One of the controversial issues with interpretation of ISO 9001 Standard is control of forms. Many companies, by some reason, treat forms differently than documents, leaving them not controlled. Per ISO 9001 standard, element 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.
Forms and tables are frequently used as quality management system documents. Very often, it is not necessary to write a traditional instruction with the purpose, scope and instruction sections, if a simple table is sufficient to provide these instructions. One of the typical non-conformities that companies get during audits of their quality management systems is against forms that are not part of the documentation system.
Frequently, being asked about not controlled forms, my clients reply: This is "just a form". I always wonder why a form should be treated differently than any other instruction or a document. If a form is not controlled, how would we know that we need it to begin with? If a form is not part of your ISO 9001 QMS, it cannot be referenced! If your forms are not controlled, how would anyone know that you use the latest revision? Well, exactly what is a form? A quick test will help answer this question. If we have a list of directions telling us to:
- use a two-column table
- enter your business name into the 1st column
- enter your company's URL into the second column
Most likely, we all would call this three-line guidance an instruction. So, since this is an instruction, it shall be controlled.
Here as another look at the same form. What if we were given a two-column table where the first column was called "You company name" and the second "Business URL" and 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".
These two examples, demonstrate that our first three-line instruction in English (that needs to be controlled), serves the same function, resulting in the same output, as the second form. Therefore, the form as an instruction and "shall": be controlled as well.
It appears that the puzzlement about forms and their control comes from the fact that forms serve 2 purposes. Blank forms are instructions in tabular language. After a form is filled out, it becomes a record. Records, as a rule, do not have a part or document number or a revision level. Records are controlled by different processes. Remember this and treat your forms as instructions controlled by your documentation procedure. There are a couple of tests you may take when you are thinking about not controlling your form.
- If you created a helpful form and found it had been changed, would you like to know who did it and why?
- If you changed your form, would you like your employees use the most resent revision?
- If you were on vacation, would you like folks to be able to find your form just by using a reference to it?
Just one "Yes" answer to these questions shows that your form perhaps is a good candidate for a document control.
Forms and tables are frequently used as quality management system documents. Very often, it is not necessary to write a traditional instruction with the purpose, scope and instruction sections, if a simple table is sufficient to provide these instructions. One of the typical non-conformities that companies get during audits of their quality management systems is against forms that are not part of the documentation system.
Frequently, being asked about not controlled forms, my clients reply: This is "just a form". I always wonder why a form should be treated differently than any other instruction or a document. If a form is not controlled, how would we know that we need it to begin with? If a form is not part of your ISO 9001 QMS, it cannot be referenced! If your forms are not controlled, how would anyone know that you use the latest revision? Well, exactly what is a form? A quick test will help answer this question. If we have a list of directions telling us to:
- use a two-column table
- enter your business name into the 1st column
- enter your company's URL into the second column
Most likely, we all would call this three-line guidance an instruction. So, since this is an instruction, it shall be controlled.
Here as another look at the same form. What if we were given a two-column table where the first column was called "You company name" and the second "Business URL" and 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".
These two examples, demonstrate that our first three-line instruction in English (that needs to be controlled), serves the same function, resulting in the same output, as the second form. Therefore, the form as an instruction and "shall": be controlled as well.
It appears that the puzzlement about forms and their control comes from the fact that forms serve 2 purposes. Blank forms are instructions in tabular language. After a form is filled out, it becomes a record. Records, as a rule, do not have a part or document number or a revision level. Records are controlled by different processes. Remember this and treat your forms as instructions controlled by your documentation procedure. There are a couple of tests you may take when you are thinking about not controlling your form.
- If you created a helpful form and found it had been changed, would you like to know who did it and why?
- If you changed your form, would you like your employees use the most resent revision?
- If you were on vacation, would you like folks to be able to find your form just by using a reference to it?
Just one "Yes" answer to these questions shows that your form perhaps is a good candidate for a document control.
About the Author:
Working as a professional auditor and consultant, I am frequently asked: 'What is quality improvement? It is simple, really. Learn more about our quality system approaches and our optimization philosophy.
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