ISO 13485 Internal Auditor Training Program integrated with EU MDR requirements

ABOUT THE COURSE

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:

• Assessing the overall context of your organization and eventually establish objectives which are in line with business goals
• Consistently provide products / services that meet customer and applicable legal requirements
• Working in a more efficient way which will result in greater productivity and reduce costs
• Expanding into new markets by having an edge over your competitors
• Identifying and addressing risks associated with your organisation
  

YOUR BENEFITS

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.

• Take the first steps towards implementation of ISO 13485:2016 Quality management system
• Understand how you can better meet regulatory requirements (EU MDR) leading to increased patient safety
• Identify mandatory documented information required by ISO 13485:2016 standard & EU MDR. Develop safe and effective medical devices
• Understand internal auditing as per ISO 13485:2016 covering the requirements of EU MDR

COURSE CONTENT/OUTLINE

Day 1
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 

Day 2
Module 1: Continued

Day 3
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

who should attend?

• Medical Device Manufacturing professionals
• Pharmaceutical professionals
• Quality Professionals
• Regulatory Affairs
• Internal and external Auditors
• Consultants and anyone involved with the implementation of the standard & regulator requirements 

TRAINING DURATION

03 days

Pre-requisites

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.

Examination

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%.

CERTIFICATION

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.