ISO 9000

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.