ISO 9000

The company at which I work is attempting to implement ISO 9000 strategies to the workflow. I dread that it will lead to more paperwork than progress… Does anyone else have experience with programs like this in the office and possibly strategies to make it work as a designer?

We are ISO 13485 (medical devices).

The NPD group (that’s me) is largely shielded from the process. If we weren’t, 1-3 year development time would be 4-12 years, which, obviously, would be completely unacceptable.

I was recently in a meeting with QA where they suggested we should have a design history record for every concept we do. I almost laughed out loud because they were dead serious. I calmly explained the launch product is Rev 0 and a DHR is not required by ISO for ideas before Rev 0. They finally agreed Rev -1 would be silly. Which is good thing because they were even seriously going to recommend us doing a risk analysis for every idea too.

When we do have a product ready for launch, there is quite a bit of paperwork to get through, but again that is a one time deal, so you put your head down and plow through with about 6 weeks of pain getting your final spec down, getting QA, purchasing and accounting sign off.

Some things like vendor qualification happens well before launch but is mostly handled by QA. We are there as the negotiator between QA and the vendor.

I’m not sure if this is the case for non-medical ISO, but when we take products out for field testing, real usage not just show & tell, we are restricted more by the FDA than ISO, but the same ideas apply. We have to prove what we say we give them is what we give them. So there is a spec, BOM, work instruction and product history record. And those documents are kept locked away in case the FDA comes calling.

Thank you for the insight! I work in packaging, so we only have the occasional brush with FDA regulations. In a way, you confirmed my fears that the process can add a burden of paperwork… But I was happy to hear that you were able to create a bit of wiggle-room for the creative process (the hundreds of bad designs before the good ones haha) in this kind of hyper-structured management system.

We recently changed our vendor approval process. It went from a 12-page questionnaire to a 6-page questionnaire. Really no skin off of me because the vendor is responsible for filling it out. But the vendors tend to call me instead of QA for clarification. I have never had a site visit go more than a day with QA. So figure that in your timing.

I’d say setting the spec takes the greatest time. And a big chuck of that time is determining your critical dims/specs and determining how QA tests to the critical dims/specs. We are a bit backwards because NPD really drives the testing procedures, not our QA department. But we have our own regulatory group within NPD and you don’t see that to often.

The next biggest hurdle is purchasing because they take a microscope to the vendor’s manufacturing process and capabilities. I’m surprised that our vendors disclose as much as they do.

All in all, not that bad but nothing like a start up. I was writing 510Ks for them. I can’t imagine that happening here.

ISO 9000 standards are meant to ensure that a product is consistently produced. It is suppose to ensure that you have good quality products. Marketing typically loves to say that they are ISO9000 certified to try to get more business.

Be sure to argue that your initial design development does not need to have quality ensured for prototypes, this is especially important if you want to try out new vendors or use an unconventional design.

iab is has a great company example.
The QA department can’t inspect into a product quality, New Product Development should always define what should be inspected in a quality check, they are the ones who knows what is important. The last thing you want is a costly inspection of a part taken out of context of the entire design.

I’d say do what you can to keep new designs away from any ISO 9000 until it is ready to be built. It will only add to your development costs.