Specifications of ISO 13485 Certification For medical Devices
ISO 13485 Certification describes requirements for a Quality Management System where an organization needs to demonstrate its ability to provide Medical Devices and services that constantly meet customer and applicable regulatory requirements. Such organizations can be involved in one or more levels of the life-cycle, including design and development, storage and distribution, production, installation, or servicing of a medical device and design and development or provision of corresponding activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product related services to such organizations including Quality Management System.
ISO 13485 Certification requirements are applicable regardless of the size of the organizations and regardless of their type except where clearly stated. Wherever requirements applying to medical devices are specified, the requirements apply equally to related services as supplied by the organization.
The ISO 13485 required processes that are applicable to the organization, but are not executed by the organization, are the role of the organization and are accounting for in the organization’s quality management system by maintaining, controlling and monitoring of the processes.
If applicable regulatory requirements permit removal of design and development controls, this can be used as a justification for their removal from the quality management system. These managing requirements can provide alternative approaches that are to be addressed in the quality management system-QMS. It is the role of the organization to ensure that claims of conformity to ISO 13485 Certification reflect any removal of design and development controls.
Benefits of being certified to ISO 13485 Standard
Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall operations, eliminate uncertainty, and widen market opportunities. Companies with this certification committed to quality to both customers and regulators.
• Increase access to more markets worldwide with certification
• Framework how to review and improve processes across your organization
• Increase efficiency, cut costs and control supply chain operations
• Demonstrate that you produce safer and more effective medical devices
• Meet regulatory requirements and customer expectations