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Adopting New Sites and Divisions into an existing ISO 9001 Scope

somashekar

somashekar

Staff member
Super Moderator
#11
#11
Manda said:
Hi all,

I have search on here for something to help me with advise for bringing new divisions and sites into an existing ISO 9001 scope and I can't find anything (that will be me rather than the information not being here :confused:)

I wondered if someone could give me some advise as to where to start. These new areas were aquistions to our business and ultimately have the same processes just to slightly different market areas.

Any ideas would be most gratefully received

Thanks

Amanda
Click to expand...
Moving from one site certification to multiple site is a major scope expansion.
Decide which of the site is the Lead site, so other sites becomes site 1, site 2, etc.,
What processes happen in the lead site ? The Central processes
What processes happen commenly across all other sites ? The Common processes
How do you address the management reviews and Internal audits ?
How is the internal communications established ?
How is the Customer related processes, CAPA and complaints monitored ? are they Central or Common ?
You clarity on these and such other questions will depend upon how you want the exercise of control over the various sites, and this decides the control of documents and records. As this is described well and truely within your process and interactions in the quality manual, and the implementation and effectiveness of PDCA gets demonstrated, your integration begin to happen well and is firm.
I suggest this type of scope expansion is taken up in stages over every annual CB audit, rather than many at one go.
 
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#12
#12
somashekar said:
Moving from one site certification to multiple site is a major scope expansion.
Decide which of the site is the Lead site, so other sites becomes site 1, site 2, etc.,
What processes happen in the lead site ? The Central processes
What processes happen commenly across all other sites ? The Common processes
How do you address the management reviews and Internal audits ?
How is the internal communications established ?
How is the Customer related processes, CAPA and complaints monitored ? are they Central or Common ?
You clarity on these and such other questions will depend upon how you want the exercise of control over the various sites, and this decides the control of documents and records. As this is described well and truely within your process and interactions in the quality manual, and the implementation and effectiveness of PDCA gets demonstrated, your integration begin to happen well and is firm.
I suggest this type of scope expansion is taken up in stages over every annual CB audit, rather than many at one go.
Click to expand...
Absolutely agree with you, as per my previous posts.
I assumed that the acquisition of these new sites is related to a sell of these sites to the company of Manda.
Manda, pls , correct me if I am wrong in my understanding of the word " aquisition".
Based upon this, the current quality system in place ( even if not certified) should be completely different from the one of the Company that aquires.
Said that, its current QMS should deploy to the new aquired sites, also considering some modifications and improvements. It is almost natural that the current QMS processes shall be modified based upon this big change.
This is my opinion:bigwave:
 
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