A little bit of yourself in this section. There are 3 three text graphics associated to this section; Subscribe me, Advertisements and About Me. I hope either one will suit your need. 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”
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.
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?
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
- 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, 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 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 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 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.
