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Author: Ray Tricker
Publisher: Taylor & Francis
ISBN: 1136378758
Category : Business & Economics
Languages : en
Pages : 608
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Book Description
The Medical Devices Directive (MDD) is an all-encompassing document legislating for the manufacture of any medical device or material used either temporarily or permanently on or in the human body. To achieve its main objectives the MDD requires the manufacturer of all products covered by the Directive to possess a fully auditable Quality Management System consisting of Quality Policies, Quality Procedures and Work Instructions, based on the ISO 9000 standard. The book is based on the sound principles of ISO 9000 and will guide to the reader, if required, to eventually set up an ISO 9000 fully compliant system. MDD-Compliance using Quality Management Techniques consists of the following: * A brief guide to the Medical Devices Directive - explaining the main requirements of the directive, translating legal "Eurospeak" into everyday language * An overview of ISO 9000 and how the MDD links in with these international requirements. * A Quality Manual - will provide a template for a complete Quality Management System that can be used by any product being produced under the requirements of the MDD * CD ROM containing a software copy of the Quality Manual * A User manual consisting of clear instructions and flow charts on how to set up and use the Quality Management System described in the Quality Manual
Author: Ray Tricker
Publisher: Taylor & Francis
ISBN: 1136378758
Category : Business & Economics
Languages : en
Pages : 608
Get Book
Book Description
The Medical Devices Directive (MDD) is an all-encompassing document legislating for the manufacture of any medical device or material used either temporarily or permanently on or in the human body. To achieve its main objectives the MDD requires the manufacturer of all products covered by the Directive to possess a fully auditable Quality Management System consisting of Quality Policies, Quality Procedures and Work Instructions, based on the ISO 9000 standard. The book is based on the sound principles of ISO 9000 and will guide to the reader, if required, to eventually set up an ISO 9000 fully compliant system. MDD-Compliance using Quality Management Techniques consists of the following: * A brief guide to the Medical Devices Directive - explaining the main requirements of the directive, translating legal "Eurospeak" into everyday language * An overview of ISO 9000 and how the MDD links in with these international requirements. * A Quality Manual - will provide a template for a complete Quality Management System that can be used by any product being produced under the requirements of the MDD * CD ROM containing a software copy of the Quality Manual * A User manual consisting of clear instructions and flow charts on how to set up and use the Quality Management System described in the Quality Manual
Author: Ray Tricker
Publisher: Routledge
ISBN: 0415526876
Category : House & Home
Languages : en
Pages : 786
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Book Description
Now in its third edition, this book is a complete guide to the requirements of the 17th Edition of the IEE Wiring Regulations (including Amendment no. 1), BS 7671 and Part P of the Building Regulations. Wiring Regulations in Brief explains complex IEE Wiring Regulations in plain English. Organized by areas of working practice, readers can quickly lay their hands on whatever they need to know, from any section of the regulations. The book also incorporates requirements from other regulations and standards that apply to electrical installation, making it an essential reference for anyone working with UK electrical systems.
Author: Ray Tricker
Publisher: Routledge
ISBN: 113648292X
Category : Technology & Engineering
Languages : en
Pages : 1058
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Book Description
The most popular and trusted guide to the building regulations, Building Regulations in Brief is updated regularly to reflect constant changes. Now in its seventh edition, it has sold over 28,000 copies since its first publication in 2003. This new edition includes the latest on all the significant amendments to Building Regulations, Planning Permission and the Approved Documents that occurred in October 2010 and includes changes to Parts F and L, as well as Approved Documents A, C, and J. There are also changes reflecting the consolidation of the building regulations included. The no-nonsense approach has made it a firm favourite with all involved in the building industry including designers, building surveyors and inspectors, students and architects. A ready reference giving practical information, it enables compliance in the simplest and most cost-effective manner possible. Building Regulations in Brief cuts through the confusion to explain the meaning of the regulations, their history, current status, requirements, associated documentation and how local authorities view their importance, as well as emphasizing the benefits and requirements of each regulation. It's an essential purchase for anyone needing to comply with the building regulations.
Author: Ray Tricker
Publisher: Routledge
ISBN: 1134504373
Category : Business & Economics
Languages : en
Pages : 614
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Book Description
Small businesses face many challenges today, including the increasing demand by larger companies for ISO compliance. Compliance is a challenging task for any organisation and can often be time consuming and costly, particularly for small businesses who are unlikely to have quality assurance experts on the payroll. However, it is still possible to achieve compliance without the need for expensive consultancy or training that takes you out of the office! Ray Tricker has already guided hundreds of businesses through the challenge and this, the 5th edition of his life-saving ISO guide, has been rewritten and refined following 5 years' field use of working with the standard. The one area that an organisation (particularly a small business) always wants to know is ‘how much is it going to cost to implement and operate a QMS compliant with ISO 9001: 2008 – and is it going to be worth the trouble?!’ Due to popular demand, Edition 5 now includes a brand new chapter on the cost of implementing ISO 9001:2008. This edition provides: Relevant examples that put the concepts and requirements of the standard into a real-life context Down to earth explanations to help you determine what you need to work in compliance with and/or achieve certification to ISO 9001:2008 An example of a complete, generic, Quality Management System consisting of a Quality Manual plus a whole host of Quality Processes, Quality Procedures and Work Instructions Access to a free, software copy of this generic QMS files (available from the author) to give you a starting-point from which to develop your own documentation. ISO 9001:2008 is the most widely followed quality management standard and the rewards can be great, opening up new business opportunities, as well as bringing real improvements to your processes and outputs.
Author: Ray Tricker
Publisher: Routledge
ISBN: 1317685679
Category : Business & Economics
Languages : en
Pages : 633
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Book Description
Small businesses face many challenges today, including the increasing demand by larger companies for ISO 9001compliance, a challenging task for any organisation and in particular for a small business without quality assurance experts on its payroll. Ray Tricker has already guided hundreds of businesses through to ISO accreditation, and this sixth edition of his life-saving ISO guide provides all you need to meet the new 2015 standards. ISO 9001:2015 for Small Businesses helps you understand what the new standard is all about and how to achieve compliance in a cost effective way. Covering all the major changes to the standards, this book provides direct, accessible and straightforward guidance. This edition includes: down-to-earth explanations to help you determine what you need to enable you to work in compliance with and/or achieve certification to ISO 9001:2015; a contextual explanation of ISO 9001 within the structure of ISO 9000 family of standards; a detailed description of the structure of ISO 9001:2015 and its compliance with Annex SL; coverage of the new requirements for Risk Management and Risk Analysis; a guide to the costs involved in implementing ISO 9001:2015 and advice on how to control costs; an example of a complete, generic Quality Management System consisting of a Quality Manual plus a whole host of Quality Processes, Quality Procedures and Word Instructions; and access to a free, software copy of these generic QMS files to give you a starting point from which to develop your own documentation. This book is also supported with a complete bibliography containing abbreviations and acronyms as well as a glossary of terms. This comprehensive text will provide you and your small business with a complete guide on your way to ISO compliance.
Author: Susanne Manz
Publisher: Academic Press
ISBN: 9780128142219
Category : Science
Languages : en
Pages : 0
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Book Description
Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309072808
Category : Medical
Languages : en
Pages : 360
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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.
Author: Susanne Manz
Publisher: Academic Press
ISBN: 0128142227
Category : Science
Languages : en
Pages : 294
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Book Description
Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry. Provides practical, real-world guidance on developing an effective and efficient Quality Management System Presents a roadmap for QMS development Covers techniques to assess current state Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans
Author:
Publisher:
ISBN:
Category : American literature
Languages : en
Pages : 3054
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Book Description
Author: OECD
Publisher: OECD Publishing
ISBN: 9264805907
Category :
Languages : en
Pages :
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Book Description
This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
