ISO 13485 System Design for an R&D Center

[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

 

[Ronen E]

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

Hello and welcome to the Cove

Given that you intend to implement an independent QMS and your customer is the manufacturing branch, your product is the design you develop.

Cheers,
Ronen.

 

[somashekar]

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

Between your R&D center and manufacturing company, your design and development transfer (the output) is the product. It will be good to have some quality agreement between you and the manufacturing company that addresses all the interaction and perticularly the authorization and approval of design changes.