ISO 13485:2016 – Foundation Training CourseISO 13485:2016 / Foundation Training Course
A highly interactive 1 day ISO 13485 foundation training course that is designed to give delegates a sound knowledge of the requirements of ISO 13485 and the fundamentals of a medical device management system.
Duration - 1 Day
who should attend?
- Executives and Senior Management
- General Managers/Business Unit Managers
- Quality and Regulatory Professionals
- Management Representatives/Internal and External Auditors
- Those seeking an understanding of the revisions
By the end of this ISO 13485 training course, delegates will be able to:
- Interpret the basic requirements of ISO 13485 as it relates to quality management systems.
- Apply the process approach to managing a company’s quality system, its control and effectiveness.
- Compare ISO 13485 with ISO9001 and the FDA’s QSR requirements with the view of implementing the Standard.
- Identify the importance of Design Control, Corrective and Preventative Action (CAPA) and Production and Process Control (P&PC) and how these can add value to processes.
- Practical workshops are designed to reinforce the discussions and topics. This style of delivery makes the course both memorable and enjoyable for participants, ensuring long-term learning.
- Introduction and overview of the requirements of ISO 13485
- Comparison of the requirements of ISO13485 with FDA’S QSR and ISO9001 requirements.
- Introduction to the Guide ISO/TR14969
- Risk management requirements and ISO 14791
- The implications of ISO 13485 for the Medical Device Industry in maintaining registration and market approval.
- Analysis of a process-based management system and the impact this may have on a company’s procedural based system.
- The approach of Regulators.
- Sources of information and further development