ISO 13485:2016 Lead Auditor Training

ISO 13485:2016 Lead Auditor Training provides practical knowledge of medical device quality management systems, audit techniques, and certification requirements.

Overview

ISO 13485:2016 Lead Auditor Training is designed to provide participants with the knowledge and skills required to plan, conduct, and lead audits of medical device quality management systems based on ISO 13485:2016.

The programme covers ISO 13485 requirements, audit principles, risk management, documented information, and audit processes relevant to the medical device industry. Participants will gain practical knowledge of how to evaluate quality management systems and perform effective audits within organisations.

This programme is suitable for professionals seeking advanced knowledge of ISO 13485 auditing 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 audit processes.

Session 1: Overview of Course and Standard
Session 2: ISO 13485 Principles
Session 3: ISO 13485:2016 Requirements
Session 4: Control of Documents and Records
Session 5: Risk Management
Session 6: ISO 13485:2016 Internal Audit Process
Session 7: Audit Roles and Responsibilities
Session 8: Performing an Audit
Session 9: Nonconformity and Corrective Action

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 audit examples and reference materials
• Audit checklists and assessment activities
• Session-based assessments and a final examination

Programme Outcomes

• Understand ISO 13485:2016 medical device quality management system requirements
• Understand audit principles, techniques, and processes
• Understand risk management within medical device quality systems
• Understand documented information and audit records
• Understand audit planning, execution, reporting, and corrective actions

Who Should Attend

This programme is designed for individuals involved in auditing and managing medical device quality management systems.

• Internal auditors and compliance professionals
• Quality managers and technical professionals
• Medical device industry personnel
• Consultants and management representatives
• Individuals seeking ISO 13485 lead auditor certification

Prerequisites

• Basic knowledge of quality management systems and auditing principles is beneficial but not required.

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:

How It Works

1. Enrol Online
2. Receive Instant Access
3. Study at Your Own Pace
4. Complete Online Assessment
5. Receive Your Certificate

+27 31 020 2248

+27 31 020 2248