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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 Here
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: R.J. Coble
Publisher: CRC Press
ISBN: 9789058093288
Category : Technology & Engineering
Languages : en
Pages : 204
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Book Description
This volume looks at many issues involved in the management of construction safety and health. It covers many different topics, such as an overview of health hazards in construction and the use of IT to help regulate public health and safety in construction.
Author: Leonard Steinborn
Publisher: CRC Press
ISBN: 0203026659
Category : Medical
Languages : en
Pages : 452
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Book Description
This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa
Author: Waldemar Karwowski
Publisher: CRC Press
ISBN: 1000450643
Category : Technology & Engineering
Languages : en
Pages : 602
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Book Description
A comprehensive review of international and national standards and guidelines, this handbook consists of 32 chapters divided into nine sections that cover standardization efforts, anthropometry and working postures, designing manual material, human-computer interaction, occupational health and safety, legal protection, military human factor standar
Author: Michael B. Weinstein
Publisher: Routledge
ISBN: 1351407716
Category : Business & Economics
Languages : en
Pages : 228
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Book Description
Total Quality Management (TQM) is a business philosophy that yields customer satisfaction and continuous process improvement. This new reference and workbook embraces the TQM revolution and explains to readers how TQM principles are applied to safety and health programs. The text also focuses on the ISO-9000 Quality Program, Voluntary Protection Program, and Process Safety Management. For each of these topics, the key principles are identified and described, and the quality principles are adapted to safety.
Author: Erik V. Myhrberg
Publisher: Quality Press
ISBN: 1636942016
Category : Business & Economics
Languages : en
Pages : 169
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Book Description
The purpose of this field guide is to assist the reader, step-by-step, in implementing a Quality Management System (QMS) in conformance with AS9100C. This field guide has been created in order to foster an inner-reliance between senior management, middle management, functional teams, and the individual. Users of the field guide will find within it practical tools, tips, and techniques useful for not only implementing a QMS but also for maintaining one. What separates this field guide from most other books on AS9100 and its implementation are the flow charts showing the steps to be taken in implementing a QMS to meet a sub-clause’s requirements. You need to turn out aerospace conforming parts on time, every time, and at a competitive cost, as that's exactly what the companies that can compete now and in the future will do. A Practical Field Guide for AS9100 will help to get you there.
Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 9781574443080
Category : Business & Economics
Languages : en
Pages : 436
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Book Description
Don't reinvent the wheel when applying for your ISO 9001 registration or updating to the new 2000 standards. ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM shows you how to develop and implement a documented quality management system based on ISO 9000 series standards. It supplies ready to use ISO 9001:2000 Template Quality Manuals and applicable Standard Operating Procedures with year 2000 revisions for documentation management in text and on CD ROM. You will understand how to: Build quality into your products and services Achieve ISO 9001 certification with time, money, and resources optimization Supply products that are totally fit for use Satisfy user/customer expectations Edge out the competitors Achieve a defined level of quality Prevent defects and provide value Yield profits from your invested resources
Author:
Publisher:
ISBN:
Category : Europe
Languages : en
Pages : 86
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Book Description
Author: Robert R. Moeller
Publisher: John Wiley & Sons
ISBN: 0471483060
Category : Business & Economics
Languages : en
Pages : 336
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Book Description
Sarbanes-Oxley and the New Internal Auditing Rules thoroughly and clearly explains the Sarbanes-Oxley Act, how it impacts auditors, and how internal auditing can help with its requirements, such as launching an ethics and whistle-blower program or performing effective internal controls reviews under the COSO framework. With ample coverage of emerging rules that have yet to be issued and other matters subject to change, this book outlines fundamental blueprints of the new rules, technological developments, and evolving trends that impact internal audit professionals. Order your copy today!
Author: Fred Dobb
Publisher: Routledge
ISBN: 1136009779
Category : Business & Economics
Languages : en
Pages : 250
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Book Description
Review of previous edition: "I recommend this book to all those who are thinking about implementing ISO 9000...because you will enjoy reading it, and will, as Dobb writes, save yourself a lot of money." QUALITY WORLD This is a tried and tested hands-on manual, with detailed steps to success and simple explanatory notes. The accompanying companion website contains the text of a complete quality manual along with all necessary operating procedures. The book explains why and how to achieve or upgrade to ISO 9001:2000. The proven successful straightforward approach will initially save you money in consultancy fees and will also help you bypass the trial and error stages. In addition to a successful registration or upgrade, you will continually achieve savings by putting in place effective, efficient and economical management systems. Fred Dobb is a Regional Director of CQA, one of the oldest accredited certification bodies, specializing and with particular expertise in the construction industry, but also covering the whole range of manufacturing, service and other industrial and business sectors. He is a Registered Lead Assessor with experience in a plethora of situations; this practical experience is brought to bear in this essentially practical guide.
