ISO 13485 Certified Auditor Training

PAS129   Type: E-Learning

The ISO 13485:2016 Certified Internal Auditor Online Training Course is launched by Punyam Academy for fulfilling the needs of people who want to audit Quality management system for medical devices. Anyone who wants to gain knowledge about ISO 13485 audit and get ISO 13485:2016 Auditor Certificate and become a certified ISO 13485:2016 Auditor can enrol to this course.

ISO 13485 Certified Auditor Training


For Quality management system of medical devices, the ISO 13485:2016 Auditor course provides training and certification that helps users to become Certified ISO 13485 Internal Auditor. In this ISO 13485 internal auditor training online course, you will learn everything you need to know about the Quality management system and fulfill all the requirements as an ISO 13485:2016 QMS auditor. This course will guide Management as well as employees of any organization in the field of manufacturing, supply or distribution of a medical device or its components, to qualify as ‘Certified internal auditor' for Quality management system based on ISO 13485:2016 standard. The online ISO 13485 auditor training will acknowledge the participants about how to perform an internal audit in such organizations. Once this ISO 13485 auditor training is successfully completed online, participant will be qualified as a certified internal auditor with an ISO 13485 internal auditor certificate.


 This ISO 13485 auditor training online course comprises four sections, as given below:

  1. Lectures
    There is a total of 8 lecture sessions, which are given to the course participants as a presentation with explanatory audio to understand the subject. The topics discussed in the lecture sessions are listed below:
    • Session 1: Overview of ISO 13485:2016.
    • Session 2: ISO 13485:2016 Principles.
    • Session 3: ISO 13485:2016 Requirements.
    • Session 4: Control of Documents and Records.
    • Session 5: ISO 13485:2016 Quality Management System Internal Audit.
    • Session 6: ISO 13485:2016 Internal Audit Records.
    • Session 7: Risk Management.
    • Session 8: Steps for ISO 13485:2016 QMS Installation & Certification.
  2. Handouts
    For all the above eight topics, the handouts are given in more than a total 160 pages in pdf format. The participant of this online ISO 13485 training can download and save the handouts in their computer and print them or read them offline to get detailed knowledge of all the eight topics mentioned above.
  3. Exam
    In this online ISO 13485 auditor course, total 7 session exams and one final exam are given. After passing these session exams, the participants can download and print their ISO 13485:2016 Certified Internal Auditor training certificate.
  4. Audit Checklist
    A complete set of more than 200 audit questions, both ISO 13485:2016 clause-wise as well as department-wise, is given as a ready tool to perform an internal audit. This ISO 13485:2016 audit checklist also helps participants to prepare for the final audit. The participants can download it for future reference and use it during the audit process of the organization.


After completion of this Online ISO 13485 auditor training course, you will be able to:

  • Familiarize yourself with ISO 13485:2016 quality management system requirements clauses and sub-clauses.
  • Get an overview of ISO 13485:2016 quality management system (QMS) and the benefits to implement it.
  • Familiarize yourself with the high-level structure and the framework of QMS.
  • Understand general and structural requirements of ISO 13485:2016 standard.
  • Know about the resource requirements and process requirements for QMS.
  • Know about the management system requirements.
  • Understand documentation and list of procedures and records to be maintained and to check them as an internal auditor.
  • Get the knowledge of internal auditing and use of audit checklist.
  • Understand the processes involved in auditing.
  • Know about the types of auditing and questioning techniques.
  • Understand how to prepare and maintain internal audit records.
  • Get the ready-to-use internal audit checklist with clause-wise questions to perform an effective audit.
  • Understand the new concepts of risk management and risk evaluation techniques, and process approach.
  • Make a team of internal auditors to establish a quick and effective system for 13485:2016 accreditations.


This course is developed and brought to you by Punyam Academy, an ISO/IEC 17024 accredited training provider company, which offers various e-learning as well as classroom training courses for working professionals, college 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.

A team of our consultants having experience of more than 25 years in ISO and management consultancy in more than 35 countries across the world as well as expertise in designing and conducting various e-learning courses and training programs in convenient and cost-effective ways, has created this ISO 13485 online auditor training course.


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.


This training program includes the Course Certificate that is issued upon course completion and passing the session exam as well as final exam given in the course with minimum 60% marks. The option to reappear in the exam is also given to student to get this course certificate


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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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.