A Practical Field Guide for ISO 13485:2016
Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes
Erik V. Myhrberg, Joseph Raciti
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A Practical Field Guide for ISO 13485:2016
Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes
Erik V. Myhrberg, Joseph Raciti
Información del libro
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