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Do you control your forms within your ISO 9001 quality management system? If you do, you are on the right track. One of the divisive issues with interpretation of ISO 9001 and other standards is control of forms. Various organizations treat forms differently than other QMS documents and do not control them. Per ISO 9001, 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".
by MarkKaganov
Do you control your forms within your ISO 9001 quality management system? If you do, you are on the right track. One of the divisive issues with interpretation of ISO 9001 and other standards is control of forms. Various organizations treat forms differently than other QMS documents and do not control them. Per ISO 9001, 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".
Organizations use forms and tables as lower-level documents. Often, ther is no need to prepare a traditional "human language" instruction or a procedure with all its sections, such as scope, purpose and instructions if a simple table can result in the same output. Frequently auditors leave companies with nonconformities during audits of their QMS because forms are not controlled.
When questioning the validity of a form without a number, I often hear: "This is just a form." It always escapes me, why should a form be different from any other instruction? How would we know that we need a form if it is not referenced in our documentation system? After all, if you are not managing forms by assigning document or part number and decide to modify them, how can you be sure that the latest revision is being revised? At best it would be difficult. In practice it would be impossible. Well, exactly what is a form? A quick quiz will help answer this question. If we have a list of directions telling us to:
- use a 2-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".
Now, let's imagine that we were given a two-column form, only being asked to complete it. 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?.
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 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 and found it had been changed, would you like to know who did it and why?
- If you changed your, let's say, test results 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?
Just one "Yes" answer to these questions shows that your form perhaps is a good candidate for a document control.
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