ISO AUDITOR Risk & Opportunity Assessment 2

Question 1

Under ISO 9001:2015, which clause specifically requires the organization to determine external and internal issues relevant to its purpose when establishing risk context?

Accepted Answer

Clause 4.1

Answer

Clause 4.1 requires determining external and internal issues that are relevant to the organization's purpose and that affect its ability to achieve intended results.

Question 2

An auditor reviews a company's risk register and finds that all risks are rated only by likelihood, with no consideration of impact. What is the primary deficiency?

Accepted Answer

The risk register lacks a two-dimensional risk evaluation approach

Answer

Effective risk evaluation under ISO 9001:2015 considers both the likelihood of occurrence and the severity of consequences to prioritize risks appropriately.

Question 3

A manufacturing firm identifies a new regulation that could restrict a key raw material. Under ISO 9001:2015, this would be classified as:

Accepted Answer

An external risk requiring action planning

Answer

New regulations are external issues (Clause 4.1) that create risks to achieving quality objectives and require actions planned under Clause 6.1.

Question 4

ISO 9001:2015 requires that actions taken to address risks and opportunities be proportionate to:

Accepted Answer

The potential effect on conformity of products and services

Answer

Clause 6.1.2 states that actions to address risks and opportunities shall be proportionate to the potential impact on conformity of products and services.

Question 5

During an audit, you discover that risk and opportunity actions are planned but never integrated into QMS processes. Which ISO 9001:2015 requirement is NOT being met?

Accepted Answer

Clause 6.1 — actions must be integrated and implemented in QMS processes

Answer

Clause 6.1.2 explicitly requires that actions to address risks and opportunities be integrated into and implemented within QMS processes.

(ISO AUDITOR) ISO 9001 Certified Auditor Practice Test

(ISO AUDITOR) ISO 9001 Certified Auditor Practice Test

ISO AUDITOR Risk & Opportunity Assessment 2