[MT22] ISO13485:2016 醫療器材品質管理系統標準 - 理解與應用


ISO13485:2016 Medical Devices QMS - Requirements for Regulatory Purposes -
Understanding & Application


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 Topics

  • 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 identification document (as standard) when submitting the application form.


Click here to explore E-learning 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 (eLearning) 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:2024-07-12    免責聲明
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