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[WS13] ISO 13485:2016 醫療器材品質管理系統標準 - 內部質量管理體系審核員培訓 (E-learning)

 

ISO 13485:2016 Medical Devices QMS - Requirements for Regulatory Purposes
Internal QMS Auditor Training  (E-learning)

 

Delivery Method

  • This course will be conducted with online platform. The e-learning platform can facilitate with an interactive communication. 

 

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

  • To provide a more comprehensive certificate service, please fill in the participant's name according to the identity document (as standard) when submitting the application form.

 

Click here to explore classroom training schedule

 

Should you have any questions, please free feel to contact Ms. Joanne Chan during office hour.

Tel: (852) 2202-9330 / (852) 6050-8153           Email: training@hkqaa.org

Office Hour: 9 a.m. to 6 p.m. (Monday to Friday)

 

備注: “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.”上課時間: 上午9時30分至下午5時。

課程編號 日期 時間 課程費用 課程費用 (提早報名) 語言 地點
WS13C/HK-04A 18-19 April 2024 2 days 3280 粵語 HKQAA 網上平台

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最後更新:2024-02-27    免責聲明
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