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
- Presentation with interactive discussions
- Exercises during the training
- End of training assessment (participants will receive a training certificate)
Who Should Attend
This training is addressed to quality personnel of medical device companies as well as to persons occupying key functions of such companies (within management, manufacturing, human resources, supply chain, etc). It is also addressed to anyone who wishes to have a global understanding of the Quality Management System goals, principles and requirements.
Price
EUR 625 including course material and certificate