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Adding a new site to 13485 Certification

Dobby1979

Involved In Discussions
#1
Hello all.

I was wondering if anyone had experience of adding a new site to their 13485 certification and in a short summery, what is required and a realistic timeline.

Example being; We currently hold 13485 certification and are looking to open a manufacturing plant in the US so our scope would need to change to incorporate them. Is it the same practice as gaining the original certification, e.g. Stage 1 and Stage 2 audits? Would 6 - 9 months be a realistic timescale for this?

Thanks in advance
 
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L

lxuejing

#2
Hi Dobby
Are all the machinaries in place and validated? How about the new clean rooms? likely onsite audit will be reqired. Try to talk to your NB and set up a schedule is important. We have recently added a new production isite n our lSO 13485 and It took more than a year via two on site audits.
Hope it is useful.
 

somashekar

Staff member
Super Moderator
#3
Hello all.

I was wondering if anyone had experience of adding a new site to their 13485 certification and in a short summery, what is required and a realistic timeline.

Example being; We currently hold 13485 certification and are looking to open a manufacturing plant in the US so our scope would need to change to incorporate them. Is it the same practice as gaining the original certification, e.g. Stage 1 and Stage 2 audits? Would 6 - 9 months be a realistic timescale for this?

Thanks in advance
Hi Dobby.
About the methodology for audit to certification., you have to discuss it with your CB.
Adding a new site is pretty straight forward. You have to have one QMS and common Management responsibility.
You have to determine which will be your lead site and which will be your other site / sites. The Lead site is usually where the major portion of the QMS activities will be performed. You have to determine how the activities of the clauses 6,7,8 will be deployed at each of the sites, describe them in the top level document, and begin to establish (Document, Implement and Maintain)
When you are ready with confidence and records of your internal audit and management review to backup, you can ask for the audit dates. Realistic timeline depends upon the size and structure of your organization, but within 12 months is good enough for most. Structuring the QMS and building the understanding across lead site and sites forms the key to success.
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#4
Good day lxuejing. Has any consideration been given to simply gaining a new/separate certification specific to the new site instead of "scoping" it in with a location in a different country?
 
L

lxuejing

#5
Hi John, l think it depends on the function of sites and the product range the sites are covering.ln our case, several manufacturer sites share the same design facility and produce the same type of the products, it makes sense to add the new manufacturer facility in current lSO 13485 certificate.
 
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