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    Course Details

    Course# QU 16453-4
    Course Desc Employee Overview Training for Meeting ISO 13485:2016 Requirements (CEU 1.5)
    Your Price $74.99

    Course Overview

    Employee Overview Training 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.

     

    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?

    Quality Management System

    What are the general requirements for a Quality Management System?

    What are the audit questions for a Quality Management System?

    What are the general documentation requirements for a Quality Management System?

    What are the documentation auditing questions for a Quality Management System?

    What are the documentation requirements for a Quality Manual?

    What are the audit questions for a Quality Manual?

    What are the requirements for control of documents?

    What are the audit questions for control of documents?

    What are the requirements for control of records?

    What are the audit questions for control of records?  

    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?