Controlling forms for ISO 9001 QMS
July 29, 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.
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.
Repeatedly I discuss this issue with my clients. Regularly I hear the same answer “This is just a form.” Honestly, I do not understand this! Why should a form be different from any other instruction or a procedure? How would one know that we need a form if it is not referenced in our QMS documentation structure? If forma are not managed by your documentation system, and decide to modify them, how can you be confident that you make changes to the latest revision? Will be difficult 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 assume, somebody gave us a two-column table. We also were asked to fill it out. The first column is titled “You company name” and the second column “Company URL”. I bet, most of us would enter our name in the first column and our phone number in the second. Does it mean that we treated the table as an “instruction”? We did!
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 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?
Just one “Yes” answer to the above questions indicates that your form perhaps is a candidate for a document control.
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