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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.
Federal regulatory agencies have embraced Hazard Analysis Critical Control Point (HACCP) as the most effective method to offer farm-to-table food safety and quality in the United States-but it is important to look beyond HACCP. The ASQ Certified Food Safety and Quality Auditor (CFSQA) Handbook serves as a baseline of knowledge for auditors of food safety and quality systems that covers other aspects of food production, including preventive controls. This handbook assists certification candidates in preparing for the ASQ Certified Food Safety and Quality Auditor (CFSQA) examination. Its chapters cover the HACCP audit and auditor, preventive principles, and quality assurance analytical tools. The updated fourth edition also includes: The history of primitive and modern food preservation methods, including the introduction of HACCP methods The evolution of prerequisite programs, such as chemical and microbiological controls The importance of other food system support programs, such as product traceability and recall, facility design, and environmental control and monitoring Preliminary tasks for developing a HACCP plan About the Division The mission of the ASQ Food, Drug, and Cosmetic Division is to achieve increased customer satisfaction and continuous improvement by identifying, communicating, and promoting knowledge and the use of management concepts, technologies, and regulations as they relate to quality principles in all functional areas of the food, drug, and cosmetic industries. The Division holds conferences, confers awards annually, awards scholarships, and provides training and networking opportunities for participants in these industries.
The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: • A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP) • Current information about federal and international regulations • New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations • A thorough explanation of quality tools and techniques
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.
This best-selling book is now revised and fully updated! it encompasses the new body of knowledge and covers nearly every aspect of the audit function. Though a valuable resource for studying for the CQA examination, it is also meant to be the single source for auditors, audit managers, audit teams, and quality professionals in the field.
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.
The first edition of The Internal Auditing Handbook received wide acclaim from readers and became established as one of the definitive publications on internal auditing. The second edition was released soon after to reflect the rapid progress of the internal audit profession. There have been a number of significant changes in the practice of internal auditing since publication of the second edition and this revised third edition reflects those changes. The third edition of The Internal Auditing Handbook retains all the detailed material that formed the basis of the second edition and has been updated to reflect the Institute of Internal Auditor’s (IIA) International Standards for the Professional Practice of Internal Auditing. Each chapter has a section on new developments to reflect changes that have occurred over the last few years. The key role of auditors in reviewing corporate governance and risk management is discussed in conjunction with the elevation of the status of the chief audit executive and heightened expectations from boards and audit committees. Another new feature is a series of multi-choice questions that have been developed and included at the end of each chapter. This edition of The Internal Auditing Handbook will prove to be an indispensable reference for both new and experienced auditors, as well as business managers, members of audit committees, control and compliance teams, and all those who may have an interest in promoting corporate governance.
This book provides construction professionals, designers, contractors and quality auditors involved in construction projects with the auditing skills and processes required to improve construction quality and make their projects more competitive and economical. The processes within the book focus on auditing compliance to ISO, corporate quality management systems, project specific quality management systems, contract management, regulatory authorities' requirements, safety, and environmental considerations. The book is divided into seven chapters and each chapter is divided into numbered sections covering auditing-related topics that have importance or relevance for understanding quality auditing concepts for construction projects. No other book covers construction quality auditing in such detail and with this level of practical application. It is an essential guide for construction and quality professionals, but also for students and academics interested in learning about quality auditing in construction projects.
Successful content strategy projects start with a thorough assessment of the current state of all content assets: their quantity, type, and quality. Beginning with a data-rich content inventory and layering in a qualitative assessment, the audit process allows content owners and business stakeholders to make informed decisions. Content Audits and Inventories, by veteran content strategist Paula Land, shows you how to begin with an inventory, scope and plan an audit, evaluate content against business and user goals, and move forward with a set of useful, actionable insights. This practical, tactic-filled handbook walks you through setting up and running an inventory using an automated tool, setting the stage for a successful audit. Specific audit tactics addressed include auditing for content quality, performance, global considerations, and legal and regulatory issues. You will also learn how to do a competitive audit and incorporate personas into an audit. Tips on presenting audit results to stakeholders will help you deliver effective strategies.