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Quality Records Register Requirements - ISO 9001:2008
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Quality Records Register Requirements - ISO 9001:2008
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  Post Number #1  
Old 25th March 2012, 09:56 AM
jennyjones

 
 
Total Posts: 14
Please Help! Quality Records Register Requirements - ISO 9001:2008

Hello

Can any one help? I have been criticised in our yearly cert audit ISO 9001:2008 for not keeping a quality records register. Does anyone know exactly what records should be on this and in what form.

Thank you

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  Post Number #2  
Old 25th March 2012, 10:18 AM
Pancho's Avatar
Pancho

 
 
Total Posts: 831
Re: Quality Records Register 9001:2008

Hi Jenny,

There is no specific requirement for such document.

Did the auditor raise a nonconformity? If so, what clause in the standard was it against?

Else, did the auditor say why she thinks you need such register?
  Post Number #3  
Old 25th March 2012, 10:31 AM
jennyjones

 
 
Total Posts: 14
Re: Quality Records Register 9001:2008

Thanks for the reply it was raised it as a minor non conformity. 4.2.4 . How I understood the doc was that all I needed was a procedure. When I questioned it they said that records were a specific type of doc not just anything that was recorded into and that I should refer to the standard for guidance. I still not too sure and there's only one of me in a small company.
  Post Number #4  
Old 25th March 2012, 10:48 AM
Richard Regalado's Avatar
Richard Regalado

 
 
Total Posts: 277
Re: Quality Records Register 9001:2008

Quote:
In Reply to Parent Post by jennyjones View Post

Thanks for the reply it was raised it as a minor non conformity. 4.2.4 . How I understood the doc was that all I needed was a procedure. When I questioned it they said that records were a specific type of doc not just anything that was recorded into and that I should refer to the standard for guidance. I still not too sure and there's only one of me in a small company.
Hi jennyjones. Can you please state the minor nonconformity in verbatim?

Regards,
Richard
  Post Number #5  
Old 25th March 2012, 10:58 AM
jennyjones

 
 
Total Posts: 14
Re: Quality Records Register 9001:2008

Its bugging me big time Pancho. The only thing I can think of is that somewhere in our Quality Manual we agreed to keep certain records on a register - so I am going to go and have a look at it from this perspective.

You know how these things can ruin a Sunday afternoon!
  Post Number #6  
Old 25th March 2012, 10:59 AM
jennyjones

 
 
Total Posts: 14
Re: Quality Records Register 9001:2008

Richard,

I can't at the minute because I am not at work. If you are still interested I will get it tomorrow and post it verbatim. I appreciate your interest.

Last edited by jennyjones; 25th March 2012 at 11:07 AM.
  Post Number #7  
Old 25th March 2012, 11:17 AM
qusys

 
 
Total Posts: 2,263
Re: Quality Records Register 9001:2008

Quote:
In Reply to Parent Post by jennyjones View Post

Its bugging me big time Pancho. The only thing I can think of is that somewhere in our Quality Manual we agreed to keep certain records on a register - so I am going to go and have a look at it from this perspective.

You know how these things can ruin a Sunday afternoon!
If you have declared in your documented records control procedure that you have a register where you physically take notice of your QMS records and the auditor did not find it, it is cleary a non conformity.
It seems strange to me that , if it is really what happened, you did not follow this. This issue can open a side to an issue that the QMS is only on the paper and not really in place.
This is more serious than a minor ncn.
  Post Number #8  
Old 25th March 2012, 11:32 AM
Richard Regalado's Avatar
Richard Regalado

 
 
Total Posts: 277
Re: Quality Records Register 9001:2008

Quote:
In Reply to Parent Post by jennyjones View Post

Richard,

I can't at the minute because I am not at work. If you are still interested I will get it tomorrow and post it verbatim. I appreciate your interest.
Thanks jennyjones. I will come back here tomorrow.
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