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Question 1

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 2

According to EU MDR 2017/745, what is the meaning of the requirement to reduce risks ‘as far as possible’?

Options :

A : The reduction of risks as far as possible without considering the benefit-risk ratio

B : The reduction of risks as far as possible even with adversely affecting the benefit-risk ratio

C : The reduction of risks as far as possible without adversely affecting the benefit-risk ratio

D : The reduction of risks as far as possible without considering regulatory compliance risk

Answer: C

Question 3

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 4

Which of the following is to identify high-risk manufacturing or product-usage steps that could lead to potential harms?

Options :

A : Control chart

B : Scatter diagram

C : Brainstorming

D : Flowchart

Answer: D

Question 5

ISO/IEC 17025 standard is applicable to _______________.

Options :

A : First- & Second- party laboratories

B : First party laboratories

C : Second-, and Third- party laboratories

D : First-, Second-, and Third- party laboratories

Answer: D