[WS12] ISO 13485:2016 醫療器材品質管理系統標準 - 理解與應用 (E-learning)


ISO 13485:2016 Medical Devices QMS - Requirements for Regulatory Purposes
Understanding & Application  (E-learning)


Delivery Method

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


Course objectives

  • Understand the principles, definitions, requirements of ISO13485:2016

  • Appreciate the actions required to establish a quality management system for manufacturing of medical devices

  • Aware of tools and techniques which can be applied to manage risks

  • Understand the preparation for certification


Course contents

  • What are the key elements of ISO13485:2016?

  • What do we need to believe?

  • What do we need to know?

  • What are the roles of staff at all levels?

  • What do we want to achieve with a quality management system for medical devices?


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:

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.” 課程時間:上午9時30分 - 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
WS12C/HK-08A 8 August 2024 1 day 1480 粵語 - 輔以英文講義 HKQAA 網上平台

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最後更新:2024-06-13    免責聲明
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