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I would say that if the pharmaceutical company was not ISO 9000 and
couldn't manufacture the drug in a consistent manner, than it'd be in
the same straits as an ISO 9000 manufacturer that could not manufacture
the drug in a consistent manner.
Before ISO 9000, I suspect pharmaceutical companies were manufacturing
drugs in a consistent manner.
So, what does ISO 9000 do? Well, I worked for a company that had crap
processes. It took feedback from departments and did nothing but provide
lip service about the feedback. That company is ISO 9000. What does that
mean? It means that, in part, ISO 9000 makes it harder for small
companies to compete. ISO 9000 generates revenue for a new industry,
"ISO 9000 compliance."
-----Original Message-----
From: Smith, Martin [mailto:martin -dot- smith -at- encorp -dot- com]
We are currently in the process of certifying to the ISO-9001:2000
standard.
This standard is a big departure from ISO-9000 and is process rather
than
procedure based. The standard calls for the organization to model the
inputs
and outputs of every department in the organization. There is also a
feedback loop reviewed by executive management to ensure continuous
product
improvement.
Yes, like all tools, you can choose to abuse them or to simply not use
them.
Yes the standard helps ensure that you can manufacture the same product
consistently. Yes if the product is garbage you will consistently
manufacture garbage. But ask yourself this: would you take your
medication
if the pharmaceutical company could not manufacture the drug in a
consistent
manner? The ability to manufacture something consistently is hugely
important.
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