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Author: Itay Abuhav
Publisher: CRC Press
Published: 2021-12-13
Total Pages: 444
ISBN-13: 9781032240428
DOWNLOAD EBOOKThis book covers all of the new ISO 9001 requirements in detail, including examples and demonstrations from various fields and industries. In the practice of industry, the changes will demand from the ISO 9001 standard certified organizations to initiate massive adjustments to their quality management system. The adjustments are to be seen in th
Author: David Hoyle
Publisher: Taylor & Francis
Published: 2017-07-06
Total Pages: 893
ISBN-13: 1317282280
DOWNLOAD EBOOKCompletely 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!
Author: Itay Abuhav
Publisher: CRC Press
Published: 2018-05-11
Total Pages: 735
ISBN-13: 1351000772
DOWNLOAD EBOOKSummary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
Author: David Hoyle
Publisher: Elsevier
Published: 2015-08-11
Total Pages: 393
ISBN-13: 1483104931
DOWNLOAD EBOOKQuality 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.
Author: Ray Tricker
Publisher: Routledge
Published: 2016-10-04
Total Pages: 633
ISBN-13: 1317685679
DOWNLOAD EBOOKSmall businesses face many challenges today, including the increasing demand by larger companies for ISO 9001compliance, a challenging task for any organisation and in particular for a small business without quality assurance experts on its payroll. Ray Tricker has already guided hundreds of businesses through to ISO accreditation, and this sixth edition of his life-saving ISO guide provides all you need to meet the new 2015 standards. ISO 9001:2015 for Small Businesses helps you understand what the new standard is all about and how to achieve compliance in a cost effective way. Covering all the major changes to the standards, this book provides direct, accessible and straightforward guidance. This edition includes: down-to-earth explanations to help you determine what you need to enable you to work in compliance with and/or achieve certification to ISO 9001:2015; a contextual explanation of ISO 9001 within the structure of ISO 9000 family of standards; a detailed description of the structure of ISO 9001:2015 and its compliance with Annex SL; coverage of the new requirements for Risk Management and Risk Analysis; a guide to the costs involved in implementing ISO 9001:2015 and advice on how to control costs; an example of a complete, generic Quality Management System consisting of a Quality Manual plus a whole host of Quality Processes, Quality Procedures and Word Instructions; and access to a free, software copy of these generic QMS files to give you a starting point from which to develop your own documentation. This book is also supported with a complete bibliography containing abbreviations and acronyms as well as a glossary of terms. This comprehensive text will provide you and your small business with a complete guide on your way to ISO compliance.
Author: Patricia A. Adam
Publisher: Springer Nature
Published: 2023-03-22
Total Pages: 84
ISBN-13: 3031235886
DOWNLOAD EBOOKDo you ask yourself what this ‘agility hype’ is actually about and in what cases agility really creates benefits? Would you like to know how to make processes more agile? Do you fancy the idea of using agile methods but don't know how to explain it to your ISO 9001 auditor? This is the book you’ve been waiting for! Written from a quality management professional’s point of view, it offers useful solutions and practical advice concerning the use of agile practices in ISO 9001-based quality management systems. Agility for organisations is defined and described in a structured way. It is shown in detail how agile practices can be integrated into a QM system while maintaining the ISO 9001 certification. You will find out what needs to be considered when systemically incorporating agile practices, and how to balance the benefits and limitations of agility in organisations. Based on a qualitative, intersectoral research initiative, this book provides unique, state-of-the-art information and valid arguments for focused organisational development. It is intended for professionals such as quality managers, innovation managers, auditors of ISO management standards, organisational developers and managers who lead ISO 9001-certified companies.
Author: Peter Mauch
Publisher: CRC Press
Published: 1994-09-01
Total Pages: 188
ISBN-13: 9781884015113
DOWNLOAD EBOOKDesigned and written by professionals with extensive ISO 9000 Certification experience, the techniques and forms in this Manual have been used successfully to achieve certification at over 50 companies. The 90-Day ISO 9000 Manual provides the basic system you need in place to satisfy an ISO 9000 Audit. First, ISO 9000 is explained and the registration process described in detail. Next, you are taken through exactly what you need to do to prepare for an audit. You are given the working instructions and forms you need to meet certification requirements. The forms are unique and have been designed specifically for ISO 9000 standards. Since ISO 9000 is not designed to be a TQM program the authors have also included a special section that provides the information, instructions and forms needed for quality audits such as Q94 or Z1. If you want to take your program further than just ISO 9000 certification, the material is available to you. The 90-Day ISO 9000 Manual includes the latest published draft of Q91 DIS, which is the formal public review copy. Companies that have recently been audited have noticed that certain improvements in documentation have been expected by registrars. These improvements require rewording the old standards. The new standards have been incorporated in this manual and several schemes have been modified. The authors of The 90-Day ISO 9000 Manual have extensive experience working on ISO 9000 standards review, consulting with companies developing programs, registrar experience and international ISO 9000 activities. This manual will reflect a practical approach to registration for the next five years.
Author: Craig Cochran
Publisher: Paton Professional
Published: 2015-11-16
Total Pages: 238
ISBN-13: 1932828737
DOWNLOAD EBOOKJust 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.
Author: Milton P. Dentch
Publisher: Quality Press
Published: 2016-05-02
Total Pages: 119
ISBN-13: 1951058925
DOWNLOAD EBOOKThe 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.
Author: Ann W. Phillips
Publisher: Quality Press
Published: 2015-09-21
Total Pages: 95
ISBN-13: 1951058968
DOWNLOAD EBOOKImplementing the requirements of ISO 9001 can be a daunting task for many organizations. In an attempt to develop a system that will pass the registration audit, we are tempted to establish processes with the primary purpose of conforming to the requirements of ISO 9001. In doing so, however, it is easy to lose sight of the primary intent of the standard: to continually improve the effectiveness of the quality management system (QMS) implemented at our organization. This book is intended to help managers, quality professionals, internal audit coordinators, and internal auditors implement a practical internal audit process that meets the requirements of ISO 9001:2015 while adding significant, measurable value to the organization. The tools, techniques, and step-by-step guidelines provided in this book can also be used by those organizations that have a well-established internal audit process but are looking for easy ways to make that process more effective.
