ISO 13485:2016 - Medical Devices - A Practical Guide
International Organization For Standardization
ISBN 10: 9267107747 ISBN 13: 9789267107745
Published by Multiple. Distributed through American National Standards Institute (ANSI), 2017
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Soft cover
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Like New condition. Great condition, but not exactly fully crisp. The book may have been opened and read, but there are no defects to the book, jacket or pages. 1.32. Seller Inventory # 353-9267107747-lkn
Bibliographic Details
Title: ISO 13485:2016 - Medical Devices - A ...
Publisher: Multiple. Distributed through American National Standards Institute (ANSI)
Publication Date: 2017
Binding: Soft cover
Condition: Fine
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A Practical Field Guide for ISO 13485:2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes
Seller: GreatBookPrices, Columbia, MD, U.S.A.
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A Practical Field Guide for ISO 13485: 2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes (Paperback or Softback)
Published by
ASQ Quality Press 11/6/2019, 2019
ISBN 10: 163694132X
ISBN 13: 9781636941325
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Seller: BargainBookStores, Grand Rapids, MI, U.S.A.
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Paperback or Softback. Condition: New. A Practical Field Guide for ISO 13485: 2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes 0.84. Book. Seller Inventory # BBS-9781636941325
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A Practical Field Guide for ISO 13485: 2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes
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A Practical Field Guide for ISO 13485:2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes
Seller: GreatBookPrices, Columbia, MD, U.S.A.
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A Practical Field Guide for ISO 13485: 2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes
Seller: Russell Books, Victoria, BC, Canada
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paperback. Condition: New. Special order direct from the distributor. Seller Inventory # ING9781636941325
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A Practical Field Guide for ISO 13485:2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes
Seller: GreatBookPricesUK, Woodford Green, United Kingdom
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A Practical Field Guide for ISO 13485: 2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes
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A Practical Field Guide for ISO 13485:2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes
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A Practical Field Guide for ISO 13485 : 2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes
Print on DemandSeller: AHA-BUCH GmbH, Einbeck, Germany
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Taschenbuch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether 'from scratch' or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015's definition of quality as the 'degree to which a set of inherent characteristics fulfills requirements,' Myhrberg, Raciti, and Myhrberg have identified the requirements and inherent characteristics (distinguishing features) for this expanded field guide. Within the guide, each subclause containing requirements is the focus of a two-page visual spread that consistently presents features that fulfill the requirements listed below.This guide will:Provide a user-friendly guide to ISO 13485:2016's requirements for implementation purposesIdentify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2016 implementationGuide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS existsDirect management on what it must do and should consider to satisfy ISO 13485:2016's enhanced requirements, as well as on the responsibilities for top managementDepict step-by-step in flowchart form what must occur to create an effective, conforming QMS. Seller Inventory # 9781636941325
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A Practical Field Guide For ISO 13485:2016: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
Seller: Revaluation Books, Exeter, United Kingdom
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Spiral-bound. Condition: Brand New. 136 pages. 11.89x6.80x1.60 inches. In Stock. Seller Inventory # 0873899903
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