Addition in the Scope of Quality Manual

[Shibs]

Hi,

Our company is adding into its various line of activities another product. The same would be produced in one of our factories.

A procedure for the same would be introduced into our Quality Manual as "Process Control - XXXX" as per Clause 7.5 Production and Service Provision.

My question is: Can I change the scope mentioned in Quality Manual by adding "Supply of XXXX" to the existing scope and wait till the next External Audit to have it added into the ISO Certificate?
Or is it so that I can't add this new procedure into the Quality Manual until the process has been audited by the External Auditors?

The facility hasn't yet started production and would only start in the next couple of months. Can the audit be performed only after production starts?

For your feedback, please.

Thanks!

 

[somashekar]

Hi,

Our company is adding into its various line of activities another product. The same would be produced in one of our factories.

A procedure for the same would be introduced into our Quality Manual as "Process Control - XXXX" as per Clause 7.5 Production and Service Provision.

My question is: Can I change the scope mentioned in Quality Manual by adding "Supply of XXXX" to the existing scope and wait till the next External Audit to have it added into the ISO Certificate?
Or is it so that I can't add this new procedure into the Quality Manual until the process has been audited by the External Auditors?

The facility hasn't yet started production and would only start in the next couple of months. Can the audit be performed only after production starts?

For your feedback, please.

Thanks!

ISO 9001 is a quality system certification.
It is good that you are adding another product. Have the processes for this product also mapped into your quality system.
Your quality manual scope must not be product specific. That sets you freedom to operate without coming to your quality manual time and again.
So for example., if your scope is to design and build special purpose machines, you can build as many new types of machines as you are capable of.
So you just begin to address such of those new product requirement documents as necessary without making changes into your quality manual.
You keep doing what your business plan is directing. Your auditor will ask you for information of changes prior to the annual assessment, and there you take a call if you have established and turned out any new products.
This activity will not change the scope of your certification as well.

 

[AndyN]

Hi,

Our company is adding into its various line of activities another product. The same would be produced in one of our factories.

A procedure for the same would be introduced into our Quality Manual as "Process Control - XXXX" as per Clause 7.5 Production and Service Provision.

My question is: Can I change the scope mentioned in Quality Manual by adding "Supply of XXXX" to the existing scope and wait till the next External Audit to have it added into the ISO Certificate?
Or is it so that I can't add this new procedure into the Quality Manual until the process has been audited by the External Auditors?

The facility hasn't yet started production and would only start in the next couple of months. Can the audit be performed only after production starts?

For your feedback, please.

Thanks!

Be careful about using the word "supply". It doesn't actually describe what you do. If you make stuff you generally "supply" it. If you buy stuff from a supplier and put it in a box, you are also in a "supply" situation, but you don't manufacture. Why are you adding "supply"?

But whatever, make the changes as you wish. When you are preparing for your next CB audit, call your point of contact and tell them you've added to the scope - they will want to know if you have added people or facilities, as a result. An increase in heads will add time. Also, the auditor won't want to have a surprise when they visit.

To have the new activity added to the scope of your certificate, you will have to have evidence that the process(es) are working and meeting the objectives set for it...

 

[Shibs]

Thank you Somashekar and Andy for the feedback!

So, I'd rephrase the sentence as "Production of XXXX..." in the scope.

Also, before the facility actually starts production, can I have the scope changed in our Quality Manual? And wait till the next audit happens to have it incorporated into the Certificate?

Will the Certificate's scope be changed after the next Surveillance Audit or would we have to wait till the next Re-certification Audit?

Please advise.

 

[AndyN]

Thank you Somashekar and Andy for the feedback!

So, I'd rephrase the sentence as "Production of XXXX..." in the scope.

Also, before the facility actually starts production, can I have the scope changed in our Quality Manual? And wait till the next audit happens to have it incorporated into the Certificate?

Will the Certificate's scope be changed after the next Surveillance Audit or would we have to wait till the next Re-certification Audit?

Please advise.

On the manual change, it's part of the overall changes you'll be making to your QMS - how you plan, implement, audit etc is far more important, don't forget! You can change your manual whenever you wish. The certification scope will be verified at the next visit - whatever that is - and a revised certificate issued after that audit. Don't forget, check with your CB.

 

[Big Jim]

This is a discussion you should be having with your certification body, and sooner is better than later. They can help you through it. Whatever you do, don't wait until you have an auditor on site and surprise him with this.

They cannot audit your new production until it is in place.

You do not need to wait for a re-certification audit, it can be done with a surveillance audit, however, it will be more than a regular surveillance audit. It would be called a "re-evaluation" and would be triggered by your expansion of scope. Expect there to be a cost increase to accommodate the additional auditing. In some cases the re-evaluation is the same thing as a re-certification somewhat depending on just how much gets changed.

Until they audit to the expanded scope, your scope of registration would continue as is (without the expansion).

After the re-evaluation audit you will get a new certification that includes the scope expansion.

This is not that unusual. Companies grow, shrink, and adjust all the time.

 

[Sidney Vianna]

Also, before the facility actually starts production, can I have the scope changed in our Quality Manual? And wait till the next audit happens to have it incorporated into the Certificate?

Will the Certificate's scope be changed after the next Surveillance Audit or would we have to wait till the next Re-certification Audit?

Please advise.

It is very important to keep in mind that the scope of the QMS and the scope of certification can be very different. You are in no obligation to include all of your products in your scope of certification.

Certainly, you can revise your quality manual at any time you desire. IF you want the new product line to be included in the ISO 9001 certification, you communicate with your registrar as early as possible. They can amend the certificate after a surveillance or recertification audit, as well as after a special (using ISO 17021 terminology) audit to allow for this scope expansion.