Gain the requisite knowledge and understanding of ISO 13485:2016 international standard requirements along with EU MDR requirements and skills to conduct an effective Internal Audit
29th, 30th & 31st Jan. 2022: Training Course on Internal Auditor for ISO 13485:2016 integrated with EU MDR requirements | Duration: 3 Days | Time: 9:30 am to 6:30 pm
The key to sustained success of any organisation depends on the effective implementation of the Quality Management System within the organisation along with applicable regulatory requirements. Thus it is very important for an organisation to keep vigilant on the adequate implementation of QMS covering the requirements of applicable requirements like EU MDR. This training program will facilitate:
This 3 days course will be conducted by our experienced experts, which will comprise of tutor-led sessions, discussions, exercises and case studies to ensure that the delegates are equipped with the knowledge and understanding of ISO 13485:2016 international standard requirements along with EU MDR requirements and skills to conduct an effective Internal Audit in their organisation.
Module 1 - ISO 13485:2016 Requirements and integration of EU MDR in QMS for Internal Audits
1. This topic will enable the 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
2. Parts of the EU MDR to be considered in IA
3. How to assess the requirements
Module 1: Continued
Module 2 - Auditing Techniques
4. Auditing techniques
5. Audit planning, Audit Execution and Audit Reporting, based on ISO 19011 Standard
Note: Classroom exercises will be spread across all 3 days
QMS foundation training or prior knowledge about ISO 13485 standard & basic understanding of EU MDR is desirable. This course is not for filling gaps in the knowledge about the standard; but for enhancing the knowledge about the same with regards to implementation context.
Participants will be assessed throughout the course for punctuality, presentation skills, their involvement in classroom exercises and finally through a written examination (open book) at the end of the course. Minimum passing% criteria: 70%.
Participants who will score 70% and above in the written examination will be issued with TÜV SÜD South Asia’s internal auditor certificate. Participants who are unable to achieve the passing criteria will be issued a certificate of attendance.