A Practical Field Guide for ISO 13485

The purpose of this field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2003, whether “from scratch” or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2005’s definition of quality as the “degree to which a set of inherent characteristics fulfills requirements,” Myhrberg and Raciti have identified the requirements and inherent characteristics (distinguishing features) for this field guide. Within the guide, each subclause containing requirements is the focus of a two-page spread that consistently presents features that fulfill the requirements listed below.

This guide will:
• Provide a user-friendly guide to ISO 13485:2003’s requirements for implementation purposes
• Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2003 implementation
• Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists
• Direct management on what it must do and should consider to satisfy ISO 13485:2003’s enhanced requirements as well as responsibilities for top management
• Depict step-by-step in flowchart form what must occur to create an effective, conforming QMS