ISO 10012:2003 - Measurement Management Systems Lead Auditor Quiz 01 26Jul25 - Practice Quiz

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Question 1 of 30

During an audit of a medical device manufacturer\'s measurement management system, an auditor reviews the calibration records for a critical pressure gauge used in product testing. The gauge\'s specified calibration interval is 18 months. However, performance monitoring data reveals that the gauge consistently drifts beyond its acceptable tolerance of \\( \\pm 0.05\\) MPa at the 12-month mark. What is the most appropriate action for the auditor to recommend regarding the calibration interval for this gauge, based on the principles of ISO 10012:2003?

Recommend a reduction in the calibration interval to 12 months or less to ensure continued fitness for purpose.

Advise the organization to continue with the 18-month interval, provided a post-calibration adjustment is always performed.

Suggest that the organization document the observed drift but maintain the 18-month interval until a failure occurs.

Propose an increase in the calibration interval to 24 months, assuming the drift is within a defined acceptable range for extended periods.

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