ISO 13485-2016 QMS Foundation Training
ISO 13485 QMS Foundation Training provides foundational knowledge of medical device quality management systems, ISO 13485:2016 requirements, and certification processes.
- Certificate
- E-Learning
- 04 Hours
- 24/7
Overview
ISO 13485 QMS Foundation Training is designed to provide participants with foundational knowledge of medical device quality management systems based on ISO 13485:2016.
The programme covers ISO 13485 requirements, documented information, quality management system principles, and certification processes relevant to medical device organisations. Participants will gain practical understanding of how quality management systems are implemented, maintained, and improved within the medical device industry.
This programme is suitable for professionals and individuals seeking introductory knowledge of ISO 13485:2016 and medical device quality management systems.
Curriculum
This programme consists of structured learning sessions designed to provide practical knowledge of ISO 13485:2016 requirements and quality management system implementation.
Session 1: Overview of ISO 13485:2016
Session 2: ISO 13485:2016 Requirements
Session 3: QMS Documented Information
Session 4: Steps for ISO 13485:2016 Certification
Course Delivery
This programme is delivered through a combination of structured learning materials and assessment activities designed to support practical understanding and application.
• Video lectures with audio-visual presentations
• Downloadable handouts and supporting documentation
• Practical examples and reference materials
• Session-based assessments and a final examination
Programme Outcomes
• Understand ISO 13485:2016 medical device quality management system requirements
• Understand clause-wise requirements of ISO 13485:2016
• Understand documented information requirements for QMS
• Understand medical device quality management system implementation processes
• Understand ISO 13485 certification requirements and processes
Who Should Attend
This programme is designed for individuals involved in medical device quality management systems and compliance activities.
• Company executives, managers, and supervisors
• QMS implementers and management representatives
• Quality management consultants
• Medical device industry professionals
• Individuals seeking foundational ISO 13485 knowledge
Prerequisites
• No formal prerequisites are required.
• Basic knowledge of quality management systems is beneficial.
Faculty & Facilitators
This programme is delivered by Qualified Skills Development Facilitators (SDFs) who are certified Lead Auditors and industry-experienced professionals. Our facilitators bring practical auditing expertise and real-world implementation experience, ensuring that training remains relevant, applied, and aligned with current industry standards.
Assessment & Certification
Each programme includes structured module summaries designed to reinforce key learning outcomes and support assessment preparation. Participants are required to complete a final online assessment to demonstrate competency. Upon successful completion of the assessment requirements, a formal course certificate is issued. Certificates are available for download and may be independently verified using the issued certificate reference number.
Programme Snapshot
Duration:
Delivery Mode:
Accreditation:
- 04 Hours
- E-Learning
- Certificate
How It Works
1. Enrol Online
2. Receive Instant Access
3. Study at Your Own Pace
4. Complete Online Assessment
5. Receive Your Certificate
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