Question about ISO 13485:2003 - Production Provisions - Contract Manufacturer

Ronen E

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#11
Agree, my point was not about the production records here, but that I would expect the design owner to have some documentation that shows that a design transfer occurred and that this activity was planned and verified or validated as appropriate. To understand this is important for the OP as it will be a very bad start for the audit when the auditor hears something like "Oh, there was no design transfer because...". Even if later on all necessary documentation will be found the auditor will get the impression that there is a lack of knowledge regarding the requirements of ISO 13485.
While this is true, I think it’s less relevant to the OP enquiry. Obviously any past shortcoming in the design control process according to ISO 13485 will reflect badly on the OP’s org during audit; however, the OP was mostly concerned about the recent move of production back home. In my terminology such a move involves some level of process validation, and has little to do with design transfer, assuming that the design has not changed and that the CM manufacturing process is merely being mimicked at the new site.
 
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