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CAS-13485-LA · v1

ISO 13485 Lead Auditor

ISO 13485:2016 + ISO 19011:2018

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Scope of certification (§8.2 a)

Lead Auditor competence for ISO 13485:2016 Medical Devices Quality Management. Includes audit principles, planning, conducting, reporting and follow-up of management-system audits.

Prerequisites (§8.2 e)

Tertiary education (B.Sc. or equivalent); 2+ years of relevant work experience; awareness or auditor training in the management system.

Equivalent training and experience from another provider are accepted (ISO/IEC 17024:2026 §5.2.3 d). CAS Academy training is not the only path.