
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.
WATERS CHROMATOGRAPHY
Marq Ransom, Director of Regulatory Affairs
Waters is one of the first U.S.-based companies to have its manufacturing
facilities registered to ISO 9000 Quality System Standards. It became apparent
to us in 1990 that ISO 9000 was changing the worldwide quality arena, and
if we wanted to compete successfully on a worldwide basis, we'd better meet
the requirements. Since Waters is an international company and more than
half of our business is conducted outside the U.S., achieving ISO 9000 was
critical for our international business. In fact, in some countries, ISO
9000 is a prerequisite to conducting business. We have ten major manufacturing
facilities in five countries, and all of them are ISO 9002 certified.
Waters' registration to ISO 9002 demonstrates our commitment to ensuring
consistent processes and products. While the certification effort for ISO
9002 was considerable, our existing company-wide quality system helped speed
the process. Many key customer benefits were realized as a result of the
certification effort.
Registration to the ISO 9002 Quality System Standard gives our customers
confidence that our manufacturing processes produce products to consistently
meet specifications. Products are consistent not only from lot to lot, but
also from plant to plant. Multinational customers have the assurance that
products supplied by one facility are the same quality as those supplied
by any other site. Our customers have added confidence that they will receive
consistent high quality products.