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 ISO's new ISO 13485 2003 quality management standard. This comparison will pinpoint the areas that fall short of the new standard.  Once you know where to focus your attention, you can begin to make the changes that are needed to comply with the new 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!

If you would like to see what our Gap Analysis Tool looks like,
please check out our ISO 13485 2003 Gap Analysis page.

Home Page

Introduction to ISO 13485 Quality System Standard for Medical Devices

ISO 13485 2003 Internal Audit Program

ISO 13485 2003 Gap Analysis Tool