Question 1

According to ISO 14644-1:2015, the condition where the cleanroom or clean zone is complete with all services connected and functioning but with no equipment, furniture, materials, or personnel present is referred to as ______________.

Options :

A : Non-unidirectional airflow

B : As-built condition

C : Operational condition

D : Unidirectional airflow

Answer: B

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

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

According to ISO 15223-1:2021, What does the below Medical Device Symbols for Labeling represent?

Options :

A : Importer

B : Distributor

C : Manufacturer

D : Biological risks

Answer: B

Question 5

According to 21 CFR 830, generally the UDI rule requires a UDI of a device on ______________.

Options :

A : Device label and package

B : Device package

C : Device itself as a permanent UDI

D : Device label

Answer: A

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