Quiz · ISO 13485:2016 9/10

Internal Audit Coordination

10 questions80% to pass

Haven't watched this lesson yet? Watch it first (8:08).

1What should an internal audit evaluate?Choose one

Only whether procedures exist Only whether the company passed its last external audit Conformity with requirements and effective implementation Only whether employees can name the quality policy

2Which elements should be defined for an audit?Choose one

Scope, criteria, interval and methods Only the meeting room and invitation list Only the final report title Only the number of findings expected

3What should influence the audit program?Choose one

Only a fixed rotation unchanged by emerging issues Process status and importance, previous results and relevant changes Only the departments that volunteer Only the available space in the annual calendar

4The Quality Manager performs document control. Can they audit their own document-control work?Choose one

Yes, if they use a different job title during the audit Yes, if the company has fewer than ten employees Yes, if they promise to be strict No; arrange an objective evaluation by another suitable auditor

5What is a practical option for a very small team with an independence conflict?Choose one

Omit the audit permanently Treat management review as the audit Use a suitably qualified external auditor for the affected scope Have the same person sign twice in different roles

6Which finding is best supported?Choose one

The supplier process feels weak A cited procedure requires supplier reevaluation; specified sampled records lack it The auditor prefers a different template color The department should have more forms

7One sampled record has a gap. What should the report avoid?Choose one

Claiming every company record has the same gap without supporting evidence Identifying the sampled record Citing the relevant requirement Explaining the observed nonconformity

8Who is responsible for ensuring action in the audited area?Choose one

Only the auditor who identified the issue Only the certification body Only the training coordinator regardless of scope The management responsible for that area

9A finding is marked closed after an employee says the issue is fixed. What is still needed?Choose one

Only changing the due date Verification of the action with a recorded result Only removing the finding from the report Only notifying the auditor that the status changed

10Where should audit results and unresolved issues be used?Choose one

Only in the auditor’s private notes Only in the next marketing presentation Only as proof that no further audit is needed In management review and appropriate improvement follow-up