How to Establish an ISO 13485
Quality Management System

If you're ISO 13485 1996, ISO 13488 1996, ISO 9001 1994,
ISO 9002 1994, or ISO 9003 1994 certified, and you need to upgrade
your quality management system, you need to carry out a gap analysis.
A gap analysis will compare your current quality management practices
with the ISO 13485 2003 quality management standard. This comparison
will pinpoint the areas that fall short of the standard. Once you know
where to focus your attention, you can begin to make the changes
that are needed to comply with the ISO standard.

Please use our ISO 13485 2003 Gap Analysis Tool to update your quality
management system. If you purchase our ISO 13485 2003 Gap Analysis
Tool, you'll find that it's integrated, detailed, exhaustive, and easy to
understand. You'll find that we've worked hard to create a high quality
product. In fact, we guarantee the quality.

Introduction to the ISO 13485 Standard

Medical Device Quality Management Definitions

Plain English Overview of ISO 13485 Quality Standard

ISO 13485 2003 Quality Standard in Plain English - Page 1 of 2

ISO 13485 2003 Quality Standard in Plain English - Page 2 of 2

Quality Management Gap Analysis Tool for Medical Devices

Quality Management Audit Program for Medical Devices