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ISO9001:2008 Change of Scope of Registration

A

AliPat

#1
Currently our scope is "The provision of a total design, artwork, reprographics and flexographic plate making service".

The company's Group IT are currently designing and developing some software that will be used with our customers and may be sold to other companies.

They are currently writing SOPs in accordance with our QMS. They want their work to be included within our ISO9001 certification. I assume this would mean a change to the scope?

Can any of you helpful people confirm this and let me know what documentation we would need to change eg. would we need to include within the Quality Manual, put on the audit schedule etc

Thank you :confused:
 
#2
You are correct. This is referred to as an expansion of scope. It is easy to accomplish. You should be working closely with you certification body so talk to them about it soon.

Basically, you need to change your scope statement, and the expansion needs to be audited, then an amended certificate is issued. Expect additional time for the audit, at least for the first one.

Call your certification body right away.
 
A

AliPat

#3
Is it possible to do it another way . . . have certification for our current scope and then an additional certification for the new scope. They are two totally different areas, not really interlinked

We would then have one 9001 certification for our design, aw etc scope and another one for software design?
 
#4
Is it possible to do it another way . . . have certification for our current scope and then an additional certification for the new scope. They are two totally different areas, not really interlinked

We would then have one 9001 certification for our design, aw etc scope and another one for software design?
I do not think so. It is all related to the Quality System of your organization and it is not dependent upon areas but on the "processes".
I think thay you should take into consideration to update your quality documentation including procedures, quality manual etcc.
 
T

t.PoN

#5
Is it possible to do it another way . . . have certification for our current scope and then an additional certification for the new scope. They are two totally different areas, not really interlinked

We would then have one 9001 certification for our design, aw etc scope and another one for software design?
Most certification bodies will issue an ISO 9001 certificate by the name of your company. and issue another certificate with detailed scope (you may ask for 2 or 1 certificate as you like).

don't worry about that.

now as the activities are not linked, you may continue using the ISO 9001 symbol on the certified activity until you decide to expand the scope of your quality activities (may be in the next surveillance or may be after 2 years, whenever you are ready) .

Just don't use the symbol on the non-certified activities (not in proposal, not in memo).

good luck
 
#6
Is it possible to do it another way . . . have certification for our current scope and then an additional certification for the new scope. They are two totally different areas, not really interlinked

We would then have one 9001 certification for our design, aw etc scope and another one for software design?
You can, but it will cost you much, much more, plus the majority of your management system will be audited twice! Can I ask why you are seeking certification for software?
 
A

AliPat

#7
Our IT department are developing software which will be used internally and with our customers, but it may have a commercial use outside the company and they may look to sell it
 
#8
Our IT department are developing software which will be used internally and with our customers, but it may have a commercial use outside the company and they may look to sell it
Good! Do you have your management behind getting certified for this part of the business? I don't mean having a QMS for the development etc. Is there a real need/desire/cost justification for an ISO certificate for the software development org?
 
#9
Is it possible to do it another way . . . have certification for our current scope and then an additional certification for the new scope. They are two totally different areas, not really interlinked

We would then have one 9001 certification for our design, aw etc scope and another one for software design?
I'm sure you could, but I'm sure the costs would be much lower to stay with one certificate.
 
A

AliPat

#10
Thanks for all your replies. Yes management is behind the change.

We will develop all the procedures and documentation in line with our QMS and then when ready will update the Quality Manual and ask our certification body for an extension of scope.

Hopefully it won't be too difficult as we work to a QMS in all areas as it is, it will just be creating and updating documentation etc
 
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