Regarding comments made in the November 2002 Quality Mailbag, one of your readers wrote about how ISO 9001: 2000 requires design changes be approved before implementation.
The same requirement the reader is griping about in section 7.3.7 is in ISO 9001: 1994, section 4.4.9. I don’t have ISO9001:1987, but I’d bet the same requirement was there also. It’s at least been around since 1994, so it’s nothing new.
There is nothing in the standard that says that a design change approval system couldn’t have an initial approval by the shop supervisor with a final approval by engineering. The shop supervisors make documented changes on the fly. Engineering does their design review, validation, verification and blesses the change. The shop maintains traceability so they can recall the product if the change is not approved.
I don’t think there is a problem with ISO, just how you implement it.
Quality Systems Manager
I read the ISO article by Scott Dalgleish in October’s Quality and was glad you asked for comments. I can find nothing wrong with your views on ISO. However, someone fed you quite a line. You thought implementing an ISO system would in itself bring out superior quality in a company? ISO is simply a framework for a quality system, universal in it’s objectives, to fit most any company, while allowing the company to “do it’s own thing” above and beyond the basics. Many companies need this guideline to help establish a system. If the company chose to stop there then their leaders had no real vision.
This is where your article rings true. It is up to the leadership of the company to have the vision to push its people, processes, procedures and resources to the limit.
For you to say, “Now that I’ve managed our ISO 9000 program for years, I regret being a champion for it,” sends a terrible message to those who may be getting started down the ISO road.
Webb City, MO