Is the up-dated ISO 9004:2009 needed to pass audit?

Q

Qualqueen

We're having our recertification audit on the 26th. I just realized that the Q9004 edition I have (2000) has been superceded by edition (2009). My question is do I need to have the new edition; would this be considered a finding? I have stamped the inside cover obsolete - reference only.
 

howste

Thaumaturge
Trusted Information Resource
Re: Is the up-dated Q9004-2009 needed to pass audit?

We're having our recertification audit on the 26th. I just realized that the Q9004 edition I have (2000) has been superceded by edition (2009). My question is do I need to have the new edition; would this be considered a finding? I have stamped the inside cover obsolete - reference only.

Since it's a guidance document, you don't even need to have a copy of it at all. I believe that it's a great resource to use to develop and maintain your system though, and I'm glad to hear that you have it.

As far as the version goes, if you feel that the 2000 version of ISO 9004 is still useful to you, there's no need to "obsolete" it. I'd suggest that you (when you get around to it) get a copy of the new version and use it for guidance in the future.
 

Randy

Super Moderator
Re: Is the up-dated Q9004-2009 needed to pass audit?

It isn't needed at all unless you have referenced it in your documentation. If you have, yep, you betcha it better be updated.
 

howste

Thaumaturge
Trusted Information Resource
Re: Is the up-dated Q9004-2009 needed to pass audit?

It isn't needed at all unless you have referenced it in your documentation. If you have, yep, you betcha it better be updated.

If they reference it in their documentation, it would only need to be updated if they refer to the latest version of it. If they reference the 2000 version, they wouldn't need to update it.
 
Q

Qualqueen

Re: Is the up-dated Q9004-2009 needed to pass audit?

It isn't needed at all unless you have referenced it in your documentation. If you have, yep, you betcha it better be updated.
I have it listed in my Master Document list under external documents!!???

If they reference it in their documentation, it would only need to be updated if they refer to the latest version of it. If they reference the 2000 version, they wouldn't need to update it.
This is how I have it listed on the Master doc. - ISO9004 rev. 2000
 

Randy

Super Moderator
Re: Is the up-dated Q9004-2009 needed to pass audit?

Either delete all references to it or change it because the one you reference is no longer valid

Why did you reference it to begin with?
 
Q

Qualqueen

Re: Is the up-dated Q9004-2009 needed to pass audit?

Either delete all references to it or change it because the one you reference is no longer valid

Why did you reference it to begin with?
The consultant we had three years ago asked for all external docs to be listed on the master doc list. I have all 5 listed that we use - ISO 9000, 9001, 9004, 13485 and 14969. Are you saying I can remove them all because they don't need to be listed on the master doc list?
 

Randy

Super Moderator
Where is there a requirement to even have a master document list?

Your consultant is having you do something that isn't necessary. Which isn't that uncommon by the way.
 
Q

Qualqueen

Where is there a requirement to even have a master document list?

Your consultant is having you do something that isn't necessary. Which isn't that uncommon by the way.
We're also ISO13485 and they have a requirement.
 

howste

Thaumaturge
Trusted Information Resource
Re: Is the up-dated Q9004-2009 needed to pass audit?

Either delete all references to it or change it because the one you reference is no longer valid

I disagree. Did the guidance suddenly become invalid simply because there's a new version of the document? Since it's not an externally required document, the document is only valid or invalid if the organization makes that determination.
 
Top Bottom