I read your article about ISO in the latest issue of Quality. I've been in the Quality field since 1977. My background is mostly nuclear. I've been with a company that just went through the 2000 ISO Certification and I can't believe some of the requirements. We manufacture custom electrical controls and switchgear. The 2000 issue of ISO 9001, paragraph 7.3.7 requires design changes to be approved before implementation. In some instances our engineers overlooked some things and they weren't on current drawings. Our shop personnel can't make obvious, needed changes (drill mounting holes for a device) without engineering approving them first. Our shop management, in the interest of time, has decided to go around the system. We have books for every job. In these books is a list of change requests. Our personnel are making the changes but not signing them off until an engineer comes out to the shop and approves it. We should be able to work at risk, make changes in the shop and have them approved before shipping the product, not standing around waiting for an engineer. We worked like that building nuclear power plants. ISO is going to put itself out of business if they keep making ridiculous requirements. Our management sees ISO as a "necessary evil" not a means to improve our products.
New Orleans, LA