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ISO (International Organization for
Standardization) is located in Switzerland. The guidelines, authored in
1947, can apply to any type of organization. They are oriented toward
companies who do business internationally. ISO
does not certify the quality of products or services. It is a
process standard and many countries have adopted it because it is believed
to control quality by standardizing management.
For firms who choose to implement the ISO quality management system, the
designation insures that the processes the company are using follows
specific guidelines. Quality management by way of ISO dictates
how records are stored, the way information is transferred, rules for
engineering changes and iterations, record keeping procedures, the
customer communications process, etc. In any
case, these companies operate under a strict regulatory structure with the
associated fixed costs and overhead.
We designed this portable
(about nine pounds) oxygen concentrator for Inogen, Inc., a start-up
company. Our flexibility
allows us to meet all of our customers’ management and quality needs
(ISO and others) without being certified ourselves.
Compliance with ISO is not necessarily
a predictor of a well-run company. s
For a design firm, the rigid rules could
easily become a complicated hindrance, and add extra layers of
bureaucracy. As an example, when the documentation process itself needs to
be documented, a likely result is a slower product development cycle. It's
possible that some companies use ISO as an excuse for why projects are
behind and things are not getting done.
Regardless of whether ISO guidelines are followed, the FDA mandates their
set of rules, the Quality Systems Regulations (QSRs), to be implemented
when developing medical devices in the U.S. The ten elements of Design
Control (plus Risk Analysis) are the foundation for the development of
medical devices in general. The QSRs assure consistency with quality
systems worldwide and allow for the correction of potential problems early
in the product design process. Every medical device manufacturer is
responsible for maintaining records which demonstrate QSR compliance as it
applies to the research and feasibility stages of product
development.
Our clients have unique design
control systems.
With the exception of some small start-up
firms (who are in their initial planning stages), all of our clients have
unique design control systems. Our challenge is to mesh the design control
system our clients have chosen with ours and comply with the FDA
regulations. Our Regulatory and Design Control group has implemented a
quality system that follows the model of the ISO guidelines and the FDA
Quality Systems Requirements (QSRs). The system describes the general
process of activity within the company during the project development
cycle.
Since we are not ISO Certified and
control our own management policies, we have the flexibility to
accommodate almost everyone.
Omnica is a close-knit horizontal
organization and we are effective without the burden of being structurally
rigid. We have checks and balances in place to insure that the devices we
design and engineer are everything the client intends them to be.
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