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

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During an ISO 13485 audit, you find that the organization's management review records show reviews conducted once every 18 months. What is the most appropriate audit finding?

Observation — management review frequency is not specified in ISO 13485 Minor nonconformity — ISO 13485 requires reviews at planned intervals but the organization has not defined its own schedule Major nonconformity — ISO 13485 Clause 5.6.1 requires management reviews at planned intervals; 18 months without an interval defined constitutes a systemic failure No finding — the standard does not prescribe a minimum frequency

Correct Answer:

Major nonconformity — ISO 13485 Clause 5.6.1 requires management reviews at planned intervals; 18 months without an interval defined constitutes a systemic failure

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