What is ISO 13485 Internal Auditor?
The ISO 13485 Internal Auditor Course is designed to provide Learners with a thorough understanding of ISO 13485 requirements and the skills needed to perform effective internal audits. This course covers audit principles, techniques, and reporting, enabling learners to evaluate and improve the implementation of QMS processes for medical devices.
Learners will learn to identify nonconformities, assess compliance with ISO 13485, and recommend corrective actions to enhance QMS performance. Practical exercises and case studies ensure learners can apply their knowledge in real-world scenarios, preparing them to contribute to their organisation’s quality objectives.
This comprehensive 2-day ISO 13485 Internal Auditor Course by Oakwood International empowers professionals to support compliance, continuous improvement, and organisational excellence in the medical device industry.
Course Objectives
- To understand the purpose and benefits of ISO 13485 for QMS in the medical device sector
- To learn the structure, scope, and requirements of the ISO 13485 standard
- To develop skills for planning and conducting internal audits effectively
- To assess compliance with ISO 13485 requirements and organisational policies
- To identify nonconformities and recommend corrective actions
- To create clear and actionable audit reports
- To ensure continuous improvement of QMS processes
Upon completion, Learners will be equipped to conduct internal audits confidently, supporting ISO 13485 compliance and QMS effectiveness.
Course Outline
ISO 13485 Internal Auditor
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
Included
Included
- No course includes are available.
Offered In This Course:
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Video Content
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eLearning Materials
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Study Resources
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Completion Certificate
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Tutor Support
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Interactive Quizzes
Learning Options
Discover a range of flexible learning options designed to meet your needs. Select the format that best supports your personal growth and goals.
Online Instructor-Led Training
- Live virtual classes led by experienced trainers, offering real-time interaction and guidance for optimal learning outcomes.
Online Self-Paced Training
- Flexible learning at your own pace, with access to comprehensive course materials and resources available anytime, anywhere.
Build your future with Oakwood International
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Frequently Asked Questions
Q. What topics are covered in the ISO 13485 Internal Auditor Course?
The course covers audit
principles, ISO 13485 requirements, planning and conducting audits,
nonconformity management, and audit reporting.
Q. How can this training benefit my career?
ISO 13485 Internal Auditor
certification validates your ability to assess and improve QMS processes,
enhancing your quality assurance and regulatory compliance career.
Q. Is ISO 13485 applicable globally?
Yes, ISO 13485 is recognised
internationally and aligns with various global medical device regulations.
Q. What support is provided during the training?
Learners receive comprehensive
study materials, practical exercises, and expert instructor guidance to ensure
effective learning and certification readiness.
Q. Is this course suitable for beginners?
Yes, the course is designed for
professionals new to internal auditing or ISO 13485. It offers foundational
knowledge and skills for performing audits effectively.