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    Course Details

    Course# QU 16453-3
    Course Desc Executive Management Review for Meeting ISO 13485:2016 Requirements (CEU 1.5)
    Your Price $75.00

    Course Overview

     Executive Management Review for Meeting ISO 13485:2016 Requirements

    CEU: 1.5

    Prerequisites:  None

    Course Time Period:

    You can take training at your own pace. You can logon and logout as many times as needed. You can re-take the exam as many times as necessary until you pass the exam and an online certificate is issued.

    Course Content::  (interpretation, examples, auditing/implementation questions, quiz)

    Introduction

    •What are the general requirements for the ISO 13485 standard?

    •What are the requirements for a ISO 13485 process approach?

    •How does ISO 13485 relate to other standards?

    •How is ISO 13485 compatible with other management systems?

    Management Responsibility

    •What are the requirements for management responsibility?

    •What are the audit questions for management responsibility?

    •What are the requirements for management commitment?

    •What are the requirements for customer focus?

    •What are the requirements for quality policy?

    •What are the audit questions for quality policy?

    •What are the requirements for planning of quality objectives?

    •What are the audit questions for planning of quality objectives?  @

    •What are the requirements for planning of Quality Management System?

    •What are the audit questions for planning of Quality Management System?

    •What are the requirements for responsibility and authority?

    •What are the audit questions for responsibility and authority?

    •What are the requirements for management representative?

    •What are the audit questions for management representative?

    •What are the requirements for internal communication?

    •What are the audit questions for internal communication?

    •What are the general requirements for management review?

    •What are the audit questions for management review?

    •What are the requirements for review input for management review?

    •What are the audit questions for review input for management review?

    •What are the requirements for review output for management review?

    •What are the audit questions for review output for management review?

    Measurement, Analysis and Improvement

    •What are the general requirements for measurement, analysis and improvement?

    •What are the audit questions for measurement, analysis and improvement?

    •What are the requirements for feedback?

    •What are the audit questions for feedback?

    •What are the requirements for internal audit?

    •What are the audit questions for internal audit?

    •What are the requirements for monitoring and measurement of processes?

    •What are the audit questions for monitoring and measurement of processes?

    •What are the requirements for monitoring and measurement of product?

    •What are the audit questions for monitoring and measurement of product?

    •What are the requirements for control of nonconforming product?

    •What are the audit questions for control of nonconforming product?

    •What are the requirements for analysis of data?

    •What are the audit questions for analysis of data?

    •What are the general requirements for improvement?

    •What are the audit questions for improvement?

    •What are the requirements for corrective action?

    •What are the requirements for preventive action?