SIO9001质量管理对照.docVIP

Introduction and support package:Guidance on the documentation requirements of ISO 9001:2008 SIO9001：2008文件要求指南 Document: ISO/TC 176/SC 2/N525R2October 2008 1. ???Introduction 说明 Two of the most important objectives in the revision of the ISO 9000 series of standards have been ISO9000：2008标准的最重要的两个目标是： to develop a simplified set of standards ?that will be equally applicable to small as well as medium and large organizations, and 开发一种简单并同时适用于小型、中型和大型企业的标准并 for the amount and detail of documentation required to be more relevant to the desired results of the organization’s process activities. 使得文件的数量和详细程度更好和组织的过程活动结果相适应。 ISO 9001:2008, Quality management systems – Requirements has achieved these objectives, and the purpose of this additional guidance is to explain the intent of the new standard with specific regard to documentation. ISO9001：2008，质量管理体系——要求已经达到了这一目标，本指南的目的是对新版标准中文件要求的意图进行解释。 ISO 9001:2008 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. ISO9001：2008允许组织灵活选择文件化其质量管理体系（QMS）.允许每个独立的组织选择最小数量的文件描述其有效策划、运行并控制其过程并实施和持续改进其QMS效果。 It is stressed that ISO 9001 requires (and always has required) a “Documented quality management system”, and not a “system of documents”. ISO9001强调（并一直要求）有一个“文件化的质量管理体系”，而不是“文件体系”。 2 ???What is a “document”? - Definitions and references 2．什么是“文件”？——定义和参考 The following are some of the main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS; 下面是一些组织的文件的主要目标，不管其是否已经实施于一个正常的QMS； Communication of Information 信息沟通 as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s