HKQAA 香港品質保證局

ISO 13485:2016 Medical Devices : Requirements for Regulatory Purposes - Internal QMS Auditor Training

Delegates are required to

Have good understanding of ISO13485:2016 Medical Devices QMS - Requirements for Regulatory Purposes - Understanding & Application
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

RTTP Funding Sponsorship

The following training class has been included in the list of registered public courses under the Reindustrialisation and Technology Training Programme (RTTP) so it is entitled to apply for the funding sponsorship.

RTTP Course Code: HKQAA/4/2022(RT)
Course Date: 25-26 April, 2022 (2-day course)
The subsidy is applicable ONLY to the classroom training at regualr course fee HK$3,580.

How to apply for RTTP? Click here

Click here to explore E-learning schedule

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 / contact us by sending an email to training@hkqaa.org.