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How to Audit ISO 9001:2015

Author : Chad Kymal

Publisher : Quality Press

Page : 136 pages

File Size : 47,71 MB

Release : 2016-04-22

Category : Business & Economics

ISBN : 087389927X

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Book Description

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.



ISO 9001:2015 Internal Audits Made Easy

Author : Ann W. Phillips

Publisher : Quality Press

Page : 95 pages

File Size : 46,92 MB

Release : 2015-09-21

Category : Business & Economics

ISBN : 1951058968

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Book Description

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 ISO 9001:2015 Implementation Handbook:

Author : Milton P. Dentch

Publisher : Quality Press

Page : 119 pages

File Size : 15,53 MB

Release : 2016-05-02

Category : Business & Economics

ISBN : 1951058925

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Book Description

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 Audit Trail

Author : David John Seear

Publisher : Author House

Page : 125 pages

File Size : 35,34 MB

Release : 2012-10-16

Category : Business & Economics

ISBN : 147723490X

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Book Description

This book has been revised to coincide with the issue of the ISO 9001 Family of Standards by the same author. The intention is to improve the standard of auditing, especially audits carried out under the banner of the ISO 9001 standard. The ISO 9001 standard is quite capable of allowing organizations, certification bodies, and auditors to judge if an organization is capable of consistently providing product or service that meets the customer and applicable statutory and regulatory requirements. At the present time, however, there is no common understanding about what the ISO 9001 audit should achieve. The aim of this book is to explain what auditing is capable of achieving, in particular the method of carrying out audits. There is, however, a need to improve the understanding of the ISO 9000 Family of Standards, and to this end, appendix C contains the first five pages of that book. Auditing can be costly and timeconsuming, and for it to be effective, it needs to give tangible benefits. This book will enable organizations and other interested parties to judge if their auditing activities are effective and beneficial. It enables them to examine their approach to audits and compare them with the techniques used within this book.



ISO 9001:2015 Explained

Author : Charles A. Cianfrani

Publisher : Quality Press

Page : 158 pages

File Size : 50,11 MB

Release : 2015-09-21

Category : Business & Economics

ISBN : 1953079741

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Book Description

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.



ISO 9001:2015 Handbook for Small and Medium-Sized Businesses, Third Edition

Author : Denise E. Robitaille

Publisher : Quality Press

Page : 99 pages

File Size : 28,8 MB

Release : 2016-03-24

Category : Business & Economics

ISBN : 0873899059

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Book Description

This handbook was developed to help small and medium-sized organizations better understand ISO 9001:2015. It is intended to facilitate implementation and improvement. The establishment, implementation, and maintenance of an ISO 9001–compliant quality management system (QMS) should allow the organization to experience multiple benefits beyond the achievement of certification. Organizations should also see improvements in the quality of products, customer satisfaction, and process effectiveness—all of which ultimately have a positive impact on the bottom line. It is expected that some readers will have already established a QMS. This handbook will serve to reinforce good practices and will help you better understand the intent and value of some of the requirements of ISO 9001. Since the handbook is especially focused on small and medium-sized organizations, the examples that are provided will have greater applicability and will enhance comprehension, again resulting in increased value. Implementing a QMS in a small organization is not easier or harder than it is in a large one. Resources are different; each organization has its own unique challenges, constraints, and advantages. The thing to always bear in mind is that this is your organization and these are your processes. ISO 9001:2015 defines the requirements, but it does not dictate the method of application. Utilizing this handbook should allow you to develop or rejuvenate your QMS so that it is a benefit to both you and your customer.



ISO 9001:2015 in Plain English

Author : Craig Cochran

Publisher : Paton Professional

Page : 238 pages

File Size : 37,48 MB

Release : 2015-11-16

Category : Business & Economics

ISBN : 1932828737

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Book Description

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.



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

Author : Stephanie L. Skipper

Publisher : Quality Press

Page : 159 pages

File Size : 44,89 MB

Release : 2015-10-12

Category : Business & Economics

ISBN : 1953079504

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Book Description

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. 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.



ISO 9001:2015 Audit Procedures

Author : Ray Tricker

Publisher : Routledge

Page : 288 pages

File Size : 32,50 MB

Release : 2016-07-01

Category : Business & Economics

ISBN : 1317685555

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Book Description

Revised and fully, ISO 9001:2015 Audit Procedures describes the methods for completing management reviews and quality audits and describes the changes made to the standards for 2015 and how they are likely to impact on your own audit procedures. Now in its fourth edition, this text includes essential material on process models, generic processes and detailed coverage of auditor questionnaires. Part II includes a series of useful checklists to assist auditors in compiling their own systems and individual audit check sheets. The whole text is also supported with a glossary of terms as well as explanations of acronyms and abbreviations used in quality. ISO 9001:2015 Audit Procedures is for auditors of small businesses looking to complete a quality audit review for the 2015 standards. This book will also prove invaluable to all professional auditors completing internal, external and third party audits.



Iatf 16949-2016 Plus Iso 9001-2015

Author : Patrick Ambrose

Publisher : Createspace Independent Publishing Platform

Page : 346 pages

File Size : 34,93 MB

Release : 2017-06-05

Category :

ISBN : 9781547033553

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Book Description

NEW SECOND EDITION 2018 The SECOND EDITION - IATF 16949:2016 Audit Guide and Checklist provides all the information necessary for an in-depth assessment of your ISO 9001:2015 / IATF 16949:2016 Quality Management System. It was written to help auditors conduct a 'process based' audit and stresses process effectiveness as well as compliance. The evidence-based questions start with top management and follow a generic product through the organization. Following the 14 insightful chapters on such topics as process design, process auditing, PDCA, Turtle Diagrams, Context of the Organization and Systems Integration, you can dive into the evidence-based questions. The Part One audit questions examine the complete systems conformity to the standards along with dozens of Best Practice questions to help you better evaluate the effectiveness of the system. The Part Two questions focus in detail on the effectiveness of each individual process in the organization. This Guide covers every requirement in both ISO 9001 and IATF (some, many more than one time) plus current '2017' Customer Specific Requirements (GM, FORD, FCA, VW, PSA), Core Tools (APQP, FMEA (2018 version), Control Plans, MSA, Process Capability, and PPAP) and CQI requirements (8, 9, 11, 12, 14, 15, 17, 19, 23, 24). The SECOND EDITION - IATF 16949:2016 Audit Guide and Checklist includes: A blend of insightful guidance and practical evidence-based questions that help take your QMS to the next level 584 Assessment Questions, 188 Questions related directly to Customer Specific Requirements, 71 Core Tools Questions 15 Specific CQI Questions 150 valuable notes designed to help auditors understand the intent of specific questions . Help in planning and organizing process audits effectively and documenting the results in a meaningful way. *Additional clarity on System Integration, Context of the Organization, Safety Related Products, and MAQMSR, *2017 - IATF Sanctioned Interpretations and FAQs. Value to organizations that want more than their money's worth from their management systems by driving best practice.