Glad to have Andrew back / Wonder what he thinks of ISO-9000 cert ification

["Smith, Martin" <martin -dot- smith -at- encorp -dot- com>]

Andrew, it's a pleasure to have you back.

It's no secret what you think of processes, methodologies, and the like.

I'm curious to hear what you think of ISO-9000 and the certification
process, especially if achieving certification is a contractual requirement
for a manufacturing company to sell its product to the OEM market.

Does the technical writing department add value by implementing processes
for document control that ensure consistency and accuracy among the
potential multitude of specifications and work instructions required to
design and manufacture said product.

What about quality management, say as mandated by the FDA for medical device
manufacturers, that ensure that every clinical MRI machine that rolls off
the shop floor is identical---especially considering that the RF power
levels used are sufficient to kill the patient if the power is set to high,
the duration of the pulses is overly long, or the delay between pulses is
exceedingly short.

I have spent the majority of my career in industries that manufacture
products based on a combination of hardware, firmware, and software. Often
these products have the potential of killing the people that manufacture,
use, and service the equipment. Rigorous methodologies used to design,
manufacture, (and yes document) these products help ensure they don't.

I have no data to support this, but I strongly suspect that more technical
writers are employed by highly regulated, process-oriented companies than by
software-only companies. Most of these writers do not belong to STC,
however.

Martin R. Smith
Technical Writer
Encorp, Inc.

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