ISO 14155 Certified Internal Auditor Training

PAS970   Type: E-Learning

This online ISO 14155 Auditor Training is specifically designed for those who want to qualify and become a certified ISO 14155 Internal Auditor for organizations conducting Clinical investigation of medical devices for human subjects. Launched by Punyam Academy, this course will provide you in-depth knowledge of internal audit process and steps  for ISO 14155 Internal Audit.

ISO 14155 Certified Internal Auditor Training


Punyam Academy’s Online ISO 14155 Auditor Training Course is designed to provide you a formal training and certification to become a certified ISO 14155 internal auditor. The participants of this course will get  ISO 14155 Internal Auditor certificate. In this online Internal Auditor training, the participants will learn in detail all the requirements of ISO 14155:2020 international standard. This online ISO 14155 Internal Auditor Training course also provides a complete overview and awareness of ISO 14155:2020 standard and the benefits of implementation and certification. Our ISO 14155 Auditor Training – E-learning course is beneficial especially for those who prefer to learn auditing process and techniques from their home or office at their own convenient time and get certified as ISO 14155 Internal  Auditor. This ISO Auditor Training comprising online lectures with audio-visual presentations, handouts, ISO 14155 audit checklist and online exams will be quite beneficial for all those who want to qualify as a certified Internal Auditor for ISO 14155 audit of medical device manufacturing organizations, healthcare organizations or research organizations, etc., conducting clinical investigation of medical devices for human subjects in any part of the world. After completion of this online course successfully, the participants will be awarded ISO 14155 Internal Auditor certificate as a trained internal  auditor.

Topics Covered: ISO 14155 Internal Auditor Online Course

Punyam Academy’s online ISO 14155 Auditor training course comprises following seven sessions:

  • Session - 1: Overview and Awareness of ISO 14155:2020
  • Session - 2: ISO 14155: 2020 Clause Wise Requirements
  • Session - 3: ISO 14155: 2020 Documents and Records
  • Session - 4: Risk Management
  • Session - 5: Internal Audit Process
  • Session - 6: ISO 14155 Internal Audit Records
  • Session - 7: Steps for ISO 14155: 2020 Installation and Certification

Each of the above sessions consists of modules such as lecture videos, hand-outs and online session exams as well as final exam at the end of all sessions, as described below:

Lectures: In this module, the user gets a video presentation with explanatory audio on each of the above-mentioned seven topics to understand the subject well.

Handouts: For all the above seven sessions, the handouts are given in approximately 125 pages in pdf format. The participants of this ISO 14155 auditor training course can download and save the handouts in their computer for future reference. Also, they can print them or read them offline to get detailed knowledge of all the topics.

Exams: In this Internal Auditor Training course, a total of seven session-exams and one final exam are given. After passing the final exam, the auto-generated ISO 14155 Internal Auditor Certificate can be downloaded from our dashboard and printed by participants. This certificate can be verified by anyone anytime from this website.

Audit Checklist: A complete set of more than 150  ISO 14155 clause wise audit questions are given as a ready tool to perform internal audit based on ISO 14155: 2020 requirements. Participants can download this checklist for future reference and use it during the internal ISO 14155 system audit in any clinical investigation organization for medical devices.

Course Objectives

After completion of this Online ISO 14155 auditor training course, the user will be able to:

  • Familiarize with ISO 14155:2020 standard
  • Know the benefits of implementation of this standard and ISO 14155 certification
  • Know about the ISO 14155:2020 good clinical practice
  • Understand the documents and records required by ISO 14155:2020.
  • Understand the process of risk management to prevent risk and accidents in clinical investigations of medical devices in human subjects
  • Know the audit process for ISO 14155:2020 management system
  • Know about the questioning techniques.
  • Know how to prepare internal audit records, including audit plan and nonconformity report (NCR).
  • Get a ready-to-use ISO 14155 audit checklist with clause-wise questions to perform an effective audit.

Who Should Attend This Course?

  • Individuals who want to become a certified  ISO 14155 Internal Auditor.
  • Clinical research professionals
  • Individuals involved in the implementation for Clinical investigation of medical devices for human subjects — Good clinical practice
  • Individuals who want to have a basic knowledge of ISO 14155 standard for working in medical device manufacturing companies or any organizations involved in Clinical investigation of medical devices for human subjects.
  • Key personnel responsible for the implementation of Good clinical practice within such organizations.
  • Other people who have found this course useful and who want to enhance their auditing knowledge and skills, and those looking to achieve formal recognition as trained certified ISO 14155 auditor.


Though there is no prerequisite for enrolling in this online course, having the following will be advantageous for the participants:

  • Basic knowledge and interest in Clinical investigation of medical devices for human subjects.
  • Having read about the ISO 14155:2020 international standard


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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