★★★★★
"The structure, the practice exams, the instructor — all top tier. Passed first try."
AS
Ranjan PradhanSenior Project Manager
— The journey
Course Outline
What the programme covers, module by module.
Module 1: Introduction to ISO 13485
- ISO 13485 overview
- Purpose of the standard
- Medical device quality management
- Regulatory environment
- Quality management principles
- Organisational benefits
Module 2: Medical Device Quality Management System
- QMS fundamentals
- Process approach
- Quality system requirements
- Organisational responsibilities
- Quality objectives
- Maintaining QMS effectiveness
Module 3: Documentation & Record Control
- Quality documentation
- Quality manual awareness
- Procedures
- Work instructions
- Document control
- Record management
Module 4: Management Responsibility & Resources
- Management commitment
- Customer and regulatory requirements
- Quality policy
- Roles and responsibilities
- Competence and training
- Infrastructure and work environment
Module 5: Risk Management & Product Realisation
- Risk-based approach
- Product requirements
- Design and development awareness
- Production controls
- Process validation
- Product safety considerations
Module 6: Supplier, Purchasing & Traceability Controls
- Supplier evaluation
- Purchasing controls
- Verification of purchased products
- Supplier monitoring
- Identification and traceability
- Product preservation
Module 7: Monitoring & Nonconforming Products
- Process monitoring
- Product monitoring
- Customer feedback
- Complaint awareness
- Nonconforming product control
- Quality data analysis
Module 8: Corrective Action & QMS Improvement
- Corrective action
- Root cause awareness
- Preventing recurrence
- Internal audit awareness
- Management review
- Maintaining QMS effectiveness
— 01.2 · Is it right for you?
Who it's for & what's included
Pick a delivery method to see exactly who it suits and everything you receive.
Who it's for
Classroom
Best for learners who want face-to-face tuition and to network with peers in person.
What's included
Everything you get
- ✓ Live instructor on-site
- ✓ Printed workbook & materials
- ✓ Group exercises & case studies
Who it's for
Online Instructor-Led
Best for learners who want a live instructor and a fixed schedule, without the travel.
What's included
Everything you get
- ✓ Live instructor via video call
- ✓ Digital workbook & resources
- ✓ Session recordings
Who it's for
Self-Paced
Best for self-motivated learners who need maximum flexibility around work and life.
What's included
Everything you get
- ✓ On-demand video lessons
- ✓ Interactive quizzes
- ✓ 24/7 access on any device
— About this course
Course Overview
The ISO 13485 Medical Devices Quality Management Awareness program provides working professionals with a fundamental understanding of quality management requirements within the medical device industry. Participants explore ISO 13485 principles, regulatory expectations, quality management systems, management responsibilities, documentation, risk management, resource management, product realisation, supplier controls, traceability, monitoring, nonconforming products, corrective actions, and maintaining an effective medical device quality system.