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.

Finally, a comprehensive process audit checklist has been developed to be used with ISO 9001:2000! This manual was developed to assist anyone involved with conducting or planning quality system audits including quality auditors, quality managers, quality system coordinators, management representatives, and quality engineers. In addition, potential auditees in any function or position should find the questions useful in preparing for an audit. Although the checklist could be amended to work for a service company, the manual was created with a focus on the manufacturing sector to cover common processes such as production, management, customer-related, design and development, training, purchasing, etc. The manual includes: a brief overview of the process approach, discussion of problem areas often found by third party auditors, the process audit checklist, and forms to be used in conjunction with the process audit checklist to increase audit effectiveness. Preview a sample chapter from this book along with the full table of contents by clicking here. You will need Adobe Acrobat to view this pdf file.

Fierce competition, globalisation and the permanent liberalisation of markets have changed the face of supply chains and operations drastically. Companies, which want to survive in a hostile environment, must establish the optimum combination of supply and operations. This book provides a holistic and practical approach to operations management 4.0 and supply management 4.0. It combines operations and supply best practices across the value chain. It explains comprehensively, how these new paradigms enable companies to concentrate on value-adding activities and processes to achieve a long-term sustainable and competitive advantage. The book contains a variety of best practices, industry examples and case studies. Focusing on best-in-class examples, the book offers the ideal guide for any enterprise in operations and supply in order to achieve a competitive advantage across all business functions focusing on value-adding activities.

ISO 9001:2015 includes many changes that not only affect the companies aiming to achieve certification to it, but also auditors. This book is the resource auditors need to fully understand ISO 9001:2015 and help them perform audits to it. This book integrates two different types of audit strategies, conformance audits and performance audits, into one process approach audit. Conformance audits confirm that the organization is meeting the requirements of the standard, while performance audits confirm that the QMS is achieving its intended results. The book includes: An introduction to ISO 9001:2015 An auditing strategy for ISO 9001:2015 How to conduct a Stage 1 audit for ISO 9001:2015 How to conduct a Stage 2 on-site audit for ISO 9001:2015 Appendices include an introduction to process focus, an assessment report template for Stage 1 audits, a confidential assessment report template for Stage 2 audits, and an ISO 9001:2015 conformance checklist.

Auditors from any industry must "learn the language of upper management" if they truly want to effect positive change throughout their environments. If quality auditors want to remain relevant and keep from becoming marginalized, they need to add new skills and credentials, and even more importantly, move beyond conformance monitoring to determine how their work might impact the corporate bottom line. The purpose of this book is to accept that challenge in presenting two ways that auditors can "learn [to speak] the language of upper management"-either by helping to drive continuous improvement or by helping to manage risk. This book has essential information that will help guide an organization's efforts to glean more value from their audit process. It helps grow the audit function beyond verification audits. It provides insight for using the audit function to improve organizations using lean principles. It also discusses how the audit function can contribute to and be formally integrated into the ongoing risk management program. This book is about advancing the profession of auditing, as well as the skills of individual auditors. "Buy. Read. Reread. It will kick start your risk-based thinking journey. Then, buy the book for each member of your auditing team." center Greg Hutchins, PE Director, Certified Enterprise Risk Manager Academy "While there is a constant influx of books on auditing entering the market today, Advanced Quality Auditing: An Auditors Review of Risk Management, Lean Improvement and Data Analysis stands out among them as Lance excels at demonstrating to readers how they can embrace the methodologies for continual improvement as they apply to the audit program and audit professionals. By combining the use of the audit checklist development matrix tool (ACDM) and various lean tools that are traditionally applied to processes other than auditing, auditors can ensure they not only audit for compliance but also add value to the audits, demonstrating the value of audit program, and in turn, themselves. The clarity of explanation and illustrative charts and diagrams of the Kano model makes it easy for the beginning auditor to understand and implement, while providing deeper insights to experienced auditors in how to leverage the model in the continual improvement of the audit program. Lance clearly makes the case that as audit professionals we should all embrace the use of the Kano model and apply it to our own audit programs to ensure we are always positioned to delight our customers." Nancy Boudreau ASQ Audit Division Chair (2014-2015) Lance Coleman has taken a traditional topic on auditing and written a professional synopsis of key concepts in terms so clear as to make them understandable and useful to the reader. A great book to use and have as reference. Well done! Dr. Erik Myhrberg IRCA Certified QMS Lead Auditor Co-author, A Practical Field Guide for ISO 13485:2003

The value of the ASQ Certified Quality Auditor Handbook, Fifth Edition, is clear. It is designed to help new auditors gain an understanding of the field and prepare for the ASQ CQA exam. In addition, experienced auditors can refer to it as a helpful reference; audit managers and quality managers can rely on it for guiding their auditing programs; and trainers and educators can use it for teaching fundamentals. This in-depth overview of quality auditing represents auditing practices for internal and external applications. It provides practical guidance for both system and process auditors as well. Many current topics have been expanded to reflect changes in auditing practices since 2012, with guidance from the recent 2017 update of ISO 19011. In addition, readers will find example audit situations, stories, and review comments to enhance their understanding of the field. Topics covered include the common elements of all types of system and process audits (quality, environmental, safety, and health): Auditing fundamentals, including types of quality audits, purpose and scope of auditing, terms and definitions, roles and responsibilities of participants, and professional conduct The audit process, from preparation and planning, to performance and reporting, to follow-up and closure Auditor competencies, including resource management, conflict resolution, communication, interviewing, and team dynamics Audit program management and business applications, including staffing, training and development, program evaluation, organizational risk management, and best practices Quality tools and techniques, including problem-solving tools, process improvement techniques, basic statistics, verification, and validation "This book is an encyclopedia of all major bodies of information a new or experienced quality auditor would need. It covers both the qualitative and the quantitative, which is a strength. I can't think of a quality auditor that would not find this work helpful." Kim H. Pries, CRE, CQE, CSQE, CSSBB, CMQ/OE, CQA "This handbook will be helpful to those who are new to auditing or require more in-depth knowledge of the implementation of an audit program. Boxed examples or scenarios provide some of the practical challenges encountered during auditing." Govind Ramu, ASQ Fellow, Co-Author ASQ SSGB Handbook, Author ASQ CSSYB Handbook Lance B. Coleman, Sr. has over 25 years of leadership experience in the areas of quality engineering, Lean implementation, quality, and risk management in the Medical Device, Aerospace, and other regulated industries. He has presented, trained, and consulted throughout the United States and abroad. Lance is currently a Director of Quality for IDEX Health and Science, LLC, in Oak Harbor, Washington.