Controlling forms for ISO 9001 QMS

One of the controversial issues with interpretation of ISO 9001 Standard is control of forms. Many companies, by some reason, treat forms differently than documents, leaving them not controlled. Per ISO 9001 standard, 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, we really do not have to write a “standard” instruction with the purpose, the scope and details if a simple table will do the job. Often companies receive audit non-conformities because their forms are not controlled.

Frequently, being asked about not controlled forms, my clients reply: This is “just a form”. I always wonder why a form should be treated differently than any other instruction or a document. If a form is not controlled, how would we know that we need it to begin with? If a form is not part of your ISO 9001 QMS, it cannot be referenced! If your forms are not controlled, how would anyone know that you use the latest revision? Well, exactly what is a form? A quick test 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 Web address into the 2nd column

I would bet that most of us would call this three-line direction above an instruction. So this instruction, since it is a ‘real’ instruction, shall be controlled.

Here as another look at the same form. What if we were given a two-column table where the first column was called “You company name” and the second “Business URL” and 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”.

These two examples, demonstrate that our first three-line instruction in English (that needs to be controlled), serves the same function, resulting in the same output, as the second form. Therefore, the form as an instruction and “shall”: be controlled as well.

It appears that misunderstanding concerning forms is because forms serve 2 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 ISO 9001 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 document number:

- If you created a form within your ISO 9001 QMS and found it had been changed, would you like to know who did it and why?

- If you changed your ISO 9001 training quiz 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 using a reference to it?

If you answered, “yes” at least once, your form should be controlled per your ISO 9001 documentation management procedure.

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