Control of forms for ISO 13485 QMS

One of the controversial issues with interpretation of ISO 13485:2003 Standard and other standards is control of forms. Many companies, by some reason, treat forms differently than documents, leaving them not controlled. Per ISO 13485:2003, clause 4.2.3, "Documents required by the quality management system shall be controlled. Let's see if a form qualifies to be a "document" that "shall" be controlled.

Forms and tables are frequently used as lower-level documents. Very often, it is not necessary to write a traditional instruction with the purpose, scope and instructions if a simple table is sufficient to provide these instructions. One of the typical non-conformities that companies get during audits of their ISO 13485 quality management systems is against forms that are not part of the documentation system.

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? If a form needs to be used per a procedure or instruction, how are we suppose to reference such a form if it is not in our QMS? 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:

- draw a two-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 an instruction. So, if this is an instruction, it shall be controlled.

Now, what if we were given a 2-column table where the first column was titled "You company name" and the second column "Company's URL”. The first column is titled "You company name" and the second column "Company's Website". Obviously, we would enter our company name and our Website address in the table. It means that we interpreted the 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 used in ISO 13485 quality management systems is based on the fact that forms serve two purposes. Empty forms are brief instructions written in tabular language. When we complete a form, information within the form becomes a quality reecord. Records are managed in a different manner than procedures. Let's realize this difference and manage blank forms as any other procedure or instruction controlled by our 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 part number:

- If you created a form for ISO 13485 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 personnel on the floor 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 within your quality management system? If you answered, "yes" at least once, your form is a definite candidate for being a part of your official ISO 13485 documentation management process.

Copyright (c) 2008 Quality Works

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Mark Kaganov is a Director of Operations and a Lead Consultant with Quality Works. Company provides ISO 9001, ISO 13485, ISO 14001 and FDA 21 CFR 820 Consulting, Documentation, Training, Audits, Implementation programs and Certification assistance. For more information on ISO 13485 documentation visit www.quality-works.com/iso-13485.htm

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