Public Training · HRD Corp ClaimableISO 13485:2016 Understanding & Internal Audit Training
A two-day, face-to-face program for medical device professionals who need to read the standard correctly and audit against it with confidence — not just pass a checklist.
Reserve your seatSee the two-day program
Built for people who own quality on the floor, not just on paper.
- QA/RA officers and executives at medical device manufacturers and suppliers
- Internal auditors preparing to run or expand a QMS audit program
- Process owners and department leads whose work sits inside the QMS scope
- Anyone newly assigned ISO 13485 responsibility and starting from scratch
Clause-by-clause understanding, plus the audit skill to prove it.
- A working grasp of ISO 13485:2016 internal audit training requirements in plain, applicable language
- The ability to plan, conduct, and report an internal audit against the standard
- Practice writing findings and nonconformities that hold up under scrutiny
- A certificate of completion and course materials to bring back to your team
Abdul Rahman
Ab Ghani
Over 30 years of hands-on experience in medical device manufacturing and QMS — including 13 years progressing from Laboratory Technician to Head of Quality Assurance, and 11 years specialising in sterilization validation across Gamma Irradiation, Ethylene Oxide, and Moist Heat.
- ✓30+ years industry experience
- ✓13 years auditing ISO 11137, ISO 11135, ISO 17665, ISO 11737, ISO 13485
- ✓HRD Corp Accredited Trainer, valid to 2028
- ✓MIM Certified Train-the-Trainer, since 2012
Day one builds the understanding. Day two puts it to work.
A practitioner-led structure that moves from the standard’s intent to the mechanics of running a credible internal audit.
ISO 13485:2016 requirements
- 01 Context, scope, and how ISO 13485 relates to regulatory frameworks
- 02 Quality management system requirements, clause by clause
- 03 Management responsibility and resource management
- 04 Product realization and risk-based thinking in a device QMS
- 05 Measurement, analysis, and continual improvement
Auditing against the standard
- 01 Audit principles, planning, and building an audit program
- 02 Preparing checklists and conducting the audit interview
- 03 Evidence, findings, and writing defensible nonconformities
- 04 Reporting, corrective action, and closing the audit loop
- 05 Live practice audit with facilitator feedback
Secure your seat before the training fills up.
Fees cover both training days, materials, and a certificate of completion. HRD Corp claimable for eligible employers.
Standard rate
Seats confirmed on a first-come basis
- ✓ 2 full training days, face-to-face
- ✓ Course materials + certificate
- ✓ HRD Corp claimable
HRD Corp claimable. Course number 10001654859 — check with your HR team on remaining levy balance before submitting your claim.
One classroom, two days, Rawang.
Common questions
Is this training HRD Corp claimable?
Yes. The program is registered under HRD Corp course number 10001654859. Confirm your levy balance and claim process with your HR or training coordinator before the session.
Do I need prior ISO 13485 knowledge to attend?
No. Day one is built to bring anyone up to speed on the standard itself before day two moves into internal audit practice, so first-timers and those refreshing their knowledge are both well served.
What does the training fee include?
Both training days at the Rawang venue, course materials, and a certificate of completion. Travel and accommodation are not included.
Can I register a group from my company?
Yes — list every participant’s name and designation when you email in, so certificates and HRD Corp claims can be prepared correctly for each attendee.
Reserve Your Spot Today
Join fellow QA, RQ, and Compliance professionals for the 29–30 September 2026 session. Seats are limited — register today.
Seats are limited to keep the audit practice hands-on.
Competence Today. Compliance Tomorrow. Patient Safety Always.