 In response to the publication of the ISO 9001:2000
standard, ISO 13485:1996 & ISO 13488:1996, the international
quality management standards for the medical device manufacturing
industry, have been combined into one standard: ISO 13485:2003.
ISO 13485:1996 provides both a a basis
for addressing USA FDA requirements and those of
the Canadian Medical
Devices Conformity Assessment System (CMDCAS) program. ISO
13485:2003 has also been adopted by the European Community as EN ISO
13485, European standards for CE Marking, replacing EN 46001.
While ISO 13485:2003 is structured in a similar way as
the new ISO 9001:2000 including the celebrated process approach, it
is a "stand-alone standard" and can be used without the ISO
9001:2000 standard.
ISO 13485:2003 does require
more documented procedures to meet customer requirements and
regulatory requirements applicable to medical devices than ISO
9001:2000, but the number of documented procedures required are not
significantly greater than was required under ISO 13485:1996.
ISO 13485:2003 no longer longer directly references the
requirements of ISO 9001, hence it is being touted as a
"stand-alone standard." But those wishing maintain ISO 9001:2000 can
do so seamlessly with the new 13485 standard, and will find them
complimentary. If you have commercial accounts as well as medical
device customers, maintaining both 13485 in tandem with ISO 9001 is
your best option, and you'll find it relatively easy to do
- Let us show you how!
Offering the best of what ISO
9001:2000 brought to quality, ISO 13485:2003 represents familiar
ground to those already accustomed to ISO 9001:2000, and an obvious
improvement to those already familiar with ISO 13485:1996. In
implementing ISO 13485:2003, medical device manufacturers are
embracing a standard that provides a better quality model
to meet regulatory requirements and ensure quality than any
previous or current standard.
You can rely
on RH ANDERSEN to
facilitate your ISO 13485 implementation or transition, train your
staff and audit your system. At RH ANDERSEN we have more than 15 years
experience in medical device standards, CMDCAS,
FDA and CE Mark
implementation . Let us
show you what we can do for you!
Don't have the
time, staff or desire to audit your quality management
system?
Let
an RH ANDERSEN's
"Team ISO" consultant perform your internal
audits for you!
Need to audit a
remote supplier? We can perform your supplier audits and help you
exercise requisite control of your supply chain performance...
At RH
ANDERSEN we are ready now to meet the challenge of
optimizing, implementing or maintaining your ISO 13485 Quality
Management System, help you implement/maintain your CE Mark; hand
elp you comply with FDA, CMDCAS,
requirements....
Call today for your free
quality
consultation:
(203) 500-8705 
RH
Andersen and Team ISO are registered trademarks of RH
Andersen Consultants. All rights
reserved.
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