| Controlling forms for ISO 9001 QMS |
| Written by Mark Kaganov |
| Thursday, 03 December 2009 08:36 |
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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.
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 Website address into the second column Hardly anybody will argue that this three-line direction is a, short, but a procedure to complete this form. So if this is a document, it "shall be controlled". OK, now, let's assume, somebody gave us a two-column table. We also were asked to fill it out. The first column was titled "You company name" and the second column "Company URL". I bet most of us would enter our business name in the first column and our URL in the second. Does it mean that we treated this table as an "instruction"? We just did! If we concur that the 1st three-line instruction written in English was a "real" instruction that needs to be controlled, the other, blank form, resulting in the same output, must also be an instruction! Shouldn't this type of an instruction 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 helpful form 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 out for awhile, would you like folks to be able to find your form just by following a reference to it? If you answered, "yes" at least once, your form should be controlled per your ISO 9001 documentation management procedure. About the Author: Tuning up your ISO 9001 documentation? Quality Works can help! Visit our ISO 9000 documentation page |