审核指南中英文对照版

International Organization for Standardization International Accreditation Forum

Date: 21 September 2004 ISO 9001 Auditing Practices Group

The ISO 9001 Auditing Practices Group is an informal group of quality management system (QMS) experts, auditors and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).

It has developed a number of guidance papers and presentations (see "QMS auditing topics" below) that contain ideas, examples and explanations about the auditing of QMSs. These reflect the process-based approach that is essential for auditing the requirements of ISO 9001:2000 Quality management systems - Requirements.

The guidance is primarily aimed at QMS auditors, consultants and quality practitioners, but is not definitive. The papers and presentations reflect a number of different views in QMS auditing. As such, their content may not always be consistent. It is not intended that the guidance will be used as specified requirements, an industry benchmark, or as criteria that all QMS auditors, consultants or practitioners have to follow.

QMS auditing topics

•The need for a 2-stage approach to auditing 2阶段审核的必要性

•Measuring QMS effectiveness and improvements测量QMS的有效性及其改进•Identification of processes 过程的识别

•Understanding the process approach 过程方法的理解

•Determination of the “where appropriate” processes 确定”适当的”过程

•Auditing the “where appropriate” requirements审核”适当的”要求

•Demonstrating conformity to the standard 证明符合标准

•Linking an audit of a particular task, activity or process to the overall system

•Auditing continual improvement 审核持续改进

•Auditing a QMS which has minimum documentation审核QMS文件化的最低要求•How to audit top management processes 如何审核最高管理层

•The role and value of the audit checklist 审核检查表的角色和价值

•Scope of ISO 9001:2000, Scope of Quality Management System and Defining Scope of Certification ISO9001：2000的范围，质量管理体系的范围和定义认证范围

•How to Add Value during the audit process审核过程如何增值

•Auditing competence and the effectiveness of actions taken审核能力要求和采取措施的有效性

•Auditing Statutory and Regulatory requirements审核法规和指令要求

•Auditing the Quality Policy andQuality Objectives审核质量方针和质量目标

•Auditing ISO 9001, Clause 7.6 Control of monitoring and measuring devices审核ISO9001, 7.6条款监视和测量装置的要求

•Making effective use of ISO 19011ISO19011的有效应用

•Auditing Customer Feedback processes审核顾客反馈过程

•Documenting a Nonconformity文件化不符合项

•Guidance for reviewing and closing nonconformities评审和关闭不符合项指南

•Auditing Internal Communications审核内部沟通

•Auditing Preventive Action审核预防措施

•Auditing Service Organizations审核服务组织

•Auditing the Effectiveness of the Internal Audit审核内部审核的有效性

•Auditing Electronic Based Management Systems审核电子管理体系

A "Zip" file of all the above documents is also available. 可获得以上文件的ZIP档。Feedback from users will be used by the ISO 9001 Auditing Practices Group to determine whether additional guidance documents should be developed, or if these current ones should be revised. Comments on the papers or presentations can be sent to the following emailaddress:*****************************.

The other papers and presentations may be downloaded from the web sites:

www.iaf.nu

/iso-tc176-sc2