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.
PE NELSON
Richard Sisk, Quality Manager
On July 27, 1993, after three days of audits by the British Standards
Institute, Perkin-Elmer (PE) Nelson's Cupertino, CA facility passed the
requirements for ISO 9001 quality system registration and TickIT, a software
certification that imposes extra requirements on the software developer.
Our Cupertino facility designs and manufactures a range of chromatography
equipment and software, including chromatographs, chromatography data handling
systems, intelligent interfaces, applications software, and LIMS. It is
the latest site to achieve registration, following close behind locations
in the United Kingdom, Germany, Puerto Rico, and Norwalk, CT.
PE Nelson's involvement in quality goes back for more than a decade when
Perkin-Elmer instituted a worldwide Quality Council and established Centers
of Excellence. Cupertino is the Center of Excellence for software development.
ISO 9001 registration provides numerous customer benefits. For example,
the FDA requires pharmaceutical companies to perform validation audits of
their suppliers. ISO 9001 registration can greatly ease and expedite the
validation process because an audit trail is already in place, and if our
customer wants up-to-date documentation and test data, we can provide it
immediately. We've documented our tests -- from user interface testing to
quantitative testing of data acquisition and analysis -- to a rigid standard
that's traceable and auditable.
PE Nelson's quality objectives seek to ensure continual improvement of product
and service quality. ISO 9001 registration is one of the tools we'll use
to meet our quality goals.