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Validation of Processes 7.5.5?

K

Karen

#1
What is Validation of Processes? I don't believe it to be a new element, however I don't knwo how to applly. Design and Development addresses validation seperately. Is it part of inspection and testing, auditing, or something all together different? My inexperience is showing badly. This forum is truely a benefit.
 
D

David Mullins

#2
7.5.5 of ISO 9001:2000 directly correlates to 4.9 (process control) in the 1994 standard. If you read 7.5.5 (2000) and then read the third block/paragraph of 4.9 (1994) that commences "Where the results of processes..." you'll see that they've simply expanded the controls to be a little more specific in their examples, and introduced the validation concept - as applies in design control.
I suppose it is an ongoing development from the 1987 concept of "special processes".
Hope this helps!

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