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

 

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.

Course Contents

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

Certificate of attendance

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

 

Should you have any questions, please contact Ms. Joanne Chan at 6050 8153 during office hour (9 a.m. to 6 p.m.) on Monday to Friday. 

 

Click here to explore E-learning schedule

 

  

Remarks: “HKQAA reserves the right to cancel the course, change the trainer, content, date, time and / or venue as necessary. Please read the terms and conditions at the bottom of this page before enrolment.”

Course Code Date Duration Course Fee Course Fee (Early Bird) Language Location
MT77C/HK-10A 21-22 Oct 2021 2 days 3900 3700 Cantonese with English materials 19/F K Wah Centre 191 Java Road North Point Hong Kong
MT77C/HK-12A 30-31 Dec 2021 2 days 3900 3700 Cantonese with English materials 19/F K Wah Centre 191 Java Road North Point Hong Kong

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Last Update: 2021-12-06   Disclaimer and Copyright
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