ISO 13485 Certification

The ISO 13485:2016 standard specifies the requirements for a quality management system that can be used by an organization for the design and development, production, facility and service of medical devices and the design, development and provision of related services.

In addition, the TS EN ISO 13485 standard can be used by internal and external organizations, including certification bodies that assess the organization’s ability to meet customer and regulatory requirements.

ISO 13485, a standard that defines the specific requirements that quality systems must meet for organizations operating in the field of trade and manufacturing of medical devices, can be applied by all organizations that include the project, production, installation and supply phases of medical devices or related services.