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How to Audit the Process-Based QMS

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This book is intended to help individuals involved in managing and conducting audits to ISO 9001:2000. It focuses on auditing as a management process as well as a key driver of continual improvement within an organization. An excellent resource for internal auditors, it is perfect for novice auditors or those who need a refresher on the fundamentals of auditing. The book can be used as a guide to establishing a new audit program or updating one that has been operational for some time. The authors participated in integrating the process approach into ISO 9001:2000 and thoroughly understand its implications for auditing a QMS.



The three main areas of focus in this book include the basics of process-based internal quality auditing, the requirements for establishing and managing an internal quality auditing process, and conducting audits. One of its best features is the section on auditing worksheets, forms, checklists, and questions. Included are useful and adaptable examples from every aspect of auditing such as: developing an audit schedule, planning an audit, writing findings, documenting positive and best practices, writing an audit report, and requesting corrective action. The book contains a comprehensive list of questions that auditors can use when conducting quality audits and features this information on the accompanying CD-ROM.

An extensive appendix offers a list of typical questions for different sector and commodity groups, including: medical devices, automotive, telecommunications, service providers, and laboratories.

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A Practical Field Guide for ISO 9001:2008

The purpose of this field guide is to assist organizations, step by step, in implementing a quality management system (QMS) in conformance with ISO 9001:2008, whether from scratch or by transitioning from ISO 9001:2000. It examines each sub-clause of Sections 4–8 of ISO 9001:2008, which contain the requirements, and gives a list of the documentation/documents required, internal audit questions, a summary of management’s responsibilities, and a flowchart of the steps that need to be undertaken to satisfy the requirements.

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