ISO Audit Execution & Evidence Gathering Flashcards

Which sampling strategy is MOST appropriate when an auditor wants to maximize the chance of finding nonconformities in a large population of records?

Answer: Judgmental sampling — select records most likely to reveal issues based on risk

Judgmental (risk-based) sampling targets areas where nonconformities are most probable, making it most effective for uncovering issues.

An auditor discovers during fieldwork that the actual audit scope needs to be expanded to cover a related process. Who must authorize this change?

Answer: The audit team leader and the audit client

Changes to audit scope require agreement between the audit team leader and the audit client, as defined in ISO 19011.

What is the key difference between a 'major' and 'minor' nonconformity in ISO 9001 third-party audits?

Answer: A major nonconformity represents a systemic failure or complete absence of a required element; a minor is an isolated lapse

Major nonconformities indicate a breakdown of the QMS or absence of a required element, while minor ones are isolated, limited-impact failures.

During an audit, an auditee shows the auditor a procedure that was revised last week to address a known gap. The auditor finds no other evidence of the gap. How should this be handled?

Answer: Verify the revision is approved and implemented, and consider whether an OFI or observation is more appropriate

The auditor should confirm the revision is properly authorized and in use; if the gap appears resolved, an observation may suffice over a nonconformity.

Which ISO 19011 guidance recommends that auditors evaluate evidence against which criteria?

Answer: Audit criteria established in the audit plan (standards, procedures, contractual requirements)

ISO 19011 defines audit criteria as the set of policies, procedures, or requirements used as a reference against which evidence is compared.

An auditor interviews a machine operator who cannot explain the quality objective relevant to their work area. Under ISO 9001:2015 clause 6.2, this most likely indicates:

Answer: A potential nonconformity if workers are required to be aware of quality objectives

ISO 9001:2015 clause 7.3 requires relevant persons to be aware of quality objectives; an inability to explain them supports a potential nonconformity.

After gathering all evidence during fieldwork, what is the auditor's next step before the closing meeting?

Answer: Review and analyze evidence with the audit team to agree on findings and conclusions

The audit team must collectively review evidence, reach consensus on findings, and formulate conclusions before presenting them at the closing meeting.