How to Audit the Process-Based QMS

This book is intended to help those involved in managing and conducting audits to ISO 9001:2008. It can be used as a guide to establishing a new audit program or for revitalizing one that has been operational for some time. It focuses on achieving an audit program that produces value-adding results for the organization. Arter, Cianfrani, and West, experts in both ISO 9001 and auditing, believe that the art and science of auditing quality management systems that have been designed and implemented following the process approach (the foundation of ISO 9001:2008) is more challenging and interesting than auditing discrete elements to determine whether documented procedures and records exist. Auditing a process-based QMS, or even small elements of such a system, requires auditors to understand and integrate into an audit all aspects of organizational activities, from high-level planning through ensuring that customers are satisfied. The role of auditing is evolving, and the skills and competence required to do it well also must evolve. The contents of this book will help auditors understand their role in the organization and discharge their auditing duties in a way that is challenging to them and contributes to the success of the organization.

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's perfect for novice auditors or those who need a refersher on the fundamentals of auditing. This book can be used as a guide to establishng 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 auditing, the requirenments 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.

Benefits:

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