Full program description

ISO 13485: 2016 Awareness Training

What's In It For Me

  • To understand the ISO 13485:2016, quality management system for medical devices and understand the requirements of ISO 13485:2016 .
  • To understand in detail on the ISO 13485:2016 requirements as well as implementation phases.
  • To provide an overview to companies who wish to develop and implement an effective quality system based on the requirements of the medical device customer's requirements.

Course Overview

This course has been specially designed to provide an overview to companies who wish to develop and implement an effective quality system based on the requirements of the medical device customer's requirements. This training will equip participants with a detailed interpretation, element by element, on the ISO 13485:2016 standard requirements.

Who Should Attend

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

Course Duration

7 Hours

Course Outline

  • Introduction to ISO 9001:2015 & ISO 13485:2016
  • Relation between ISO 9001:2015 to ISO 13485:2016
  • ISO 13485:2016 & ISO 14971 requirements
  • Quality management system
  • Management responsibility
  • Resource Management
  • Product Realisation
  • Measurement, analysis and improvement

Mode of Assessment

Certification Obtained and Conferred by

Certificate of Participation

Course Objectives

This one day course is designed to make understand the ISO 13485:2016, quality management system for medical devices and understand the requirements of ISO 13485:2016  
Upon completion of this course, participants will able to understand in detail on the ISO 13485:2016 requirements as well as implementation phases.

Pre-requisites

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

Medium of Instruction & Trainer

1:20

Price

$374.50 (Inclusive of GST)
IS13AT