Control of Outsourced Production (Contract Templates) - ISO 13485:2003

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BARRY SKEEL

Hi

Can any one help me please

We are applying for ISO 13485:2003 and all our production of medical devices is Outsourced to OEM's based in Asia

We need Agreements / contract with these suppliers specifying things like
- Who the Legal Manufacturer is
- Management of any changes to the product
- Notification of any Changes to ISO status of the supplier
- etc

Does any one have such a template they could let me have OR know where we can find one

Thanks
:agree1:

Barry
 
B

BARRY SKEEL

Re: Iso 13485:2003 - control of outsourced production (contract templates)

Thanks Somashekar BV, india
 
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bbuck

Introduction and support package : Guidance on 'Outsourced processes'
Document: ISO/TC 176/SC 2/N 630R3
October 2008

I hope this helps
 
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