Marketing Requirements vs Product Specifications

Wes Bucey

Quite Involved in Discussions
#11
sardonyx said:
Sorry, my bad.... it should be 7.3.2 I was asking not 7.2.3 :confused:
Could be my error. I was citing ISO9k2k, this thread is ISO 13485, a tiny detail I failed to note the first time around. I don't have a copy of 13485 handy for reference.
 
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V

Vincnet

#12
sardonyx said:
Sorry, my bad.... it should be 7.3.2 I was asking not 7.2.3 :confused:
Hi Sardonyx,
we had last week a gap audit on the ISO 13485, and our auditor said she was very pleased to see that we were taking into account Marketing data in our design inputs (7.3.2). I went 2 years ago to a BIVDA meeting in UK where in one of the tutorials they stressed the importance to have marketing input from the beginning of the developement. This is all nicely put together in Craig Cochran's thread about Innovation Management in the September Registered Users articles section.
If you have access to it here is the link:
http://elsmar.com/Forums/showthread.php?t=9410

IMHO it makes sense, as the final goal of a business is to make moneyvia selling "something", it is of crucial importance to make sure from the beginningthat the product you are developping is the one that will sell and not the one that you want to make. :)) and the only way to do that efficiently is to ask the customer right from the beginning.

Hope this will help you.

V

PS: some "i"s might be missing in the text sorry about that but my putter is pretty old, and I must have abused of "i"'s in my procedure so the keyboard is not giving me all the "i"s I need anymore :)
 
S

sardonyx

#15
Wes

The only difference with ISO9001 and ISO13485 under 7.3.2 is that the latter includes output of risk management. The rest are the same.

thanks :bigwave:
 
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