Design & Development - We sell products that we design and products we don't design

[Rosana]

In the company I am working at we sell products that we design and products we don't design. The products that we don't design we buy from our suppliers. My question is, how can I handle this? Do I need to prepare a FMEA, Control Plan and PSW? I don't think so but I am new to this standard. I think it will be enough if we receive the PSW from our supplier and then we test the products in our installation. Do I need to do something else?

Thanks

Rosana

 

[Manoj Mathur]

For the products you design or you don't design if Design Responsibility is yours you MUST to comply comply all the requirements mentioned in Clause 7.3 and its sub clauses. It includes DFMEA also. In any case Control plan which is more specifically deals with Manufacturing Process You have to do it whether you do design and get it from outside.
Ofcourse, if Company is not design responsible DFMEA may be skipped of but all other requirements must be complied.

Manoj