IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) MD 7.2.5: Require supervised audit experience before first authorisation, more for team leaders

What does MD 7.2.5 require?

For a first authorisation an auditor has shown, in audits under guidance and supervision, experience of the whole process of auditing a medical device quality management system, including document review and the risk management of the devices, parts or services concerned, the implementation audit and reporting, and has taken part as a trainee in four or more audits adding up to 20 days or more within an accredited QMS programme, half or more against ISO 13485 (preferably accredited) and the remainder in any other accredited QMS programme. An audit team leader has additionally led three or more ISO 13485 audits while a qualified team leader supervised.