A Practical Field Guide for ISO 13485: 2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes

Myhrberg, Erik V; Raciti, Joseph A

ISBN 10: 163694132X ISBN 13: 9781636941325

Published by ASQ Quality Press, 2019

Language: English

Condition: New Soft cover

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Bibliographic Details

Title

A Practical Field Guide for ISO 13485: 2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes

Publisher

ASQ Quality Press

Publication Date

2019

Language

English

ISBN 10

163694132X

ISBN 13

9781636941325

Binding

Soft cover

Condition

New

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About this title

Synopsis

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 purposes -Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2016 implementation -Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists -Direct 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 management -Depict step-by-step in flowchart form what must occur to create an effective, conforming QMS

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