Understanding ISO 13485:2016 Requirements
Live Remote Training
Description
8 hours of live, instructor-led remote training that provides a thorough review of the ISO 13485:2016 requirements for medical device quality management. Participants will gain a detailed understanding of the standard’s requirements as well as the principles that support a management system.
NOTE – This training session can be combined with the “Internal Audits” module to gain competency as an ISO 13485:2016 internal auditor.
Format
Live, instructor-led remote training.
Duration
8 hours (2 x 4 hour sessions)
Technical/System Requirements for Participants
- Windows 7 – Windows 10 (Microsoft), OR
- Mac OS X 10.9 (Mavericks) – macOS Mojave 10.14
- Google Chrome or Mozilla Firefox browser required for breakout activities
- Internet connection of 1 Mbps or better (broadband recommended)
- JavaScript enabled
- Microphone and speakers if using computer audio (USB headset recommended but not required)
- Telephone if using available long-distance # for audio
- Webcam optional
Course Outline
- Introduction
- ISO 13485:2016 – Scope, Normative References, Terms and Definitions
- ISO 13485:2016 – Section 4: Quality Management System
- ISO 13485:2016 – Section 5: Management Responsibility
- ISO 13485:2016 – Section 6: Resources
- ISO 13485:2016 – Section 7: Product Realization
- ISO 13485:2016 – Section 8: Measurement, Analysis & Improvement
