ISO 13485:2016 Internal Auditor (16 hrs)

Course Code: ISO13485-IAMD-02

In the pursuit of continual improvement, organisations are constantly embarking on the journey to strengthen its quality management systems and processes with the aim to produce high customer loyalty, satisfaction and build long term partnerships with them.

To keep quality management system standards relevant to the community of users, ISO 13485, the internationally recognised quality management system standard for medical devices industry, underwent major changes by the Standard Body and the revised medical standard ISO 13485:2016 was published on February 25, 2016. Participants will gain an understanding of how the changes impact their organisations and learn how to audit against the revised ISO 13485:2016 standard.

  • Understand the requirements of ISO13485:2016 for medical products and related services
  • Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
  • Acquire the skills to take on the position of an internal medical services auditor in the company
  • Introduction to Quality Management System
  • Overview of ISO 13485:2016 requirements
  • Comparisons between ISO 13485:2016 and ISO 13485:2003 requirements
  • Audit planning and preparation
  • Audit execution
  • Non-conformity reporting
  • Closing meeting
  • Audit report preparation
  • Audit follow-up

Participants will learn through lectures, case studies, group exercises and discussions.

This course is suitable for:

  • Quality and regulatory managers / supervisors
  • Product designers
  • Management representatives and consultants
  • Internal auditors
  • Consultants

Duration : 2 days (16 hrs)
Time : 9:00am – 6:00pm

Course Fee : $750.00
Nett Fee Incl. 7% GST : $802.50

(A course in partnership with TÜV SÜD)

Key Benefits
  • Understand the requirements of ISO13485:2016 for medical products and related services
  • Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
  • Acquire the skills to take on the position of an internal medical services auditor in the company
Course Contents
  • Introduction to Quality Management System
  • Overview of ISO 13485:2016 requirements
  • Comparisons between ISO 13485:2016 and ISO 13485:2003 requirements
  • Audit planning and preparation
  • Audit execution
  • Non-conformity reporting
  • Closing meeting
  • Audit report preparation
  • Audit follow-up
Learning Methodology

Participants will learn through lectures, case studies, group exercises and discussions.

Who Should Attend

This course is suitable for:

  • Quality and regulatory managers / supervisors
  • Product designers
  • Management representatives and consultants
  • Internal auditors
  • Consultants
Course Details

Duration : 2 days (16 hrs)
Time : 9:00am – 6:00pm

Course Fee : $750.00
Nett Fee Incl. 7% GST : $802.50

(A course in partnership with TÜV SÜD)

Course Application

Details Registration
February 27, 2020 - February 28, 2020 (9:00 am - 6:00 pm) Closed