ISO 13485 Internal Auditor Training

The 13485 Internal Auditor Training equips individuals with the knowledge and skills to conduct internal audits of a Medical Device organization’s Quality Management System (QMS) following ISO 13485 requirements. Participants learn how to plan, conduct, and report on audits for organizations implementing the ISO 13485 standard.

Benefits of Participating in ISO 13485 Internal Auditor Training

By undertaking ISO 13485 Internal Auditor Training in India, delegates can expect to achieve the following objectives:

1. Gain a comprehensive understanding of auditing procedures, including the fundamentals and principles involved.
2. Develop the ability to effectively initiate, manage, and complete audits, as well as prepare detailed audit reports that highlight suggested improvements.
3. Acquire in-depth knowledge of the ISO 13485:2016 standard and its requirements specific to the medical device industry.
4. Enhance auditing knowledge and skills, enabling delegates to perform audits more efficiently and effectively.
5. Assist medical device manufacturers in successfully implementing the ISO 13485 standard within their organizations, providing valuable support in achieving compliance and maintaining quality management systems.

Course Objective

The ISO 13485 Internal Auditor Training course is designed to provide participants with a solid understanding of auditing principles and equip them with the necessary skills to design, conduct, and manage internal audits of Quality Management Systems for medical devices. The course also covers the ISO 19011 standard, which provides guidelines for auditing management systems.

The primary objective of the ISO 13485 Internal Auditor Course is to enable individuals to become effective internal auditors. By completing the training, participants will have the knowledge and tools to perform thorough and objective internal audits, ensuring compliance with ISO 13485 requirements and identifying areas for improvement within the Quality Management System of medical device organizations.

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 highly beneficial for individuals seeking to expand their knowledge and skills in the field of auditing. It is particularly recommended for quality managers, representatives, consultants, and executives who are part of the quality assurance team in the medical device industry.

By undertaking this training course, participants will gain a comprehensive understanding of auditing principles and practices specific to the ISO 13485 standard. They will learn how to effectively plan, conduct, and manage internal audits within the context of a medical device Quality Management System. This course will equip them with the necessary expertise to contribute to the successful implementation and maintenance of quality assurance processes in accordance with ISO 13485 requirements.

IBC – Training Formats

IBC offers the ISO 13485 Internal Auditor Training in two formats: in-class training and online training. The in-class training is a two-day program, spanning 16 hours. It includes continuous assessments throughout the training and concludes with a written exam.

For individuals who prefer self-paced learning, the online self-learning option is available. This 30-day program allows participants to access the learning modules at their convenience from anywhere. Upon completion of the self-learning modules, individuals can request to take the online examination.

The virtual tutor-led classroom option provides a similar experience to in-class training but is conducted entirely online via Zoom meetings. Experienced trainers lead the sessions, which include activities, quizzes, group exercises, and real-world examples to enhance the learning process.

These different training formats cater to individuals with varying schedules and learning preferences, providing flexibility and convenience in acquiring ISO 13485 Internal Auditor certification.

Why Choose IBC?

IBC is a recognized third-party Conformity Assessment Body that holds approval from IRCA-CQI for ISO lead auditor training. With expertise in ISO management system certifications and training, IBC offers comprehensive programs to individuals seeking ISO certifications.

One of the key strengths of IBC is the utilization of experienced auditors who possess extensive industry knowledge. These auditors serve as instructors, sharing real-world examples and practical insights to enhance participants’ understanding of auditing principles.

If you are interested in registering for the ISO 13485 Internal Auditor Training, you can download the Application form from our website. Fill in the required details and email the completed form to us. Our dedicated executives will promptly contact you to provide further assistance and guidance throughout the registration process.