
ISO 13485: 2016 Internal Audit
DATE: 12- 13 November 2025
TIME: 9.00am – 5.15pm
ONLINE via Zoom
DURATION: 2 full-day course
COURSE OBJECTIVES
After participating in the training, you will be able to:
• Gain a good understanding of the principles of audit and auditing guidelines based on the ISO 19011.
• Master the knowledge and skills to plan, execute, report and follow-up an internal audit.
• Learn how to avoid common mistakes in internal auditing.
COURSE OUTLINE
1. Overview of auditing and the introduction to ISO 19011
2. ISO 13485 requirements for internal auditing
3. Risk-based approach and Process-based approach in auditing
4. Personal behaviour of auditor
5. Initiating audit
6. Preparing audit activities
7. Conducting audit activities
8. Preparing and distributing audit report
9. Completing audit
10. Conducting audit follow-up
DURATION
Two (2) full days
MODE OF TRAINING
Online Training
COURSE FEES (8% SST included)
Early Bird Price (until 22 October 2025)
Member: RM 1,652.40
Public: RM 1,868.40
Normal Price (from 23 October 2025 onwards)
Member: RM 1,868.40
Public: RM 2,084.40
CONTACT
For enquiries, please email to Medsociate Sdn Bhd Authorised training provider of AMMI
Email: learning@ammi.com.my / admin@medsociate.com
Tel: +6012 539 4194