In the September editorial ("Silent ISO Majority?," Sept. 2002, p. 6), the editor asked if anyone supported ISO 9000. As a corporate quality systems manager, I can tell you that ISO and QS-9000 have done some good for us (Luminex Corp., Austin, TX). I am in total support of ISO 9000 as the system to use -- provided it is implemented and correctly used, and is used in addition to other systemic operations deemed necessary by the organization.
We first became certified in 1997 with the development and implementation movement starting back in 1993. At first, owners, and rank and file were unsure about IS0 9000. Was it just a flavor of the month? Was it just some deterrent to slow us down? After the first two of the U.S. (Luminex) sites became certified, the second two achieved certification in 1998. In 1999, we raised the bar and put all locations under a corporate multisite QS-9000 (and now ISO 9000:2000) certification. Doing so increased each location's awareness of our quality management system as a whole, in addition to making everyone actually aware of what happens -- good and bad -- during the process.
While it is true that ISO is no panacea for effective systems (what is!), ISO did help us do one thing -- learn to document what we do and follow what we document. That, in itself, has been our biggest challenge. The mindset and the processes we learned during the ISO/QS-9000 implementation and certification audits have also helped with implementing the systems needed for customers requiring FDA compliance and UL registration.
True, ISO in itself will not cause any organization to make parts well and sell a lot of those parts. Rather, ISO is meant to be a start and, yes, a marketing tool. If the whole process of documenting what a company does is too cumbersome, then heaven help the company if it has to fight a product liability lawsuit or an FDA complaint that caused death or serious injury.
Maybe those organizations that find ISO the enemy or the camel, as some other readers have said, need to take the KISS approach to ISO. Nothing says that I need to write long manuals when five or 10 pages spell it out. Nothing says that I need expensive procedures when a simple flowchart works. I have told all of our employees to just write down what they do in simple terms and follow it.
Yes, we have ISO and QS certificates, and yes, we have to audit ourselves (what reputable company would not want to?) and follow the guidelines of ISO. We have had more success using ISO principles to assist us in understanding our processes and using common sense when setting up how we track, monitor, plan, do, check and act.
Teresa Whitacre, CQA, CQE, CQManager
Quality Systems Manager
Carclo Technical Plastics