ISO 13485:2016 Overview

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ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. Estimated to take up to four-hours to complete, this ISO 13485 overview is an overview.

Objectives

By participating in this online course, you will understand:

• The high level requirements and intent of this international standard
• The methods to managing an organization’s QMS in compliance with ISO 13485:2016
• How the requirements can be interpreted/should be implemented within an organization

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