ISO 13485 - Quality Management System: EN ISO 13485:2016 / A11:2021
QMS Architecture and Content
November 5th and 7th, Online
8:30 – 11:30 AM US Eastern Standard Time / 2:30 – 5:30 PM Central Europe Time

Duration: 6 hours
Speaker: Dr Lydie Moreau

Training objectives:

● Understand the QMS principles and the links between the different QMS processes
● Define a QMS architecture
● Establish a roll-out plan for leading the implementation of a QMS
● Identify the content requirements of key standard operating procedures

Training content:

● Introduction to ISO 13485:2016: why implementing a QMS, QMS goals and benefits,
the certification process
● Implementation Phases of the standard
● Visit of the architecture of a QMS
● Deep dive into the requirements of key processes (such as Management
Responsibilities, Resource Management, Design and Development, Manufacturing,
CAPA, etc), during dedicated sections
● Review of concrete examples of key QMS documents (quality manual, key standard
operating procedures…)


Training format:

• Presentations with interactive discussions
• Group and individual exercises
• End of training assessment