Iso 13485 2003 - Managing Forms
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.
Organizations use forms and tables within their quality management systems Often, it is not necessary to prepare a traditional instruction or a procedure with all the sections, such as scope, purpose and process description if a effortless table can provide this information. Frequently companies get non-conformities during audits of their QMS because forms used 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 13485 management system? If forms are not managed by your documentation system, and you decide to modify them, how can you be confident that you make changes to the latest revision?
How can we define 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
- write down your business name into the 1-st column
- write down your company's Website address 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, let's imagine that we were given a two-column form, only being asked to complete it. 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!
It seems to me that misunderstanding concerning forms is because forms serve two purposes. Blank forms are short directions written in tabular language. When a form is completed, it becomes a record. Not like instructions, records are controlled by different means. Let's realize this difference and treat not completed forms as any other procedure or instruction controlled by our documentation management procedure. If you want to have a not controlled form, you may consider answering three questions:
- Let's say that somebody changed your favorite form. Would you want to know why?
- If you changed your form, would you like personnel on the floor use the most resent revision?
- If you were absent, would you like folks to find your form just by finding a reference to it in your ISO 13485:2003 quality management system?
If there was a "yes" at least once, your form should be controlled as required by the standard.
by: Mark Kaganov
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