Who approves the Quality Manual and Quality Policy?

Q

QMSvigilanti

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.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Re: Who approves the Quality Manual?

Welcome to the Cove! :bigwave:

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!
 

qusys

Trusted Information Resource
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:

Jim Wynne

Leader
Admin
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..."?
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
In my experience, having top management sign off on the manual is one way of showing their committment to the management system.
 

qusys

Trusted Information Resource
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.:bigwave:
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
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.:bigwave:

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.
 
K

kgott

Hello all,

My question is, is it a requirement that Quality Policy be approved by top management? Thanks for your help clarifying this.


In my view, 'authorised', 'approved' or 'endorsed' yes but signed no.

There is nothing wrong with stating in the policy something like 'this policy is authorised' or 'endorsed by executive management.' This removes the need to keep re-signing it each time personnel change.

Correct me if Im wrong but I dont think there is any need to sign it or even date it at all.

I have said in our manual that the policy is reviewed only when:

  • There is a change in legislation that may affect the contents of the policy
  • A change in company strategy may indicate a need to review the policy
  • Investigation of events indicates that the root cause may be linked to a possible shortcoming in the policy
  • Any other reason management deems a review of the policy necessary
  • That any review of the policy may result in no change to the policy
 
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