ISO 9001 Controlling forms
Posted by | Posted in Marketing and Advertising | Posted on 03-12-2009
Auditing hundreds of companies of different sizes in various industries, I found that control of forms is one of the notorious issues with maintenance of ISO 9001:2008 QMS. Various companies, by a strange reason, treat forms differently than other instructions. This leaves forms not controlled. ISO 9001, element 4.2.3, requires: “Documents required by the quality management system shall be controlled.” Now let’s find out if a form is the same as a “document”
Forms and tables are frequently used as quality management system documents. Very often, it is not necessary to write a traditional instruction with the purpose, scope and instruction sections, 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.
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:
- 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 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 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 helpful 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 your employees 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 is a definite candidate for revision control, and falls under the scope of your ISO 9001 2008 documentation management process.
If you are in the process of optimizing your ISO 9000 documentation system, we can help! Look at our quality assurance consulting page to learn about our on-line and on-site services.
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