Quiz · ISO 13485:2016 3/10

Management Responsibilities and Review

10 questions80% to pass

Haven't watched this lesson yet? Watch it first (8:33).

1Who retains accountability for the QMS when a Quality Manager coordinates it?Choose one

Top management The external certification auditor The document-control software provider The supplier with the largest contract

2What establishes a person’s management-representative role?Choose one

The phrase quality in the job title Attendance at an ISO course alone A defined appointment with responsibilities and authority Possession of a document-editing account

3What is the central purpose of management review?Choose one

Approve every purchase order Reperform every completed product test Replace the internal audit program Evaluate QMS suitability, adequacy and effectiveness

4How should review intervals be established?Choose one

Assume the handbook requires an identical monthly schedule for everyone Document planned intervals suited to the organization and its risks Hold reviews only when an external auditor requests one Let each participant choose an unrelated interval

5Which input best supports a decision about CAPA effectiveness?Choose one

Trends showing whether the targeted failures recurred after action Only the number of CAPA forms filed Only the number of people invited to CAPA meetings Only a statement that the CAPA folder is complete

6A previous review action is overdue. What should the next review include?Choose one

Only newly opened actions A new completion date without acknowledging the delay Removal of the action because it belongs to the previous review Its status, implications and any necessary follow-up decision

7Which is a management-review output?Choose one

A chart of complaint volume prepared before the meeting An internal audit report supplied as background A decision to allocate resources to improve complaint investigation A list of new regulations awaiting analysis

8Required trend information is missing. What should the coordinator do?Choose one

Record that there were no problems Identify the gap and arrange follow-up rather than mark it reviewed Remove the topic from future review agendas Substitute the previous year’s results without explanation

9What makes a review action easier to follow up?Choose one

A general statement to improve quality An unsigned note in a personal notebook A copied list of last year’s actions with no status An owner, intended result and follow-up date

10Management signs a packet without discussing or evaluating it. What is missing?Choose one

A larger binder Meaningful review of evidence and decisions A second copy of the agenda A different document title