Course Duration

7.0 hr(s)

Who Should Attend

Personnel who involve in quality management, management system, project engineering and production planning & control are encouraged to attend

Course Overview

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ISO 13485:2016 specifies requirements for a quality management system where organisations need to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Such organisations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device; and design and development or provision of associated activities (e.g. technical support).

ISO 13485:2016 can also be used by suppliers or external parties that provide a product, including quality management system-related services to such organisations.

Course Schedule

Next available schedule


Persons with some industrial, business and/or service sector experience

Course Outline

  • Introduction to ISO 9001: 2015 & ISO 13485: 2016
  • The relation between ISO 9001: 2015 to ISO 13485: 2016
  • ISO 13485: 2016 requirements
  • Cross-reference to ISO 14971: 2007 (Application of risk management to medical devices)
  • Quality Management System
  • Management Responsibility
  • Resource Management
  • Product Realisation
  • Measurement, analysis and improvement

Certificate Obtained and Conferred by

Certificate of Participation from NTUC Learninghub

Note: Due date for all companies to transit to ISO 13485 : 2016 is February 2019.

  • Certificate of completion from NTUC LearningHub

Upon meeting at least 75% attendance and passing the assessment(s), participants will receive a Certificate of Completion from NTUC LearningHub.

Additional Details

Medium of Instruction & Trainer

Trainer: Trainee Ratio 1: 20


Course Fee


Individual Sponsored Trainee

Company Sponsored Trainee

before GST

after GST

before GST

after GST

Full Course Fee







Union Training Assistance Programme (UTAP)
NTUC members enjoy UTAP* benefit of up to $250 each year when you sign up for courses with NTUC LearningHub

* UTAP supports 50% of the course fees paid cap at $250 per year. You must be a union member throughout the course duration and at the time of claim. You must achieve a minimum of 75% attendance for each application and have sat for all prescribed examinations. Other terms and conditions apply.

Terms & Conditions apply. NTUC LearningHub reserve the right to make changes or improvements to any of the products described in this document without prior notice.

Prices are subject to other LHUB miscellaneous fees

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