ISO 14155:2026 Auditor Training – Online Course with Certification

Description

Punyam Academy’s ISO 14155:2026 Auditor Training Online Course is designed to provide comprehensive training for professionals seeking to become certified  ISO 14155 Internal Auditors. The course covers the requirements of the ISO 14155:2026 international standard, internal audit principles, auditing techniques, and the practical process of conducting effective internal audits.

Participants will gain a clear understanding of ISO 14155:2026 requirements, clinical investigation processes, audit planning, audit preparation, evidence collection, audit findings, reporting, and follow-up actions. The course also provides an overview of the benefits of implementing and maintaining an ISO 14155-compliant system for organizations involved in clinical investigations of medical devices involving human subjects.

This online ISO 14155 Internal Auditor Training is ideal for professionals who prefer flexible, self-paced learning from home or the workplace. The e-learning course combines audio-visual lectures, presentations, downloadable handouts, ISO 14155:2026 audit checklist, and online examination to provide a practical and convenient learning experience.

The course is suitable for professionals involved in medical device organizations, healthcare institutions, clinical research organizations, and other organizations conducting clinical investigations of medical devices for human subjects. It helps participants develop the knowledge and skills required to plan and conduct ISO 14155 internal audits effectively.

Upon successful completion of the online training and examination, participants will receive an ISO 14155 Internal Auditor Training Certificate, demonstrating successful completion of the auditor training program.

Topics Covered: ISO 14155 Auditor Training Online Course

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

• Session - 1: Overview and Awareness of ISO 14155:2026
• Session - 2: ISO 14155:2026 Clause Wise Requirements
• Session - 3: ISO 14155:2026 Documents and Records
• Session - 4: Risk Management
• Session - 5: Internal Audit Process
• Session - 6: ISO 14155 Internal Audit Records
• Session - 7: Steps for ISO 14155:2026 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:

1. 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.
2. 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.
3. 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 Training Certificate can be downloaded from our dashboard and printed by participants. This certificate can be verified by anyone anytime from this website.
4. 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: 2026 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 successfully completing the Online ISO 14155:2026 Auditor Training Course, participants will be able to:

• Understand the structure, scope, and key requirements of the ISO 14155:2026 standard.
• Recognize the benefits of ISO 14155:2026 implementation and certification for organizations conducting clinical investigations of medical devices.
• Understand the principles of Good Clinical Practice (GCP) applicable to clinical investigations involving human subjects.
• Identify the documents, documented information, and records required for an effective ISO 14155:2026 management system.
• Understand risk management principles for identifying, evaluating, and controlling risks associated with clinical investigations of medical devices involving human subjects.
• Understand the ISO 14155:2026 internal audit process, including audit planning, preparation, execution, reporting, and follow-up.
• Develop effective auditor questioning and interview techniques for collecting objective audit evidence.
• Learn how to prepare essential internal audit records, including audit plans, audit reports, and Nonconformity Reports (NCRs).
• Gain access to a ready-to-use ISO 14155 audit checklist containing clause-wise questions to support systematic and effective internal audits.
• Get ISO 14155 Internal Auditor Training Certificate

Who Should Attend the ISO 14155:2026 Auditor Training Course?

This online ISO 14155 Auditor Training Course is suitable for:

• Professionals who want to become a trained and certified ISO 14155:2026 Internal Auditor.
• Clinical research professionals involved in the planning, management, conduct, or monitoring of clinical investigations.
• Individuals responsible for implementing Good Clinical Practice (GCP) for clinical investigations of medical devices involving human subjects.
• Professionals seeking a basic or practical understanding of ISO 14155:2026 requirements for working in medical device manufacturing, healthcare, clinical research, or related organizations.
• Personnel responsible for establishing, implementing, maintaining, or improving Good Clinical Practice and clinical investigation processes.
• Quality, regulatory, compliance, clinical affairs, and audit professionals involved in medical device clinical investigations.
• Professionals seeking to strengthen their ISO 14155 auditing knowledge and skills and obtain formal recognition through an ISO 14155 Internal Auditor Training Certificate.

Prerequisites

There are no mandatory prerequisites for enrolling in the ISO 14155:2026 Auditor Training Online Course. However, participants may benefit from having:

• A basic understanding of or interest in clinical investigations of medical devices involving human subjects.
• Prior familiarity with the ISO 14155:2026 international standard or its key requirements.

AUTHORS & INSTRUCTORS

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

STUDY MATERIALS

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.

EXAMINATION AND COURSE CERTIFICATE

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.

END OF COURSE INSTRUCTION

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.