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.
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?
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
- write down your company's Website address 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, 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 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 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:
- 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 updated your form, would you like users to know about your change?
- 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?
Just one "Yes" to the above questions indicates that your form is definitely a candidate for Documentation Control practices. - 15246
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?
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
- write down your company's Website address 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, 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 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 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:
- 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 updated your form, would you like users to know about your change?
- 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?
Just one "Yes" to the above questions indicates that your form is definitely a candidate for Documentation Control practices. - 15246
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