H
Hello
I am implementing 13485:2016 in my company and i am a bit confused with section 8.2.5 / 8.2.6 Monitoring and measurement of processes and product. To me this is just a way of flagging up when something has gone wrong with the product or the process, coming from customer complaint, audit, near-miss etc - which then leads on to CAPA. Am I missing something here?
Many thanks
I am implementing 13485:2016 in my company and i am a bit confused with section 8.2.5 / 8.2.6 Monitoring and measurement of processes and product. To me this is just a way of flagging up when something has gone wrong with the product or the process, coming from customer complaint, audit, near-miss etc - which then leads on to CAPA. Am I missing something here?
Many thanks