PLUS 13485 (1st ed. pub. 2006)

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.

The numbering of this Handbook corresponds to the numbering of the clauses in ISO 13485, and each section contains

a) the actual text of ISO 13485;

b) definitions excerpted from ISO 9000, ISO 13485, and ISO 19011. The notes contained in these definitions are not always included in each section. Appendix 1 provides all definitions and accompanying notes in alphabetical order;

c) guidance, provided by ISO/TR 14969 or by other sources;

d) typical audit questions asked by auditors when registering the QMS to ISO 13485; and

e) self-assessment questions to be considered by an organization while developing its QMS.

Detailed guidance on the QMS registration process and implementation path, and other valuable information is found in PLUS 9001, The ISO 9000 Essentials, published by CSA. The information provided in The ISO 9000 Essentials is not reproduced here. (Contact CSA at 1-800-463-6727 for more information.)