Category Archives: 2026 Training

ISO 13485:2016 Quality Management System

DATE: 3 & 4 August 2026 (Mon & Tues) 

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

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

Effective Root Cause Analysis

DATE: 29 July 2026 (Wed)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)

INTRODUCTION
Root Cause Analysis (RCA) is one of the most common actions required at every organisation, not only to solve day-to-day operational problems but also to play an important role in other improvement activities such as lean sigma, risk management, etc. Root cause analysis involves searching backwards from an undesirable effect (or problem) to its cause(s) and addressing those causes to effectively prevent recurrence.

This training provides the learner with a basic understanding of the principles and techniques of effective root cause analysis and providing concepts needed to effectively perform investigation.

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

• Understand the principles and techniques of effective root cause analysis.
• Recognise common barriers to root cause analysis and apply techniques to overcome those barriers.
  

COURSE OUTLINE
1. Challenges in root cause analysis
2. Benefits of effective root cause analysis
3. Symptoms vs cause of the problem
4. Contributing factor vs root cause
5. Types of root cause
6. Root cause analysis problem solving model
7. Root cause analysis tools
8. Actions to prevent future problem – corrective action preventive action
9. Human error
10. Root cause analysis in a regulated environment
11. Tips for performing effective root cause analysis

Medical Device Change Control

DATE: 20 & 21 July 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)

COURSE OBJECTIVES
This course provides quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills to implement change control for medical devices.

COURSE OUTLINE
1. Introduction to design control
2. Application of risk management to design control
3. Design control system

• Design and development planning
• Design and development input
• Design and development output
• Design and development review
• Design and development verification
• Design and Development validation
  
• Design and development transfer
• Design and development changes
• Design history file

4. Validation system (Design/Installation/Operational and Performance Qualification)
5. Statistical tools and techniques
6. Design control – Quality system inspection technique

Design of Experiments

DATE: 30 June 2026 (Tue)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Olive Tree Hotel, Penang
Option 2: Online (via Zoom)

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

• Differentiate traditional experimentation and Design of Experiments (DOE) methods.
• Understand and apply crucial DOE concepts.
• Plan a full factorial or a fractional factorial experiment.
• Analyze DOE results.
• Handle confounding effects.
• Develop process models for process predictions and simulations.
• Use Minitab software for DOE analysis.
  

COURSE OUTLINE
1. Types of experimentations
2. Minitab navigation
3. Factorial design and analysis for experimentation
4. Develop process models for process performance prediction and simulations
5. Statistical process control