D
david_r
Hello All...
Just picking the brains of the vast knowledge of the forum with this simple question...
I have been involved in a few recent management discussion with a few fellow RA/QA personnel and it has been mentioned that ISO 9001 and 13485 will be hitting "Process Mapping" hard starting this summer (2012) because it will be part of the standard and as a requirement to be in compliance with the standard.
My question is have I missed something (which would not be the first time) in the standard? Is process mapping required, or will it be mandated in the future for certification?
If it is mandated can someone point me to where in the standard it is stipulated?
We are in the process of mapping on this end and I do know the importance of having this in place, but I wanted to know if this is actually a requirement within the standard that I should be aware of.
Any input would be greatly appreciated
Dave
Just picking the brains of the vast knowledge of the forum with this simple question...
I have been involved in a few recent management discussion with a few fellow RA/QA personnel and it has been mentioned that ISO 9001 and 13485 will be hitting "Process Mapping" hard starting this summer (2012) because it will be part of the standard and as a requirement to be in compliance with the standard.
My question is have I missed something (which would not be the first time) in the standard? Is process mapping required, or will it be mandated in the future for certification?
If it is mandated can someone point me to where in the standard it is stipulated?
We are in the process of mapping on this end and I do know the importance of having this in place, but I wanted to know if this is actually a requirement within the standard that I should be aware of.
Any input would be greatly appreciated
Dave