About the course
In the pursuit of continual improvement, organizations are constantly embarking on the journey to strengthen its quality management systems and processes with the aim to produce high customer loyalty, satisfaction and build long term partnerships with them.
To keep quality management system standards relevant to the community of users, ISO 13485, the internationally recognized quality management system standard for medical devices industry, underwent major changes by the Standard Body and the revised medical standard ISO 13485:2016 was published on February 25, 2016.
This two-day training is to highlight the significant changes that affect registrants within the scheme, to help organizations understand some of the changes, how the changes may impact them, and how to audit against the revised ISO 13485:2016 standard.
What will you learn from the course?
- Introduction to Quality Management System
- Overview of ISO 13485:2016 requirements
- Comparisons between ISO 13485:2016 and ISO 13485:2003 requirements
- Audit planning and preparation
- Audit execution
- Non-conformity reporting
- Closing meeting
- Audit report preparation
- Audit follow-up
What is the course methodology?
Participants will learn through lectures, case studies, group exercises and discussions.
Who should take the course?
This course is designed for Quality and Regulatory Managers/Supervisors, Product Designers, Management Representatives and Consultants.
Contact us for enquiries
To contact someone from TÜV SÜD, you may email us at firstname.lastname@example.org or call +62 21 2986 5795 / +62 21 2986 5796.
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