ISO AUDITOR Risk & Opportunity Assessment 3

Question 1

A SWOT analysis is conducted during strategic planning. Under ISO 9001:2015, how does this relate to risk and opportunity assessment?

Accepted Answer

Weaknesses and threats map to risks; strengths and opportunities map to opportunities

Answer

SWOT analysis is a recognized tool for identifying context (Clause 4.1); weaknesses/threats inform risk identification and strengths/opportunities inform opportunity exploitation under Clause 6.1.

Question 2

ISO 9001:2015 does not require a formal risk management process such as ISO 31000. This means:

Accepted Answer

Organizations have flexibility in choosing their risk assessment methodology

Answer

ISO 9001:2015 intentionally does not mandate a specific methodology, allowing organizations to use any proportionate approach — from simple checklists to full ISO 31000 frameworks.

Question 3

During surveillance audit, an auditor finds that the organization updated its risk assessment two years ago and has not reviewed it since. Which ISO 9001:2015 principle is most directly violated?

Accepted Answer

Risk assessments must be reviewed at planned intervals or when significant changes occur

Answer

Clause 6.1 requires risks to be determined in the context of the organization; Clause 9.3 management review must include information on risks, implying ongoing review when context changes.

Question 4

A quality manager states that risk-based thinking eliminates the need for preventive action in ISO 9001:2015. This statement is:

Accepted Answer

Correct — risk-based thinking replaced the formal preventive action clause from ISO 9001:2008

Answer

ISO 9001:2015 deliberately replaced the standalone preventive action clause (8.5.3 in 2008) with risk-based thinking embedded throughout the standard, making proactive risk management systemic rather than reactive.

Question 5

Which of the following scenarios represents an opportunity that an ISO 9001:2015 auditor would expect to see formally addressed?

Accepted Answer

Adopting automation to reduce defect rates and improve delivery times

Answer

Exploiting automation as a means to improve quality performance and achieve objectives is a classic opportunity that should be captured, evaluated, and acted upon under Clause 6.1.

(ISO AUDITOR) ISO 9001 Certified Auditor Practice Test

(ISO AUDITOR) ISO 9001 Certified Auditor Practice Test

ISO AUDITOR Risk & Opportunity Assessment 3