11 – 12 May 2026: ISO 13485:2016 Quality Management System

ISO 13485:2016 Quality Management System

DATE: 11 & 12 May 2026

TIME: 9.00am – 5.15pm

VENUE: Dorsett Grand Subang Hotel, Selangor

DURATION: 2 full-day course

INTRODUCTION
ISO 13485:2016 is the internationally recognized Quality Management System (QMS) standard
specifically developed for organizations involved in the design, manufacture, installation, and servicing
of medical devices. It places strong emphasis on regulatory compliance, risk-based thinking, process
control, and continual improvement to ensure the safety, performance, and reliability of medical
devices throughout their lifecycle.

This training provides participants with a practical and structured understanding of ISO 13485:2016
requirements, focusing on how the standard is applied in real manufacturing and quality system
environments. The course bridges the gap between standard requirements and day-to-day
operations, helping organizations establish, implement, maintain, and improve an effective medical
device QMS.

Through interactive discussions, real-life examples, and industry best practices, participants will gain
clarity on key QMS elements such as management responsibility, resource management, risk
management, product realization, supplier control, documentation, internal audit, CAPA, and
regulatory alignment. The training is designed to support organizations in achieving compliance with
global regulatory expectations, and improving operational effectiveness.

COURSE OBJECTIVES
After participating in the training, you will be able to:

• Understand the key requirements and intent of ISO 13485:2016.
• Recognize how ISO 13485 applies to daily work activities in the medical device industry.
• Understand and interpret the ISO 13485:2016 requirements.
• Learn the practical implementation examples.

COURSE OUTLINE
1. Introduction of ISO 13485:2016
2. 7 Quality Management Principles
3. Clause by clause interpretation of ISO 13485:2016

• Clause 0: Introduction
• Clause 1: Scope
• Clause 2: Normative References
• Clause 3: Terms and Definitions
• Clause 4: Quality Management System
• Clause 5: Management Responsibility
• Clause 6: Resource Management
• Clause 7: Product Realization
• Clause 8: Measurement, Analysis and Improvement