ISO 13485 Lead Auditor Course
Have you decided that you want to perform audits of medical device management systems? Take this online course to learn all about ISO 13485, and get the auditor training you need to become certified as an ISO 13485 certification auditor. You don’t need any prior certification audit skills, and you don’t need to know anything about medical device management systems—this course is designed especially for beginners.
Once you have finished the ISO 13485 Lead Auditor training and passed the exam, you will receive an official certificate acknowledging your competencies in medical device management systems, audits, and leading audit teams.
There are three parts to this course: the first includes video lectures, the second is an interactive workshop, and the third is the online exam. Completing each part will move you further down the path to becoming a certified ISO 13485 certification auditor. Read on to learn about each part of the course, and how it will prepare you for certification as an ISO 13485 lead auditor.
Kristina Zvonar Brkic & Carlos Pereira Da Cruz & Garry Cornell
Course Curriculum
| Introduction | |||
| Introduction to the course | 00:00:00 | ||
| Module 1 - Introduction to ISO 13485 | |||
| Introduction & suggested reading | 00:00:00 | ||
| What is ISO 13485:2016? | 00:00:00 | ||
| What is the QMS? | 00:00:00 | ||
| Why is ISO 13485:2016 important? | 00:00:00 | ||
| What is the structure of ISO 13485? | 00:00:00 | ||
| Key principles of quality management | 00:00:00 | ||
| Key interested parties in ISO 13485 | 00:00:00 | ||
| Implementing ISO 13485 using The Plan Do Check Act Process | 00:00:00 | ||
| The ISO 13485 Project | 00:00:00 | ||
| Certification FAQs | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 2 - Management and Supporting Processes | |||
| Introduction & suggested reading | 00:00:00 | ||
| What is a process? | 00:00:00 | ||
| Top management commitment (clauses 5.1 and 5.2) | 00:00:00 | ||
| Quality Policy and objectives (clauses 5.3 and 5.4) | 00:00:00 | ||
| Roles and responsibilities (clause 5.5) | 00:00:00 | ||
| Management review (clause 5.6) | 00:00:00 | ||
| Documentation process (clauses 4.1 and 4.2) | 00:00:00 | ||
| Quality Manual (clause 4.2.2) | 00:00:00 | ||
| Medical Device File (clause 4.2.3) | 00:00:00 | ||
| Handling the QMS documentation (clause 4.2.4) | 00:00:00 | ||
| Records for the QMS (clause 4.2.5) | 00:00:00 | ||
| Importance of Resources management process (clause 6.1) | 00:00:00 | ||
| Managing human resources (clause 6.2) | 00:00:00 | ||
| Managing infrastructure resources (clause 6.3) | 00:00:00 | ||
| Managing work environment (clause 6.4.1) | 00:00:00 | ||
| Managing contamination (clause 6.4.2) | 00:00:00 | ||
| Managing monitoring and measuring equipment (clause 7.6) | 00:00:00 | ||
| Related documentation | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 3 - Product Realization Planning, Contract Review, and Design & Development | |||
| Introduction & suggested reading | 00:00:00 | ||
| Planning of Product Realization (clause 7.1) | 00:00:00 | ||
| Example of planning Product Realization | 00:00:00 | ||
| Overview of Customer-Related processes (clause 7.2.1) | 00:00:00 | ||
| Review of a contract or customer purchase order (clause 7.2.2) | 00:00:00 | ||
| Communication methods for the Customer-Related processes (clause 7.2.3) | 00:00:00 | ||
| Design and development overview (clause 7.3.1) | 00:00:00 | ||
| Planning for design and development (clause 7.3.2) | 00:00:00 | ||
| Design and development inputs (clause 7.3.3) | 00:00:00 | ||
| Design and development outputs (clause 7.3.4 and 7.3.5) | 00:00:00 | ||
| Design and development verification and validation (clause 7.3.6 and 7.3.7) | 00:00:00 | ||
| Design and development transfer to production (clause 7.3.8) | 00:00:00 | ||
| Control of design and development changes (clauses 7.3.9, 7.3.10) | 00:00:00 | ||
| Related documentation | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 4 - Purchasing, Production, and Service Provision | |||
| Introduction & suggested reading | 00:00:00 | ||
| Purchasing overview (clause 7.4) | 00:00:00 | ||
| Vendor Evaluation and performance (clause 7.4.1) | 00:00:00 | ||
| Purchasing information and verification of product (clauses 7.4.2 and 7.4.3) | 00:00:00 | ||
| Production and service provision overview (clause 7.5.1) | 00:00:00 | ||
| Qualification of your infrastructure (clauses 7.5.3 and 7.5.6) | 00:00:00 | ||
| Validation of processes (clauses 7.5.6 and 7.5.7) | 00:00:00 | ||
| Labeling and packaging (clause 7.5.11) | 00:00:00 | ||
| Cleanliness of product (clauses 7.5.2 and 7.5.5) | 00:00:00 | ||
| Identification and traceability (clauses 7.5.8 and 7.5.9) | 00:00:00 | ||
| Customer property and preservation (clauses 7.5.10 and 7.5.11) | 00:00:00 | ||
| Post-delivery processes (clauses 7.5.3 and 7.5.4) | 00:00:00 | ||
| Related documentation | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 5 - Measurement, Analysis, and Improvement | |||
| Introduction & suggested reading | 00:00:00 | ||
| Monitoring and measuring overview (clause 8.1) | 00:00:00 | ||
| Monitoring and measurement of products (clause 8.2.6) | 00:00:00 | ||
| Monitoring and measurement of processes (clause 8.2.5) | 00:00:00 | ||
| Feedback (clause 8.2.1) | 00:00:00 | ||
| Complaint handling (clause 8.2.2) | 00:00:00 | ||
| Reporting to regulatory authorities (clause 8.2.3) | 00:00:00 | ||
| Internal audits (clause 8.2.4) | 00:00:00 | ||
| Control of non-conforming product (clause 8.3) | 00:00:00 | ||
| Analysis of data (clause 8.4) | 00:00:00 | ||
| Improvement (clause 8.5.1) | 00:00:00 | ||
| Corrective actions (clause 8.5.2) | 00:00:00 | ||
| Preventive actions (clause 8.5.3) | 00:00:00 | ||
| Related documentation | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 6 - Auditing basics | |||
| Introduction & suggested reading | 00:00:00 | ||
| Auditor assumptions | 00:00:00 | ||
| Techniques for finding evidence | 00:00:00 | ||
| Sampling the records | 00:00:00 | ||
| Interviewing techniques | 00:00:00 | ||
| The audit findings | 00:00:00 | ||
| Nonconformities | 00:00:00 | ||
| Observations | 00:00:00 | ||
| Internal vs. external audit | 00:00:00 | ||
| Annual audit program | 00:00:00 | ||
| Audit plan for an individual audit | 00:00:00 | ||
| Creation of the checklist | 00:00:00 | ||
| Internal audit report | 00:00:00 | ||
| Corrective action requests and corrective action follow-up | 00:00:00 | ||
| Recording the evidence | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 7 - Understanding auditing standards | |||
| Introduction & suggested reading | 00:00:00 | ||
| What is certification? | 00:00:00 | ||
| Certification process | 00:00:00 | ||
| Certification of integrated management systems | 00:00:00 | ||
| Introduction to accreditation and ISO 17021 | 00:00:00 | ||
| Competences of lead auditors required by ISO 17021-1 | 00:00:00 | ||
| Introduction to International Accreditation Forum (IAF) documents | 00:00:00 | ||
| Introduction to ISO 19011 | 00:00:00 | ||
| Principles of auditing | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 8 - Understanding audit roles and responsibilities | |||
| Introduction & suggested reading | 00:00:00 | ||
| Audit Team Leader / Lead Auditor | 00:00:00 | ||
| Auditor | 00:00:00 | ||
| Technical Specialist | 00:00:00 | ||
| Certification Reviewer | 00:00:00 | ||
| Audit Client | 00:00:00 | ||
| Management Team | 00:00:00 | ||
| Auditee | 00:00:00 | ||
| Hosts / Guides | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 9 - Planning the audits | |||
| Introduction & suggested reading | 00:00:00 | ||
| Audit criteria and objectives | 00:00:00 | ||
| Audit scope | 00:00:00 | ||
| Selecting audit methods | 00:00:00 | ||
| Sampling evidence in audits | 00:00:00 | ||
| Types of remote auditing techniques | 00:00:00 | ||
| Deciding when to use remote auditing techniques | 00:00:00 | ||
| Planning the use of remote auditing techniques | 00:00:00 | ||
| Selecting the audit team | 00:00:00 | ||
| Managing audit risks | 00:00:00 | ||
| Preparing the audit plan | 00:00:00 | ||
| Allocating audit activities to auditors | 00:00:00 | ||
| Making contact with the audit client | 00:00:00 | ||
| Preparation of audit resources | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 10 - Managing the audit process | |||
| Introduction & suggested reading | 00:00:00 | ||
| Opening meeting | 00:00:00 | ||
| Managing site visits | 00:00:00 | ||
| Interviews | 00:00:00 | ||
| Audit evidence requests | 00:00:00 | ||
| Debriefing sessions | 00:00:00 | ||
| Dealing with conflicts | 00:00:00 | ||
| Related documentation | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 11 - Managing your audit team | |||
| Introduction & suggested reading | 00:00:00 | ||
| The importance of managing your audit team | 00:00:00 | ||
| Communication with the team before the audit | 00:00:00 | ||
| Managing audit progress | 00:00:00 | ||
| Team meetings | 00:00:00 | ||
| Managing audit findings | 00:00:00 | ||
| Managing audit records | 00:00:00 | ||
| What to do when you hit problems | 00:00:00 | ||
| Evaluating your audit management | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 12 - Completing a successful audit | |||
| Introduction & suggested reading | 00:00:00 | ||
| Audit findings | 00:00:00 | ||
| How to reach audit conclusions | 00:00:00 | ||
| Planning the closing meeting | 00:00:00 | ||
| Holding an effective closing meeting | 00:00:00 | ||
| Dealing with feedback at closing meetings | 00:00:00 | ||
| Effective audit report writing | 00:00:00 | ||
| Post-audit activities, corrections, and correction actions | 00:00:00 | ||
| Certification review process | 00:00:00 | ||
| Related documentation | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Instructions for taking the exam and obtaining the certificate | 00:00:00 | ||
The 12 modules in the video lectures portion of this ISO 13485 training are available for absolutely no cost. Each module contains several video lectures and quizzes for enhancing your skills and to help you get ready for certification audits of a management system. You can read about the content of each module in the curriculum above. All of the video lectures are recorded, meaning that you are free to take the course at home, at work, or anywhere else, whenever it is convenient.
Course instruction is provided by Garry Cornell and Kristina Zvonar Brkic. Garry has extensive experience working with ISO standards in various capacities, including as a senior manager, a consultant, and a management system certification auditor. He has worked with a wide range of companies all over the world, helping them with their ISO standard implementation projects and their efforts toward continual improvement of their management systems. Kristina has broad experience in ISO 13485, ISO 9001, ISO 22716, MDD, and MDR. She is the author of numerous articles in the leading ISO 13485 blog, and also of the ISO 13485 & MDR Integrated Toolkit.
Type: Online video lectures
Course language: English
We know you’re not going to develop all of the necessary skills for ISO 13485 auditing through watching videos. That’s why we designed a one-day, interactive workshop where you can acquire practical knowledge about performing management system certification audits. Through an online workshop via webinar, you will enjoy enhanced learning opportunities through roleplay, case studies, and other activities. You will also work on developing the soft skills needed to prepare for the certification exam, and to excel as a certification auditor.
Check out the list of dates to see if one is convenient for you. You can attend the online workshop from home, your office, or anywhere else.
Duration: 1-day workshop
Type: Online webinar
Workshop language: English
After you finish watching the video lectures and attending the workshop, you will be ready to take the final step: the certification exam. You can take this online exam from your home, your office, or any other place that is convenient for you.
You will receive your certificate once you successfully pass the test. This certification is highly regarded, serving as evidence that you are competent to perform certification audits according to ISO 13485.
The fee for the exam is included in the price of the workshop, and you will have access to the exam after you schedule your workshop.
Number of questions: 94
Type: Online proctored exam
Exam language: English
Benefits of getting the certificate
The certificate of competence proves that you attended the auditor training course, and that you passed the exam. This ensures that you understand and can apply the knowledge you gained in each of the course's modules.
How to get certified?
It's simple:
1) Watch complete videos of all lectures, and answer all practice exams.
2) Attend the workshop.
3) Pass the online exam.
Bonuses with the certificate
Once you purchase the certificate, you will receive the following bonuses:
Internal Audit Checklist (Word document)
The purpose of this document is to provide a list of questions in order to help you perform an internal audit against ISO 13485. For each clause or control from the standard, the checklist provides one or more questions that should be asked during the audit in order to verify the implementation.
Course Script (PDF)
If you decide to purchase the exam you will get the PDF script from the course completely free. The script includes everything said in the videos and all quizzes.
This way, you can access the course materials any time you like, making it much easier to practice and prepare for the exam.
Free exam retake
Once you purchase the exam, you will be able to retake it.
This means, if you do not pass the exam on your first attempt, you can retake it one time, free of charge.
There is no mandatory waiting period between the two attempts.
Practice Exam
You can use these exams to test your knowledge and familiarize yourself with the exam environment.
The result from practice exam does not have any effect on the results from the final exam.
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Frequently Asked Questions
No, this course was developed for beginners, so you don’t need any prior knowledge of ISO 13485 or experience with management system audits.
No, you can take as much time as you need to watch the course videos. You should, however, try to watch all auditor training videos within three to four weeks to realize the most benefit from them.
You may access the recorded video lectures at any time, along with the quizzes, extra reading materials, and other activities.
We need to cover our costs somehow :). We provide our video lectures at no cost to you, but there is a fee to attend the workshop, take the certification exam, and receive the certificate. However, this fee is far less than the average price to attend comparable courses in a classroom environment. Plus, after making your payment, you will have access to a PDF download containing scripts from all of the video lectures, along with activity questions, practice exams, and links to helpful articles – everything you need to prepare for the certification exam.
To participate in the online workshop, we will send you a special link to connect to the GoToWebinar. All you need is a computer with microphone and speakers.
To attend the workshop, you will need to complete all of the video lectures.
You will take the certification exam online, from your home, your workplace, or anywhere else that is convenient for you. We use an online proctoring service to ensure the integrity of the certification process – click here to learn more.
After you have completed all the video lectures and participated in the workshop, you will have access to the certification exam. Upon successful completion (after passing the exam), you will receive the certificate. During the exam we employ an online proctoring service, which will require proof of your identity and ensure that you are taking the exam yourself, without any outside help. Click here to learn more about this online proctoring service.
The course is available on any PC, Mac, or mobile device, using a broadband internet connection and any popular browser (like Mozilla, Chrome, Internet Explorer, or Safari).
The materials available in this course (the pre-recorded video lectures, quizzes, extra readings, practice exams, and other activities), along with the skills you learn during the workshop, are the only things you will need to successfully pass the certification exam and receive your certificate.
If you do decide to pay to access the exam, in addition to the opportunity to attend the auditor training videos and the online workshop, you will receive a bonus PDF that includes the scripts from all of the video lectures, extra quiz questions, links to helpful reading materials, and access to the practice exams – making your exam preparation that much easier!
