For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. This book was written to assist quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting process validations that meet regulatory and certification requirements. It provides an introduction and background to the requirements necessary to perform process validations that will comply with regulatory and certification body requirements.
Competitive advantage as it existed in the 1970s and 1980s is no longer valid. Leaders must be ready to adopt the thinking that there is no such thing as long-term competitive advantage anymore, due to the constantly changing landscape, and they will have to repeatedly redefine and redesign business strategies to survive. ISO 9004:2018 represents a major contribution in the application of sound business and quality management systems practices, but authors Jarvis and Palmes will help you go beyond” it with the current widely used state-of-the-art technologies and practices described in this book. They have spent years evaluating where mature and successful organizations are heading, whether they are small or large, and are among the group of experts who developed ISO 9004:2018. Topics covered include disruptive technologies, culture for sustained success, organizational identity, leadership, process management, and more.
This is an important and timely book. Students of organizational behavior for the last 15 years have been asking how to integrate the technology of data gathering and data analysis with critical organizational challenges. This book shows how to do that, using the field of customer service to illustrate the broader point. This volume allows lay readers to understand telemetry and helps them enhance their data-gathering activities to strengthen customer relations. Author of The Agenda Mover: When Your Good Idea Is Not Enough and Transforming the Clunky Organization: Pragmatic Skills for Breaking Inertia (Cornell University Press) Telemetry is an automated way of collecting data at remote sites or locations, and transmitting it to collectors at receiving site for monitoring, analyzing, and driving improvement actions. This book provides the necessary knowledge and information to understand the telemetry infrastructure and associated details. It will enable readers to implement a telemetry program to address customer experience pain and improve customer experience. The authors of this book have all served in different roles and capacities in one of Silicon Valley's premier technology companies. These roles include software engineering, customer assurance, quality management, technology development, and implementation. Their paths intersected in the area of quality management, and they have witnessed first-hand how the latest technology/market transitions around Internet of Things (IoT), digitization, and telemetry are impacting the company they work, as well as the high-tech industry and global economy as a whole. The real-time nature of data and the advent of machine-learning algorithms have set the stage for a new era that the authors call adaptive customer experience. The premise of this concept is that real-time availability of customer experience data opens the door for real-time responses based on machine-learning algorithms. This creates an unprecedented opportunity to change the relationship between customers and the systems they depend on in their digital world. The proliferation of sensors and improvements in data science capabilities are creating an environment where the possibilities for telemetry are limitless. The book provides several examples of use cases and applications that help bring telemetry to life.
Purpose The purpose of this book is to provide the reader with an understanding of the ISO 9000-3 guideline and how it applies to the specification, development, test, and maintenance of software. We will show that the basic practices and procedures that define software engineering and the ISO guideline are, for all intents and purposes, one and the same. We hope that the readers of this book will use the information found within not only to pass the certification audit but as a tool to be used to create the well-managed engineering environment needed to create reliable, well engineered products in a consistent manner. Audience This book is intended for senior software engineers, software managers, and non software managers within software organizations whose aim is to create an engi neering environment within their company or organization. In addition, individ uals outside the software organization who have responsibility for the specification of the software product and preparing their organization to take ownership of the developed product will find this book of great interest. Finally, those who must choose software companies to do business with or audit software companies to determine their ability to engineer and maintain a software product will find this book helpful. 2 Introduction Overview This book is made up of twenty-four chapters that can be grouped into four sections. Chapter 1 through Chapter 4 set the basis for the following chapters that deal directly with the guideline.
The rapid pace of technology often catches organizations unprepared and unable to take advantage of every leading-edge benefit. Cloud technology allows forward-thinking companies to launch products and services rapidly, control costs, streamline processes, and mitigate risks—when done correctly. This book addresses technological basics, as well as practical steps for implementing and fitting the cloud into your overall business strategy—which ultimately benefits your bottom line in delivering the best possible product and services to customers quickly. Capitalizing on their collective years of experience working in Silicon Valley, authors Jarvis, Anand, and Jose share best practices for adopting the cloud, including: ■ Calculating cloud usage and crafting a cost management strategy ■ Breaking down the total cost of ownership (TCO) ■ Optimizing DevOps practices for the cloud ■ Understanding the challenges and risks involved with cloud migration and security Armed with step-by-step guidance, you can generate a plan of action to meet and exceed your cloud management goals.
ISO 9001:2015 improves on the world’s most widely used Quality Management Standard (QMS), reflecting current trends in economics, innovation, technology, business, and customer requirements. Using ISO 9001:2015, organizations can prevent and quickly address quality problems, deliver better customer experiences, and improve both profitability and sustainability. This guide combines a complete critical explanation of ISO 9001:2015’s contents, as well as indispensable expert guidance for effective implementation. Two members of the Technical Committee that developed ISO 9001:2015 and ISO 9000:2015 show exactly how it affects your organization, so you can efficiently pass audits and gain or maintain registration. In modular, building-block format, Alka Jarvis and Paul Palmes clearly present each requirement and the value it delivers. They also offer a logical, structured process for applying ISO 9001:2015 to improve product or service quality. If you have already implemented ISO 9001:2008, the authors identify each key change, so you can locate gaps and plan an efficient migration. Practical appendixes include reusable templates and audit meeting agendas, plus essential information on documentation. Coverage includes ISO 9001:2015’s business relevance and role in operational excellence Why revisions were necessary, and how they impact and benefit you Deepening your understanding of customer/stakeholder needs and expectations Scoping your QMS in the context of ISO 9001:2015 Understanding leadership’s key role Identifying risks, opportunities, objectives, resources, and competencies Performing operational activities related to planning, control, requirements, design, and development Measuring QMS performance Addressing non-conformities and analyzing their root causes Promoting ongoing improvement This guidewill be indispensable to every leader and professional concerned with quality, throughout any organization that holds or seeks ISO 9001 certification.
We are in what many call The Age of the Customer. Customers are empowered more than ever before and demand a high level of customer attention and service. Their increasing expectations and demands worldwide have forced organizations to transform themselves and prepare for the customer experience (CX) battlefield. This landmark book addresses: What customer experience really means Why it matters Whether it has any substantial business impact What your organization can do to deliver and sustain your CX efforts, and How we got to this particular point in CX history This book is the result of exhaustive research conducted to incorporate various components that affect customer experience. Based on the research results, the authors make a case for seeing CX and associated transformations as the next natural evolution of the quality management system (QMS) already in place in most companies. Using an existing QMS as the foundation for CX not only creates a more sustainable platform, but it allows for a faster and more cost effective way to enable an organization to attain world-class CX.
Telemetry is an automated way of collecting data at remote sites or locations, and transmitting it to collectors at receiving site for monitoring, analyzing, and driving improvement actions. This book provides the necessary knowledge and information to understand the telemetry infrastructure and associated details. It will enable readers to implement a telemetry program to address customer experience pain and improve customer experience. The authors of this book have all served in different roles and capacities in one of Silicon Valleys premier technology companies. These roles include software engineering, customer assurance, quality management, technology development, and implementation. Their paths intersected in the area of quality management, and they have witnessed first-hand how the latest technology/market transitions around Internet of Things (IoT), digitization, and telemetry are impacting the company they work, as well as the high-tech industry and global economy as a whole. The real-time nature of data and the advent of machine-learning algorithms have set the stage for a new era that the authors call adaptive customer experience. The premise of this concept is that real-time availability of customer experience data opens the door for real-time responses based on machine-learning algorithms. This creates an unprecedented opportunity to change the relationship between customers and the systems they depend on in their digital world. The proliferation of sensors and improvements in data science capabilities are creating an environment where the possibilities for telemetry are limitless. The book provides several examples of use cases and applications that help bring telemetry to life.
Purpose The purpose of this book is to provide the reader with an understanding of the ISO 9000-3 guideline and how it applies to the specification, development, test, and maintenance of software. We will show that the basic practices and procedures that define software engineering and the ISO guideline are, for all intents and purposes, one and the same. We hope that the readers of this book will use the information found within not only to pass the certification audit but as a tool to be used to create the well-managed engineering environment needed to create reliable, well engineered products in a consistent manner. Audience This book is intended for senior software engineers, software managers, and non software managers within software organizations whose aim is to create an engi neering environment within their company or organization. In addition, individ uals outside the software organization who have responsibility for the specification of the software product and preparing their organization to take ownership of the developed product will find this book of great interest. Finally, those who must choose software companies to do business with or audit software companies to determine their ability to engineer and maintain a software product will find this book helpful. 2 Introduction Overview This book is made up of twenty-four chapters that can be grouped into four sections. Chapter 1 through Chapter 4 set the basis for the following chapters that deal directly with the guideline.
Competitive advantage as it existed in the 1970s and 1980s is no longer valid. Leaders must be ready to adopt the thinking that there is no such thing as long-term competitive advantage anymore, due to the constantly changing landscape, and they will have to repeatedly redefine and redesign business strategies to survive. ISO 9004:2018 represents a major contribution in the application of sound business and quality management systems practices, but authors Jarvis and Palmes help you go beyond it with the current widely used state-of-the-art technologies and practices described in this book. They have spent years evaluating where mature and successful organizations, whether they are small or large, are heading, and are among the group of experts who developed ISO 9004:2018. Topics covered include disruptive technologies, culture for sustained success, organizational identity, leadership, process management, and more.
The rapid pace of technology often catches organizations unprepared and unable to take advantage of every leading-edge benefit. Cloud technology allows forward-thinking companies to launch products and services rapidly, control costs, streamline processes, and mitigate risks—when done correctly. This book addresses technological basics, as well as practical steps for implementing and fitting the cloud into your overall business strategy—which ultimately benefits your bottom line in delivering the best possible product and services to customers quickly. Capitalizing on their collective years of experience working in Silicon Valley, authors Jarvis, Anand, and Jose share best practices for adopting the cloud, including: ■ Calculating cloud usage and crafting a cost management strategy ■ Breaking down the total cost of ownership (TCO) ■ Optimizing DevOps practices for the cloud ■ Understanding the challenges and risks involved with cloud migration and security Armed with step-by-step guidance, you can generate a plan of action to meet and exceed your cloud management goals.
Cosmetic surgery was once associated with a one-size-fits-all approach, modifying patients to conform to a single standard of beauty. As this surgery has become more accessible worldwide, changing beauty trends have led to a proliferation of beauty standards for members of different racial groups. Alka V. Menon enters the world of cosmetic surgeons, journeying from a sprawling convention center in Kyoto to boutique clinics in the multicultural countries of the United States and Malaysia. She shows how surgeons generate and apply knowledge using racial categories and how this process is affected by transnational clinical and economic exchanges. Surgeons not only measure and organize but also elaborate upon racial differences in a globalized field of medicine. Focusing on the role of cosmetic surgeons as gatekeepers and producers of desired appearances, Refashioning Race argues that cosmetic surgeons literally reshape race--both on patients' bodies and at the broader level of culture.
ISO 9001:2015 improves on the world’s most widely used Quality Management Standard (QMS), reflecting current trends in economics, innovation, technology, business, and customer requirements. Using ISO 9001:2015, organizations can prevent and quickly address quality problems, deliver better customer experiences, and improve both profitability and sustainability. This guide combines a complete critical explanation of ISO 9001:2015’s contents, as well as indispensable expert guidance for effective implementation. Two members of the Technical Committee that developed ISO 9001:2015 and ISO 9000:2015 show exactly how it affects your organization, so you can efficiently pass audits and gain or maintain registration. In modular, building-block format, Alka Jarvis and Paul Palmes clearly present each requirement and the value it delivers. They also offer a logical, structured process for applying ISO 9001:2015 to improve product or service quality. If you have already implemented ISO 9001:2008, the authors identify each key change, so you can locate gaps and plan an efficient migration. Practical appendixes include reusable templates and audit meeting agendas, plus essential information on documentation. Coverage includes ISO 9001:2015’s business relevance and role in operational excellence Why revisions were necessary, and how they impact and benefit you Deepening your understanding of customer/stakeholder needs and expectations Scoping your QMS in the context of ISO 9001:2015 Understanding leadership’s key role Identifying risks, opportunities, objectives, resources, and competencies Performing operational activities related to planning, control, requirements, design, and development Measuring QMS performance Addressing non-conformities and analyzing their root causes Promoting ongoing improvement This guidewill be indispensable to every leader and professional concerned with quality, throughout any organization that holds or seeks ISO 9001 certification.
Thank you for visiting our website. Would you like to provide feedback on how we could improve your experience?
This site does not use any third party cookies with one exception — it uses cookies from Google to deliver its services and to analyze traffic.Learn More.