ISO 9001:2015 Explained, Fourth Edition

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Publisher : Quality Press
ISBN 13 : 0873899016
Total Pages : 264 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis ISO 9001:2015 Explained, Fourth Edition by : Charles A. Cianfrani

Download or read book ISO 9001:2015 Explained, Fourth Edition written by Charles A. Cianfrani and published by Quality Press. This book was released on 2015-11-04 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2015 edition of ISO 9001 has been modernized to update terminology and content to meet current and anticipated user needs. The major emphasis of ISO 9001:2015 is still consistent provision of products and services that meet customer and applicable statutory and regulatory requirements. This book explains the meaning and intent of the requirements of ISO 9001:2015 and discusses the requirements as they relate to each of the product categories. Where appropriate, it includes an elaboration of why the requirements are important. It also includes typical audit-type questions that an organization may consider to assess conformity to internal needs and ISO 9001 requirements. Recommendations for implementation are also included. This book addresses the needs of: Users and organizations seeking a general understanding of the contents of ISO 9001:2015 Users and organizations desiring guidance to ensure their ISO 9001:2015 QMS meets the new version requirements Users and organizations considering the use of ISO 9001:2015 as a foundation for the development of a comprehensive QMS Educators who require a textbook to accompany a training class or course on ISO 9001:2015 Auditors who desire to increase their level of auditing competence Authors Cianfrani and West, members of the expert group that developed ISO 9001:2015, strive to provide a context for all requirements to enable you to develop and deploy processes that will strengthen your QMS. Getting or retaining a certificate is not the real objective. Satisfied customers and organizational sustainability should be primary objectives for the organization.

Cracking the Case of ISO 9001:2015 for Service, Third Edition

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Publisher : Quality Press
ISBN 13 : 0873899083
Total Pages : 296 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis Cracking the Case of ISO 9001:2015 for Service, Third Edition by : Charles A. Cianfrani

Download or read book Cracking the Case of ISO 9001:2015 for Service, Third Edition written by Charles A. Cianfrani and published by Quality Press. This book was released on 2016-09-08 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guide is intended to help everyone in a service organization participate in creating and sustaining a foundation of integrity, meet requirements and customer expectations, and support robust processes, to the advantage of everyone in the organization and to each of its customers. It provides a simplified explanation of the clauses of ISO 9001:2015, including: - What’s required - Why to do it - Implementation tips - Questions to ask to assess conformity Also included is a chapter that answers the question “Why do ISO 9001:2015?” and a chapter that summarizes the key differences with past editions of ISO 9001. To assist the user in implementation of QMS processes, this guide also includes a chapter that describes 12 quality tools. For each tool, the authors describe (1) what it is, (2) where it’s used, (3) how it’s done, and (4) cautions to be considered when using the tool. The contents of this book can help organizations save time in achieving compliance with the ISO 9001 requirements and also facilitate effective implementation. This has the potential to lower internal costs and to improve customer satisfaction.

Cracking the Case of ISO 9001:2015 for Manufacturing, Third Edition

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Author :
Publisher : Quality Press
ISBN 13 : 0873899075
Total Pages : 298 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis Cracking the Case of ISO 9001:2015 for Manufacturing, Third Edition by : Charles A. Cianfrani

Download or read book Cracking the Case of ISO 9001:2015 for Manufacturing, Third Edition written by Charles A. Cianfrani and published by Quality Press. This book was released on 2016-09-08 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt:

How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements

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Publisher : Quality Press
ISBN 13 : 0873899172
Total Pages : 156 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements by : Stephanie L. Skipper

Download or read book How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements written by Stephanie L. Skipper and published by Quality Press. This book was released on 2015-10-14 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains the requirements for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls, and presents a methodology for compliance. The document control system (DCS), or documented information control system (DICS), is the foundation of a quality management system. It is the first quality system element that must be implemented because the establishment and control of documented processes and information in a quality-controlled environment is dependent on the ability to proactively manage access to documents and the movement of documents through the document life cycle. A well-developed document control system benefits business by: Improving knowledge retention and knowledge transfer within and across business units Improving access to knowledge-based information Improving employee performance by providing standardized processes and communicating clear expectations Improving customer communication and satisfaction by providing documented information from which common understanding can be achieved Providing traceability of activities and documentation throughout the organization Improving organization of and access to documents and data Sample documents are included in the appendixes of this book to help clarify explanations, and a full set of formatted procedures and document templates are available for download to get you off to an even faster start. This book provides a process-based approach that can be used for controlling all forms of documented information that are required to be managed under the quality management system.

A Practical Field Guide for ISO 9001:2015

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Author :
Publisher : Quality Press
ISBN 13 : 1953079423
Total Pages : 166 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis A Practical Field Guide for ISO 9001:2015 by : Erik V. Myhrberg

Download or read book A Practical Field Guide for ISO 9001:2015 written by Erik V. Myhrberg and published by Quality Press. This book was released on 2016-10-03 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: The intent of this field guide is to assist organizations, step by step, in implementing a QMS in conformance with ISO 9001:2015, whether “from scratch” or by transitioning from ISO 9001:2008. Within the guide each sub-clause containing requirements is the focus of a two-page spread that consistently presents features that fulfill the requirements listed below. This book examines each sub-clause of clauses 4–10 of ISO 9001:2015, which contain the requirements, with a visual representation provided in flowchart format on the facing page. This field guide will: *Provide a user-friendly guide to ISO 9001:2015’s requirements for implementation purposes *Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 9001:2015 implementation *Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists *Direct management on what it must do and should consider to satisfy ISO 9001:2015’s enhanced requirements and responsibilities for top management *Depict step by step what must occur to create an effective, conforming QMS What separates this field guide from most other books on ISO 9001:2015 and its implementation are the flowcharts showing the steps to be taken in implementing a QMS to meet a sub-clause’s requirements. As the flowcharts themselves can be overwhelming when you first look at them, a text box appears with each flow chart that explains pertinent facts and/or what the flowchart represents and how it is to be used.

How to Audit ISO 9001:2015

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Publisher : Quality Press
ISBN 13 : 1953079547
Total Pages : 161 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis How to Audit ISO 9001:2015 by : Chad Kymal

Download or read book How to Audit ISO 9001:2015 written by Chad Kymal and published by Quality Press. This book was released on 2016-04-04 with total page 161 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 example of the format for an ISO 9001:2015 conformance checklist.

The ISO 45001:2018 Implementation Handbook

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Publisher : Quality Press
ISBN 13 : 1953079377
Total Pages : 138 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis The ISO 45001:2018 Implementation Handbook by : Milton P. Dentch

Download or read book The ISO 45001:2018 Implementation Handbook written by Milton P. Dentch and published by Quality Press. This book was released on 2018-06-05 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guidance on how an organization can build and use a management system to both control and improve its safety or occupational health and safety performance in alignment with the requirements of ISO 45001:2018.

A Practical Field Guide for ISO 14001:2015

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Publisher : Quality Press
ISBN 13 : 0873899636
Total Pages : 84 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis A Practical Field Guide for ISO 14001:2015 by : Erik V. Myhrberg

Download or read book A Practical Field Guide for ISO 14001:2015 written by Erik V. Myhrberg and published by Quality Press. This book was released on 2017-01-01 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field guide depicts step by step what must occur for organizations to create an effective environmental management system (EMS) in conformance with ISO 14001:2015, whether “from scratch” or by transitioning from ISO 14001:2004. In keeping with ISO 9000:2015’s definition of environmental as the “degree to which a set of inherent characteristics fulfills requirements,” the authors have identified the requirements and inherent characteristics (distinguishing features) for this field guide. Within the guide, each sub-clause containing requirements is the focus of a two-page spread that consistently presents features that fulfill ISO 14001’s requirements. What separates this field guide from most other books on ISO 14001:2015 and its implementation are flowcharts showing the steps to be taken in implementing an EMS to meet a sub-clause’s requirements. This field guide has been created to foster an inner reliance between senior management, middle management, functional teams, and the individual. Users of the field guide will find within it practical tools, tips, and techniques useful for not only implementing an environmental management system (EMS) but also maintaining one. The revised ISO 14001:2015 standard is both useful to the organization and here to stay. May this logistical field guide serve you and your organization well!

The Magic of ISO 9001

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Publisher : Quality Press
ISBN 13 : 0873899598
Total Pages : 45 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis The Magic of ISO 9001 by : John F. Graham

Download or read book The Magic of ISO 9001 written by John F. Graham and published by Quality Press. This book was released on 2017-05-19 with total page 45 pages. Available in PDF, EPUB and Kindle. Book excerpt:

ISO 9001:2015 In Brief

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Author :
Publisher : Routledge
ISBN 13 : 131768561X
Total Pages : 290 pages
Book Rating : 4.3/5 (176 download)

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Book Synopsis ISO 9001:2015 In Brief by : Ray Tricker

Download or read book ISO 9001:2015 In Brief written by Ray Tricker and published by Routledge. This book was released on 2016-06-23 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: ISO 9001: 2015 In Brief provides an introduction to quality management systems for students, newcomers and busy executives, with a user friendly, simplified explanation of the history, the requirements and benefits of the new standard. This short, easy-to-understand reference tool also helps organisations to quickly set up an ISO 9001:2015 compliant Quality Management System for themselves at minimal expense and without high consultancy fees. Now in its fourth edition, ISO 9001:2015 In Brief consists of a number of chapters covering topics like: What is Quality? – An introduction to the requirements and benefits of quality, quality control and quality assurance What is a QMS? – The structure of a Quality Management System and associated responsibilities. Who produces Quality Standards? – An opportunity to see how interlinked the various Standards Bodies are today. What is ISO 9001:2015? - The background to this particular standard, how it has grown and developed over the years and what ‘Annex SL’ is all about. What other standards are based on ISO 9001:2015? – Details of other standards that replicate or are broadly based on ISO 9001:2015. What to do once your QMS is established – Process improvement tools, internal auditing and the road to ISO 9001:2015 certification. This is supported by: Annex A – A summary of the requirements of ISO 9001:2015 - including an overview of the content of the various clauses and sub clauses, the likely documentation required and how these would affect an organization. A cross-reference to the previous ISO 9001:2008 Clauses is also provided as well as a complete bibliography and glossary.

ISO Lesson Guide 2015

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Publisher : Quality Press
ISBN 13 : 0873899032
Total Pages : 102 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis ISO Lesson Guide 2015 by : J.P. Russell

Download or read book ISO Lesson Guide 2015 written by J.P. Russell and published by Quality Press. This book was released on 2016-07-18 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ISO Lesson Guide translates ISO 9001 into easy-to-understand words. This pocket guide was designed as a quick reference for anyone to carry around conveniently. Each element containing requirements is discussed and key concepts are highlighted at the beginning of each section. In the ISO Lesson Guide: Quality is defined The ISO process approach is explained Key concepts are accompanied by an illustration Risk-based thinking is introduced Concepts are described in easy-to-understand words A brief conspectus summarizes ISO 9001 requirements Quality management principles are described in easy-to-understand words An entertaining fable explains the difference between ISO 9001 and ISO 9004 Ideal for handing out to existing and new employees, this pocket guide can also be used as supplemental study material for ISO 9001 training courses.

The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing

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Publisher : Quality Press
ISBN 13 : 0873899253
Total Pages : 216 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing by : J.B. Smith

Download or read book The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing written by J.B. Smith and published by Quality Press. This book was released on 2016-03-08 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The author’s lessons learned—during more than 25 years of hands-on quality management experience in environments including manufacturing, medical devices, military, aerospace, automotive, and logistics—are condensed in this book to provide reference material to both beginners and seasoned professionals in the development and sustainability of an effective quality and operational system. Experiences shared in this book include the design from ground zero-to-deployment, risk mitigation, and maintenance of quality standards such as ISO 9001, AS9100, ISO/TS 16949, TL 9000, FDA/GMP and C-TPAT standard, and Lean Six Sigma principles. The main focus of this book is to promote the use of the internal auditing tool as a feedback mechanism not only for compliance verification but also for the measurement and enhancement of the system’s effectiveness. The catalysts for this goal are: Auditing beyond compliance to include identification of improvement opportunities Use of process metrics as feedback mechanism in the discovery of hidden factories and risks Concepts and models discussed in this book are clearly illustrated using anonymous real-life examples encountered in day-to-day operations. These examples include lessons learned associated with compliance, continuous improvement, and techniques in the conversion of performance metrics as process indicators, savings’ generators, and risk mitigation. The examples and models are simple and easy to understand accompanied with templates for quick application on the creation of problem statements, root cause analysis methods, and design of action plans with measurement of success. Workshop modules for ‘training the trainers’ are included in this book with practical hands-on exercises on the different tools associated with problem solving, development of process metrics for risk mitigations and auditing.

ISO 9001:2015 In Brief

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Author :
Publisher : Routledge
ISBN 13 : 1317685628
Total Pages : 258 pages
Book Rating : 4.3/5 (176 download)

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Book Synopsis ISO 9001:2015 In Brief by : Ray Tricker

Download or read book ISO 9001:2015 In Brief written by Ray Tricker and published by Routledge. This book was released on 2016-06-23 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: ISO 9001: 2015 In Brief provides an introduction to quality management systems for students, newcomers and busy executives, with a user friendly, simplified explanation of the history, the requirements and benefits of the new standard. This short, easy-to-understand reference tool also helps organisations to quickly set up an ISO 9001:2015 compliant Quality Management System for themselves at minimal expense and without high consultancy fees. Now in its fourth edition, ISO 9001:2015 In Brief consists of a number of chapters covering topics like: What is Quality? – An introduction to the requirements and benefits of quality, quality control and quality assurance What is a QMS? – The structure of a Quality Management System and associated responsibilities. Who produces Quality Standards? – An opportunity to see how interlinked the various Standards Bodies are today. What is ISO 9001:2015? - The background to this particular standard, how it has grown and developed over the years and what ‘Annex SL’ is all about. What other standards are based on ISO 9001:2015? – Details of other standards that replicate or are broadly based on ISO 9001:2015. What to do once your QMS is established – Process improvement tools, internal auditing and the road to ISO 9001:2015 certification. This is supported by: Annex A – A summary of the requirements of ISO 9001:2015 - including an overview of the content of the various clauses and sub clauses, the likely documentation required and how these would affect an organization. A cross-reference to the previous ISO 9001:2008 Clauses is also provided as well as a complete bibliography and glossary.

ISO 9001:2015 Internal Audits Made Easy, Fourth Edition

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Author :
Publisher : Quality Press
ISBN 13 : 0873899024
Total Pages : 176 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis ISO 9001:2015 Internal Audits Made Easy, Fourth Edition by : Ann W. Phillips

Download or read book ISO 9001:2015 Internal Audits Made Easy, Fourth Edition written by Ann W. Phillips and published by Quality Press. This book was released on 2015-11-10 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: Implementing 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. The tools in the appendices of this book have also been provided on the enclosed CD to facilitate your customizing them to fit the specific needs of your organization.

ISO 9001:2015 in Plain English

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Author :
Publisher : Paton Professional
ISBN 13 : 1932828737
Total Pages : 284 pages
Book Rating : 4.9/5 (328 download)

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Book Synopsis ISO 9001:2015 in Plain English by : Craig Cochran

Download or read book ISO 9001:2015 in Plain English written by Craig Cochran and published by Paton Professional. This book was released on 2015-11-16 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: ISO 9001 hasn't changed much in the last 15 years... until now! ISO 9001:2015 is a MAJOR revision. A LOT has changed. Requirements have been added and removed. Content has shifted to different sections and clauses. ISO 9001:2015 is built upon a completely different structure with the adoption of Annex SL. This may seem like a lot to take in, and it is. Fortunately, bestselling author Craig Cochran has translated ISO 9001:2015 into plain English that anyone can understand. 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. Plus, Cochran shows what has changed between the 2008 and 2015 version. 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.

The ISO 9001:2015 Implementation Handbook:

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Author :
Publisher : Quality Press
ISBN 13 : 1951058925
Total Pages : 119 pages
Book Rating : 4.9/5 (51 download)

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Book Synopsis The ISO 9001:2015 Implementation Handbook: by : Milton P. Dentch

Download or read book The ISO 9001:2015 Implementation Handbook: written by Milton P. Dentch and published by Quality Press. This book was released on 2016-05-02 with total page 119 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

ISO 9001:2015 for Small Businesses

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Author :
Publisher : Routledge
ISBN 13 : 1317685679
Total Pages : 633 pages
Book Rating : 4.3/5 (176 download)

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Book Synopsis ISO 9001:2015 for Small Businesses by : Ray Tricker

Download or read book ISO 9001:2015 for Small Businesses written by Ray Tricker and published by Routledge. This book was released on 2016-10-04 with total page 633 pages. Available in PDF, EPUB and Kindle. Book excerpt: Small 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.