Reviewing Documentation in preparation for an Audit

R

rharold

#1
I am looking for a good way to go through all or most documentation in preparation for an Audit. I believe an Internal Audit would be the most effective but wasn't sure if anyone had any other methods.
 
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Randy

Super Moderator
#2
Weigh it and if it's less than 1lb per person you don't have enough.

Seriously what kind of audit?

If you have a QMS based upon 9001 then your documentation must be consistant to it's requirements and your specificatons for control and so forth.

Doesn't get any more simple than that.
 

RoxaneB

Super Moderator
Super Moderator
#3
I am looking for a good way to go through all or most documentation in preparation for an Audit. I believe an Internal Audit would be the most effective but wasn't sure if anyone had any other methods.
Why were you looking for some means of reviewing your documentation? How mature is your system? If it is mature enough, document review should be part of the document control process and no review necessary. Your document authors should be capable enough to review their documentation and make changes when necessary and ensure that it is valid (i.e., reflects the process that it is documenting).

Otherwise, find a nice quiet room and starting reading...bring lots of coffee. :)
 
R

rharold

#4
It is an older and proven system updated to meet the 9001 standard. It is the first part of an audit and will cover documentation. However, I think that answered my question. We will have to go through and try to determine if requirements are met by our "documentation".
 

RoxaneB

Super Moderator
Super Moderator
#5
It is an older and proven system updated to meet the 9001 standard. It is the first part of an audit and will cover documentation. However, I think that answered my question. We will have to go through and try to determine if requirements are met by our "documentation".
Then, yes, I do believe that what you consider an internal audit to be will meet your initial needs. However, an audit should not look at documentation alone. I hope that you would take the opportunity to also review the processes and determine if they are effective, as well.

ISO 9001, while a lovely document of requirements, does not ensure a great system if all one does is try to meet the listed "shall's". In fact, I have learned that if all an organization does is document a system to meet the requirements, that piece of paper on the wall is meaningless and everyone justifies what they do "because of ISO."

It is rather refreshing to have a system which not only meet the requirements of ISO 9001 but also meets our requirments. To have people justify what they do "because it's what we need to do in order to meet stakeholder requirements"...that's a breath of fresh air.
 

Paul Simpson

Trusted Information Resource
#6
I am looking for a good way to go through all or most documentation in preparation for an Audit. I believe an Internal Audit would be the most effective but wasn't sure if anyone had any other methods.
In doing a document review I do two things.
  • I first of all just read the document. I hope to read a document that flows through how the organization operates (in the case of this thread for quality) and to get a feel for how they are organized for quality
  • I then do the boring bit (the bit the CB requires of me) and run through the list of shalls to make sure the company has addressed them in the manual or referenced supporting documents

If you want to follow the trail to supporting documents as part of the document review then you can do so.

All of the above is known as a desktop audit of the quality system - intended to ensure the documented system is suitable for an implementation (on site) audit - which checks the system (that you have reviewed as being effective at meeting the standard requirements) is in place and working.

But I'm giving away all the trade secrets now :lol:

What about a new thread - a certification body / registrars "top tips?"
 
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