This ISO 13485 lead auditor course aims to provide learners with the knowledge and skills required to perform first, second and third-party audits of medical device quality management systems against ISO 13485:2016 and applicable international regulatory standards in accordance with ISO 19011:2026, ISO/IEC 17021-1:2015 through an ISO 13485 Auditor Course learning format. All references to standards in this document are to the current versions, unless stated otherwise.
Medical Devices Quality Management System
PR 369 ISO 13485:2016 Auditor/Lead Auditor Training Course
Approved by:
Course ID: PR 369 / 17584
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Requirements
Prior Knowledge Requirements
Prior knowledge requirements:
ISO 13485
Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA or Exemplar Global Certified MD-QMS ISO 13485: 2016 Foundation (FD132) course or equivalent.
Medical device management systems audit
Knowledge of the following quality management principles and concepts:
The Plan, Do, Check, Act (PDCA) cycle.
The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.
The process approach used in MD-QMS.
A working knowledge of medical device regulatory process applicable to countries the course is designed to cover, including device regulations, regulatory auditing standards and their relationship with ISO 13485. This knowledge may be gained by successfully completing a CQI and IRCA or Exemplar Global course relating to individual regulatory authority standards, which will be available subject to demand (e.g. MD-QMS Comprehensive EU Medical Device Regulation 2017/745 (EU MDR) Practitioner – PT219)
A working knowledge of risk-management principles related to the design of a medical device, for example ISO 14971: 2019.
Virtual Technology Requirements
To participate in the virtual training sessions, you will need:
- Workplace Networks & VPN Connections
- In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted, and may not perform well.
- The use of a VPN connection can result in poor performance and interfere with the SSO (Single Sign On) that connects users from our website and associated applications to their eLearning modules. We strongly recommend ensuring you are disconnected from a VPN or Proxy Server if experiencing any issues with accessing the eLearning modules.
- Recommended Operating Systems
- Windows 7/10, macOS Sierra, iPad iOS 10
- Mobile Devices
- The Kelmac Group Academy LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device to complete any eLearning modules. However, if completing any final assessment, we recommend completing it via a desktop browser.
- Internet Speed & Reliability
- We recommend using an internet connection of 256 Kbit/sec or faster, which will ensure that you can successfully access our eLearning modules. A stable connection is important to ensure you do not experience any outages during the completion of any module or any final assessment (s).
- Recommended Internet Browsers
- Google Chrome 32-bit version 50 or later (most recommended)
- Safari 10 or later
- Note: Add-ons and toolbars can affect any browser’s performance.
- Recommended Settings
- We recommend that the following settings be enabled:
- Cookies
- Pop-ups (in both Internet browsers and security software)
- JavaScript
- Plugins
- Latest Version of Adobe Flash Player
- Latest Version of Adobe Acrobat Reader
- To view all resources made available within our LMS, you will probably need Microsoft Office (Word, Excel, PowerPoint) or an equivalent (i.e. Open Office, Viewer) installed.
- Virtual Learning Technology Requirements
- General
- Laptop or desktop computer (Note: A tablet or mobile device is not suitable for this training)
- Advisory: Certain features ONLY work on the laptop/desktop version & each Learner will be required to actively participate in online exercises/assignments via virtual breakout rooms in groups
- Webcam – Built-in or USB plug-in
- Advisory: This is required to be enabled for the duration of any live or group exercises, as 100% attendance & participation are required on all virtual workshops. We must be able to verify attendance during live sessions and during any virtual breakout sessions.
- Speakers and a microphone – Built-in or USB plug-in. We strongly recommend a headset for this training.
- Advisory: A headset will ensure that each Learner can effectively communicate & listen. Plus, a headset will provide a better filter for any background noise or interference that may impact the Learner experience, and that of other Learners.
- Internet connection – Minimum of 1.0 Mbps
- Advisory: Naturally, each Learner should ensure that they have reliable access to the Internet during the training, either through a suitable Wi-Fi or wired connection. Any disruptions may cause difficulties during the training and, in certain cases, if large portions of the training are missed, a Learner may not be able to complete the program (Certification Criteria may not be met).
- Zoom Workday
- This is the platform we use for video and team collaboration. Approximately 1 week in advance, a calendar invite including a link to access training material where the course documentation & resources are located. This team’s environment will also be used for submitting/sharing completed individual and team-based assignments.
- We will be sharing access with the EMAIL ID that was provided to us when each Learner was registered for the course.
- It is important that each Learner verifies that they can access the Zoom Workday platform successfully in advance of the live workshops to avoid delays or their planned attendance being impacted by not being able to access the Zoom Workday platform during the training.
- For support with accessing the Zoom Platform, please contact one of our representatives for assistance in advance of the start date to ensure you can gain access on the date of your training.
- Mimeo DRM Application - Digital Course Material
- This is the platform we use for distributing digital versions of course material, ISO standards, case study material, and reference material. Please note International standards are subject to international copyright laws and are not available to download or print.
Course Overview
Advance your career in environment auditing with our ISO 13485:2016 Auditor/Lead Auditor Training Course, designed for professionals aiming to lead successful external and internal audits or delegates who have the experience but who may not have an Internationally Certified CQI-IRCA or Exemplar Global training certificate.
This comprehensive program is available in In-Person/ Classroom, Online Live/Virtual or Blended Learning formats, ensuring flexibility for your learning needs.
Through this training, you'll gain the essential skills and knowledge to confidently lead audit teams and assess conformity with the ISO 13485 Medical Device Quality Management System standard.
Whether you're stepping into quality auditing or looking to enhance your expertise, this ISO 13485:2016 Auditor/Lead Auditor course provides the tools to achieve excellence. Start your journey toward becoming a certified leader in Medical Device Quality Management System auditing today!
Learning Objectives
The learning objectives of this ISO 13485 lead auditor programme include:
Knowledge
Explain the purpose of a medical device quality management system (MD-QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of the quality management system.
Explain the role and responsibilities of an auditor to plan, conduct, report, and follow-up a quality management system audit in accordance with ISO 19011:2026 and ISO/IEC 17021-1:2015.
Skills
Plan, conduct, report, and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485:2016 and applicable medical device regulatory requirement documents in accordance with ISO 19011:2026, ISO/IEC 17021-1:2015.
Our Methodology
Introducing our skilled Consultants!
Gerard Kelly
Principal Consultant
IRCA Registration No: A143267
Syllabus breakdown
1.0 Hour
Introduction and Welcome
- Course Introduction and Welcome
- Course Certification
- Course Learning Objectives
- Course Program/Rules
- Auditor Certification
- Privacy, Data Processing, Special Considerations,
- Course Materials
- Virtual Platform Overview
- Learner Support
2.0 Hours
Introduction to ISO 13485:2016
- Purpose and Benefits of a Medical Device Quality Management System
- ISO 13485:2016 Overview and Structure
- Management System Principles and their relevance
- ISO 13485:2016 Process Model
- ISO 13485:2016 Key Concepts
- ISO 13485:2016 Terminology
- ISO 13485:2016 Requirements [Overview only]
5.0 Hours
ISO 19011:2016 Purpose, Scope and Requirements
- Overview and Context
- Introduction, Scope and Structure
- Terminology
- Audit Principles
- Audit Program
- Audit Life Cycle
- Auditor Roles and Responsibilities
- Auditor Behaviors
- Auditor Competency, Evaluation and Performance
7.0 Hours
Audit Initiation and Planning
- Initiation and Activities
- Audit Preparation Activities
- Document and Data Review
- Audit Risks and Opportunities
- Audit Planning, Sequence and Strategy
- Audit Checklist/PEAR Report
- Audit File
- Final Audit Preparation Requirement Activities
1.0 Hour
Audit Examination / Debrief
- Examination Overview/De-Brief and Resources
- Examination Platform and Access
- Examination Preparation and Evaluation
- Examination Practice and Review
8.0 Hours
Conducting the Audit
- Audit Activities
- Pre-Opening Meeting Activities
- Opening Meeting Role Play Exercise
- Guides and Consultants Do's and Don'ts
- Audit Evidence and Trails Exercise
- Auditee Documentation and Records
- Audit Meetings Exercise
- Lead Auditor Leadership and Coaching
- Auditee Reactions and how to handle Exercise
- Audit Investigations
- Final Audit Team Meeting
- Audit Conclusion Statement
8.0 Hours
Conducting the Audit
- Audit Investigation - Case Study Exercise
- Audit Findings
- Audit Examination Preparation
2.0 Hours
Conducting the Audit
- Closing/Exit Meeting Role Play Exercise
5.0 Hours
Audit Post-Delivery
- Audit Post-Delivery Activities
- Reviewing Non-Conformities including Closure
- Extent Analysis, Root Cause Analysis, Correction, Corrective Action
- Correction/Corrective Action Implementation and Monitoring
- Corective/Corective Action Verification
- Corrective Action/Corrective Action Effectiveness Review
- Audit Completion
- Audit Program Review and Update
1.0 Hour
Class Close
- Summary/Review of Learning Objectives
- Examination Strategy
- Examination Results/Training Certificate
- Class Evaluation
- Class Close
Frequently Asked Questions
Yes, this is a CQI-IRCA Certified Lead Auditor programme under Course ID 17584. The course is designed to build and verify your competence to audit a complete Medical Device Quality Management System, known as QMS, against ISO 13485:2016. It also includes formal assessment requirements aligned with Auditor and Lead Auditor expectations.
This course is intended for professionals who need to audit a complete Medical Device Quality Management System against the requirements of ISO 13485:2016. It is particularly suitable for learners involved in second-party audits, such as customer or supplier audits, and third-party audits, including certification-focused audit activities. It is also suitable for those preparing to work in these audit environments. As this is a five-day intensive training programme with practical audit activities and a final examination, it is best suited to learners who are ready for a more advanced and demanding level of auditor training.
Yes, before registering for this course, you should already be familiar with the requirements of ISO 13485:2016, or you should have completed ISO 13485 QMS Fundamentals training beforehand. This background knowledge is required because it provides the essential foundation needed for Auditor and Lead Auditor training. It also helps ensure that you can fully engage with the full audit lifecycle activities covered during the course, including planning, conducting audits, reporting audit results, and following up on audit outcomes.
This course is the right level if your goal is to develop the competence to perform and lead audits of a complete Medical Device QMS, rather than simply understand the standard requirements. The course is structured around the full audit lifecycle, including planning, conducting, reporting, and follow-up. If you are new to ISO 13485:2016, then a Fundamentals course would be the best starting point before progressing to Lead Auditor training.
The delivery format for your course will be confirmed at the time of registration. If your cohort is delivered virtually, the training will take place on the Zoom platform, and you will receive the relevant joining instructions, access details, and platform guidance in advance. To participate effectively, you will need a stable internet connection and a laptop, desktop, iPad, or other tablet device that supports the required platform, together with working audio and an active web camera.
The course is practical and skills-focused, not just theory-based. It includes consultant-facilitated activities and follows a structured audit approach aligned with the ISO 19011 audit lifecycle. There is also strong emphasis on audit tools, audit techniques, auditor behaviours, and the responsibilities expected of a Lead Auditor.
Yes, learners complete a facilitated audit covering the full audit lifecycle. During this practical audit work, learners apply audit planning, evidence gathering, findings development, and reporting methods in practice. Competence is developed and verified through structured course activities and applied audit work.
Yes, the course includes a final written Medical Device QMS Lead Auditor examination. The exam forms part of the formal assessment requirements for successful course completion. Successful completion of both the course and examination supports achievement of the programme outcome in line with CQI-IRCA requirements.
After completing the course, you will be able to plan, conduct, report, and follow up audits of a complete Medical Device QMS against ISO 13485:2016. You will also be able to apply the ISO 19011 audit lifecycle across different medical device QMS audit scenarios in a structured and professional manner. In addition, you will be able to deliver evidence-based audit findings and conclusions that support QMS effectiveness, conformity, product safety, and product effectiveness.
This Lead Auditor course focuses on auditing a complete Medical Device QMS through a structured, facilitated audit approach. It places strong emphasis on consistent interpretation of ISO 13485:2016 requirements, together with the evaluation of process effectiveness, regulatory expectations, and product safety and effectiveness. The course also provides practical development of auditor tools, techniques, behaviours, and the leadership capability expected of professional Lead Auditors.
An ISO 13485 Internal Auditor course focuses on auditing an organization’s own medical device quality management system and is typically focused on the organization’s product or process, while an ISO 13485 Lead Auditor course develops the advanced skills needed to lead audit teams, plan and conduct management system audits, manage audit activities, evaluate findings, and report audit results against all the ISO 13485:2016 requirements.
An ISO 13485 Lead Auditor course provides practical knowledge of audit principles, planning, preparation, execution, evidence collection, interviewing, documenting nonconformities, reporting, and follow-up. It helps participants develop the audit and social skills required to lead systematic and effective audits of medical device quality management systems.
An ISO 13485:2016 Lead Auditor course typically covers an overview of the structure and requirements of ISO 13485:2016, and more fully the audit principles, audit program management, audit planning including risks/opportunities, audit team management, audit meetings, collecting and evaluating objective evidence, identifying and documenting nonconformities, audit communication, audit reporting, corrective actions, and audit follow-up activities.
Yes. The ISO 13485 Lead Auditor course is suitable for professionals involved in auditing or managing medical device quality management systems, including internal auditors, quality professionals, regulatory and compliance personnel, consultants, and professionals working with medical device manufacturers, suppliers, importers/distributors, authorized representatives and service organizations.
Completing an ISO 13485 Lead Auditor course can strengthen your qualifications for roles involving quality management system auditing, supplier audits, internal audits, regulatory compliance, quality assurance, and medical device quality management. The training can also support professionals who want to develop their capabilities in leading ISO 13485 and regulatory affairs audits.
Virtual Technology Requirements
To participate in the virtual training sessions, you will need:
- A current generation laptop or desktop computer with the latest web browser installed, capable of handling multiple software applications at the same time (a tablet or mobile device is not suitable for this training).
- HD webcam (built-in or USB plug-in).
- Speakers and a microphone (built-in or USB plug-in). A headset is highly recommended for optimal audio quality.
- Internet connection with a minimum of 2.5 Mbps download and 3.0 Mbps upload.
- Two display monitors are highly recommended: one for joining the virtual classroom and viewing e-course documentation (if applicable), and the other for completing class exercises and assignments.
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Upon successful completion, each learner shall receive a digital Certificate of Completion that is recognized globally.