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The 2015 version of ISO 9001 brings many enriching changes to promote quality excellence by organizations. The most significant change is the reinforcement of the fact that ISO 9001 is not just a quality issue. It is relevant as an overarching management topic. The book explains the requirements of the revised (2015) version of ISO 9001 in simple and practical manner. The objective has been to enhance understanding of the subject matter by managers and quality professionals. A conceptual understanding shall enable managers and professionals to design better systems and processes uniquely suited to their respective organizations. In view of this the first five chapters of the book explain concepts on QUALITY, PROCESS, PROCESS APPROACH / MANAGEMENT and PDCA. These are relevant for all management system standards being developed by International Organization for Standardization with the High Level Structure. Part II of the book goes into details of each clause focusing on processes and process interactions. We expect that the readers will appreciate that ISO 9001, now focuses more on expected outcomes through processes than mandating too many requirements.
The handbook is structured to guide organizations new to ISO 9001 through the process necessary to connect their current practices to the requirements of ISO 9001:2015. For organizations already certified to ISO 9001, it advises how to use your upgrade to ISO 9001:2015 as an opportunity to rebuild your QMS into a helpful asset in managing your business.
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.
This landmark publication distills the body of knowledge that characterizes mineral processing and extractive metallurgy as disciplinary fields. It will inspire and inform current and future generations of minerals and metallurgy professionals. Mineral processing and extractive metallurgy are atypical disciplines, requiring a combination of knowledge, experience, and art. Investing in this trove of valuable information is a must for all those involved in the industry—students, engineers, mill managers, and operators. More than 192 internationally recognized experts have contributed to the handbook’s 128 thought-provoking chapters that examine nearly every aspect of mineral processing and extractive metallurgy. This inclusive reference addresses the magnitude of traditional industry topics and also addresses the new technologies and important cultural and social issues that are important today. Contents Mineral Characterization and AnalysisManagement and ReportingComminutionClassification and WashingTransport and StoragePhysical SeparationsFlotationSolid and Liquid SeparationDisposalHydrometallurgyPyrometallurgyProcessing of Selected Metals, Minerals, and Materials
This book defines, develops, and examines the foundations of the APQP (Advanced Product Quality Planning) methodology. It explains in detail the five phases, and it relates its significance to national, international, and customer specific standards. It also includes additional information on the PPAP (Production Part Approval Process), Risk, Warranty, GD&T (Geometric Dimensioning and Tolerancing), and the role of leadership as they apply to the continual improvement process of any organization. Features Defines and explains the five stages of APQP in detail Identifies and zeroes in on the critical steps of the APQP methodology Covers the issue of risk as it is defined in the ISO 9001, IATF 16949, the pending VDA, and the OEM requirements Presents the role of leadership and management in the APQP methodology Summarizes all of the change requirements of the IATF standard
Just as he did with the bestselling ISO 9001 in Plain English Cochran has written a comprehensive yet easily understandable guide to ISO 9001:2015. ISO 9001:2015 in Plain English was written so that anyone at any level of the organization can get to the heart of the standard’s requirements and how they apply to the organization quickly and simply. This straightforward book is ideal for people who are new to ISO 9001:2015, experienced ISO coordinators who want to get more out of an established system as they transition to the new standard, and for employees who just need a basic understanding of what ISO 9001:2015 is and how it applies to them. Cochran explains each of ISO 9001:2015’s sections and clauses using real-world examples and frequently asked questions.
Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. This book provides the background theory, applied descriptions of the guidelines and concepts, plus questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts. In this book the authors share their combined 60+ years of extensive practical experience in the industry and in process improvement combined with detailed understanding of the needs of the industry and education system. This book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management.This book is fully revised, updated, and expanded with new content in areas such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools. - Fully revised, updated, and expanded new edition - Features new topics such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools - Includes end-of-chapter summaries and end-of-chapter question and/or problems - Provides detailed steps and examples for applying the guidelines and quality tools - Written in an accessible style making the content easy to understand and apply
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!
A step-by-step, full-color guide to successful medical technology innovation with a new focus on value-based innovation and global opportunities.
The New Manager’s Guide and Mentor The Harvard Business Essentials series is designed to provide comprehensive advice, personal coaching, background information, and guidance on the most relevant topics in business. Whether you are a new manager seeking to expand your skills or a seasoned professional looking to broaden your knowledge base, these solution-oriented books put reliable answers at your fingertips. Decision making is a critical part of management, and bad choices can damage careers and the bottom line. This book offers the tools and advice managers need to avoid common biases and arrive at and implement decisions that are both sound and ethical.