Quiz · ISO 13485:2016 5/10

Risk and Design-Control Interfaces

10 questions80% to pass

Haven't watched this lesson yet? Watch it first (8:52).

1Which item is a design input?Choose one

A released assembly drawing A completed verification report A defined safety requirement derived from risk management A production batch record

2Which item is typically a design output?Choose one

A specification with product acceptance criteria An unresolved user need A draft statement of intended use awaiting review A list of hazards with no design requirements yet

3What does design verification establish?Choose one

Whether every user need has been validated in actual use Whether outputs meet the design inputs Whether marketing approval has been granted Whether the production team has received training

4What does design validation address?Choose one

Whether a document has the correct file name Whether all drawings were emailed to production Whether every supplier invoice was paid Whether the device meets requirements for its intended use or application

5A bench test meets an engineering specification. What can be concluded without further evidence?Choose one

That all intended-use requirements have been validated That every possible use error has been controlled That the tested requirement has verification evidence, within the test’s scope That regulatory approval is automatic

6When should a proposed design change receive the required review and approval?Choose one

At the next annual management review regardless of timing Before implementation Only after a complaint identifies a problem After the first production batch using the change

7Which products may need consideration in a change assessment?Choose one

Components, work in process and already-delivered devices Only future devices that have not been ordered Only units still in the design laboratory Only units for which the customer requested a change

8A replacement sensor has the same package dimensions. What is the appropriate next step?Choose one

Approve it solely because it fits mechanically Treat it only as a purchasing price change Wait for field experience before assessing the change Evaluate performance, interfaces, risk and required verification or validation

9What is the Quality Manager’s appropriate role in the sensor-change example?Choose one

Approve every engineering conclusion solely by holding the quality title Coordinate evidence and ensure the proper technical decisions and approvals occur Replace the risk assessment with a completed checklist Treat a supplier certificate as final design approval

10What does design transfer need to establish?Choose one

That the drawing files were sent by email That all validation can be deferred until after customer release That the design plan no longer needs maintenance That the design outputs are suitable for manufacturing