B
Hi all,
I'm trying to create an SOP for new product development and am having difficulty with one particular aspect. Prior to verifying the design, the design outputs will need to be documented (e.g. engineering prints), right? But do the manufacturing processes need to be specified at this stage/ are they part of the "design output" as well? Does it really matter how product for design verification is made, or is it enough to just provide evidence that product used for design verification conforms with the design prints? I'm really not gone on the idea of having to tie down (unproven/ unvalidated) manufacturing processes so early in the product development process.
I couldn't find any previous threads on this, so if anybody has any thoughts I'd really appreciate. I'm working to section 7.3 of ISO 13485, but assume its the same considerations as with ISO 9001.
Thanks,
Damien
I'm trying to create an SOP for new product development and am having difficulty with one particular aspect. Prior to verifying the design, the design outputs will need to be documented (e.g. engineering prints), right? But do the manufacturing processes need to be specified at this stage/ are they part of the "design output" as well? Does it really matter how product for design verification is made, or is it enough to just provide evidence that product used for design verification conforms with the design prints? I'm really not gone on the idea of having to tie down (unproven/ unvalidated) manufacturing processes so early in the product development process.
I couldn't find any previous threads on this, so if anybody has any thoughts I'd really appreciate. I'm working to section 7.3 of ISO 13485, but assume its the same considerations as with ISO 9001.
Thanks,
Damien