Quality Records Register Requirements - ISO 9001:2008

J

jennyjones

#1
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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Pancho

wikineer
Super Moderator
#2
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?
 
J

jennyjones

#3
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.
 

Richard Regalado

Trusted Information Resource
#4
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.
Hi jennyjones. Can you please state the minor nonconformity in verbatim?

Regards,
Richard
 
J

jennyjones

#5
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!:)
 
J

jennyjones

#6
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 a moderator:

qusys

Trusted Information Resource
#7
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!:)
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.
 
J

jennyjones

#9
Re: Quality Records Register 9001:2008

I take your point. Our QMS is something I take seriously. I don't want to change the discussion topic but I know what your driving at.

If it is as you say then perhaps I should consider myself lucky that I only got a minor NC. Sometimes I am not completely perfect:bonk:
 

qusys

Trusted Information Resource
#10
Re: Quality Records Register 9001:2008

I take your point. Our QMS is something I take seriously. I don't want to change the discussion topic but I know what your driving at.

If it is as you say then perhaps I should consider myself lucky that I only got a minor NC. Sometimes I am not completely perfect:bonk:
Hi jennyjones,
my reflection did not want to be a critique for you, if you perceived this , my apologizes.It was only tobe an help and support to consider the eventual non conformity under a real light and not as bureaucracy.
My reflection to help was directed on the organization and not on you, because I think that the QMS drives all the organization if it is effective and efficient and if it belongs to all the organization and not only to the guys of quality like you. Only under this consideration , it will carry to fruitfull results.:cool:
let us know more about the issue.
Good evening:bigwave:
 
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