ISO 13485/9000 is the baseline

This medical device company I know has finally wrapped up their ISO 13485 certification and they are pretty jazzed about it, even though doing so is probably going to end up delaying their project by several months due to pulling people off project work and putting them on paperwork. However, my thinking now is that certification is unimpressive and if you're making a big deal out of this, you might have bigger problems down the road. Ten years ago, maybe this was cause for celebration, but as it stands now, ISO 13485 and 9000 are pretty much the baseline and while you will undoubtedly run into some quirks (obviously more depending on the size of your company), it shouldn't be a major effort to get certification and if it is, then maybe you should think about adding, changing, or training personnel. There are something like 400,000 companies ISO 9000 certified now, I'm just saying, if you have a hard time joining that elite group perhaps some changes are needed.

UPDATE: Tom in the comments makes a similar point: "The big deal with 13485 is that it has to be done day by day as a normal part of medical device product development. If one has to stop and "catch up" with paperwork, not only are you doing it wrong, but missing a lot of the benefits that a great quality system can give you." If you don't have the resources to keep up ISO 13485 as Tom notes, then a rethinking is in order.

Materials handling- contaminated product & paper based document system

The ISO 13485 auditor picked on us for not having a procedure for dealing with returned product that was contaminated. Fortunately, MD&DI was on top of this issue in a John Lincoln article in 1999.

Also there is a request to reorganize the design history file (DHF), device master record (DMR) and the "technical file". Is it too late to get a summer intern?

We're also trying to switch from a paper based documentation system to an electronic one. This seems to be fairly popular in the quality department, but it is actually more work for them. They still have to file away the master copies with the signatures and now they have to make sure the electronic versions get put in the right place. I'm all for it, but I'm confused by their uncharacteristic willingness to do more work. The main debate is do we do it going forward as we need documents or is someone going to scan them all in. I think its a little ridiculous to not just scan them all in now and be done with it, it will save time in the long run, but I think I'm going to lose that argument. Thats fine, it better be worded very carefully or I'll bide my time until I can write up a corrective action when I can't find an electronic document I need.