ISO 13485 Internal Auditor Training
Master the essentials of auditing Medical Device Quality Management Systems (MDQMS) based on ISO 13485. This course builds the knowledge and confidence needed to perform internal audits and support continuous improvement in medical device organisations.
ISO 13485 Internal Auditor Training Course is accredited by global certification board
- Uncompromising Quality Standards Accreditation backed by rigorous global benchmarks.
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Credentials that lead to interviews, promotions and mobility.
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Designed With Industry Insight
Trainings based on evolving market demands.
ISO 13485 Internal Auditor Training Overview
The ISO 13485 Internal Auditor provides a detailed understanding of how to conduct internal audits in line with ISO 13485. Participants will learn to plan, perform, and report audits effectively, helping ensure medical device quality and patient safety. It also supports organisations in maintaining robust internal controls and identifying opportunities for operational improvement.
Key Topics Covered
ISO 13485 Structure: Learn how the standard is organised and applied to medical device organisations.
Audit Planning: Prepare audit schedules, checklists, and plans tailored to ISO 13485.
Audit Execution: Gain confidence in conducting interviews, identifying issues, and gathering objective evidence.
Reporting and Review: Report findings and contribute to quality improvement.
Course Benefits
Enhance Audit Skills: Build practical expertise in internal auditing for ISO 13485 processes.
Support Quality Improvement: Contribute to safer, more efficient medical device operations.
Career Growth: Strengthen your professional standing in the healthcare and life sciences sector.
Global Application: Learn practices recognised across international medical device industries
This course is suitable for professionals involved in quality, manufacturing, or auditing within the medical device industry, including:
Quality Assurance Officers
Internal Auditors
Regulatory Affairs Specialists
Manufacturing Supervisors
Risk Managers
Quality Control Technicians
ISO 13485 Internal Auditor Training Outline
Module 1: Introduction to ISO 13485:2016
- Introduction
- What is ISO 13485:2016?
- Benefits of Implementing ISO 13485
- Applications of ISO 13485
- First Steps to ISO 13485:2016 Compliance
- What is a Medical Device?
- Purpose of a Quality Management System
- Importance of ISO 13485
- Basic Principles of ISO 13485
- Exercise
Module 2: ISO 13485 Clauses 1 and 2
- Clause 1 – Scope
- Clause 5 - Management Responsibilities
- Clause 6 - Resource Management
- Clause 2 - Normative References
Module 3: ISO 13485 Clauses 3 and 4
- Clause 3 - Terms and Definitions
- Clause 4 - Quality Management System
- Clause 4.1 General Requirements
- Clause 4.2 Document Requirements
- Exercise
Module 4: Requirements and Quality Systems
- Requirements and Quality Systems
- Clause 5 - Management Responsibilities
- Clause 6 - Resource Management
- Clause 7 - Product Realisation
- Clause 8 - Measurement, Analysis, and Improvement
- Exercise
Module 5: Overview of ISO 13485:2016 Requirements
- Requirements of ISO 13485:2016
- General Requirements
- Documentation Requirements
- Management Responsibility
- Resources
- Product Realisation
- Infrastructure
- Risk Management
Module 6: Implementation Phases of the ISO 13485 Frameworks
- Stages to Implementation
- Gap Analysis
- Process Mapping
Module 7: Conducting an ISO 13485 Certification Audit
- Certification Audits
- Exercise
Module 8: Relationship Between ISO 13485 and ISO 9001
- Scope
- Focus
- Continual Improvement
- Terminology
- Differences Between the Standards
- Similarities Between the Standards
Module 9: Internal Auditing
- Internal Auditing
- Internal Audit Objectives
- Auditing Skills
- Steps in Internal Auditing
- Planning, Preparation, and Management of Audits
- Internal Audit – PDCA Cycle
- Types of Audit
- Audit Techniques
- Exercise
Module 10: Internal Audit Plan
- Audit Plan
- Criteria
Module 11: Audit Process
- Audit Process
- Conducting Process Audits
- Scope
- Criteria
- Reporting Audit Findings
Module 12: Internal Audit Evidence and Findings
- Internal Audit Evidence and Findings
- Classification
- Closing Report
- Nonconformities
- Documented Procedure
- Exercise
Module 13: Roles and Responsibilities
- Internal Auditor Responsibilities
- Closing Meetings
Module 14: Resource Management and Product Realisation
- Provision of Resources
- Infrastructure
- Planning and Development of Products
What You’ll Learn in this Course
By the end of the course, you will be able to:
- Understand ISO 13485 principles and structure
- Conduct effective internal audits based on ISO 19011
- Identify and report nonconformities clearly and objectively
- Support your organisation’s efforts to improve medical device processes
What’s Included
ISO 13485 Internal Auditor Examination
World-Class Training Sessions from Experienced Instructors
ISO 13485 Internal Auditor Certificate
Digital Delegate Pack
ISO 13485 Internal Auditor Training Exam Details
Individual Training
Boost your expertise with our Individual Training, tailored for professionals seeking ISO knowledge at their own pace. Learn core standards, industry best practices, and implementation skills from certified experts.
Corporate Training
Empower your teams with our Corporate Training solutions, designed to align ISO standards with your organisational goals. Ensure compliance, boost efficiency, and build a culture of continuous improvement across your workforce.
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Engage with real-world scenarios, interactive tasks, and simulations that bridge theory and practical application.
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Learn from seasoned professionals with deep industry experience and insight into ISO standards and beyond.
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Choose from Online Instructor-Led, Online Self-Paced, or Classroom sessions designed to suit your pace and preferences.
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Training aligned with your sector, goals, and challenges, ensuring relevant, targeted learning every time.
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Empowering Growth with Tailored Training Solutions
We help organisations equip their teams with the skills and knowledge needed to consistently meet industry standards. Our corporate training is designed around your specific operational goals, ensuring alignment with the ISO framework.
With a strong focus on real-world application and measurable outcomes, each session drives practical capability and lasting improvement. By fostering standard-driven performance across all levels, we empower your workforce to contribute confidently and consistently to organisational success.
- Delivered by industry-certified trainers with hands-on experience
- Custom content aligned to your sector, standards, and strategy
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Feedback From Our Clients
The ISO 9001 Internal Auditor Training gave me practical insight into quality systems and how to apply audit techniques effectively. The sessions were clear and approachable, even without prior auditing experience. I now feel confident reviewing documentation, identifying nonconformities, and contributing to continuous improvement. The real-world examples and audit scenarios helped me understand the practical side of compliance and how it fits into our daily operations.
Completing the ISO 45001 Foundation Training provided me with a solid understanding of occupational health and safety standards. The training clarified legal requirements, hazard identification, and risk control measures. I’ve applied this knowledge to improve our incident response protocols and reinforce safety culture within the team. It’s also made me more effective at communicating compliance expectations and supporting ongoing H&S initiatives.
The ISO 22301 Foundation Training helped deepen my knowledge of business continuity planning and risk preparedness. The course content was practical and focused on real implementation challenges, which I could immediately relate to my role. I now play a more active part in reviewing continuity plans and coordinating recovery strategies. The training has improved how we manage operational risks and strengthened our overall resilience.
I registered my team in the ISO 9001 Lead Implementer Training, and the improvements were visible right away. The training gave us the tools to standardise workflows, enhance documentation, and build a consistent quality management system. The team has taken ownership of processes and is now more proactive in identifying areas for improvement. It’s significantly enhanced how we align with best practices and deliver results with greater reliability.
Our team participated in the ISO 45001 Lead Auditor Training to reinforce our internal safety and compliance framework. The training not only improved our auditing skills but also helped us critically assess our workplace health and safety practices. We’ve since implemented stronger controls and improved reporting structures. The shift in awareness and engagement has been very positive, especially in high-risk areas.
Frequently Asked Questions
What is the ISO 13485 Internal Auditor Course about?
This course teaches the fundamentals of auditing medical device quality systems. It covers ISO 13485 requirements, audit techniques, and reporting methods to help ensure product safety, regulatory alignment, and process performance.
Do I need any prior knowledge to join this course?
No prior auditing experience is required. However, basic familiarity with ISO standards or medical device environments can help you understand system requirements, audit procedures, and key terminology more effectively throughout the course.
Is this course suitable for all types of organisations?
Yes, it suits all medical device organisations including manufacturers, suppliers, and service providers. The course supports internal audit practices in both small and large companies across regulated global healthcare markets.
Is the ISO 13485 Internal Auditor Course internationally recognised?
Will I learn how to conduct ISO 13485 internal audits?
Yes, you’ll learn the full audit cycle including planning, conducting, reporting, and follow-up. The course provides practical tools and scenarios to build your confidence and skills in assessing system effectiveness and quality.
