ISO 13485 2003INTRODUCTION |
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ISO 13485 is a Quality
Management Standard for Medical Devices.
ISO published the new ISO 13485: 2003
standard on July 15, 2003.
It replaces the old ISO 13485:1996 and ISO 13488:1996 standards.
INTRODUCTION TO ISOISO
is the International Organization for Standardization. ISO standards are developed by
technical committees. |
INTRODUCTION TO ISO 13485Use ISO 13485 2003:
ISO 13485 is
not a product standard. It’s a process standard. |
ISO 13485 VERSUS ISO 9001ISO 13485:2003 is based on the ISO 9001:2000 quality However, some ISO 9001 requirements were modified ISO
13485 excludes ISO 9001 requirements related to When ISO 9001 wants you to document a procedure,
it also
But you don’t have to remember this rule. Our plain
English ISO 13485 also places a greater emphasis on the use Since ISO 13485 is all about medical devices and
related |
POSSIBLE EXCLUSIONSISO 9001 2000 says that you may exclude or
ignore some You may also exclude section 7.3 design and
development if Occasionally ISO 13485 uses the phrase “if appropriate”
or Whenever you decide to
exclude or ignore an ISO 13485 |
HOW TO DEVELOP A QMSIn order to become certified, you need to develop a One common approach is to carry out a Gap Analysis. If you need to
develop a quality management system that Use our
ISO 13485
Gap
Analysis Tool either to develop a Once
you've completed your Gap Analysis and filled all |
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