Extensive Quality Manual Changes

wooden nickle

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#1
Change in management has required an extensive rewrite to the QM. My question is; Do we have to submit this dramatically changed manual to our registrar prior to releasing it internally?
 
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Marc

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#3
IF you are referring to ISO 9001 requirements: You can make all the changes you want and issue the new quality manual, but you will have to notify your registrar. They will probably want a copy - It's their call, though.

I have been through it and typically a phone call does it unless you make significant changes in which case they will probably want a copy to review.

You say you have made "significant" changes. Call your registrar contact and have a chat. If your quality manual is the only document in your system which has changed, it probably will not be a big deal. But - If you have made changes which flow down and cause changes to lower level documents, such as procedures, the impact of the changes may be important.

Also remember - A "Quality Manual" is no longer a requirement as of ISO 9001:2015.
 
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Sidney Vianna

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#4
In addition to what Marc described, the agreement you have in place with your CB should have stipulated that any significant change in the certified management system to be communicated to them.

ISO 17021, which applies to the CB, requires that. Explicitly mentioned in the type of changes that should be communicated to the CB include organization and management changes.
 

Marc

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#5
Thanks for pointing that out, Sidney. My mind was thinking ISO 9001 and since the original poster didn't specify I was very negligent in my reply. I apologize. :bonk:

Typically aspects of requirements such as ISO 17025 are communicated to the customer during the registration process. I think in most regulated industries any changes in documentation, management, etc. must be approved by the registrar first. What the registrar will actually require of you only your registrar can tell you.
 

dsanabria

Quite Involved in Discussions
#6
Change in management has required an extensive rewrite to the QM. My question is; Do we have to submit this dramatically changed manual to our registrar prior to releasing it internally?
Never heard of a registrar requiring a QM be provided - most of the QM are copy paste of the standard or proprietary.

You can request a special audit if you feel a need for the registrar to review the QM.

Now if you made significant changes to the Quality Management system... (location, addition, change in ownership...) - yes you must contact them.
 
J

JoShmo

#7
Never heard of a registrar requiring a QM be provided - most of the QM are copy paste of the standard or proprietary.

You can request a special audit if you feel a need for the registrar to review the QM.

Now if you made significant changes to the Quality Management system... (location, addition, change in ownership...) - yes you must contact them.
Unless it's in their (arcane) agreement only registers living in the past do reviews of updates to a manual. I agree with the above.
 

howste

Thaumaturge
Super Moderator
#8
Unless it's in their (arcane) agreement only registers living in the past do reviews of updates to a manual. I agree with the above.
Pretty much every audit I've done for a CB has included review of QMS changes, either onsite or in pre-audit planning. Every change has some element of risk, and it would be ridiculous to ignore these risks in auditing.

However, there is no requirement that the CB approve quality manual changes before implementation - I hope this is what you meant. In some cases regulatory requirements (i.e. FAA) may require an outside organization to approve changes prior to implementation.
 
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