The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Author: Amiram Daniel

Publisher: Quality Press

Published: 2008-01-01

Total Pages: 338

ISBN-13: 0873897404

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How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.

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

Published: 2015-10-12

Total Pages: 159

ISBN-13: 1953079504

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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.

Achieving Customer Experience Excellence through a Quality Management System
Achieving Customer Experience Excellence through a Quality Management System

Author: Alka Jarvis

Publisher: Quality Press

Published: 2016-07-08

Total Pages: 245

ISBN-13: 0873899350

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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.

Laboratory Quality Management System
Laboratory Quality Management System

Author: World Health Organization

Publisher:

Published: 2011

Total Pages: 0

ISBN-13: 9789241548274

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Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".

Designing A World-Class Quality Management System For FDA Regulated Industries
Designing A World-Class Quality Management System For FDA Regulated Industries

Author: David N. Muchemu

Publisher: AuthorHouse

Published: 2008-04-07

Total Pages: 136

ISBN-13: 1468522728

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Having a robust and functional Quality Management system is a QSR requirement for all Pharmaceutical,Biomedical,and Medical Device companies.This book does the following for you: 1.It helps Managers in Startup companies design a Quality management system that meets and exceeds QSR requirements. 2.It helps you understand requirements for the design of a Quality Management system for Medical Device,Pharmaceutical,Tissue,and Biomedical industries 3.It provides the Quality system document structure 4.It helps you understand Quality system requirements for ISO 13485,and ISO 9001 5.It provides standard definitions for the Quality management system 6.It provides examples of Quality system related warning letters written by the FDA during onsite audits 7.It provides the reader several models of a Quality Management system

Standards, Quality Control, and Measurement Sciences in 3D Printing and Additive Manufacturing
Standards, Quality Control, and Measurement Sciences in 3D Printing and Additive Manufacturing

Author: Chee Kai Chua

Publisher: Academic Press

Published: 2017-06-03

Total Pages: 270

ISBN-13: 0128134909

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Standards, Quality Control and Measurement Sciences in 3D Printing and Additive Manufacturing addresses the critical elements of the standards and measurement sciences in 3D printing to help readers design and create safe, reliable products of high quality. With 3D printing revolutionizing the process of manufacturing in a wide range of products, the book takes key features into account, such as design and fabrication and the current state and future potentials and opportunities in the field. In addition, the book provides an in-depth analysis on the importance of standards and measurement sciences. With self-test exercises at the end of each chapter, readers can improve their ability to take up challenges and become proficient in a number of topics related to 3D printing, including software usage, materials specification and benchmarking. - Helps the reader understand the quality framework tailored for 3D printing processes - Explains data format and process control in 3D printing - Provides an overview of different materials and characterization methods - Covers benchmarking and metrology for 3D printing

Code of Federal Regulations
Code of Federal Regulations

Author:

Publisher:

Published: 1982

Total Pages: 1316

ISBN-13:

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Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.

Quality Management Essentials
Quality Management Essentials

Author: David Hoyle

Publisher: Routledge

Published: 2007-03-15

Total Pages: 224

ISBN-13: 1136370293

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From the best-selling quality management author, David Hoyle, Quality Management Essentials is the perfect brief, yet authoritative, introduction to the fundamentals of quality management. Quality in organizations, large or small, is achieved with intelligent use of various concepts, principles, tools and techniques. For those coming to the subject for the first time, these philosophies associated with quality management can be quite overwhelming. This very readable book provides a fast track introduction and executive level appraisal of the field from a respected and experienced author.