controlled per your documentation management procedure.
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