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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. Very often, companies use forms as lower-level documents. Frequently, it is not necessary to write a typical, instruction with the purpose, scope and details if a simple table will do the job. Very often companies receive audit non-conformities because their forms 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 Most likely, we all would call this three-line direction an instruction. So, since this is an instruction, it shall be controlled. Now, what if we were given a two-column table where the first column was titled "You company name" and the second column "Company's URL". 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". 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.
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