Is "Master Documents and Records list" required per ISO 9001 ?

Haddad9921

Starting to get Involved
#1
Hi
I have question about controlling The Master Documents and Records list. If we to change the rev on a form we will update the history of revisions approval sheet. After that i will update the master document and records list to reflect the new Rev for the form we updated. My question, do i have to have a History of revision and approval sheet for the master document and records list as well?
Thank you
 
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Mikishots

Trusted Information Resource
#3
Re: ISO 9001-2008 Master document and records list

Hi
I have question about controlling The Master Documents and Records list. If we to change the rev on a form we will update the history of revisions approval sheet. After that i will update the master document and records list to reflect the new Rev for the form we updated. My question, do i have to have a History of revision and approval sheet for the master document and records list as well?
Thank you
This is a lot of work for something that simply isn't required. From my point of view, you are leaving yourself open to multiple opportunities for misidentification of documentation simply based on the fact that so much redundant and unnecessary work is required.

If I was to audit your Control of Documents and Records processes, my recommendation would be simple; consider getting rid of all these master document lists. You can identify the revision history of your work instructions and procedures using a basic revision block. Revision levels of forms can be identified with a letter in the footer. Use a "Documents Incorporated By Reference" list if you want (depending on what method you chose to satisfy Clause 4.1a).

When you say "The Master Documents and Records List", it sounds as if you feel this is required. The Standard is clear - identify your changes and revisions, make sure they're available to staff, make obsolete documents unavailable. I'm curious as to what method you use to distribute procedures, work instructions and forms to staff; do you use online docs? Is everything hardcopy? Many companies that I have audited use a Portal, or Intranet-based system, and in this way, control is easy - if it's on the Portal, it's current.
 
Last edited:
P

PaulJSmith

#4
Re: ISO 9001-2008 Master document and records list

Nowhere in this standard does it require you to have a "Master Document and Records List," much less control its revisions. So, unless you have a documented procedure which calls for that, you need not worry about it.
 
J

JaneB

#5
No, you don't. You may perhaps think it's needed because someone told you it was (not true) or you have seen it done this way (true, but onerous and can be done better these days).
Good advice already given by others.
Focus on what the Standard actually says, and work out how you can do this in the simplest most practical and least time-consuming way.
 
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