Understanding ISO 13485:2016 Requirements (Remote)

Course Description

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

Who Should Take It

Individuals with responsibility for management, operation, implementation or maintenance of an ISO 13485:2016 QMS.  This includes, but is not limited to:

• Those responsible for implementing their organization’s QMS to meet the ISO 13485:2016 requirements.
• Senior Management
• ISO Coordinators, Quality Managers & Management Representatives
• Members of the Quality Team and/or Internal Audit Team
• ISO 13485 Auditors, Quality Professionals and Consultants

Course Content

• Introduction to ISO 13485:2016 – Quality management for medical devices.
• ISO 13485:2016 – Scope, Normative References, Terms and Conditions
• 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 and Improvement

Prerequisites

This is an introductory course.  However, participants will benefit from previous experience working with, or within, an ISO 13485 quality management system.