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This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
As well as being an integral part of compliance and regulatory requirements, audits are essential for assessing the success of processes, products, and systems-whether existing or newly implemented. They are also a vital tool for verifying objective evidence of processes and providing evidence for the reduction and elimination of any problem areas. To ensure maximum benefit for an organization, quality auditing should highlight examples of good practice, rather than simply identifying non-conformance, process issues, and corrective actions. This will allow other departments to share information and adjust their working practices, delivering continuous improvement as a result. This book is perfect for anyone charged with implementing a quality audit program or those performing the audit, this book is an ideal reference on the established techniques of quality auditing. This third edition serves as a guide to learning and applying the basics of quality auditing, and expands on the basic auditing principles by showing how the quality audit can be used to improve business performance. This new edition includes: - An expanded background and history of quality auditing - A general model for auditing any quality management system - Added information on process audits and the system-process-product relationship - Auditor competencies and qualifications - An explanation of audit reports and the role of the auditor after the report - New material on remedial and corrective action - Example audit procedures and a glossary of auditing terms
This book is an excellent reference for learning and applying basic quality auditing principles. Examples and checklists throughout the book help make this one of the best single-source reference guides. Quality practitioners, registrars, and those preparing for certification exams will find this book to be a useful tool. the new edition expands on established techniques and addresses both internal and supplier auditing as it relates to any quality management system, including ISO 9001, GMP, automotive, and others.
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.
Explanations are given for pertinent steps in the audit process, from determining the purpose of the audit through planning and implementing the process to evaluating, reporting, and following up on the results. Annotation copyrighted by Book News, Inc., Portland, OR
There are as many views on audits and auditing auditing as there are people who have ever thought about the subject and the process. Any author writing about it is faced with some common problems, such as how to make a description of a technical process anything less than dry to read. How to deal with the general belief that anyone can conduct an audit without any specific training or experience. Auditing is often viewed as a waste of time, money and resources with little, if any, real value to an organization. It is seen as something of a judgemental process. People see themselves as being under scrutiny and examination and as very few of us enjoy such a process, audits are not generally welcomed at first. I cannot claim to have found solutions to these problems or to have come up with an easy five-minute way of understand ing the detailed points that make up this whole subject. As with any form of technical textbook, this work must not be viewed as a volume to be read in one sitting from cover to cover but used to dip into as and when required. Thankfully the practice of auditing, in real life has compensa tions for those involved. Those being audited, the auditees, if sensible, will be able to learn from what is hoped will be an objective and skilled overview of the areas and subjects being audited.
This edition includes coverage on ethics, the correlation of auditing to business performance, and the expansion into areas not covered by the Certified Quality Auditor Body of Knowledge. It has been designed to be used as a resource for nearly every aspect of the auditing function.
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.
Since the publication of the first edition of this book in 2000 the revised ISO 9001 standard has been implemented and is being used widely. While the basic premise of the original book is still sound, the reality of auditing the new standard has shown up various areas which require refinement - this new edition addresses that need. It remains a pragmatic guide, covering all aspects of auditing, including certification assessment, supplier investigation and internal audit, enabling auditors to appreciate the approaches adopted by those working in related areas. With its detailed analysis of the requirements of ISO 9001:2000, this book will also be of interest to all those involved in implementing certified quality management systems, as well as the auditors who are required to examine those systems. A down-to-earth approach is taken throughout The Quality Audit for ISO 9001:2000, avoiding the impractical and nit-picking methods which have so often characterized quality management audits, making it an invaluable source of realistic advice. It demonstrates how to produce real benefits from an audit programme rather than simply guaranteeing compliance to a documented system. Everyone who sees audits as a useful tool for business improvement should read this book!