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Who approves the Quality Manual and Quality Policy?

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Related Topic Tags
approvals, quality manuals (general), responsibilities
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  #1  
Old 7th March 2012, 09:51 PM
QMSvigilanti's Avatar
QMSvigilanti

 
 
Posts: 1
Please Help! Who approves the Quality Manual and Quality Policy?

Hello all,

ISO 13485 indicates (paraphrasing) that top management is responsible for ensuring that the quality management system is in place, and establishing the quality policy and quality objectives, etc. I was told today that the quality manual is a 'policy' and therefore, top management needed to approve this document, which is in our company under change control. However, after reading section 5.0, I believe they need to sign the 'Quality Policy', which may be included in the Quality Manual, but is a separate document, different from the Manual. In our case, we've had managers and directors of different disciplines approve the Quality Manual on an ECO, but have not included top management. My question is, is it a requirement that both the Quality Manual and Quality Policy be approved by top management? Thanks for your help clarifying this.

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  #2  
Old 7th March 2012, 10:57 PM
Jennifer Kirley's Avatar
Jennifer Kirley

 
 
Posts: 5,542
Re: Who approves the Quality Manual?

Welcome to the Cove!

Since the top executive is widely considered to set policy and culture in a given organization, standards very often require evidence of that person's acknowledgment of responsibility to the management system via signing the Quality Policy.

But the policy and the Quality Manual are different documents. The Quality Manual does very often include the Quality Policy, but it does a good deal more than that. Its contents will likely address organization-wide subjects and as such it's worth considering the department heads be included in the approval list, at least for initial drafts and major changes.

I hope this helps!
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  #3  
Old 8th March 2012, 05:09 AM
qusys

 
 
Posts: 2,210
Re: Who approves the Quality Manual and Quality Policy?

Quote:
In Reply to Parent Post by QMSvigilanti View Post

Hello all,

ISO 13485 indicates (paraphrasing) that top management is responsible for ensuring that the quality management system is in place, and establishing the quality policy and quality objectives, etc. I was told today that the quality manual is a 'policy' and therefore, top management needed to approve this document, which is in our company under change control. However, after reading section 5.0, I believe they need to sign the 'Quality Policy', which may be included in the Quality Manual, but is a separate document, different from the Manual. In our case, we've had managers and directors of different disciplines approve the Quality Manual on an ECO, but have not included top management. My question is, is it a requirement that both the Quality Manual and Quality Policy be approved by top management? Thanks for your help clarifying this.
In any ISO standards you 'll find that it is not needed a signature or what else on policy or Quality Manual. It depends on the documentcontrol procedure you set as well as roles, responbilities and aithorities.

Last edited by qusys; 8th March 2012 at 08:30 AM. Reason: added"not" missed for hurry up in writing.Thanks for feedback to Jim
  #4  
Old 8th March 2012, 08:27 AM
Jim Wynne's Avatar
Jim Wynne

 
 
Posts: 14,077
Re: Who approves the Quality Manual and Quality Policy?

Quote:
In Reply to Parent Post by qusys View Post

In any ISO standards you 'll find that it is needed a signature or what else on policy or Quality Manual. It depends on the documentcontrol procedure you set as well as roles, responbilities and aithorities.
I think you meant "...not needed..."?
Thanks to Jim Wynne for your informative Post and/or Attachment!
  #5  
Old 8th March 2012, 08:32 AM
qusys

 
 
Posts: 2,210
Re: Who approves the Quality Manual and Quality Policy?

Quote:
In Reply to Parent Post by Jim Wynne View Post

I think you meant "...not needed..."?
Absolutely yes, you are right Jim!
Apologize.
I was hurry up in writing.
It is NOT needed.
I have also updated the previous prost.
Thanks
  #6  
Old 8th March 2012, 08:46 AM
RCBeyette's Avatar
RCBeyette

 
 
Posts: 2,825
Re: Who approves the Quality Manual and Quality Policy?

In my experience, having top management sign off on the manual is one way of showing their committment to the management system.
Thanks to RCBeyette for your informative Post and/or Attachment!
  #7  
Old 8th March 2012, 08:51 AM
qusys

 
 
Posts: 2,210
Re: Who approves the Quality Manual and Quality Policy?

Quote:
In Reply to Parent Post by RCBeyette View Post

In my experience, having top management sign off on the manual is one way of showing their committment to the management system.
In the substance you are right RCBeyette, we also do it in electronic way with a sign off of the top mgmt members as well as mgt representative, but this has been establishe din the documented procedure for document control.
For example, another way could be making the signing by pen .
However the signature is no an explicit requirment of the standard, but it is up to the organziation show how the commitment is done.
  #8  
Old 8th March 2012, 09:20 AM
RCBeyette's Avatar
RCBeyette

 
 
Posts: 2,825
Re: Who approves the Quality Manual and Quality Policy?

Quote:
In Reply to Parent Post by qusys View Post

In the substance you are right RCBeyette, we also do it in electronic way with a sign off of the top mgmt members as well as mgt representative, but this has been establishe din the documented procedure for document control.
For example, another way could be making the signing by pen .
However the signature is no an explicit requirment of the standard, but it is up to the organziation show how the commitment is done.
In my case, top management signed off electronically and their names appeared at the front of the manual when a hard copy was printed off for the external auditors.

I avoided hardcopy (aka pen) signoffs as much as possible. Too much running around for my liking.
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