Discover the changes in ISO 13485:2016 and boost your audit capabilities
In the pursuit of continual improvement, organisations 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 organisations understand some of the changes, how the changes may impact them, and how to audit against the revised ISO 13485:2016 standard.
Duration: 2 - day course
At the end of this course, participants will be able to:
• Understand the requirements of ISO13485:2016 for medical products and related services
• Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
• Acquire the skills to take on the position of an internal medical services auditor in the company
Topics to be covered in this course include:
• 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
Participants will learn through lectures, case studies, group exercises and discussions.
This course is specially designed for:
• Quality and Regulatory Managers/Supervisors
• Product Designers
• Management Representatives and Consultants
• Internal Auditors
The course content and structure are designed by the domain experts from TÜV SÜD Malaysia and global
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
World-class training – by learning from TÜV SÜD’s industry experts and training specialists
Interactive learning style – with interactive formats such as lectures, illustrations and simulations are used
Networking opportunity – where you can meet and build network with like-minded individuals at our instructor-led training
Gain a competitive edge – by getting trained by experts known in the fields of safety, security and sustainability
To know more about TÜV SÜD, please click here.
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Bosnia and Herzegovina