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ISO 9001:2000 - Forms control

Do you control your forms within your ISO 9001 quality management system? One of the divisive issues with interpretation of ISO 9001:2000 and other standards is control of forms. Various organizations treat forms differently than other QMS documents and do not control them. Per ISO 9001:2000, element 4.2.3, “Documents required by the quality management system shall be controlled.” Let’s investigate if a form qualifies to be a “document” that “shall” be controlled.

Organizations use forms and tables as lower-level documents. Often, it is not necessary to prepare a traditional instruction or a procedure with all its sections, such as scope, purpose and instructions if a simple table can provide this information. Frequently companies get non-conformities during audits of their QMS because forms used are not controlled.

Often, being asked about not controlled forms, my clients reply: “This is “just a form” a form.” I always wonder why should a form be treated differently than any other instruction or a document? If a form is not controlled, how would we know that we need it? If it is not controlled, it cannot be referenced! If your forma are not controlled, how would you know that you use the latest revision of it? 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

Hardly anybody will argue that this three-line direction is an instruction to make and complete this form. So if this is an instruction, it “shall” be controlled, right?

Now, let?s imagine that we were given a two-column form, only being asked to complete it. where the first column is titled ?You company name? and the second column ?Company?s URL?. Obviously, we would enter our company name and our Website address in the table. It means that we interpreted the table as an ?instruction?.

If we concur that the first three-line instruction in written in English was a “real” instruction, that needs to be controlled, the other, completed form, resulting in the same output, must also be an instruction! Shouldn’t this type of an instruction be controlled also?

It seams to me that misunderstanding concerning forms is because forms serve two purposes. Blank forms are short directions written in tabular language. When a form is completed, it becomes a record. Not like instructions, records are controlled by different means. Let’s realize this difference and treat not completed forms as any other document controlled by our documentation management procedure. 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 is a definite candidate for a part number, and falls under the scope of your documentation management process.

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