ISO 13485:2016 Quality Management Systems

SOCSO Course Category:
Quality Management Systems

SOCSO Course Code:

Course Title:
ISO 13485: 2016 Quality Management System

2 Days

Target Group:

  • Those involved in the Design, Production, Subcontract Manufacturing (including Sterilization, Aseptic Packaging etc.), Importation, Distribution, Installation, Servicing or appointed as Authorized Representatives in the Medical Device sector.
  • Anyone tasked with development of a QMS or conversion from ISO 13485:2003.
  • Management representatives.
  • Implementation team members.
  • Auditors (Internal or External /Supply Chain).
  • Quality Managers.
  • Regulatory Affairs personnel.


Target Industry:
Medical Device Manufacturing Industry

Certificate of Attendance in ISO 13485:2016 Quality Management System by the Association of Malaysian Medical Industries

Course Objectives:
The new ISO 13485:2016 extends the scope to the entire medical device supply chain, introduction of the Risk Based Approach to QMS processes, with new as well as expansion of existing requirements and an increased focus on the organisations ability to meet applicable customer and regulatory requirement.

This course introduces the concepts needed to understand, develop/upgrade, and deploy a quality management system as outlined in the medical devices quality management standard ISO 13485:2016.  This course also discusses the aspects of ISO 14971, which contains key principles and guidance for risk management.     

 Methods/ Methodology:

  • Lecture
  • Case Studies
  • Pre-Test & Post-Test


Course Content:

  • Overview of Requirements
  • Overview of the ISO 13485:2016 Standard
  • Interpretations of ISO 13485 Clauses
  • Transition to ISO13485:2016
  • Steps to Transition
  • ISO 13485 Linkage to Regulatory Requirements


Learning Outcomes:

Upon successful completion of the training, participants will be able to:

  • Understand Quality Management Terminology & Definitions (including revisions), Concepts and Guidelines.
  • Understand differences in objective evidence between ISO 13485:2003 and ISO 13485:2016 to be demonstrated.
  • Interpret All Clauses of ISO 13485:2016 to accurately address your company’s Role in the Medical Device Supply Chain.
  • Understand what is meant as Risk Based Approach, how it differs from Risk Management and how to evident its incorporation in to your ISO 13485:2016 based Quality Management System.
  • Learn World Class Practices to ensure Effective Implement of each Clause of ISO 13485:2016.
  • Understand requirements for Transition from 13485:2003 and ISO 13485:2016 – Timelines and Strategies.
  • Learn how to Prepare for an Audit and to Maintain ISO 13485:2016 Certification.
  • Understand relationship of ISO 13485:2016 and its roles in compliance to medical device regulations –Malaysia, ASEAN Medical Device Directive and the significantly amended EU regulations.