ISO 13485 2003 has expired. See the new ISO 13485 2016 standard.
EXECUTIVE SUMMARY ISO 13485 is a quality management
standard for medical ISO standards are developed by technical
committees. Use ISO 13485 2003:
• To
establish a quality management system that
• To demonstrate your
ability to supply medical devices
• To
evaluate how well your organization is able • To become certified or registered.
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
• When ISO
13485 wants you to document a
• When ISO
13485 wants you to document a
• When ISO
13485 wants you to document
• When ISO
13485 wants you to document 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 |
Praxiom Research Group Limited help@praxiom.com 780-461-4514 |
|||
Updated on May 16, 2016. First published on December 20, 2004. |
|||
Legal Restrictions on the Use of
this Page Copyright © 2004 - 2016 by Praxiom Research Group Ltd. All Rights Reserved. |