What is 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 and suppliers. The standard details the requirement for quality management systems, to meet customer requirement and allows the incorporation of applicable regulatory requirements within an organization’s quality management system.
- Take the first steps towards 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
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 knowledge to participants on the Auditing Techniques like Auditing Concepts, Audit Planning, Audit Execution and Audit Reporting, based on ISO 19011 Standard. This will be followed by a written examination, for evaluation purposes.
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
Participants are preferred to have basic knowledge of Quality Management System - ISO 13485 Standards and / or experience in medical device operations.
Participants will be assessed through a 50 marks written examination (open book) at the end of the course. Minimum passing % criteria: 70%.
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.