Brenda Goh

Modified 3 Years ago.

ISO 13485:2016 AWARENESS TRAINING

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

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

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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.

Fees and Funding

Medium of Instruction & Trainer

Trainer: Trainee Ratio 1: 20

Price

	w/o GST	w GST
Course Fee	$300.00	$321.00

Remarks:

Terms and 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.

Course Code

IS13AT

Course Overview
Course Schedule
Pre-requisites
Course Outline
Certificate Obtained and Conferred by
Fees and Funding

Before Funding 300

Please contact us through our enquiry form if there are no schedules available.

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IS13AT: ISO 13485:2016 AWARENESS TRAINING

ISO 13485:2016 AWARENESS TRAINING

Course Duration

Who Should Attend

Course Overview

Course Schedule

Pre-requisites

Course Outline

Certificate Obtained and Conferred by

Fees and Funding

Medium of Instruction & Trainer

Price

What Others Also Enrolled In

PROTECTED AREA