ISO 13485 is a quality management system standard that specifies requirements for a medical device quality management system. It is based on the ISO 9001 standard but has been tailored specifically for the medical device industry. The aim of the ISO 13485 Lead Auditor Certification Online is to provide delegates with the knowledge and skills required to audit a medical device quality management system against the requirements of ISO 13485.

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ISO – International Organization for Standardization is an independent organization that sets out standards for businesses in terms of quality, safety, and environment of the management system. IAS audits and issues certification towards such standards.