Quality Management Systems

Quality Management Systems PDF Author: Ray Tricker
Publisher: Routledge
ISBN: 1000728129
Category : Business & Economics
Languages : en
Pages : 302

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Book Description
This book provides a clear, easy to digest overview of Quality Management Systems (QMS). Critically, it offers the reader an explanation of the International Standards Organization’s (ISO) requirement that in future all new and existing Management Systems Standards will need to have the same high-level structure, commonly referred to as Annex SL, with identical core text, as well as common terms and definitions. In addition to explaining what Annex SL entails, this book provides the reader with a guide to the principles, requirements and interoperability of Quality Management System standards, how to complete internal and external management reviews, third-party audits and evaluations, as well as how to become an ISO Certified Organisation once your QMS is fully established. As a simple and straightforward explanation of QMS Standards and their current requirements, this is a perfect guide for practitioners who need a comprehensive overview to put theory into practice, as well as for undergraduate and postgraduate students studying quality management as part of broader Operations and Management courses.

Quality Management Systems

Quality Management Systems PDF Author: Ray Tricker
Publisher: Routledge
ISBN: 1000728129
Category : Business & Economics
Languages : en
Pages : 302

Get Book Here

Book Description
This book provides a clear, easy to digest overview of Quality Management Systems (QMS). Critically, it offers the reader an explanation of the International Standards Organization’s (ISO) requirement that in future all new and existing Management Systems Standards will need to have the same high-level structure, commonly referred to as Annex SL, with identical core text, as well as common terms and definitions. In addition to explaining what Annex SL entails, this book provides the reader with a guide to the principles, requirements and interoperability of Quality Management System standards, how to complete internal and external management reviews, third-party audits and evaluations, as well as how to become an ISO Certified Organisation once your QMS is fully established. As a simple and straightforward explanation of QMS Standards and their current requirements, this is a perfect guide for practitioners who need a comprehensive overview to put theory into practice, as well as for undergraduate and postgraduate students studying quality management as part of broader Operations and Management courses.

Quality Systems and Controls for Pharmaceuticals

Quality Systems and Controls for Pharmaceuticals PDF Author: Dipak Kumar Sarker
Publisher: John Wiley & Sons
ISBN: 0470773049
Category : Science
Languages : en
Pages : 204

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Book Description
Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models. Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice. The author has both industry and academic experience and many ‘best practice’ examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.

Basic Quality Management Systems

Basic Quality Management Systems PDF Author: James O. Westgard
Publisher:
ISBN: 9781886958289
Category : Medical
Languages : en
Pages : 286

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Book Description


Building Quality Management Systems

Building Quality Management Systems PDF Author: Luis Rocha-Lona
Publisher: CRC Press
ISBN: 1040084370
Category : Business & Economics
Languages : en
Pages : 205

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Book Description
Quality has quickly become one of the most important decision-making factors for consumers. And although organizations invest considerable resources into building the right quality management systems (QMSs), in many instances, the adoption of such quality improvement tools are just not enough. Building Quality Management Systems: Selecting the Righ

Intelligent Quality Systems

Intelligent Quality Systems PDF Author: Duc T. Pham
Publisher: Springer Science & Business Media
ISBN: 1447114981
Category : Technology & Engineering
Languages : en
Pages : 212

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Book Description
Although the tenn quality does not have a precise and universally accepted definition, its meaning is generally well understood: quality is what makes the difference between success and failure in a competitive world. Given the importance of quality, there is a need for effective quality systems to ensure that the highest quality is achieved within given constraints on human, material or financial resources. This book discusses Intelligent Quality Systems, that is quality systems employing techniques from the field of Artificial Intelligence (AI). The book focuses on two popular AI techniques, expert or knowledge-based systems and neural networks. Expert systems encapsulate human expertise for solving difficult problems. Neural networks have the ability to learn problem solving from examples. The aim of the book is to illustrate applications of these techniques to the design and operation of effective quality systems. The book comprises 8 chapters. Chapter 1 provides an introduction to quality control and a general discussion of possible AI-based quality systems. Chapter 2 gives technical information on the key AI techniques of expert systems and neural networks. The use of these techniques, singly and in a combined hybrid fonn, to realise intelligent Statistical Process Control (SPC) systems for quality improvement is the subject of Chapters 3-5. Chapter 6 covers experimental design and the Taguchi method which is an effective technique for designing quality into a product or process. The application of expert systems and neural networks to facilitate experimental design is described in this chapter.

The Strategic Quality Manager

The Strategic Quality Manager PDF Author: Cathy Balding
Publisher: Arcade Custom Publishing
ISBN: 0987171410
Category : Business & Economics
Languages : en
Pages : 193

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Book Description
Are you a quality professional working in health and aged care (or other service industry) who wants to: design and implement quality systems that make a real, positive difference to consumers? • develop your role to be more strategic and influential? • create sustained change and improvement? • build your credibility and expertise? • play a key role in your organisation’s strategic direction? • increase your job satisfaction? The Strategic Quality Manager synthesises theory, research and real world experience into a handbook developed specifically for those in quality management roles. As the pressure on our health and aged care services grows, so do the demands on the quality professional and continuing to increase the quality and transparency of healthcare will require new and savvier ways of working. If you have looked for assistance within this challenging environment, you’ll know that there is no shortage of material on quality management, but very little on being a quality manager. The Strategic Quality Manager contains theory, tips, step by step models and practical examples to assist every quality professional to more easily and proactively navigate the many of challenges of their roles – and to enjoy the journey!

Quality Systems Handbook

Quality Systems Handbook PDF Author: David Hoyle
Publisher: Elsevier
ISBN: 1483104931
Category : Business & Economics
Languages : en
Pages : 393

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Book Description
Quality Systems Handbook is a reference book that covers concepts and ideas in quality system. The book is comprised of two parts. Part 1 provides the background information of ISO 9000, such as its origin, composition, application, and the strategies for registration. Part 2 covers topics relevant to the ISO 9000 requirements, which include design control, internal quality audits, and statistical techniques. The text will be useful to managers, auditors, and quality practitioners who require reference in the various aspects of quality systems.

Crossing the Quality Chasm

Crossing the Quality Chasm PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309132967
Category : Medical
Languages : en
Pages : 359

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Book Description
Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices PDF Author: Amiram Daniel
Publisher: Quality Press
ISBN: 0873897404
Category : Medical
Languages : en
Pages : 355

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Book Description
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.

Pharmaceutical Quality Systems

Pharmaceutical Quality Systems PDF Author: Oliver Schmidt
Publisher: CRC Press
ISBN: 142002602X
Category : Medical
Languages : en
Pages : 392

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Book Description
When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr