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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.

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
STEP 1: Watch video lectures

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.

ISO 13485 Lead Auditor Course

Type: Online video lectures

Course language: English

STEP 2: Attend a workshop

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.

ISO 13485 Lead Auditor Course

Duration: 1-day workshop

Type: Online webinar

Workshop language: English

STEP 3: Pass the online exam

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.

ISO 13485 Lead Auditor Course

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:

Discount badge

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!

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