ISO 13485:2016 cho Hệ thống Quản lý Chất lượng Thiết bị Y tế (Cập nhật 2025)

The standard ISO 13485:2016 is an internationally recognized document, used by several regulatory authorities, which outlines the requirements to be fulfilled by the Quality Management System (QMS) of organizations working in the medical devices industry.

The standard 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. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

A detailed understanding of this standard is critical for the correct implementation of the required processes and operating procedures in the quality system, to meet the applicable requirements during product design, production, distribution and servicing of the medical devices.

The aim of this training course is to provide the students with a solid understanding of the ISO 13485:2016 requirements, so they can be prepared to implement those requirements in their organization.