IS13AT: ISO 13485:2016 AWARENESS TRAINING
ISO 13485:2016 AWARENESS TRAINING
Course Duration
Who Should Attend
Personnel who involve in quality management, management system, project engineering and production planning & control are encouraged to attend
Course Overview
To express your interest for enrolment in this course, please fill up this form at www.surveymonkey.com/r/WSHdemandform. We will contact you when the class schedule is released. Thank you!
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
Pre-requisites
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.
Additional Details
Medium of Instruction & Trainer
Trainer: Trainee Ratio 1: 20
Price
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Course Fee |
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Individual Sponsored Trainee |
Company Sponsored Trainee |
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before GST |
with GST |
before GST |
with GST |
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Full Course Fee |
$300.00 |
$327.00 |
$300.00 |
$327.00 |
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Remarks
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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