I'm trying to add ISO 13485 requirements to my ISO 9001 quality manual and quality procedures. (I'm also adding AS9100 requirements too :mg: but I'll leave that one for another thread.)
While my company manufactures medical devices, we do not manufacture or package sterile devices. As such, could I claim that actions to meet 6.4 a) thru d) of the spec are excluded from the scope of my quality system? Is anybody out there in the same situation? How did you handle it? I'm seeking opinions here.
I can't see coming up with contamination procedures when the quality of my product isn't affected.
While my company manufactures medical devices, we do not manufacture or package sterile devices. As such, could I claim that actions to meet 6.4 a) thru d) of the spec are excluded from the scope of my quality system? Is anybody out there in the same situation? How did you handle it? I'm seeking opinions here.
I can't see coming up with contamination procedures when the quality of my product isn't affected.