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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.
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 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.
"A comprehensive yet easily understandable guide to internal auditing ... [going] beyond the basics with comprehensive detail about establishing an internal audit program, selecting and training auditors, auditing requirements, interview techniques, planning audits, reporting, audit follow ups, and much more."--Back cover.
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.
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.
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.
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.
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.