基于ISO9001-2000 质量管理体系的审核和文件要求aen.pdfVIP

AUDIT AND DOCUMENTATION EXPECTATIONS FOR QUALITY MANAGEMENT SYSTEMS BASED ON ISO 9001-2000 基于ISO9001-2000 质量管理体系的审核和文件要求 Introduction 简介 This document identifies AQA,s expectations for clients seeking registration to ISO 9001:2000. It is organized into the following sections: 此文件提出了AQA 对申请注册ISO9001 ：2000 客户的要求。概括起来包括下面几部分: Ⅰ Pre-Audit Expectations 预审要求 Ⅱ Conformance Audit Expectations 正审要求 Ⅲ Surveillance Audit Expectations 监督审核要求 Ⅳ Nonconformance Response Expectations 不符合项整改要求 I. Pre-Audit Expectations 预审要求 The quality management system, including the quality manual and procedures must be reviewed by the auditor prior to the audit to establish ISO 9001-2000 requirements are addressed. 在审核前，审核员必须对包括质量手册和程序文件的质量管理体系进行审核。 The client will complete AQA form F-019(2K) to depict how the client’s quality management system addresses ISO 9001-2000 requirements and send it to the auditor along with the quality manual and procedures. 客户需要填写 F-019 （2K ）表来描述质量管理体系是如何支持 ISO9001 ：2000 的要求，需要把 F-019 （2K ）表连同质量手册和程序文件发给审核员。 Guidance to the significant requirements that must be addressed includes: 必须阐明的重要要求包括: 1. The quality manual must include the scope of the quality management system, including justification for any exclusions to the requirements of the standard. 质量手册必须包括质量管理体系的范围以及任何删减的原因。 Exclusions are only permitted to requirements in clause 7. 只允许对第七章节的内容进行删减。 All exclusions must be justified in the manual and will be verified by the auditor that they do not affect the organizations ability nor responsibility in providing a product or service. 所有的删减必须在质量手册中注有合理的删减理由，并且需要审核员证明此删减不会影响其组织在提供产品 或服务方面的能力以或责任。