ISO 13485:2016 MEDICAL DEVICES MANAGEMENT SYSTEM

 

WHAT IS ISO 13485:2016 MEDICAL DEVICES MANAGEMENT SYSTEM?

ISO 13485:2016 outlines the standards for a quality management system that requires an organization to show its capability in delivering medical devices and related services that consistently adhere to both customer expectations and relevant regulatory standards. These organizations may engage in various stages of the device's life cycle, such as design and development, manufacturing, storage, distribution, installation, or maintenance, as well as the design and provision of related services (for example, technical support). Additionally, ISO 13485:2016 is applicable to suppliers or external entities that offer products, including services related to the quality management system, to these organizations.

The standards of ISO 13485:2016 are relevant to organizations of all sizes and types, with the exception of situations where it is clearly indicated otherwise. When the standards are mentioned in relation to medical devices, they also apply to the services provided by the organization.

The procedures mandated by ISO 13485:2016 that the organization is not directly involved in, but still needs to manage, are the organization's duty. These procedures are recorded in the organization's quality management system through the oversight, upkeep, and regulation of these processes.