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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
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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: Leonard Steinborn
Publisher: CRC Press
ISBN: 0203026659
Category : Medical
Languages : en
Pages : 453
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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: Thomas A. Ratliff
Publisher: John Wiley & Sons
ISBN: 0471721662
Category : Technology & Engineering
Languages : en
Pages : 246
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Book Description
Both the 17025:1999 standard and especially ANSI/ISO/ASQ,9001-2000 standard require that a laboratory document its procedures for obtaining reliable results. The Laboratory Quality Assurance Manual details to the user how to a prepare a new laboratory quality assurance manual, which will be appropriate to use as a procedures manual for a particular laboratory, a sales tool to attract potential customers, a document that can be to answer regulatory questions, and ultimately a tool to become a registered ISO 9001/2000 Lab and gain related certifications based on the standard. The Laboratory Quality Assurance Manual: -Incoporates changes to ANSI/ISO/ASQ 9001-2000 pertaining to laboratories. -Provides blank forms used in preparing a quality manual. -Provides information on the interrelationship of ANSI/ISO 17025:1999 and ANSI/ISO/ASQ 9001-2000.
Author: Dr. R. Sundhararajan
Publisher: Thakur Publication Private Limited
ISBN: 9389627907
Category : Education
Languages : en
Pages : 200
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Book Description
Buy E-Book of Quality Assurance (English Edition) Book For B.Pharm 6th Semester of U.P. State Universities
Author: Dyadem Press
Publisher: CRC Press
ISBN: 0203009681
Category : Technology & Engineering
Languages : en
Pages : 143
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Book Description
These guidelines form a comprehensive overview of Failure Mode and Effects Analysis (FMEA) and examines why FMEA has become a powerful and respected analytical technique for effectively managing and reducing risks. Readers learn how to use FMEA throughout the life cycles of their product to improve customer satisfaction and assure safety and regulatory compliance. They will obtain sound advice on selecting a study team, setting up and conducting a study, and analyzing the results. Other topics include Failure Mode, Effects, and Criticality Analysis, Risk Management Planning, Advanced Quality Planning, Product Quality Control Plans, and Dynamic Control Plans.
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: Sohrab
Publisher: Allied Publishers
ISBN: 9788170235811
Category :
Languages : en
Pages : 240
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Book Description
Author: Ray Tricker
Publisher: Routledge
ISBN: 075066617X
Category : Business & Economics
Languages : en
Pages : 540
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Book Description
Small and medium-sized companies face many challenges today including the demand by larger customers for ISO 9000 compliance. Four years into the current version of ISO 9000, the new edition of this life-saving book incorporates the hard-won field experience of actually working with the standard. Along with a thoroughly updated and customisable generic Quality Manual with audit checklists for developing a complete Quality Management System, the book provides valuable advice on: Compatibility and Inter-Relationship between other Management Standards; Basic Requirements to Set Up an Integrated Management System; and, The Eight Principles of Management, among others.
Author: Food and Agriculture Organization of the United Nations
Publisher: Food & Agriculture Org.
ISBN: 9789251040652
Category : Political Science
Languages : en
Pages : 160
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Book Description
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
