Category Archives: 2021 Training

ISO13485:2016 INTERNAL AUDITING

PAST SESSION
24-25 May 2021

INTRODUCTION

The ISO 13485 Standard mentioned the organization shall conduct internal audits at planned intervals to determine whether the quality management system conforms to relevant requirements and if it is effectively implemented and maintained.

 

The organization must have a process established to conduct an internal audit at planned intervals. The internal audit shall be planned, executed, reported and follow-up to ensure an effective closed-loop internal audit process is conducted. The internal audit results are important to provide Top Management with the status of the quality management system and to identify improvement initiatives.

 

This training is developed to give an understanding to the organization regarding the requirements on internal audit from the ISO 13485 standard as well as the ISO 19011 standard. This training is aimed to develop a team of internal auditors that are competent in conducting internal audit.

 

COURSE OBJECTIVES
This course aims to provide delegates the competence to plan, execute, report, and follow-up on an internal audit based on the ISO 13485:2016 Standard requirements. The consultant will also share practical examples through assignments and/or workshops to help delegates understand the content of the training better.

 

The course content outlined is to provide delegates with:

• The principles of audit and auditing guidelines based on ISO 19011 standards
• Knowledge and skills to plan, execute, report and follow-up an internal audit
• Understanding of common mistakes in internal auditing

 

COURSE OUTLINE

Session 1 (half-day):

Opening and introduction

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

 

 

Session 2 (half-day):

Day 1 Recap

5. Initiating audit
6. Preparing audit activities

 

Session 3 (half-day):

Day 2 Recap

7. Conducting audit activities
8. Preparing and distributing audit report

 

Session 4 (half-day):

Day 3 Recap

9. Completing audit
10. Conducting audit follow-up
11. Course summary

 

COURSE BENEFITS
Upon completion of this training, delegates will: –

1. Have a good understanding of what is audit and the principles of auditing.
2. Understand how to establish audit programme, develop an audit plan and audit checklist.
3. Understand the audit methodology (the audit triangle) to collect audit evidence.
4. Learn the personal behaviour of auditors.

TARGET AUDIENCE

This programme is designed for ALL functions and levels of an organization that need to gain knowledge and practical skills on internal auditing based on ISO 13485.

 

This programme is particularly useful to those managing the quality management system, and internal auditors.

TRAINER’S PROFILE

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 Associate Director, 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.

 

PAYMENT AND CONFIRMATION OF REGISTRATION
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 (admin@medsociate.com) 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.

CANCELLATION / REFUND POLICY
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

 SUBSTITUTION
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.

 

CONTACT

For enquiries, please email to secretariat@ammi.com.my
Tel: +6010 4040 662  Fax: +603 2178 4347