Internal Auditor Training Program on Medical Devices - Quality Management System based on ISO 13485:2016
- Understand the implementation of ISO 13485:2016 Quality management system.
- Understand how you can better meet regulatory requirements leading to increased patient safety
- Develop safe and effective medical devices
- Understand the requirements of ISO 13485:2016
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- Medical Device Manufacturers.
- Quality Professionals
- Regulatory Professionals
- Internal and external Auditors
- Consultants and anyone involved with the implementation of the standard
- Understand the implementation of ISO 13485:2016 Quality management system.
- Understand how you can better meet regulatory requirements leading to increased patient safety
- Develop safe and effective medical devices
- Understand the requirements of ISO 13485:2016
- Understand the implementation of ISO 13485:2016 Quality management system.
- Understand how you can better meet regulatory requirements leading to increased patient safety
- Develop safe and effective medical devices
- Understand the requirements of ISO 13485:2016
ISO 13485 – Medical Device – Quality Management Systems –Requirements for regulatory purpose – address the development, implementation and maintenance of quality management system intended for use by medical device manufacturers, developers, and suppliers. The standard details the requirement for quality management systems, to meet customer requirements and allows the incorporation of applicable regulatory requirements within an organization’s quality management system.
Module 1 – ISO 13485:2016 Requirements (Day 1)
This topic will enable participants to understand the requirements of ISO 13485:2016, a standalone Quality Management Systems standard for Medical Device manufacturers and mandatory while fulfilling the regulatory compliance.
Module 2 – Auditing Techniques (Day 2)
This topic will provide participants with knowledge on Auditing Techniques, such as Auditing Concepts, Audit Planning, Audit Execution, and Audit Reporting, based on the ISO 19011 Standard. This will be followed by a written examination for evaluation purposes.
Preferred to have basic knowledge of Quality Management System - ISO 13485 Standards and / or experience if medical device operations.
Participants who score 70% and above in the written examination will be issued a TÜV SÜD South Asia’s internal auditor certificate. Unsuccessful candidates will be issued a certificate of attendance.
1. When can I get the certificate?
Internal Auditor Training Program on Medical Devices - Quality Management System certification will be issued within 21 working days from the examination date.
2. When can I get the training material and invite?
One day before the commencement of the training program.
3. How do I pay the fees for training and examination?
Online mode
4. What are the benefits of the Internal Auditor Training Program on Medical Devices - Quality Management System Program?
5. Is there any refund policy for the paid fees?
Please refer to Cancellation and Refund policy page.