Quiz · ISO 13485:2016 8/10

Feedback, Complaints and Reporting Escalation

10 questions80% to pass

Haven't watched this lesson yet? Watch it first (8:23).

1A distributor phones to describe intermittent device failures. What should happen first?Choose one

Wait for the distributor to complete a formal complaint form Capture the information and arrange timely evaluation Classify it as a sales issue because it came by phone Close it if no device has yet been returned

2Which decisions should be distinguished?Choose one

The color, font and file size of the complaint form Purchase approval and supplier payment The employee’s job title and course score Complaint classification, investigation and reporting assessment

3A device meets its specification but users report a problem during use. What is appropriate?Choose one

Evaluate the reported problem, including possible design or instruction issues Dismiss it automatically because the specification was met Record it only as customer satisfaction feedback with no evaluation Wait until the specification is changed before recording it

4An evaluation concludes that feedback is not a complaint. What should be retained?Choose one

Only a deleted-message record Only a statement that no action is necessary The evaluation and its rationale Nothing because it was not classified as a complaint

5When can a previous investigation be referenced for a similar complaint?Choose one

Whenever the new report uses the same device model name When a documented evaluation and rationale establish that a new investigation would be duplicative Whenever the complaint workload is high Only after deleting the new complaint entry

6A reporter has not supplied all requested information. What should be done?Choose one

Make reasonable documented follow-up efforts proportionate to risk Fill the gaps using assumptions without identifying them Close the complaint automatically after one unanswered call Delay all safety review until every field is complete

7A complaint mentions serious harm while the technical investigation is incomplete. What is appropriate?Choose one

Wait for the root cause before considering reporting obligations Wait for the next scheduled management review Require the customer to prove the device caused the event first Promptly involve the designated safety and reporting personnel

8What should happen if a supplier’s activity may have contributed?Choose one

Transfer the complaint entirely to the supplier and close your file Wait for the supplier’s next audit before communicating Exchange relevant information through the defined arrangements Send the full patient record without considering confidentiality

9Repeated complaints show a known failure is occurring more often. What process should receive this information?Choose one

Risk management and improvement processes Only the sales forecast Only the purchasing invoice archive Only the employee attendance log

10Returned units pass a bench test despite repeated shutdown reports. What is the best next step?Choose one

Conclude that every complaint was invalid Delete the complaints because no failure was reproduced Evaluate the pattern and whether the test represents the reported circumstances Treat the pass result as a universal exemption from reporting assessment