Hong Kong Quality Assurance Agency

[MT77] ISO13485:2016 Medical Devices QMS - Requirements for Regulatory Purposes - Internal QMS Auditor Training

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Course Information

Schedules
  • 30 Dec 2021 (Thu) - 31 Dec 2021 (Fri)
Registration period
6 Sep 2021 (Mon) - 29 Dec 2021 (Wed)
Price
HKD 3,900
Course Level
Study Mode
Duration
2 Day(s)
Language
Cantonese
Location
19/F K Wah Centre 191 Java Road North Point Hong Kong
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Course Overview

ISO 13485:2016 Medical Devices : Requirements for Regulatory Purposes

Internal QMS Auditor Training

Course Objectives

  • Have thorough understanding of the requirements and applications of ISO 13485:2016
  • Understand the basic principle of internal audit
  • More practice to gain experience how to perform an internal audit

Delegates are required to

  • Have thorough understanding of the requirements and applications of ISO 13485:2016
  • Understand the basic principle of internal audit
  • More practice to gain experience how to perform an internal audit.

Certificate of attendance

Certificate of Attendance will be issued to participants who have attended more than 90% of the enrolled course hours

 

What You’ll Learn


Course Contents
    • Scope
    • Normative references
    • Terms and definitions
    • Qualtiy Management System
    • Management responsibility
    • Resource management
    • Product realization
    • Measurement, analysis and improvement


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