RE: a good book on ISO documentation?

Subject: RE: a good book on ISO documentation?
From: Kelly Parr <kparr -at- Vertica -dot- com>
To: Peter Neilson <neilson -at- windstream -dot- net>, techwr-l <techwr-l -at- lists -dot- techwr-l -dot- com>
Date: Fri, 27 Apr 2012 12:04:44 +0000

My experience wasn't the same as Peter's wife, but I worked in an FDA-regulated industry, where inspectors had zero sense of humor and carried yellow crime scene tape in their back pockets. Lunch? I don't think those robots had stomachs.

For businesses who are NOT doing R&D/D&D in pharmaceuticals, biomed, or medical devices, complying with an ISO-9000 standard is probably better in theory than practice. Why go through all that money, effort, time, overhead and training (not to mention frustrated staff) just to have a regulating body tick off a bunch of boxes on a clipboard and say "Congratulations! You're doing what you said you would do."

Meanwhile, I will never forgive ISO for costing me a grade. I had to miss one of my evening grad classes because the FDA hadn't yet left the premises, and that instructor's syllabus stated that she would remove one full grade for each missed class at the end of the term. She did, and even the FDA couldn't get my final A back. ;)



-----Original Message-----
From: Peter Neilson

ISO 9000 is good for documentation people, but not necessarily for
business. Apparently many formerly ISO-compliant companies have now dumped
the stuff.

One of the difficulties is that it tends to replace inspection with
documentation.

My wife the quality engineer has seen this scenario:

"Hi, I'm the ISO-9000 inspector for HJKLMNP Co."
-- "Pleased to meet you."
"So do you have the required ISO documents for the stuff you sell us?"
-- "Right here." (Gee, they're last year's. I hope he doesn't look too
closely at them.)
"Excellent. What do you say we go to lunch?"

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Follow-Ups:

References:
a good book on ISO documentation?: From: Becca
Re: a good book on ISO documentation?: From: Peter Neilson

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