Does ISO require that documents/procedures have a page/list of revision histories?

[Jim-S]

Hi Everyone,

I'm new here and new to the field. I have a real basic, but one that I can't seem to get past. Does ISO require that documents/procedures have a section that lists the revision history? Is so, which ISO reg. requires this?

I just started working in a company that isn't currently ISO certified & doesn't include revision history sections. I want to make sure that our format is compliant before I start working on that procedures.

Thanks!
Jim

[Randy]

1st....Welcome to the Cove

2nd...One of the easiest ways to find out what is required is to read the requirements of the Standard itself. Now you are going to get a lot of answers which are going to boil down to "Lot's of cooks helping to stir the pot" Just read what the Standard says below and see if there is anything that says that revision histories are required.

ISO 9001:2000; 4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

Now when you ask questions you need to be a bit more specific because the ISO doesn't require anything to be honest. I assumed (kinda dangerous) that you may be doing a QMS so I used ISO 9001:2000. There are nearly 20,000 ISO Standards out there, so I had to take a guess.

If you read the above as I asked you would see that nowhere is the phrase "revision histories" used. The closest you come is in (c) when assuring current revision status can be identified. You make the decision about histories of obsolete (no longer relevant) documents.

You'll get lots of good stuff and advice here (maybe not from me). Try to make good use of the "SEARCH" tool and also just scroll through the pages.

Now prepare to have "Stone Soup" made for you.

[Stijloor]

In Reply to Parent Post by Randy

1st....Welcome to the Cove

2nd...One of the easiest ways to find out what is required is to read the requirements of the Standard itself. Now you are going to get a lot of answers which are going to boil down to "Lot's of cooks helping to stir the pot" Just read what the Standard says below and see if there is anything that says that revision histories are required.

ISO 9001:2000; 4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed

a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

Now when you ask questions you need to be a bit more specific because the ISO doesn't require anything to be honest. I assumed (kinda dangerous) that you may be doing a QMS so I used ISO 9001:2000. There are nearly 20,000 ISO Standards out there, so I had to take a guess.

If you read the above as I asked you would see that nowhere is the phrase "revision histories" used. The closest you come is in (c) when assuring current revision status can be identified. You make the decision about histories of obsolete (no longer relevant) documents.

You'll get lots of good stuff and advice here (maybe not from me). Try to make good use of the "SEARCH" tool and also just scroll through the pages.

Now prepare to have "Stone Soup" made for you.

Randy,

Clause 4.2.3 c) comes very close to "revision history."
Many organizations maintain a revision history to keep track of the "changes."
It's not unusual to have to revert back to a previous version of a document.
With today's computer/software capabilities, it's no big deal.

Stijloor.

[Randy]

In Reply to Parent Post by Stijloor

Randy,

Clause 4.2.3 c) comes very close to "revision history."
Many organizations maintain a revision history to keep track of the "changes."
It's not unusual to have to revert back to a previous version of a document.
With today's computer/software capabilities, it's no big deal.

Stijloor.

I believe I said that...................

The closest you come is in (c) when assuring current revision status

[Stijloor]

In Reply to Parent Post by Randy

I believe I said that...................

I apologize Randy, you're absolutely correct.

Stijloor.

[AndyN]

In Reply to Parent Post by Jim-S

Hi Everyone,

I'm new here and new to the field. I have a real basic, but one that I can't seem to get past. Does ISO require that documents/procedures have a section that lists the revision history? Is so, which ISO reg. requires this?

I just started working in a company that isn't currently ISO certified & doesn't include revision history sections. I want to make sure that our format is compliant before I start working on that procedures.

Thanks!
Jim

No - indeed it's better (IMHO) not to burden any document with the history of changes. It's better accomplished with a change form/notice. Otherwise you end up with a document which is larger than it needs to be by keeping all the history within it. My advice - don't! There are far better ways to keep people informed of changes.

[Jim-S]

Thanks for the feedback! This is good news to me. I really didn't want to include a revision history section. They can be helpful, but I always think that it's best to go back to the change controls. - My company just purchased the right to manufacture a medical device. The original manufacturer is ISO certified and did list the revision histories in their procedures, so I was unsure how to proceed.

[Stijloor]

In Reply to Parent Post by Jim-S

Thanks for the feedback! This is good news to me. I really didn't want to include a revision history section. They can be helpful, but I always think that it's best to go back to the change controls. - My company just purchased the right to manufacture a medical device. The original manufacturer is ISO certified and did list the revision histories in their procedures, so I was unsure how to proceed.

Jim-S,

Regardless of all the revision history advice given here; if you are involved with medical devices, please be aware that there are regulatory requirements that go above and beyond ISO 9001:2000. And those apply for example to documents, records and devices among many other things..

Hope this helps.

Stijloor.