How often must a Quality Management System (QMS) be audited for compliance with ISO 13485?

A Quality Management System (QMS) must be audited annually for compliance with ISO 13485. This standard outlines the requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

Annual audits are critical in ensuring that the QMS remains effective and continues to meet the necessary standards and regulatory requirements. These audits help in identifying areas for improvement and ensuring that processes are followed correctly. Regular audits foster an environment of continuous improvement, which is essential in the highly regulated medical device industry.

Moreover, annual audits align with the principles of quality management embodied in ISO 13485, emphasizing the importance of maintaining compliance and handling any non-conformities promptly. This frequency also allows organizations to be proactive in addressing any potential issues that could lead to violations or product failures, thereby protecting both consumer safety and the manufacturer's integrity.