ISO 13485 Internal Auditor Training

PECB-accredited training program

Intensive 24-hour learning sessions

Understand the role of an internal auditor

Ensure continuous improvement in quality management

Pick sessions from weekday or weekend options

Online and live classroom learning

4.8/5

6410 Enrolled

Overview

Skills we aim to impart

Develop and use audit checklists and protocols
Gather and evaluate evidence during audits
Identify and report non-conformities accurately
Implement corrective and preventive actions (CAPA)
Plan and prepare for internal audits effectively
Acquire practical exercises to reinforce auditing skills

Learning Objectives

On completing this course, you will master:

Understand the principles of quality management, such as customer focus, leadership and continual improvement, apply to the requirements of ISO 13485:2016

Ensure that the QMS addresses the specific requirements and considerations of the medical device industry

Apply the techniques of auditing to assess the effectiveness and conformity of the QMS with ISO 13485:2016 requirements

Consider factors such as organisational structure, resource availability and the scope of the QMS conduct audits

Stay informed about regulatory updates and changes to ensure that the QMS remains compliant

Develop and apply personal attributes such as integrity, objectivity and effective communication skills during the audit process

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Prerequisites

To enrol for the ISO 13485 Internal Auditor Training:

It is highly recommended to have a solid understanding of the ISO 13485:2016 requirements
Have a minimum of six months of work experience in applying or auditing quality management systems

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Upcoming sessions

Our Trainers

We, at Learners Point, take immense pride in our teaching methods and instructors. Our instructors are some of the best experts in their fields and employ a practical approach to learning. Many of them are globally recognised and have a diverse set of experience in their field of expertise. You are always sure to have the best in the industry as your teachers who are ready to guide you at every step and make the experience informative yet enjoyable. Apart from the focus on learning your chosen course, our instructors also encourage students to develop communication skills and interpersonal skills necessary to excel in the practical world.

Our cutting edge teaching methods make every program an immersive and productive experience for the learners. Our learning methods are research-driven and are continuously updated to stay relevant to present times as well as the future. You will enjoy practical applications of everything learned through theory and regular mock examinations to help monitor your progress. Our courses are led by an instructor in a classroom setup and we do offer online high-quality sessions as well for individuals. We also monitor the training sessions with a progress tracker to maintain high standards of instruction & ethics.

Our Trainers

Related courses

Curriculum

It is highly recommended to have a solid understanding of the ISO 13485:2016 requirements and a minimum of six months of work experience in applying or auditing quality management systems. This background knowledge and experience will greatly enhance the learning experience and enable participants to grasp the concepts and principles more effectively.

Introduction to ISO 13485, History
Classification of Medical Devices as per MDR and EU
Overview of Changes in ISO 13485:2016 with a Focus on QMS planning, leadership, Risk-Based Thinking Performance Evaluation & Improvement
Introduction to Auditing: Definition, Types of Audits
Internal Audit Planning & Preparation
Conducting Internal Audits & Reporting Non-Conformities
Corrective Action & Audit Follow-Up Activities
Auditor Attributes, Competence & Evaluation
Individual / Syndicate Exercises

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Frequently asked questions

The role of an ISO 13485 Internal Auditor is to assess and evaluate the organization's compliance with the ISO 13485 standard and related regulatory requirements through internal audits.

Many training providers offer ISO 13485 Internal Auditor training in online or virtual formats, allowing participants to access the training remotely.

ISO 13485 Internal Auditor certification enhances career prospects by demonstrating expertise in quality management systems and regulatory compliance, making individuals valuable assets to organizations in the medical device industry.

ISO 13485 Internal Auditor training equips participants with the skills to conduct effective internal audits, which in turn helps organizations identify areas of non-compliance and take corrective actions before external audits.

Individuals who have already obtained certifications such as ISO 9001 Internal Auditor can benefit from additional ISO 13485 Internal Auditor training to specialize in the medical device industry and enhance their audit capabilities.

The training sessions at Learners Point are an interactive, immersive, and intensive hands-on program. We offer three modes of delivery and participants can choose from instructor-led classroom-based group coaching, one-to-one training session, or high-quality live and interactive online sessions as per convenience.

At Learners Point Academy, if a participant doesn’t wish to proceed with the training after the registration due to any reason, he or she is entitled to a 100% refund. However, the refund will be issued only if we are notified in writing within two days from the date of registration. The refund will be processed within four weeks from the day of exit.