ISO 9001 Requirements for Control of Forms

Haddad9921

Starting to get Involved
Hi,
We are in the process of implementing ISO 9001. To start with, we have many forms that we are currently use and they are all over our production floor.
We were told that we need to control our forms. My question is;
Do we need to have form number and revision date printed on the footer of each form we are controlling? I know it is a good practice, but is it a requirement of the ISO 9001 standard under 4.2.3?
Any help will be appreciated.
Thank you
 

NikkiQSM

Quite Involved in Discussions
Re: ISO 9001 Control of forms

It is common practice to control documents with a number and rev level - but ISO does not require it to be controlled like that. It is up to you how you will control the documents.

The commonly used number and rev is the easiest way I have found.
 

Haddad9921

Starting to get Involved
Re: ISO 9001 Control of forms

Does that mean that I can choose not to have any numbers at all at the footer and still control the forms?
I am just trying to find out if I have to reprint all the forms that they are out there with nothing on the footer and replace them.
Thank you
 

NikkiQSM

Quite Involved in Discussions
Re: ISO 9001 Control of forms

It doesnt have to be a number, but you have to have some sort of identification. The standard DOES specify that... You must identify the document. This includes identifying the version of the document (rev level).
 

leftoverture

Involved In Discussions
Re: ISO 9001 Control of forms

Does that mean that I can choose not to have any numbers at all at the footer and still control the forms?
I am just trying to find out if I have to reprint all the forms that they are out there with nothing on the footer and replace them.
Thank you

I would tend to think you do, in fact, have to reprint. If the revision is not printed on the form how will you know you're using the latest version short of reading through the whole form?
 
F

Frankie11

Re: ISO 9001 Control of forms

I am just trying to find out if I have to reprint all the forms that they are out there with nothing on the footer and replace them.
Thank you

Just change the master copy and as they run out of forms replace them with your new controlled version.

Be aware that some people like to photocopy new forms rather than go to the source so let everyone know what you're doing and why. And make it easy for them to access the new versions.
 

AndyN

Moved On
Re: ISO 9001 Control of forms

I would tend to think you do, in fact, have to reprint. If the revision is not printed on the form how will you know you're using the latest version short of reading through the whole form?

By only making the latest version available! Just like the bank notes in your pocket, you don't have to know what the latest version is, just that you have to get rid of the old ones when a new design comes out! Seriously!
 

leftoverture

Involved In Discussions
Re: ISO 9001 Control of forms

By only making the latest version available!

If only it was that easy. But it has been my experience that people have forms stored in strange places and those old versions will pop out of the woodwork at the most inopportune times. As an auditor, I would definitely question the lack of revision info on the form.
 

AndyN

Moved On
Re: ISO 9001 Control of forms

If only it was that easy. But it has been my experience that people have forms stored in strange places and those old versions will pop out of the woodwork at the most inopportune times. As an auditor, I would definitely question the lack of revision info on the form.

What's difficult? And why, as an auditor would you question not seeing a rev on a form? It's not a requirement! You have to dig deeper than the superficial appearance of a rev number on a form to determine if document control is effective.
 

leftoverture

Involved In Discussions
Re: ISO 9001 Control of forms

What's difficult? And why, as an auditor would you question not seeing a rev on a form? It's not a requirement! You have to dig deeper than the superficial appearance of a rev number on a form to determine if document control is effective.

Indeed. But forms become quality records and often forms have instructions on them. So depending on what I see in any particular instance, I may need to understand if it is the correct form to understand if the applicable process is being followed. It could also be that the form is used to document process settings, and an incorrect revision form may not be consistent with the current process.

Remember that document control is about having the correct information available at the point of use. An outdated or incorrect form could mean that requirement is not being met. I would reference these excerpts of the standards:

4.2.3: Documents required by the quality management system shall be controlled.
c: to ensure that changes and current revision status of documents are identified
d: the ensure that relevant versions of applicable documents are available at the point of use

4.2.4: Records shall remain legible, readily identifiable, and retrievable.

That is how I see it. Always subject to interpretation, but in this case I would say it depends on the particular form and what it is used for.
 
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