ISO AUDITOR Process Audit Techniques 4

Question 1

In a process audit, 'process inputs' that must be evaluated include all of the following EXCEPT:

Accepted Answer

Corrective actions from unrelated processes

Answer

Corrective actions from unrelated processes are not direct inputs to the process being audited; inputs are the materials, information, and requirements that the process transforms.

Question 2

An ISO 9001 auditor asks: 'How does this process monitor and measure its performance?' The auditee replies, 'We just know when something goes wrong.' This response most suggests a gap in:

Accepted Answer

Clause 9.1.1 — Monitoring, measurement, analysis and evaluation

Answer

Clause 9.1.1 requires the organization to determine what needs to be monitored and measured and to evaluate performance; an informal 'we just know' approach does not satisfy this.

Question 3

Which of the following best describes 'vertical' (or 'depth') sampling in a process audit?

Accepted Answer

Tracing a single transaction or product from start to finish through the entire process

Answer

Vertical sampling (depth sampling) follows one item or transaction through every stage of the process, testing end-to-end conformity and process integration.

Question 4

A process auditor finds that the operator performs a step differently from the work instruction but the outputs always meet specification. The auditor should:

Accepted Answer

Raise a nonconformity because the process is not followed as documented

Answer

ISO 9001 requires controlled conditions including the use of documented information (work instructions); undocumented deviations are nonconformities regardless of output quality.

Question 5

The concept of 'process approach' in ISO 9001:2015 requires organizations to manage processes as a system. What does this mean for auditors?

Accepted Answer

Assess process interactions and how outputs of one process become inputs to another

Answer

The process approach requires understanding how processes interrelate; auditors must therefore evaluate the handoffs, interfaces, and dependencies between processes.

(ISO AUDITOR) ISO 9001 Certified Auditor Practice Test

(ISO AUDITOR) ISO 9001 Certified Auditor Practice Test

ISO AUDITOR Process Audit Techniques 4