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Although we haven't gone through the 9000 process ourselves (yet!), we are
closely associated with one of our organizations that have, and I have spent
quite a bit of time talking with the QA manager who lead the effort to get
certified in 90 days. He was responsible for overseeing and motivating the
group so that they were able to go through their six month audit with ZERO
findings. He succeeded because he had full management backing.
So, what are the key points I have picked up in my association?
1. Auditors are sticklers!
2. The groups that have trouble are those that write their procedures of
how they think it should be done, not how people will actually do it! For
example, if you write that all documents will conform to a certain template,
and one doesn't--That's a finding. If you write that certain documents will
have approvals by six different people, and only five approve--that's a
finding. If you write that certain documents must have certain sections and
one document is missing one section--that's a finding. It doesn't matter if
the sections or signatures or templates really don't apply in that case.
Because your policy said the document has to have it, it has to be there,
whether it applies or not.
3. If it doesn't add value, it doesn't belong in your policy! People love
to write paper monsters! It's fun and it looks impressive! But they will eat
you alive. Pull out any of your existing policies or procedures, then check
random documents and see how many follow the letter of the policy. If you find
more than a quarter that follow the letter, I would be surprised.
4. ISO doesn't dictate your policy--you do! ISO only tells what elements
you must address with you policy--you define how you address them! Strive for
the shortest policy that will accomplish the goals you are trying to
accomplish. If you can't see yourself following the procedures that you
establish, then nobody will follow them.
For the organization I referred to earlier, their Quality Policy AND their
Operating Procedures for their ISO 9001 certification fits into a 1/4" thick
5"x7" perfect bound manual with 96 pages. Take a look at your existing system.
It probably fills up at least one shelf, if not two. Prior to 9001 their
quality system filled up a book shelf. Of course, nobody followed all of the
procedures all of the time, and many were obsolete and ignored.
A few more thoughts on ISO 9000 (actually, ISO 9001, 9002, and 9003):
If you are doing good business, you should be doing everything listed in the
standards already. Unfortunately, many view certification as an endpoint, not
as the first step on a journey. Certification is not a panacea. You can
design, make, and sell cement life jackets as long as you follow your policies.
All you get from certification (assuming you follow your policies) is the
ability to be consistent with your product. It doesn't assure that you are
building the right product, or that the product is designed well.
Good luck!
Derrel Fincher
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