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Work Instructions for manufacturing software

T

ttwerp65 - 2009

#1
I am wondering if I need to document every instruction for functioning in our purchased system "Visual" for our QMS ISO 9001:2000. Built into the system is a "help" feature that will walk you thru any process you might perform. Can I just make reference to the system as the instructor for how to perform the functions?
 
M

Martijn

#2
I am wondering if I need to document every instruction for functioning in our purchased system "Visual" for our QMS ISO 9001:2000. Built into the system is a "help" feature that will walk you thru any process you might perform. Can I just make reference to the system as the instructor for how to perform the functions?
No, you don't have to make instructions for everything software does. You do have to train your people so they're able to use the software properly.

Software can replace documents / workinstructions / procedures on quite a few occasions. The ISO 9001:2000 says nothing on what format your procedures and workinstructions are. If they are in the form of software, that guides you through a manufacturing process, why bother writing a procedure that explains what the software does. It's creating two descriptions of one thing, with the risk of mistakes and discrepancies increasing.

It's a good idea indeed to make a reference to software help files. Giving proper training, and making sure that the software itself contains all the critical actions / decisions in the process is also advisable.
 

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