ISO 13485 LA Practice Questions - PECB ISO 13485 Lead Auditor Exam

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A PECB ISO 13485 Lead Auditor is planning a Stage 1 audit for an organization manufacturing Class II medical devices. What is the PRIMARY purpose of the Stage 1 audit?

To verify all product conformity records and release decisions To review the organization's documented MDQMS and assess readiness for the Stage 2 audit To issue the ISO 13485 certificate if documentation is satisfactory To conduct full process sampling and raise all nonconformities

Correct Answer:

To review the organization's documented MDQMS and assess readiness for the Stage 2 audit

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