The following application article is part of a larger set of articles
published under the title ISO 9000 in Scientific
Computing as a special supplement to Scientific Computing & Automation
magazine.
Once the steering committee is formed and responsibilities are assigned,
the next step is to assess the existing quality system. Many companies perform
a pre-audit at this time -- either by their own employees or by their registrar
-- to determine what they've got before they start documenting or changing
their documentation.
"First we checked our existing documentation," remarks Rob Ireland,
Beckman. "Then we appointed people to review current procedures against
the standard. Once we knew what we had, we then turned procedures into ISO-speak
and performed internal audits to hone in on the quality of that system.
Ask yourself if you are following documented procedures, look at your audit
trail, and make your internal audits similar to a registrar's audit by looking
at samples and key areas."
Beckman's Jim Quirk adds that "we determined how to interpret the criteria
by sitting back and thinking 'What is good for our company?' and deciding
what made the most sense. Just be consistent in the way you handle it. Most
importantly keep it simple."
U.K. Country Manager David Lowe states that Varian Analytical Instruments
"used a consultant as a member of the quality improvement team to identify
procedures below the quality manual. We trained as many staff as we could
to write the procedures and then just let them get on with it. We discovered
that we had about 60% existing procedures of some kind, and only had to
create about 40%."
Most companies discover that many procedures are already in place, but the
documentation is inconsistent or rudimentary. Often it's just a matter of
reformatting existing work instructions. New procedures generally need to
be implemented to address the management review, document control, and internal
quality audits requirements. Other procedures may need to be expanded to
address elements of the standard.
According to Tony Cox, U.K. ISO Project Leader, Hewlett Packard, "You
need to check what's there, what's missing, what's required, and then fill
in the gaps. Thoroughly address the requirements of the standard, and you'll
find that you have a very small percentage of new procedures."
"We had about 75% of our procedures in place but not documented,"
recalls Chris Rew, U.K. Marketing Manager, Bio-Rad Laboratories. "Don't
try to make the perfect system when you start, instead seek to continuously
improving quality as you go along," he advises. "Most of our manufacturing
units had GMP in place and were subject to FDA audits, but auditing is new
to sales units, particularly the contract review and purchasing segments.
It's important to note that the framework you build is yours, so be careful
how you do it."
While external training and consultants can help clarify and expedite the
process, understanding the standard's requirements to compare them to your
existing system isn't easy. "Learning how to read this seven page document
is like going to law school to learn how to read the law," declares
Will Cowan, Hewlett Packard.