It requires that manufacturers have a quality system
for the design, manufacture, packaging, slot age, installation, and servicing of finished medical devices that are to be commercially distributed in the U.S.
CLIA Final Rules for Quality Systems
: Quality Assessment Issues and Answers.
Published by Integrated Productivity & Quality Systems
laboratory must demonstrate that it has maintained its quality system
The second is the GMP Workshop for Packaging Suppliers: suppliers will learn to develop an effective product safety program that consistently meets the demands of food customers, gain a working knowledge of how to develop and manage product safety programs, quality systems
, preventive pest control programs and HACCP plans.
These standards were designed to relieve organizations of the burden of producing a multitude of different versions of documentation of their quality system
. The idea was that the different company-specific, sector-specific or national standards of quality system
requirements should be replaced by an international standard (Geiger 1994).
NEVALAINEN, PhD, MT(ASCP)SH Quality Systems
Consultant Baileys Harbor, WI 54202
Also, regulators in export markets may waive product certification requirements for companies whose quality systems
are registered by organizations recognized as competent.
Increasingly customers prefer to work with suppliers whose quality systems
conform to the ISO 9001 quality standard; this is particularly true for European customers.
Establishing an ISO 9000 quality system
depends on a number of factors such as the nature of business, current status of quality control and market requirements.
The following CoCo description of these criteria could apply equally to a quality system
: "A person performs a task, guided by an understanding of its purpose (the objective to be achieved) and supported by capability (information, resources, supplies and skills).
The five standards in the series (ISO 9000-ISO 9004) provide a framework for quality system
development in nearly all types of industry.