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Course Information

ISO 13485 Lead Auditor Course Outline

The following subjects will be taught during this course

Module 1: Introduction to ISO 13485:2016

  • What is ISO 13485:2016?
  • Importance of ISO 13485 for an organisation

Module 2: A Overview of ISO 13485:2016 Requirements

  • General requirements
  • Documentation requirements
  • Management responsibility
  • Resources
  • Product realisation
  • Infrastructure
  • Risk management

Module 3: Implementation Phases of the ISO 13485 Frameworks

  • Stages to implementation
  • Gap analysis
  • Process mapping

Module 4: Conducting an ISO 13485 Certification Audit

  • Certification audits

Module 5: The Relationship Between ISO 13485 and ISO 9001

  • Scope
  • Focus
  • Continual improvement
  • Terminology
  • Differences between the standards
  • Similarities between ISO 13485 and ISO 9001

Module 6: Internal Auditing

  • Internal audit objectives
  • Auditing skills
  • Planning, preparation, and management of audits
  • Internal audit – PDCA cycle
  • Types of audits
  • Audit techniques

Module 7: The Internal Audit Plan

  • The audit plans
  • Criteria

Module 8: The Audit Process

  • Conducting process audits
  • Internal audit scope and criteria
  • Reporting audit findings

Module 9: Internal Audit Evidence and Findings

  • Classification
  • The closing of reports
  • Nonconformities
  • Documented procedure

Module 10: Roles and Responsibilities

  • Internal Auditor responsibilities
  • Closing meeting
  • Management responsibilities

Module 11: Resource Management and Product Realisation

  • Provision of resources
  • Infrastructure
  • Planning and development of products

Module 12: ISO 13485 and Quality Management Systems

Module 13: Principles of Quality Management System

  • Customer and regulatory focus
  • Leadership
  • Involvement
  • The process approach
  • Common tools
  • Decision making
  • Supplier management
  • System management
  • Continuous improvement

Module 14: The Fundamentals of Quality Management Systems

Module 15: Requirements and Quality Systems

Module 16: Measurement, Analysis, and Improvement

  • Monitoring and measurement
  • Control of non-conforming products
  • The performance of the QMS
  • Analysis of data
  • Improvement of quality
  • Corrective action
  • Preventive action
  • Identification of improvement opportunities

Module 17: Risk Management

  • Risk management principles
  • The risk management process
  • Risk lifecycle
  • Risk management tools
  • Risk management culture
  • Assessments and control of risk management

Module 18: Key Terms and Definitions of Lead Auditor

Module 19: Lead Auditor Responsibilities

  • Roles, responsibilities, and authorities

Module 20: Team Leader Skills

Module 21: ISO 13485 Clauses 1 and 2

Module 22: ISO 13485 Clauses 3 and 4

Module 23: Structure and Intent of ISO 13485

Module 24: Medical Devices, Quality, and Auditing Terminology

Module 25: Processes, Procedures, and Records

Module 26: Checklist Development

Module 27: Planning, Preparation, and Management of Audits

Module 28: Interviewing Skills

Module 29: Corrective Action and Verification

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Who Should Attend this ISO 13485 Training Course?

This course has been recommended for professionals who are involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier quality assurance programme.


We recommend completing the ISO 13485 Foundation certification before studying this course.

ISO 13485 Lead Auditor Course Overview

This highly interactive course enables individuals to plan, lead, and report audits within their own organisation, with their suppliers and with third-party organisations. This course will benefit our delegates by ensuring that they are able to conduct effective audits in any auditing situation. This will be achieved through the attainment of the relevant skills in planning, coordinating, reporting, and reviewing with regards to QMS auditing. By putting these skills into practice, certified individuals can improve overall organisational performance. Our expert instructors will provide informative and engaging sessions and will include a hands-on run through of the complete auditing process, including managing an audit programme and reporting the results. It is essential that our candidates understand the role of an ISO 13485 Lead Auditor and can explain their role in terms of the entire auditing process outlined in this course. At the end of the course, delegates will be required to sit an exam to become certified.

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What's included in this ISO 13485 Training Course?

This training course includes:

  • The ISO 13485 Lead Auditor Examination
  • The Knowledge Academy ISO 13485 Lead Auditor Manual 
  • Certificate
  • Experienced ISO Instructor 
  • Refreshments 

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ISO 13485 Lead Auditor Exam

In order to complete this ISO 13485 Lead Auditor training course, delegates will need to pass the associated examination. The exam is:

  • Multiple choice questions
  • Duration of 40 minutes
  • 50% pass mark
  • Closed book

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Why choose us

Ways to take this course

Our easy to use Virtual platform allows you to sit the course from home with a live instructor. You will follow the same schedule as the classroom course, and will be able to interact with the trainer and other delegates.

Our fully interactive online training platform is compatible across all devices and can be accessed from anywhere, at any time. All our online courses come with a standard 90 days access that can be extended upon request. Our expert trainers are constantly on hand to help you with any questions which may arise.

This is our most popular style of learning. We run courses in 1200 locations, across 200 countries in one of our hand-picked training venues, providing the all important ‘human touch’ which may be missed in other learning styles.


Highly experienced trainers

All our trainers are highly qualified, have 10+ years of real-world experience and will provide you with an engaging learning experience.


State of the art training venues

We only use the highest standard of learning facilities to make sure your experience is as comfortable and distraction-free as possible


Small class sizes

We limit our class sizes to promote better discussion and ensuring everyone has a personalized experience


Great value for money

Get more bang for your buck! If you find your chosen course cheaper elsewhere, we’ll match it!

This is the same great training as our classroom learning but carried out at your own business premises. This is the perfect option for larger scale training requirements and means less time away from the office.


Tailored learning experience

Our courses can be adapted to meet your individual project or business requirements regardless of scope.


Maximise your training budget

Cut unnecessary costs and focus your entire budget on what really matters, the training.


Team building opportunity

This gives your team a great opportunity to come together, bond, and discuss, which you may not get in a standard classroom setting.


Monitor employees progress

Keep track of your employees’ progression and performance in your own workspace.

What our customers are saying

ISO 13485 Lead Auditor FAQs


Please arrive at the venue for 08:45am
The course begins at 9am and finishes around 5pm.
Vital for Professionals involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier quality assurance program.
We can provide support via phone & email prior to attending, during and after the course
Delegate pack consisting of course notes and exercises, Manual, Experienced Instructor and Refreshments
This course is 5 days
Once your booking has been placed and confirmed, you will receive an email which contains your course location, course overview, pre-course reading material (if required), course agenda and payment receipts
The price for ISO 13485 Lead Auditor certification in Australia starts from AUD3295
The Knowledge Academy is the Leading global training provider in the world for ISO 13485 Lead Auditor.

Why choose us


Best price in the industry

You won't find better value in the marketplace. If you do find a lower price, we will beat it.


Many delivery methods

Flexible delivery methods are available depending on your learning style.


High quality resources

Resources are included for a comprehensive learning experience.

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"Really good course and well organised. Trainer was great with a sense of humour - his experience allowed a free flowing course, structured to help you gain as much information & relevant experience whilst helping prepare you for the exam"

Joshua Davies, Thames Water

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