Marketing

ISO 9001 Controlling forms

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”.

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.

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 URL into the second column

I would bet that most of us would call this three-line direction above an instruction. So this instruction, since it is a ‘real’ instruction, shall be controlled.

Here as another look at the same form. What if we were given a two-column table where the first column was called “You company name” and the second “Business URL” and 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!

It appears that the puzzlement about forms and their control comes from the fact that forms serve 2 purposes. Blank forms are instructions in tabular language. After a form is filled out, it becomes a record. Records, as a rule, do not have a part or document number or a revision level. Records are controlled by different processes. Remember this and treat your forms as instructions controlled by your documentation procedure. There are a couple of tests you may take when you are thinking about not controlling your form.

- If you created a form within your ISO 9001 QMS and found it had been changed, would you like to know who did it and why?

- If you changed your form, would you like your employees 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 is a definite candidate for revision control, and falls under the scope of your ISO 9001 2008 documentation management process.

Before investing into your ISO 9001 Quality Management System documentation, visit our quality management documentation page. Quality Works helped dozens of companies around the World in developing and implementing their ISO 9001 documentation systems.

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