Can someone point me to where I can get a copy of this Standard? I didn't CALL ASQ, I was just at their site and can't seem to dig it up. I may not be looking in the correct spot.

Thanks.

Try BSI's (British Standards Institution) online ordering site:

http://bsonline.techindex.co.uk

Depending on your product, especially if you come under the friendly auspices of the FDA, you might also want a copy of ISO 13485. Very similar to EN 46001 and its star seems to be rising, while EN 46001's is fading.

Just my take on what I'm seeing. Good luck with your devices.

Check out Global Engineering Documents, this is a great site for all types of standards.
http://global.ihs.com

Also checkout tuv.com, it has a very good technical library.
Hope this helps.