Preface

The primary objective of this handbook is to provide both novice and experienced quality practitioners with a concise, user- friendly guide for understanding and implementing the requirements of the two standards ISO 13485 and ISO 13488, which are based on ISO 9001 and ISO 9002 respectively.

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The first section (1. Foreword) of the handbook outlines the background of the ISO 9000 family of standards as it now looks and gives an insight into the forecasted year 2000 version.

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The second section (2. Conceptual Overview of the ISO 9000 and 13485 Standards) presents a conceptual overview of these and other standards, and helps explain the mandatory nature of quality assurance requirements as it applies to the medical device industry.

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The third section (3. An Implementation Path) describes a quality system registration process for organizations that are pursuing the path of third-party certification.

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The fourth section (4. Quality System Requirements) contains - the actual text of ISO 9001:94 and ISO 13485:96,, - guidance made up of excerpts from CAN/CSA-ISO 9000-1-94, CAN/ CSA- Q10001-94, and ISO 9000-2:97; from the Global Harmonization Task Force guidance; from the ISO/FDIS 14969:97 draft guidance prepared by ISO Technical Committee 210; and from guidance developed by the Medical Devices Bureau of Canada. - definitions from the vocabulary CAN/CSA-ISO 8402-94, and from ISO 13485:96 (which are specific for medical devices) - typical self-diagnostic and audit questions - where applicable, interpretations provided by the CSA Technical Committee on Quality Management,,

The standard ISO 9000-2:97 issued on June 15, 1997, is an update of ISO 9000-2:1993 and is based on the 1994 edition of ISO 9001 and 9002.

Finally, a series of Appendices further describes these and other st andards which form quality assurance requirements for medical devices.