ISO Audit Execution & Evidence Gathering Flashcards
7 cards from real ISO AUDITOR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 ISO Audit Execution & Evidence Gathering flashcards as text
When auditing clause 8.4 of ISO 9001 (control of externally provided processes), which evidence is MOST relevant?
Answer: Approved supplier lists, purchase orders, and supplier evaluation records
Clause 8.4 focuses on external providers, so approved supplier lists and evaluation records are the primary evidence sources.
An auditor uses a checklist but the auditee's answers reveal an unexpected risk area not on the checklist. What should the auditor do?
Answer: Note the area and explore it further with additional questions
Checklists guide but do not limit auditors — unexpected risk areas should be explored to ensure complete evidence gathering.
Which of the following best describes 'objective evidence' as used in ISO 9001 auditing?
Answer: Data or information that can be proven true based on facts obtained through observation, measurement, or testing
Objective evidence must be verifiable and fact-based, not opinion or unverified assertion.
During a closing meeting, the lead auditor presents a finding the auditee strongly disputes. What is the correct approach?
Answer: Record the auditee's disagreement and retain the finding if supported by evidence
Disputed findings should be acknowledged and logged, but retained if the evidence is sound; resolution can occur post-audit.
An auditor is evaluating conformity of the inspection and testing process. Which combination of evidence sources provides the most robust conclusion?
Answer: Procedure review, calibration records, inspection logs, and observation of the inspection activity
Combining document review, records, and direct observation triangulates evidence and reduces the risk of missing nonconformities.
What is the primary purpose of conducting an opening meeting at the start of an audit?
Answer: To confirm the audit scope, objectives, and methods, and introduce the audit team to auditee management
The opening meeting establishes mutual understanding of scope, objectives, methods, and logistics before evidence gathering begins.
When auditing a calibration process, an auditor finds that one measuring instrument is past its calibration due date. The calibration procedure requires monthly calibration. This is best classified as:
Answer: A nonconformity against the calibration procedure requirement
Failure to calibrate per the documented schedule is a clear nonconformity regardless of the instrument's likely accuracy.