J
Jahagnir
Hi all,
For an R&D center of a manufacturing company, I am involved in developing the QMS per ISO 13485: 2016 and then getting certified. My question is about the clause 7 (Product Realization). knowing that the customer of this site is only internal (design will be delivered to the MFG site), and knowing that the QMS does not include the MFG site itself (it is only for R&D), how I can define the product and approach to this clause requirement?
Thank you very much for inputs and for your time,
Jahangir
For an R&D center of a manufacturing company, I am involved in developing the QMS per ISO 13485: 2016 and then getting certified. My question is about the clause 7 (Product Realization). knowing that the customer of this site is only internal (design will be delivered to the MFG site), and knowing that the QMS does not include the MFG site itself (it is only for R&D), how I can define the product and approach to this clause requirement?
Thank you very much for inputs and for your time,
Jahangir