CSA Group The ISO 13485 Essentials - A Practical Handbook for Implementing the ISO 13485 Standard for Manufacturers of Medical Devices

Preface The primary objective of this Handbook is to provide both novice and experienced quality practitioners with a concise, user-friendly guide to understanding and implementing the requirements of ISO 13485 as it relates to their quality management system (QMS). The Canadian National Standard CAN/CSA-ISO 13485:03 is identical to its international counterpart, ISO 13485:03. To facilitate reading, the CAN/CSA prefix and year of issue have not been systematically included in the references to the Standard throughout this Handbook. Similarly, when ISO 9000 is used in the text, it refers to the 2000 edition. Please refer to the bibliography for the full title and designation of these Standards