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ISO
13485 offers medical device
manufacturers an avenue to
effective management systems.
ISO 13485:
2003
represents the requirements that
medical device manufacturers
must incorporate into their
management systems. The current
document supersedes its 1996
incarnation as well as EN 46001,
EN 46002 and ISO 13488.
Though
based on ISO 9001, 13485 removes
9001's emphasis on continual
improvement and customer
satisfaction. In its place is an
emphasis on meeting regulatory
as well as customer
requirements, risk management
and maintaining effective
processes, namely the processes
specific to the safe design,
manufacture and distribution of
medical devices.
ISO 13485
is in part designed to produce a
management system that
facilitates compliance to the
requirements of customers
and-preeminently-various global
regulators. While being
certified to 13485 does not
fulfill the requirements of
either the FDA or foreign
regulators, the certification
aligns an organization's
management system to the
requirements of the FDA's
Quality System Regulation (QSR)
requirements as well as many
other regulatory requirements
found throughout the world.
Therefore, 13485 certification
serves to create a management
system that can be thought of as
a framework on which to build
compliance to various regulatory
and customer requirements.
Medical
device manufacturers can benefit
from being both 9001 and 13485
certified. While such manufacturers
are not required to have 9001
certification, it can bring further
business benefits, because it
focuses on business aspects that are
good for all businesses-for example,
the emphasis on customer
satisfaction and continuous process
improvement that a 13485 management
system omits. Manufactures of
medical devices also will need to
acquire 9001 certification if they
want to branch out to other
industries, as 13485 certification
will not be honored where 9001 is
required.
This article is an excerpt
from Quality Magazine. For full
article go to
www.qualitymag.com
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