ISO 13485 is an international standard that outlines the requirements for a Quality Management System (QMS) in the medical device industry. It is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services. The standard specifies requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and associated services that consistently meet customer and regulatory requirements. ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
ISO 13485 is a stand-alone document, but it is generally harmonized with ISO 9001. However, there are some differences between the two standards. For example, ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.
ISO 13485 can help companies identify and mitigate risks associated with the design, development, and production of medical devices. It can also help companies improve their processes and increase efficiency, leading to better products and higher customer satisfaction. Certification to ISO 13485 is not a requirement of the standard, but third-party certification can demonstrate to regulators that an organization has met the requirements of the standard.
