We're developing an upgraded satellite-relay controlled sensor system for DoD, with the system enclosed in a transportable shelter. We also have a small testbed within our building, consisting of two standard 19" wide electronic equipment racks. The intention is incorporating a different LAN distribution system in the transportable system, using the testbed as a "proof of concept" evaluation tool. We're in the process of implementing ISO9000/9001/900* under the guidance of our QA wizard. His issue is that we don't have schematics or working drawings for what we're doing (or trying to do) on the testbed, even though the design is based on the working system in the transportable shelter. It's been explained that we're using the existing design and "red-lining" the changes as we develope the new LAN system (which requires re-wiring a great number of connections over the previous LAN system). We are still working out the particulars for the new system, but as he interprets ISO9000 we need a working drawing before we do anything, so we've been shut down. How the Hell am I supposed to develop anything if I can't even activate the equipment to explore how it operates, let alone integrate it with the rest of the system? What's in ISO9000 that will allow me to produce this system under Research and Development (which is what we're doing), or is this a real-world Dilbert situation?
I'm a 14000 guru and not a 9000 one but i have been doing 9000 internal for about 2 years so I'll give it a shot.
4.4 Design control seems to allow quite a bit of lattitude in how an organization conducts it's product development. It seems to me that if you establish some type of scheduled oversight period, maintain good documentation of the steps being taken with the results + and -, and possibly map out courses of action to be taken, you might be ok.
The standard was not meant to hinder or stop productivity, but to insure the quality of it (my reading).
Maybe too much is being read into it at you location.
Randy is correct. Your 'wizard' may want to shoot me, but you can do what you want as long as your system supports it. It is quite common for a company to take an existing design and 'redline'. The standard only requires that you have a defined design 'system' with design reviews at 'appropriate' stages (may only be 1 stage in some companies). There is absolutely no requirement for you to have a schmatic or working drawing until you reach the late stages of the design phase where you are past prototype (which is what it sounds like you are doing). You DO have to record what you're doing. Some companies just have engineering notebooks
Read 4.4 for your self. Then ask your local 'guru' where it says "...a company must have schematics or working drawings for what they're doing (or trying to do) on the testbed during the early stages of the process." It doesn't say that. Period.
Just out of curiousity, is your company registered to any quality standard yet? My company is strictly R&D and I have come across a few people in upper management that do not see the benefit of what I'm doing. They also have me chopping out large sections because "they do not apply".