What is the ISO 13485 Internal Auditor Course?

The 13485 internal auditor training is designed to equip you with the skills and knowledge required to conduct internal audits of an organization’s Quality Management System (QMS) for Medical Devices following ISO 13485 requirements. Individuals will learn how to plan, conduct and report a first- or second-party audit for organizations that are implementing the ISO 13485 standard.

Benefits of Participating in ISO 13485 Internal Auditor Training

The delegates who pursue ISO 13485 Internal Auditor Training in India will be able to:

  • Learn the fundamentals of auditing procedures
  • Initiate, manage, and complete an audit as well as prepare a successful audit report with suggested improvements
  • Learn the requirements of ISO 13485:2016
  • Improve auditing knowledge and skills
  • Assist medical device manufacturers for successful implementation of the ISO 13485 standard within their organizations

Course Objective

The ISO 13485 Internal Auditor Training course aids participants in comprehending the fundamentals of auditing to design, conduct, and manage an internal audit of a Quality Management System for medical devices. This course also addresses the ISO 19011 standard – guidelines for auditing management systems. Furthermore, the main objective of the ISO 13485 Internal Auditor Course is to help individuals become effective internal auditors.

Also, refer to How to become ISO Auditor for more information

 What Does the ISO 13485 Internal Auditor Course Cover?

  • Introduction to ISO 13485
  • Overview of ISO 13485:2016
  • ISO 13485 requirements
  • Learn about audit definitions, types, and concepts
  • ISO 19011 auditing guidelines
  • Prepare the audit report and checklists
  • Follow-up procedures for internal audit
  • Roles and responsibilities of an internal auditor

Who Should Attend?

The ISO 13485 Internal Auditor Training course is ideal for those who want to learn more about auditing. It is recommended for quality managers, representatives, consultants, and executives in the quality assurance team for medical devices.

EAS – Training Formats

ISO 13485 Internal Auditor Training is available through EAS in two different formats, in-class training, and online training. The classroom training lasts two days (16 hours) and includes continuous assessments as well as a written exam after the course.

Online Self-Learning: The 30-day online program consists of learning modules that may be accessed from anywhere, at any time. This mode of training is especially useful for individuals who may not have the time to attend a live training session. Individuals can request to take the online examination once they have completed the self-learning modules.

Virtual Tutor-Led Classroom: This mode of training is similar to the classroom method but is conducted completely online through Zoom meeting. Our experienced trainers will guide participants throughout the course with activities, quizzes, group exercises and real-world examples.

Why Choose EAS?

EAS is a third-party Conformity Assessment Body approved by IRCA-CQI for ISO lead auditor training that specializes in ISO management system certifications and training.

We provide real-time auditors with extensive industry knowledge to instruct prospects using real-world examples to help gain a better understanding of auditing principles.

Interested in registering for ISO 13485 Internal Auditor Training? Download the Application form, fill in the details and e-mail it to us. Our executives will contact you shortly.

Want to know more about the ISO 13485 Internal Auditor training in India? Kindly contact us today to find out more!

E-mail: info@easiso.com