So what is an ISO 9001?

[Nathan Potter]

Jorges' comments are quite accurate. I've been involved in ISO certification and found a lot of resistance among workers in small companies to doing a thorough manufacturing process plan. You have to wring the process they are responsible for out of them, then get them to document it exactly, then make sure they do that part of the process exactly the same each time. ISO requires that the process variables be measured at critical steps and at a frequency that results in a trend chart over time of process consistency. If something is out of spec then an out of conformance form has to be generated to document what went wrong and what steps are required to fix it. Out of conformance better not happen very often. ISO officials do an onsite inspection periodically to insure that the manufacturer is following the process and procedures that they submitted as their manufacturing process.

Yes you can submit a loose process for what you are doing but then you risk losing customers due to your poor process control. But in a competitive environment a company will want to have a high degree of quality control if they are going to be very successful in the market place so typically management will push an ISO certification under most circumstances.

In general ISO certification does stand for a degree of quality control above that of no ISO certification. But it is also true that many companies without ISO certification produce more consistent product than those with.

Nate Potter

[Michael Chmilar]

Being ISO 9000 certified just means that the entire manufacturing process is documented, and auditable.

You could still be producing crap. But you know exactly how the crap is made, and can verify that the crap is made the way you intended.

Here is where it is useful: You want to contract for manufacturing from another party, possibly very far away from you. If they are ISO 9000 certified, you can send an auditor in, and he will be able to determine if the factory is doing something wrong (or fishy), ie. if they are manufacturing "extra product" to sell on a black market, the auditor will likely find extra source materials, more power usage, or something like that.

It doesn't provide much advantage to you as the consumer. It is really for business-to-business confidence.

[Nathan Potter]

Michael has an interesting and commonly held belief that even if ISO certified, a company can still produce "crap" if a "crap" process is what was certified. But there is also a caveat in this notion. Crap can seldom be produced consistently and the paper trail required by ISO certification requires (thru in process measurements) a consistency of process thru each process step. Thus the production of "crap" usually becomes transparent to the ISO inspectors by simply examining the paper trail. Of course some inspectors are more thorough and astute than others so the examination of the paper trail will vary somewhat. But as I said above, the production of crap in a competitive environment will eventually fail in the market place.

As Michael says above there is a big advantage of ISO certified manufacturing processes in business to business transactions. I've depended on the ISO certification in several instances of technology transfer.

Nate Potter

[neil poulsen]

I was trained as an ISO 9000 lead oddity. (I mean auditor.) Jorge et.al. explain it well.

I think of a company that meets the standard as set up well to establish a relationship with customers and suppliers. I think that companies set up this way are also in a better position to engage in self-improvement. There are other benefits.

[Dirk Rösler]

Crap can seldom be produced consistently

My contact sheets seriously challenge that assertion...

[Jiri Vasina]

A very heavy load on documentation for quality assurance, especially for those that are typically under staffed.
...

And now try and imagine applying this thing in a hospital, where a screw up is defined as any patient's complaint. Where do you end - treating the patient or filling out the papers?

[Robert A. Zeichner]

In my view, a method of changing a company from being outcome oriented to one that is process oriented. "The operation was done by the book and perfectly executed Dr. The patient just died"!

[Mark Sampson]

John, if you'd just submit to purchasing the high-priced stuff you wouldn't have to worry about the boasts of the second-rate manufacturers. I'm not objective, though; having worked for EK for 19 years, I'm sticking with the film made in my home town. Despite their idiotic marketing decisions, their product is still superior. I've tried British and ?european? films, and always go back to Tri-X Pan.

[Nathan Potter]

Dirk, very good - I find the same thing with most of my contact sheets! I'm contemplating getting my printing ISO certified!

Nate Potter

[BrianShaw]

In theory... doesn't ISO 9000 (or any other process documentation) theoretically embrase process improvement processes? That was my belief. Statistical process control, etc. should lead to the production of less crap as time goes on... in theory, of course.

Another important thing to remember is that many of these certifications are awarded at the corporate level. It does not necessarily mean that all units of the company are compliant.