ISO 13485 (EN 46000) Requirements, 99 Requirements Checklist And Compliance Guide

This is a focused and well-organized book with in-depth interpretation of ISO 13485 (EN 46000) requirements. It identifies and explains 99 distinct, auditable requirements that must be implemented to pass the certification audit. Every requirement is systematically explained with regard to interpretation, procedures and records, and examples of how auditors will verify conformance. In essence, the book reinterprets the standards into a list of specific actions that need to be taken to achieve conformance, and explains how to implement them in the organization. The list of all requirements discussed in the book is provided under the Table of Contents in the Book Information menu on the left side of this page.