ISO13485:2016 Quality Management Systems
12-13 December 2023
9.00am – 5.00pm
Two (2) full days
Online via Zoom
Medical device regulatory requirements are becoming more stringent throughout every step of a medical device life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes are compliant and ensure best practice in everything they do.
This internationally accepted ISO 13485 2016 standard sets out the requirements for a quality management system specific to the medical devices industry. Its implementation in a quality management system is mandatory for an organisation involved is one or more phases of a medical device life cycle either as a manufacturer, supplier or external organisation providing products which has to consistently meet customer and applicable regulatory requirements.
Participants will be introduced to the concepts required to understand, implement and maintain an ISO 13485 2016 medical device quality management system (QMS). Participants will also be imparted with the knowledge on the utilisation of mandatory requirements within an ISO 13485 2016 compliant QMS for the one or more stages of a medical device life-cycle.
- Introduction on the background of this standard currently in its third edition.
- An understanding of what is termed and defined as a medical device.
- Guided understanding of the of the ISO 13485 2016 clauses and its application.
- An overview of the ISO 13485 2016
- Clause 1: Scope
- Clause 2: Normative References
- Clause 3: Terms and Definitions
- Clause 4: Quality Management System
- Clause 5: Management Responsibility
- Clause 6: Resource Management
- Clause 7: Product Realization
- Clause 8: Measurement, Analysis and Improvement
At the end of the session, participants will;
- Gain an understanding of the intent of the various clauses.
- Be aware of the application of the clauses in its implementation.
- Be knowledgeable on the maintenance of the QMS effectiveness to reflect current ‘state of the art’.
- Fulfil the prerequisite competence prior to participating in an ISO13485 2016 Internal Audit training.
This programme is designed for ALL functions and levels of an organization who need to gain understanding of the requirements in the standard, especially organizations that has embarked on the journey and plan to be certified with ISO 13485.
This programme is particularly useful to those managing the quality management system, process owners and internal auditors.
Enjoy Early Bird Course Fees when you register by 21 November 2023.
|Early Bird Course Fees
||RM (inc 6% SST)|
|Normal Course Fees
|Group Registration (6th -9th pax)||1,166.00|
|Bonus Deal (10th – 18th pax)||398.00|
Option 1: HRD Corp Claimable Course Scheme
A quotation together with course outlines and course agenda will be sent to you for HRDCorp grant application upon confirmation of the training. Please send us the grant application number for our record upon submission.
Option 2: Self-paying
2a) Direct Bank-in or via E-Banking
An invoice will be sent to you within 3 working days upon your registration. Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice. Please email us (email@example.com) the bank-in slip / remittance slip once the payment is made.
Please refer the following bank account details:
Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 230-302-078-2
Bank: UOB Bank
Swift Code: UOVBMYKL
For Government Sector – A Local Order (LO) or letter of approval to participate must be submitted before your registration can be confirmed.
2b) Direct Online Payment
You may choose to make credit card payment via Paypal. An invoice with payment link will be sent to your email address separately when you choose this option.
The organisers, AMMI/ Medsociate Sdn Bhd 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/ Medsociate Sdn Bhd. 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 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.