By that I mean - can you draw a division between what needs to follow all the ISO steps and what can be done in the Chief Engineer's office at 7:00 at night on a piece of graph paper?
This is killing us. We just don't have the resources to make project out of every modification.
Can I define when the system needs to be used?
For example:
1) a distributor calls and asks to get a valve with SAE threads rather than the standard NPT. All we are changing is the threads - the working parts and all the materials remain exactly the same.
2) A customer calls and says - here's our idea, design us a valve that will do it.
Clearly case 2 would require a whole soup to nuts process... but what of case 1? If we follow the extended process it'll take days, where if we handle it more sensibly, the parts can be made and shipped in a day and we will still end up with the stuff needed in the QMS (drawings, specs, etc).
Can someone give me an example of how to draw the line that will pass and ISO auditor's muster?
This is killing us. We just don't have the resources to make project out of every modification.
Can I define when the system needs to be used?
For example:
1) a distributor calls and asks to get a valve with SAE threads rather than the standard NPT. All we are changing is the threads - the working parts and all the materials remain exactly the same.
2) A customer calls and says - here's our idea, design us a valve that will do it.
Clearly case 2 would require a whole soup to nuts process... but what of case 1? If we follow the extended process it'll take days, where if we handle it more sensibly, the parts can be made and shipped in a day and we will still end up with the stuff needed in the QMS (drawings, specs, etc).
Can someone give me an example of how to draw the line that will pass and ISO auditor's muster?