Quiz · ISO 13485:2016 7/10

Production and Measuring-Equipment Controls

10 questions80% to pass

Haven't watched this lesson yet? Watch it first (8:25).

1Which condition supports controlled production?Choose one

Current instructions, suitable resources and defined monitoring and release controls An experienced operator working from memory with no applicable instructions A completed order quantity regardless of acceptance status A production schedule that takes priority over quality holds

2What should a device or batch record identify?Choose one

Only the planned delivery date Only the total material cost The manufactured quantity, quantity approved for distribution and required traceability Only the name of the purchasing contact

3How does acceptance status differ from identification?Choose one

Status is always the serial number Identity alone proves all tests passed Acceptance status is relevant only after shipment Status shows the product’s inspection or acceptance position; identity shows which product it is

4A device has a serial number but no linked history. What is missing?Choose one

Only the label color The records needed to provide the required traceability Only a second serial number Nothing; a serial number alone always establishes traceability

5When does this lesson identify a need for process validation?Choose one

When output is not adequately verified later and deficiencies appear during use or after service Whenever a process uses more than one operator Only after a customer complaint occurs Only when the process is outsourced

6What is insufficient by itself to establish process validation?Choose one

Defined methods and acceptance criteria Qualified equipment and personnel Recorded validation results and conclusions One successful trial without the planned validation evidence

7A gauge has a current calibration label but was calibrated outside the range used for product testing. What should be assessed?Choose one

Only whether the label is easy to read Only whether the supplier is well known Whether the calibration supports the actual measurement need Whether the result can be rounded to an acceptable value

8What should happen when a test instrument is found out of tolerance?Choose one

Recalibrate it and automatically accept all earlier results Assess previous results and affected product as well as correcting the instrument Discard the instrument without reviewing product impact Wait until a customer reports a failure

9What is relevant to software calculating a product acceptance result?Choose one

Only whether it is a commercial software product Only whether the screen displays a pass message Only whether the file has a password Risk-proportionate validation of the intended application

10Several lots were tested with the failed pressure gauge. What is the appropriate quality coordination task?Choose one

Assume all lots fail without evaluating the measurement impact Identify and control potentially affected lots and coordinate the documented technical assessment Assume all lots pass because no complaint exists Change the calibration date on the historical records