Question 1

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 2

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 3

Employees working in the controlled environment should be properly trained on ___________.

Options :

A : Gowning procedures

B : Requirements for attire and behavior

C : Gowning procedures, requirements for attire and behavior

D : Gowning procedures and requirements for attire

Answer: C

Question 4

Which of the following is an auditor should NOT do for both internet correspondence and for translations from English to another language?

Options :

A : Maintain consistency of terminology

B : Use complex or compound sentence

C : Stick to logical sequence of events

D : Avoid words that have multiple meanings

Answer: B

Question 5

Which of the following result when analysis of the data sources detects the potential or an unfavourable trend that has not previously occurred.

Options :

A : Corrective actions

B : Corrections

C : Preventive actions

D : Corrections or corrective actions

Answer: C

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