ISO 13485 Basic Training has been designed to provide an insight into the use of ISO 13485 as the basis for a quality management system implemented by medical device manufacturers.
Time will be spent during the course reviewing requirements of ISO 13485 and making comparisons to ISO 9001.
Who should attend?
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Anyone involved with the implementation of the standard
What will I learn?
On completion of this training, participants will be able to:
- Compare the requirements between ISO 13485 and ISO 9001
- Interpret the clauses of ISO 13485
- Recognize the role and responsibilities of management in ISO 13485
- Appreciate the use of ISO 13485 as the basis of Medical Device Regulations worldwide.
- Understand the implementation of a Quality Management System in accordance with ISO 13485
- Understand the relationship between a Quality Management System and compliance with customer and regulatory requirements
- Know the concepts, approaches, standards, methods and techniques allowing to effectively manage a Quality Management System as specified in ISO 13485
- Acquire the necessary knowledge to contribute in implementing a Quality Management System as specified in ISO 13485
How will I benefit?
- Take the first steps towards ISO 13485 certification
- Understand how you can better meet customer and regulatory requirements
- Find ways to increase efficiency and cost savings through quality management
- Monitor supply chains to achieve continuous improvement
- Develop safe and effective medical devices
- Motivate employees.