ISO 13485:2016 Lead Auditor Training

PAS929   Type: E-Learning

The ISO 13485 standard initiates the quality management system requirements for medical device industry specifically. Punyam Academy provides ISO 13485 Lead Auditor Training E-learning Course for people who want to qualify and get certified they as Lead Auditor for ISO 13485:2016 with enrolling this course.

ISO 13485:2016 Lead Auditor Training


To fulfill all requirements of Quality Management System for medical devices, Punyam Academy’s Online ISO 13485 lead auditor training course provides training and certification which is very useful for users to become ‘Certified ISO 13485 lead Auditor’. In this ISO 13485 lead auditor training online, you will learn everything you need to know about the QMS and ISO 13485:2016 requirements as the ISO 13485 lead auditor. This online ISO 13485 lead auditor training course will help to guide company employees of any organization as well as provides a well understanding of various activities involved in Audit Techniques, Audit Processes, and Requirements. The participants will be awarded ISO 13485 Lead Auditor certificate for a trained lead auditor with successful completion of this online lead auditor training course.


There is including a total of 9 interactive online sessions this ISO 13485 lead auditor training with combinations of lectures with audio-visual presentation, hand-outs, and videos as well as online exams to ensure a complete understanding of the subject.

  • Session - 1: Overview of Course and Standard
  • Session - 2: ISO 13485 Principles
  • Session - 3: ISO 13485:2016 Requirements
  • Session - 4: Control of Documents and Records
  • Session - 5: Risk Management
  • Session - 6: ISO 13485:2016 Internal Audit Process
  • Session - 7: Audit Terms and Definitions and Roles and Responsibilities
  • Session - 8: Performing an Audit
  • Session - 9: Nonconformity and Corrective Action

Each of the above session consists of modules such as Audio lectures, hand-outs, videos and session exams as well as one final exam as below:

  1. Lectures: There is a total of 9 lecture sessions, which are given in this course as a presentation with explanatory audio and visuals to understand the subject well.
  2. Hand-outs:For all the above 9 sessions, the hand-outs are given in a total of 200 pages in .pdf format. The participants of this ISO 13485 lead auditor course can download and save the hand-outs to their computer and print them or read them offline to get detailed knowledge of all the 9 topics mentioned above.
    • Manaul - In Session 8, a practical example of real-life quality management system for medical devices manual is given for performing document review and understanding adequacy audit findings. Such a real-life case study of a ISO 13485 manual will help participants to gain better knowledge and skill of auditing.
    • Audit Checklist - The ISO 13485 Audit checklist contains a complete set of more than 400 audit questions as per ISO 13485:2016 standard requirement-wise as well as department-wise. ISO 13485:2016 audit checklists also help participants to prepare for the final audit.
  3. Videos: Actual videos for performing an actual audit with the real practical example of audit questions and answers. The Lead Auditor can watch and learn how to perform the audit in the organization and manage the opening and closing meetings with management employees.
  4. Exams: In this ISO 13485 lead auditor training course, the participant has to clear all session exams and one final exam as given in a separate section of the course. After successfully passing the final exam, an auto-generated ISO 13485:2016 Lead Auditor Training Certificate will be issued and can be downloaded and printed from the dashboard.


After completion of this Online course for ISO 13485 lead auditor training, the users will be able to:

  • Familiarize yourself with ISO 13485:2016 requirements in detail.
  • Know about the resource requirements and process requirements.
  • Understand the documentation required by ISO 13485:2016.
  • Understand documentation and list of procedures to be maintained, and to check them as lead auditor.
  • Get the knowledge of internal auditing and use of audit checklist.
  • Know about the types of auditing and questioning techniques.
  • Familiarize yourself with principles & implementation of ISO 13485:2016 lead audit programs in detail.
  • Get the ready-to-use audit checklist with clause-wise questions to perform an effective audit.


This ISO 13485 Lead Auditor Training course is developed for working professionals, management students, and other individuals for enhancing their career to new heights. Our e-learning courses help them to succeed in today's competitive environment, to renew licenses, and to update, strengthen and add quality to their existing knowledge and skills. Our courses are also useful for those who want to get a certification or start a new profession.

Any working professional, any graduate, undergraduate, management student, an entrepreneur, quality manager, technical manager, etc., are eligible to attend this certified ISO 13485 lead auditor training.


  • Knowledge of Quality management systems
  • Understand the Plan-Do-Check-Act (PDCA) cycle.
  • Knowledge of the following quality management system principles and concepts):
    1. The assignment of responsibility for quality;
    2. Incorporating management commitment and the interests of stakeholders;
    3. Enhancing societal values;
    4. Using the results of risk assessments to determine appropriate controls to reach acceptable levels of risk.


For details of the authors, trainers and instructors experience and background, please visit our trainers page. They have very rich experience on the subject.


This e-Learning course is provided with study materials and you can read it after your log in or download (PDF format). Use the study materials to reinforce key points and to keep a reminder of what you already learned as well as you can save it in your computer for future reference. The access of this study material is removed after exam is cleared and on line certificate is prepared for the student.


All paid E-learning course includes the Course Certificate that is issued upon course completion and passing the session exams as well as a final exam given in the course with minimum 60% marks. The option to reappear in the exam is also given to student, if failed in any exam.


After completing the session and passing each session examination the student can appear for final exam. Once the final exam is cleared then it is considered a end of course. The training certificate is ready on our LMS and student can print it or save the training certificate. It is also available for verification by entering the name and certificate number.

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What Our Customer Says...

Blaizon C Mathai
Abu Dhabi, UAE

I would like to extend my sincere gratitude in introducing this program. Course material and presentations very valuable indeed and informative too. Even presentations made in simple language

Maria Garcia
California, USA

Great e-learning course by Punyam Academy, easy to use and learning can be done at your own pace. Material and content provided is exceptional. I would definitely recommend to anyone

Paul Thompson
South Africa

My first online course experience and it was pleasant to attend PAS102. I found the course to be very thorough and covered all aspects that are needed to carry out auditing.

Mary Smith
Dubai, UAE

The course has good information for new auditors or anyone that wants to be an internal auditor for understanding the standard. The content was very relevant, and the process of assessment required me to really understand the coursework

Nancy Lewis
South Africa

I was very happy to be able to complete the course online. I enjoyed being able to complete the course at my own pace. The support from Punyam Academy team has been great. Thanks!

Edward Anderson
California, USA

A valuable online opportunity to further skills and knowledge. Enrol for ISO/IEC 17025 auditor course, and fills best certified course in minimum cost

John Davis
Abu Dhabi, UAE

Excellent training at Punyam Academy, friendly atmosphere and lovely staff, highly recommended. Voice enable presentation gives me filling like live training, which saves my time.

Jennifer Nelson

Best place to go for ISO/IEC 17025:2017 Internal Auditor training. I have attended classroom training and found them extremely beneficial and enjoyable. Trainers are very understanding and knowledgeable.

Daniel Johnson
Washington, USA

I appeared for ISO 45001 auditor training course. Highlight of this course is good audio visual presentation, study material to download as well as exams to review my knowledge.

Charles Wilson
Abu Dhabi, UAE

Congratulations to Punyam Academy team for providing best knowledge sharing platform online. Achieved ISO 9001 internal auditor certificate, looking forward to enrol next auditor course very soon.

Karen Smith
California, USA

The course more economical compared to classroom training and flexible timings make it more recommendable. Looking forward for more complex courses like PMP, IRCA certified courses etc.

Ajit Patel
Altrafine Gums

I am highly satisfied with your course on food safety management system. Now I am fully aware about FoSTaC requirements and appreciate efforsts of Punyam Academy throughout the training session.

Dr. Bharat Agrawal
Analytical Development Laboratory Torrent Research Center

The training materials given by Punyam Academy experts proved to be very useful in managing our own requirements. We appreciate trainer's knowledge and efforts in delivering good sessions. All the best for upcoming training programs.

Alpesh Patel
Meghmani Industries Limited

I am happy with the certified ISO/IEC 17025:2017 auditor training course at Punyam Academy. Now I am fully aware about ISO/IEC 17025:2017 transition auditing and quality management requirements for testing laboratory.

Shreeyansh Kumar

Thank you Punyam Academy for providing me world class learning at affordable cost. Trainer has very good knowledge about subject. Training environment & facility at training center is exceptional.

Dattatray Sawarbandhe
CEO, Bombaywalla Foods

A great step has been taken by organizing Food Safety Training and Certification (FoSTaC). This knowledge sharing will only bring all the business motive together of common standard, quality and good healthy surrounding. My India is growing - Keep it up Punyam Academy.

Subhashchandra Pathak
Terapanth Foods Limited

Attending FoSTaC training course for food safety management system is awasome experience. Now I am fully aware about food and quality management requirements in food manufacturing organization.

Sachin Patel
Mazda Limited

Attending classroom training at Punyam Academy was a wonderful experience. I got the opportunity to learn FSSAI requirements as FoSTaC training from experienced instructors.

Sajan Peter
Saudi Arabia

I have purchased and successfully completed ISO 9001:2015 certified internal auditor training course. It is Very professional and helpful training program customised to achieve maximum customer satisfaction.

John Watson
United Kingdom

Training material was of a high standard. Exams were very goo and made you think.

Billy Croker
United States of America

Very good and through course. Make you really think about somethings and the way you perform an audit.

Irron R Collins
United States of America

Course is very informative, easily understood and provides good understanding of requirements as needed. However could not print my certificate.

Bibi Ruwaydah Soreefan

I loved the course. Just what I needed for my calibration journey. Looking forward to taking more courses at Punyam Academy.

Jose Cabrera
United States of America

The material provided during the course was adequate to provide the required knowledge of ISO 13485:2016 in preparation for each session exam and final exam. Very happy with the course, will recommend it to other colleagues.

Dr. A. K. Gupta

Nicely prepared learning programme , helpful to prepare Quality Manual and accreditation for laboratory.

Trinidad and Tobago

The course was very comprehensive and practical! An indispensable training resource for prospective ISO 45001 lead auditors.

UK Lee
South Korea

It was very helpful to get ISO 14001 auditor qualification, thanks a lot.


Well defined Training Program... Thanks...!!!

Johan Pretorius
South Africa

The course was very comprehensive and practical! every thing is well explained.

Maud Van Looy

The content of the training was very useful to the team, and all of our team members have completed the training successfully.

Shiv Prakash Bhutra

There was a good pace and tone to the training in online E- learning course, which kept it interesting throughout.

Rohit Prajapati

The design of the course, including clarity of presentation, quality of video and audio, session exam are excellent.

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