Re: Grizzly and ISO 9000. Was: Disturbing Trend

On 12 May 2006 06:18:55 -0700, petengail@xxxxxxxxx wrote:

<snip boatloads of whining about ISO>

Ya know, I have worked as a Software Quality Engineer in the medical
device industry for 14 years. Currently, my company comply both with
9001 and 13485, as well as a host of other US and foreign Quality
System regulations. I have observed the work habits and attitudes of
the engineers and managers I work with and I am extremely happy, and
you should be too, that these medical devices development are
subjected to these controls. Not that all, or even most of these
people would make decisions that would threaten people's health or
lives, but the presence of a quality system helps to prevent these
attitudes and work habits from negatively impacting people's health and
possibly lives.


I think you miss the point of some of the comments. For safety-critical
items, there darn well better be strong processes in place to assure that
all appropriate validations and verifications as well as configuration
controls are performed properly. Those processes and methodologies existed
well before ISO-9000. (IIRC, NASA and its subcontractors weren't ISO
certified when we went to the moon). Those processes however, can be
independent of an ISO-9000 certification.

When it comes to safety critical products, the suggestion to let
"market forces insure quality" means nothing to me. Would YOU be
willing to accept that it would take 20 extra deaths (perhaps YOU, or
your loved ones?) to cause a company to fix a product that has a defect
in it that they deemed unnecessary to fix because there was a sale on
the line?


The issue with ISO, as I and other posters have pointed out is that even
with ISO certification in place, the processes in place can actually allow
for the situation you cite above. ISO does *not* guarantee defect-free nor
high quality products. It only assures that the process you have in place
allows you to *consistently* produce whatever level of product quality from
your process that you choose.

For safety-critical applications, ISO-900x process certification is
certainly a *tool* to assure that appropriate processes are followed to
assure that consistent product results are obtained. However, it is not a
panacea and is not the *only* solution to assure that the desired results
are obtained.




Klingspor can do what they want, companies whose products can kill, on
the other hand......

D'ohBoy


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If you're gonna be dumb, you better be tough

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