ISO 13485:2003 – Managing Forms

Auditing numerous companies of different sizes in medical device manufacturing industries, I found that control of forms is one of the notorious issues with maintenance of ISO 13485:2003 QMS. Various companies, by odd reasons, treat forms in a different way than other instructions, leaving them not controlled. ISO 13485:2003, element 4.2.3, requires: “Documents required by the quality management system shall be controlled.” Now let’s find out if forms are the same as “documents”

Very often, companies use forms as lower-level documents. Frequently, it is not necessary to write a typical, instruction with all distinctive components, such as the purpose, scope, references, etc., if a simple table will do the job. Very often companies receive non-conformities during certification audits because their forms are not controlled.

Often, being asked about not controlled forms, my clients reply: “This is “just a form” a form.” I always wonder why a form should be treated differently than any other instruction or a procedure. If a form is not controlled, how would we know that we need it? If it is not controlled, it cannot be referenced within one’s QMS.If your forma are not controlled, how would you know that you use the latest revision of it?

Anyway, what is a form? A short review will help answering this question. If we have a list of directions telling us to:

– make a table with two columns

– enter your company name into the first column

– enter your company’s URL into the second column

Hardly anybody will argue that this three-line direction is an instruction to make and complete this form. So if this is an instruction, it “shall” be controlled, right?

Now, what if we were given a two-column table where the first column was titled “You company name” and the second column “Company’s URL”. 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 first three-line instruction in written in English was a “real” instruction that needs to be controlled, the other, empty form, resulting in the same output, must also be an instruction! Shouldn’t this type of an instruction be controlled also?

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

– If in the past you developed a form and found it had been changed, would you want to know why it was done?

– If you updated your form, would you like users to know about your change?

– If you are not in the office, would you like other employees to know where your form is?

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.

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