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.
Forms and tables are frequently used as lower-level documents. Very often, it is not necessary to write a traditional instruction with the purpose, scope and instructions if a simple table is sufficient to provide these instructions. One of the typical non-conformities that companies get during audits of their quality management systems is against forms that are not part of the documentation system.
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
Most likely, we all would call this three-line direction an instruction. So, since this is an instruction, it shall be controlled.
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 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.

