ISO 9001:2015 requires auditors to base conclusions on objective evidence and to investigate potential issues before determining whether a nonconformity exists.
In this scenario, the auditor has observed:
A freezer temperature of -17.2 °C .
An understood storage requirement of less than -18.0 °C .
A statement from the supervisor regarding measurement uncertainty of ±1 °C .
Before raising a nonconformity, the auditor must verify:
The exact storage requirements and any permitted tolerances.
The validity and calibration status of the measuring equipment.
Why A is Correct
Ask to see the documented test method to determine if there is additional information on the limits for storage temperature.
The auditor must confirm:
The exact specification.
Whether tolerances or measurement uncertainty have been considered in the requirement.
Whether the storage criterion is truly a hard limit or includes allowable variation.
This follows the audit principle of obtaining sufficient objective evidence before reaching a conclusion.
Why B is Correct
Ask to see the calibration report for the measuring equipment.
ISO 9001 Clause 7.1.5 requires monitoring and measuring resources to be suitable and maintained to ensure valid results.
The supervisor has based his justification on measurement uncertainty. Therefore, the auditor should verify:
Why the Other Options Are Incorrect
C. Raise a non-conformance immediately
At this point there is insufficient evidence. The auditor has not yet verified the specification or calibration records.
D. Ask to see competence records of supervisors of all terminals
This is not the immediate audit trail arising from the observation.
E. Immediately halt the vaccination process
Auditors do not normally have authority to stop operations except in exceptional circumstances defined by legal or contractual arrangements. The auditor must first gather evidence.
F. Accept the comment and proceed
Auditors must verify statements with objective evidence rather than accepting explanations without verification.
ISO-Aligned Conclusion
The next appropriate audit actions are to:
Verify the storage temperature requirements, and
Verify the calibration and uncertainty information of the measuring equipment.
Therefore, the correct answers are:
A. Ask to see the documented test method to determine if there is additional information on the limits for storage temperature.
B. Ask to see the calibration report for the measuring equipment.
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