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    Course Details

    Course# QU 16453-1
    Course Desc ISO 13485: 2016 Lead Auditor (CEU 6.0)
    Your Price $250.00

    Course Overview

    ISO 13485:2016 Lead Internal Auditor

    CEU: 6.0

    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?Lead Auditor ManagementQuality System
    • Lead Auditor Qualifications and Competency
    • Lead Auditor Foundations
    • 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?Management
    • What are the audit questions for control of records?
    • 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?
    • Resource
    • What are the requirements for provision of resources?
    • What are the audit questions for provision of resources?
    • What are the general requirements for human resources?
    • What are the requirements for human resources competence, awareness and training?
    • What are the audit questions for human resources competence, awareness and training?
    • What are the requirements for infrastructure?
    • What are the audit questions for infrastructure?
    • What are the requirements for work environment?
    • What are the audit questions for work environment?Product
    •  
    • What are the requirements for planning of product realization?
    • What are the audit questions for planning of product realization?
    • What are the requirements for determination of requirements related to the product?
    • What are the audit questions for determination of requirements related to the product?
    • What are the requirements for review of requirements related to the product?
    • What are the audit questions for review of requirements related to the product?
    • What are the requirements for customer communication?
    • What are the audit questions for customer communication?
    • What are the requirements for design and development planning?
    • What are the audit questions for design and development planning?
    • What are the requirements for design and development inputs?
    •            What are the audit questions for design and development inputs?
    • What are the requirements for design and development outputs?
    • What are the audit questions for design and development outputs?
    • What are the requirements for design and development review?
    • What are the audit questions for design and development review?
    • What are the requirements for design and development verification?
    • What are the audit questions for design and development verification?
    • What are the requirements for design and development validation?
    • What are the audit questions for design and development validation?
    • What are the requirements for control of design and development changes?
    • What are the audit questions for control of design and development changes?
    • What are the requirements for purchasing process?
    • What are the audit questions for purchasing process?
    • What are the requirements for purchasing information?
    • What are the audit questions for purchasing information?
    • What are the requirements for verification of purchased product?
    • What are the audit questions for verification of purchased product?
    • What are the requirements for traceability?
    • What are the audit questions for traceability?
    • What are the particular requirements for implantable medical devices?
    • What are the audit questions for implantable medical devices?
    • What are the requirements for status identification?
    • What are the audit questions for status identification?
    • What are the requirements for customer property?
    • What are the audit questions for customer property?
    • What are the requirements for preservation of product?
    • What are the audit questions for preservation of product?
    • Control of Monitoring
    • What are the requirements for control of monitoring and measuring devices?
    • What are the audit questions for control of monitoring and measuring devices?
    • Measurement
    • 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?
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    Exam (One can take exam as many times needed until one pass the exam and upon passing the exam, certificate will be issued online.)