前言本手册的主要目的是为新手和经验丰富的质量从业者提供一份简明、用户友好的指南，用于理解和实施分别基于ISO 9001和ISO 9002的两个标准ISO 13485和ISO 13488的要求。，手册的第一部分（1.前言）概述了ISO 9000系列标准的背景，并对预测的2000年版本进行了深入了解。，第二部分（2.ISO 9000和13485标准的概念概述）介绍了这些标准和其他标准的概念概述，并有助于解释适用于医疗器械行业的质量保证要求的强制性。，第三部分（3.实施路径）描述了寻求第三方认证路径的组织的质量体系注册流程。，第四部分（4。 质量体系要求）包含ISO 9001:94和ISO 13485:96的实际文本，指南由CAN/CSA-ISO 9000-1-94、CAN/CSA-Q10001-94和ISO 9000-2:97的摘录组成；来自全球协调工作组指南；来自ISO/FDIS 14969:97指南草案，由ISO技术委员会210编制；以及加拿大医疗器械局制定的指南。-词汇CAN/CSA-ISO 8402-94和ISO 13485:96（医疗器械专用）中的定义——典型的自我诊断和审核问题——在适用的情况下，由CSA质量管理技术委员会提供的解释，即1997年6月15日发布的标准ISO 9000-2:97，是ISO 9000-2:1993的更新，基于1994年版的ISO 9001和9002。最后，一系列附录进一步描述了构成医疗器械质量保证要求的这些标准和其他标准。

PrefaceThe 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.,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.,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.,The third section (3. An Implementation Path) describes a quality system registration process for organizations that are pursuing the path of third-party certification.,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CAN/ CSA- Q10001-94, and ISO 9000-2:97; from the Global Harmonization Task Force guidance; from the ISO/FDIS 14969:97 draft guidance prepared by ISO Technical Committee 210; and from guidance developed by the Medical Devices Bureau of Canada.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.