Author Archives: Melissa

ISO 13485:2016 Internal Audit

DATE: 30 November & 1 December 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

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

INTRODUCTION
A robust internal audit program is an essential requirement for maintaining compliance with ISO 13485:2016 and ensuring the consistent quality and safety of medical devices throughout their lifecycle.

This course equips participants with the knowledge and practical skills needed to plan, conduct, report, and follow up on internal audits systematically and effectively. The training emphasizes understanding process-based auditing, identifying compliance gaps, evaluating the effectiveness of the Quality Management System (QMS), and driving continual improvement within the organization.

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

• Understand the purpose, structure, and key requirements of ISO 13485:2016.
• Explain the principles, responsibilities, and ethics of internal auditors.
• Apply a process-based auditing approach aligned with ISO 19011 guidelines.
• Plan, prepare, and execute internal audits effectively using audit tools and checklists.
• Evaluate evidence, identify nonconformities, and assess process effectiveness.
• Document findings in a clear and objective audit report.
• Verify corrective actions and contribute to continual QMS improvement.
• Strengthen organizational compliance with regulatory and customer requirements through a strong internal audit program.
  

COURSE OUTLINE
1. Introduction to auditing quality management system

• Dilemma of internal quality audit
• Auditing fundamental
• Why audit is essential
• Audit requirements: FDA QSR/ QMSR & ISO 13485:2016
• ISO guideline in auditing management system
• The role of internal quality audit
• Why audit
• What to audit
• Management responsibility
• Management Representative responsibility

2. Types of audit
3. Principles of auditing
4. Internal audit process
5. Application of PDCA in audit process
6. Managing audit program

• Establish program objectives
• Determine audit program risk & opportunities
• Establish audit program
• Implement audit program
• Monitor audit program
• Review & improving audit program

7. Conducting the audit

• Preparing audit
• Conduct audit
• Prepare audit report
• Audit follow up
  

8. Auditor competency
9. The future of internal quality audit
10. Understand ISO 23485:2016 QMS from auditor perspective 

• Introduction
• Mandatory documentation
  
• Clause by clause interpretation from auditor perspective

ISO 13485:2016 Quality Management System

DATE: 16 & 17 November 2026 (Mon & Tue) 

TIME: 9.00am – 5.15pm

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

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