Description:
Designed to introduce participants to the ISO 13485 standard. This course provides an overview of the requirements of the standard, including required documentation and processes.
Background & Concepts
- What does ISO 13485 mean?
- Where did ISO 13485 come from?
- The third-party audit concept
- Process Approach to a Quality Management System
Understanding the Requirements
- The requirements and sections of the standard
- How to address the requirements at your organization
- How to build an ISO 13485 conforming quality management system
- The steps taken to achieve certification
The ISO 9001 Registration Process
- How to choose a Certification Body
- The costs & benefits associated with certification
- Time and resource allocation
- Next steps
Who Should Attend?
Executive officers of your organization, managers, process owners, supervisors, and quality assurance personnel who want to understand the requirements of ISO 13485, what is needed for an effective quality management system, and how to prepare for ISO 13485 conformance and/or certification.
Prerequisites:
No prior knowledge of the ISO 13485 Standard is required.
Duration: 4 hours
Type: On-Site or Virtual Training
Price: $2,500.00 (for up to 15 people) plus course manuals and travel for the instructor.