Do you control your forms within your ISO 13485 quality management system? One of the divisive issues with interpretation of ISO 13485:2003 and other standards is control of forms. Various organizations treat forms differently than other QMS documents and do not control them. Per ISO 13485:2003, 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.
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.
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:
- make a table with two columns
- note your organization's name in the first column
- write down your company's Website address into the second column
Most likely, we all would call this three-line direction an instruction. If we agree that this is an instruction, it should be controlled as any other QMS.
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! Should not 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 revised your form, would you like your assemblers to use the latest 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?
Just one "Yes" to the above questions indicates that your form is definitely a candidate for Documentation Control practices. - 16890
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.
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:
- make a table with two columns
- note your organization's name in the first column
- write down your company's Website address into the second column
Most likely, we all would call this three-line direction an instruction. If we agree that this is an instruction, it should be controlled as any other QMS.
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! Should not 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 revised your form, would you like your assemblers to use the latest 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?
Just one "Yes" to the above questions indicates that your form is definitely a candidate for Documentation Control practices. - 16890
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3 comments:
Hi
I like this post very much. It help me to solve some my work under my director’s requirements.
Apart from that, below article also is the same meaning
ISO 13485 standard
Tks again and nice keep posting
Rgs
This is really an nice blog......Thanks for sharing with us.ISO 13485 Consultants in Bangalore
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