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This 40+ page tool (in Excel spreadsheet format) uniquely outlines every clause
in the standard. Upon completing The Big Picture for your organization, this
document becomes the ultimate "CliffsNotesTM" for tracing every requirement of the
standard back to its location in your own quality management system.
This tool includes a comprehensive cross-reference of clauses to give its reader
a complete understanding of the standard with a relational perspective of how your
organization fulfills it.
You will clearly see what documented procedures and records are required by the
standard, and which requirements may simply be proven effective and/or embedded as
part of another requirement fulfillment.
You will soon be able to see a sample below for a better understanding of this tool’s usefulness. This
is the perfect companion for any ISO Management Representative or any member of
your team who wants a comprehensive and relational perspective of the ISO 13485:2003
standard implemented in your organization.
Get an electronic copy of the The Big Picture coming soon and begin "bringing it all together" in your
organization and gain a more comprehensive and relational understanding of the ISO 13485:2003 standard!
If you are interested in this resource, please contact us to help us prioritize our development efforts!
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ISO 13485:2003 - The Big Picture