Submitted by: Submitted by dhanya188
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Pages: 56
Category: Other Topics
Date Submitted: 04/16/2013 08:06 PM
COMPARISON OF
ISO 9001:2000 AND
ISO 13485:2003
ISO 9001:2000
ISO 13485:2003
0 Introduction
0.1 General
The adoption of a quality management
system should be a strategic decision of an
organization. The design and implementation
of an organization’s quality management
system is influenced by varying needs,
particular objectives, the products provided,
the processes employed, and the size and
structure of the organization. It is not the
intent of this International Standard to imply
uniformity in the structure of quality
management systems or uniformity of
documentation.
0 Introduction
0.1 General
This
International
Standard
specifies
requirements for a quality management
system that can be used by an organization
for the design and development, production
installation, and servicing of medical devices,
and the design, development, and provision
of related services.
The
quality
management
system
requirements specified in this International
Standard
are
complementary
to
requirements for products.
Information
marked “NOTE” is for guidance in
understanding or clarifying the associated
requirement.
It
is
emphasized
that
the
quality
management system requirements specified
in
this
International
Standard
are
complementary to technical requirements for
products.
This International Standard can be used by
internal and external parties, including
certification
bodies,
to
assess
the
organization’s ability to meet customer,
regulatory, and the organization’s own
requirements.
The quality management principles stated in
ISO 9000 and ISO 9004 have been taken
into consideration during the development of
this International Standard.
0.2 Process approach
This International Standard promotes the
adoption of a process approach when
developing, implementing, and improving the
effectiveness of a quality management
system, to enhance customer satisfaction by
meeting customer requirements....