ISO 9000 Quality Systems Handbook - updated for the ISO 9001:2008 standard

ISO 9000 Quality Systems Handbook - updated for the ISO 9001:2008 standard

Author: David Hoyle

Publisher: Routledge

Published: 2009-10-26

Total Pages: 816

ISBN-13: 1136438254

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Whether you are establishing a quality management system for the first time or improving your existing system, this best-selling guide to effective quality management using the ISO 9000 family of standards as a framework for business process management (BPM) and improvement is an essential addition to your quality bookshelf. For newcomers to the field and those needing a refresh on the fundamental principles, quality expert David Hoyle covers the crucial background including the importance and implications of quality system management, enabling those seeking ISO 9001 certification to take a holistic approach that will bring about true business improvement and sustained success. Packed with insights into how the standard has been used, misused and misunderstood, ISO 9000 Quality Systems Handbook will help you to build an effective management system, help you decide if ISO 9001 certification is right for your company and gently guide you through the terminology, requirements and implementation of practices to enhance performance. With chapter headings matched to the structure of the standard and clause numbers included for ease of reference, each chapter now also begins with a preview to help you decide which to study and which to skip. The book also includes essential concepts and principles, important issues to be understood before embarking upon implementation, different approaches that can be taken to achieving, sustaining and improving quality, and guidance on system assessment, certification and continuing development. Clear tables, summary checklists and diagrams make light work of challenging concepts and downloadable template report forms, available from the book's companion website, take the pain out of compiling the necessary documentation. Don't waste time trying to achieve certification without this tried and trusted guide to improving your business—let David Hoyle lead you towards a better quality management system and see the difference it can make to your processes and profits!


ISO 9000 Quality Systems Handbook-updated for the ISO 9001: 2015 standard

ISO 9000 Quality Systems Handbook-updated for the ISO 9001: 2015 standard

Author: David Hoyle

Publisher: Taylor & Francis

Published: 2017-07-06

Total Pages: 893

ISBN-13: 1317282280

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Completely revised to align with ISO 9001:2015, this handbook has been the bible for users of ISO 9001 since 1994, helping organizations get certified and increase the quality of their outputs. Whether you are an experienced professional, a novice, or a quality management student or researcher, this is a crucial addition to your bookshelf. The various ways in which requirements are interpreted and applied are discussed using published definitions, reasoned arguments and practical examples. Packed with insights into how the standard has been used, misused and misunderstood, ISO 9000 Quality Systems Handbook will help you to decide if ISO 9001 certification is right for your company and will gently guide you through the terminology, requirements and implementation of practices to enhance performance. Matched to the revised structure of the 2015 standard, with clause numbers included for ease of reference, the book also includes: Graphics and text boxes to illustrate concepts, and points of contention; Explanations between the differences of the 2008 and 2015 versions of ISO 9001; Examples of misconceptions, inconsistencies and other anomalies; Solutions provided for manufacturing and service sectors. This new edition includes substantially more guidance for students, instructors and managers in the service sector, as well as those working with small businesses. Don’t waste time trying to achieve certification without this tried and trusted guide to improving your business – let David Hoyle lead you towards a better way of thinking about quality and its management and see the difference it can make to your processes and profits!


Building Quality Management Systems

Building Quality Management Systems

Author: Luis Rocha-Lona

Publisher: CRC Press

Published: 2017-08-21

Total Pages: 205

ISBN-13: 1040084370

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Quality has quickly become one of the most important decision-making factors for consumers. And although organizations invest considerable resources into building the right quality management systems (QMSs), in many instances, the adoption of such quality improvement tools are just not enough. Building Quality Management Systems: Selecting the Righ


Quality Systems Handbook

Quality Systems Handbook

Author: David Hoyle

Publisher: Elsevier

Published: 2015-08-11

Total Pages: 393

ISBN-13: 1483104931

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Quality Systems Handbook is a reference book that covers concepts and ideas in quality system. The book is comprised of two parts. Part 1 provides the background information of ISO 9000, such as its origin, composition, application, and the strategies for registration. Part 2 covers topics relevant to the ISO 9000 requirements, which include design control, internal quality audits, and statistical techniques. The text will be useful to managers, auditors, and quality practitioners who require reference in the various aspects of quality systems.


Quality Management Systems

Quality Management Systems

Author: Ray Tricker

Publisher: Routledge

Published: 2019-11-05

Total Pages: 302

ISBN-13: 1000728129

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This book provides a clear, easy to digest overview of Quality Management Systems (QMS). Critically, it offers the reader an explanation of the International Standards Organization’s (ISO) requirement that in future all new and existing Management Systems Standards will need to have the same high-level structure, commonly referred to as Annex SL, with identical core text, as well as common terms and definitions. In addition to explaining what Annex SL entails, this book provides the reader with a guide to the principles, requirements and interoperability of Quality Management System standards, how to complete internal and external management reviews, third-party audits and evaluations, as well as how to become an ISO Certified Organisation once your QMS is fully established. As a simple and straightforward explanation of QMS Standards and their current requirements, this is a perfect guide for practitioners who need a comprehensive overview to put theory into practice, as well as for undergraduate and postgraduate students studying quality management as part of broader Operations and Management courses.


Laboratory Quality Management System

Laboratory Quality Management System

Author: World Health Organization

Publisher:

Published: 2011

Total Pages: 0

ISBN-13: 9789241548274

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Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".


Achieving Customer Experience Excellence through a Quality Management System

Achieving Customer Experience Excellence through a Quality Management System

Author: Alka Jarvis

Publisher: Quality Press

Published: 2016-07-08

Total Pages: 245

ISBN-13: 0873899350

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We are in what many call “The Age of the Customer.” Customers are empowered more than ever before and demand a high level of customer attention and service. Their increasing expectations and demands worldwide have forced organizations to transform themselves and prepare for the customer experience (CX) battlefield. This landmark book addresses: What customer experience really means Why it matters Whether it has any substantial business impact What your organization can do to deliver and sustain your CX efforts, and How we got to this particular point in CX history This book is the result of exhaustive research conducted to incorporate various components that affect customer experience. Based on the research results, the authors make a case for seeing CX and associated transformations as the next natural evolution of the quality management system (QMS) already in place in most companies. Using an existing QMS as the foundation for CX not only creates a more sustainable platform, but it allows for a faster and more cost effective way to enable an organization to attain world-class CX.


ISO 9001:2000 Quality Management System Design

ISO 9001:2000 Quality Management System Design

Author: Jay J. Schlickman

Publisher: Artech House

Published: 2003

Total Pages: 408

ISBN-13: 9781580535960

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"The book describes the design rules required to document, implement, and demonstrate quality management system effectiveness in compliance with the latest version of the ISO 9000 International Standard. This systematic and engineering approach simplifies the many complexities in maintaining compliance with ISO standards. This hands-on guide is packed with tips and insights the author has garnered from personally designing quality management systems that integrate organizational strategy with quality management. Moreover, the book helps professionals create meaningful documentation and a user-friendly, informative quality manual that together form the core of an effective and responsive quality management system."--Jacket.


Quality Systems and Controls for Pharmaceuticals

Quality Systems and Controls for Pharmaceuticals

Author: Dipak Kumar Sarker

Publisher: John Wiley & Sons

Published: 2008-07-31

Total Pages: 204

ISBN-13: 0470773049

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Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models. Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice. The author has both industry and academic experience and many ‘best practice’ examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.