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

Cracking the Case of ISO 9001:2015 for Service, Third Edition
Author: Charles A. Cianfrani
Publisher: Quality Press
Total Pages: 135
Release: 2016-09-08
Genre: Business & Economics
ISBN: 0873899083

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.

ISO 9001:2015 Internal Audits Made Easy

ISO 9001:2015 Internal Audits Made Easy
Author: Ann W. Phillips
Publisher: Quality Press
Total Pages: 95
Release: 2015-09-21
Genre: Business & Economics
ISBN: 1951058968

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.

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

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
Total Pages: 159
Release: 2015-10-12
Genre: Business & Economics
ISBN: 1953079504

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.

The ISO 9001:2015 Implementation Handbook:

The ISO 9001:2015 Implementation Handbook:
Author: Milton P. Dentch
Publisher: Quality Press
Total Pages: 119
Release: 2016-05-02
Genre: Business & Economics
ISBN: 1951058925

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.

How to Audit ISO 9001:2015

How to Audit ISO 9001:2015
Author: Chad Kymal
Publisher: Quality Press
Total Pages: 136
Release: 2016-04-22
Genre: Business & Economics
ISBN: 087389927X

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 Handbook for Small and Medium-Sized Businesses, Third Edition

ISO 9001:2015 Handbook for Small and Medium-Sized Businesses, Third Edition
Author: Denise E. Robitaille
Publisher: Quality Press
Total Pages: 99
Release: 2016-03-24
Genre: Business & Economics
ISBN: 0873899059

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

ISO 9001:2015 in Plain English
Author: Craig Cochran
Publisher: Paton Professional
Total Pages: 238
Release: 2015-11-16
Genre: Business & Economics
ISBN: 1932828737

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 Audit the Process-Based QMS

How to Audit the Process-Based QMS
Author: Dennis R. Arter
Publisher: Quality Press
Total Pages: 209
Release: 2012-08-17
Genre: Business & Economics
ISBN: 0873898982

This book is intended to help those involved in managing and conducting audits to ISO 9001:2008. It can be used as a guide to establishing a new audit program or for revitalizing one that has been operational for some time. It focuses on achieving an audit program that produces value-adding results for the organization. Arter, Cianfrani, and West, experts in both ISO 9001 and auditing, believe that the art and science of auditing quality management systems that have been designed and implemented following the process approach (the foundation of ISO 9001:2008) is more challenging and interesting than auditing discrete elements to determine whether documented procedures and records exist. Auditing a process-based QMS, or even small elements of such a system, requires auditors to understand and integrate into an audit all aspects of organizational activities, from high-level planning through ensuring that customers are satisfied. The role of auditing is evolving, and the skills and competence required to do it well also must evolve. The contents of this book will help auditors understand their role in the organization and discharge their auditing duties in a way that is challenging to them and contributes to the success of the organization.

Unlocking the Power of Your QMS

Unlocking the Power of Your QMS
Author: John (Jack) E. West
Publisher: Quality Press
Total Pages: 191
Release: 2005-02-01
Genre: Business & Economics
ISBN: 0873890744

Some organizations just get by. While they may realize some successes over time, they often aren’t traceable to the organization’s quality management system (QMS). Other organizations can trace performance improvements to their QMSs, and therefore are able to sustain and expand upon them. Working from the tenet that performance improvement is too important to be left to chance, the authors of Unlocking the Power of Your QMS have meticulously combed the most fundamental, globally accepted quality standards and criteria, and have culled 12 principles that can serve as a foundation for mature quality management systems. Next, through an assessment by top management, the mission, vision, and business model of the organization are determined and aligned with these 12 principles.West and Cianfrani make the case that “...there is nothing an organization can do that can have more benefit than the development and deployment of its principles.” This book not only convinces you, it provides you with the guidelines you need to dramatically improve performance in your organization.