Hello all,
We received the following minor non conformity in our last 13485 audit from our notified body: “the outsourced processes and their control are not properly described in the quality manual”.
In order to address this feedback, we are looking at different options to make our current approach of managing the outsourced processes more transparent to all involved parties. One simple approach would be to do a procedure.
- Do you think that it is the best way to show that organization controls the outsourced processes?
- Do you have any example of “control of outsourced processes” procedure to share?
Appreciate your input.
We received the following minor non conformity in our last 13485 audit from our notified body: “the outsourced processes and their control are not properly described in the quality manual”.
In order to address this feedback, we are looking at different options to make our current approach of managing the outsourced processes more transparent to all involved parties. One simple approach would be to do a procedure.
- Do you think that it is the best way to show that organization controls the outsourced processes?
- Do you have any example of “control of outsourced processes” procedure to share?
Appreciate your input.