Question 1

According to QSIT (Quality System Inspection Technique), ‘medical device reporting’ is a satellite subsystem of which subsystem?

Options :

A : Corrective and preventive action

B : Production and process controls

C : Material controls

D : Management controls

Answer: A

Question 2

According to ISO 19011:2018, Determining auditor competence should consider __________.

Options :

A : Personal behaviour

B : Generic knowledge and skills

C : Discipline and sector-specific competence

D : Personal behaviour, Generic knowledge and skills, and Discipline and sector-specific competence

Answer: D

Question 3

Which of the following is not a terminal sterilization process?

Options :

A : Moist heat sterilization processing

B : Ethylene Oxide sterilization processing

C : Aseptic processing

Answer: C

Question 4

Which of the following control charts is used to trend continuous data?

Options :

A : X-bar chart

B : U chart

C : np chart

D : P chart

Answer: A

Question 5

What can be the best suitable ‘severity’ rating to measure the possible consequences of hazard if the hazard can result in ‘patient death’? NOTE: Rating scale from highest to lowest: catastrophic, critical, serious, minor & negligible.

Options :

A : Serious

B : Minor

C : Catastrophic

D : Negligible

Answer: C

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