Saturday, January 30, 2016

Controlling forms for ISO 9001 QMS

September 20, 2011 by  
Filed under Marketing

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, there 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.

Repeatedly I discuss this issue with my clients. Regularly I hear the same answer “This is just a form.” Honestly, I do not understand this! Why should a form be different from any other instruction or a procedure? How would one know that we need a form if it is not referenced in our ISO 9001 quality management structure? If forms are not controlled by your documentation system, and you decide to modify them, how can you be confident that you make changes to the latest revision? That will be difficult! Anyway what is a form? A quick exercise will help answer this question. If we have a list of directions telling us to:

– draw a two-column table

– enter your business name into the 1st 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.

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 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 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.

Working on your QMS documentation system? Let our quality management experts help you! Visit our Quality Control page.

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