And the people driving a car using the same procedure should normally drive similarly.” If you give some gaz to the car, the mechanism will make it move to the direction you want. ![]() Your procedure will be helping the person driving this process by providing a guidance. He explained me how this should work in terms of processes with inputs and output. ![]() I was working on a Dental Company in France and my Manager initiated me to the way to read this standard. It was more than 10 years ago but I remember like it was yesterday. When I started to work with ISO 13485 it was with version 2003. Have you already reviewed it? Did you notice a change? ![]() Recently there was an update on the Standards ISO 13485 with the release of the 2016 version that should be transitioned to by March 2019.
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