ISO13485:2016 Internal Auditing



AMMI Member: RM 1,200 per pax
Non Member: RM 1,400 per pax

AMMI Member: RM 1,400 per pax
Non Member: RM 1,600.00 per pax


The two-day course is designed to develop participants with in-depth knowledge and skills needed to audit, report and effective corrective action implementation to ensure the effectiveness of their QMS. This intensive training has been designed to provide delegates both the confidence and necessary skills to apply audit tools, techniques, methodology and desired behaviours to assess organization’s Quality Management Systems (QMS) process to consistently provide safe and effective products as per ISO 13485:2016 to meet customer and applicable statutory and regulatory requirements.



  • Upon completion of training, you will be able to:
  • Understand the requirements of ISO 13485:2016.
  • Identify the key principles of auditing and auditor role and responsibilities.
  • Know how to conduct internal quality system audits.
  • Understand the role of internal audits in the maintenance and improvement of management systems.
  • Plan and prepare for an internal audit.
  • Learn to gather evidence by observation, questioning and sampling.
  • Write factual reports on the compliance of the management system against the audit standards.
  • Determine if corrective action has been effectively implemented.

The training comprises presentations, workshops and interactive role-play exercises with medical device lead auditors experienced in ISO 13485 and Notified Body audits.




  1. Introduction to auditing Quality System
  • Auditing Fundamentals
  • What is Audit?
  • Why Audit is Essential
  • Audit Requirements
  • The role of Internal Audit
  • Why audit?
  • What to audit
  • Management Responsibility
  • Quality Managers responsibilities
  1. Types of Audit
  • Internal Audit
  • External Audit
  • System Audit
  • Process Audit
  • Audit Relationship
  1. Principles of Auditing 
  1. Internal Audit Process
  • Audit Program
  • Audit Process Flow
  • Audit Initiation
  • Audit Plan
  • Conducting document review
  • Prepare Work document
  • Audit Checklist Preparation
  • Conducting on-site audit
  • Non-Conformance
  • Prepare audit conclusion
  • Audit Follow-up
  • Principles of Auditing


  1. Way towards Effective Internal Quality audits


Day 2:

  1. ISO 13485:2016 Mandatory Documents and Records
  2. Risk Based Auditing System
  3. Understanding ISO 13485:2016 QMS from Audit Perspective
  • Clause 4- Quality Management System
  • Clause 5- Management Responsibility
  • Clause 6- Resource Management
  • Clause 7- Product Realization
  • Clause 8- Measurement, Analysis and Improvement
  1. Brainstorming Activity: Develop Audit Checklist


Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016, individuals interested in conducting first-party or second-party audits, management representatives, internal auditors and consultants.


An understanding of the ISO 13485:2016 requirements and a minimum 6 months of work experience in applying or auditing quality management systems is recommended.

Two (2) full days

Harry Wong has over 19 years’ of professional work experience in Quality Assurance of medical device, Ceramic Former and Metal Stamping for Electrical, Electronics and Automotive industries. He currently holds the position of Senior Manager, Global Complaint and Risk Management, Global Quality Assurance in one of the global leaders in protection solutions. As the subject matter expert of risk management, he provides advice, direction and training for Risk Management personnel across global sites and facilities; ensuring their risk management process complies with all necessary regulatory standards including QSR (FDA), MDD and ISO requirements. He is responsible for developing the global harmonized risk management SOP and tools which are implemented in the global organization facilities and sites.

Harry Wong is also an ASQ Certified Quality Engineer and Lead Auditor for ISO 9001 and ISO 13485 and has extensive involvement in mock audits for global sites preparing for CCC, ANVISA, SEI and FDA.

All payment is due immediately upon receipt of invoice. Please note that a confirmation letter for HRDF submission will only be issued upon receipt of payment.

Option 1: Direct Bank-in or via E-Banking upon receipt of Invoice
An invoice will be sent to you within 3 working days upon your registration.  Please note that any Early Bird Discounts (for registration within the validity period) will be reflected in the invoice. Please email us ( the bank-in slip/remittance slip once the payment is made. A confirmation letter for your HRDF submission will be issued to you upon receipt of payment.

Please refer the following bank account details:

Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 800 3930 348
Bank: CIMB Bank
Swift Code: CIBB MYKL 

For Government Sector – A Local Order (LO) or letter of approval to participate must be submitted before your registration can be confirmed. 

Option 2: Direct  Online Payment
You may choose to make a direct online payment, via Paypal or your credit/ debit card. A tax invoice and confirmation letter will be sent to your email address within 3 working days, when you choose this option.

AMMI reserves the right to cancel or postpone any training or event but with due notice to the registered participants/company (s). Any payment made will be refunded in full if the cancellation is made by AMMI.  No shows and cancellations made by participants/ companies within the specified period will incur the specified costs as per below schedule.

Prior to Training Date Cancellation Charges
30 days or more  No charges
15-29 days 25% of training course fee 
8 – 14 days 50% of training course fee
0 – 7 days 100% of training course fee

Replacement of the participant is allowed at no additional cost if you are unable to attend. Please inform us of the replacement in writing at least 3 working days before the training date.



For enquiries, please email to
Tel: +6010 4040 662  Fax: +603 2178 4347