ISO AUDITOR Process-Based QMS Approach 2

Question 1

In a process-based QMS, what does the 'turtle diagram' tool primarily help an auditor analyze?

Accepted Answer

The inputs, outputs, resources, and controls of a single process

Answer

The organization's quality objectives hierarchy

Answer

The sequence of all processes across the entire organization

Answer

The risk register associated with nonconformities

Question 2

Which ISO 9001:2015 clause specifically requires the organization to determine the sequence and interaction of QMS processes?

Accepted Answer

Clause 4.4

Answer

Clause 4.1

Answer

Clause 6.1

Answer

Clause 8.1

Question 3

An auditor finds that a process owner cannot identify the internal customer for their process output. What ISO 9001 requirement is most likely unmet?

Accepted Answer

Defining process sequence and interaction under Clause 4.4

Answer

Determining interested parties under Clause 4.2

Answer

Establishing quality objectives under Clause 6.2

Answer

Controlling externally provided processes under Clause 8.4

Question 4

What is the primary distinction between a 'process' and a 'procedure' in ISO 9001 terminology?

Accepted Answer

A process transforms inputs to outputs using resources; a procedure is a specified way to carry out an activity

Answer

A process describes what is done; a procedure describes who does it

Answer

A process is mandatory; a procedure is optional

Answer

A process applies to manufacturing; a procedure applies to services

Question 5

During an audit, you discover that a support process for calibration has no defined performance indicator. Which process-based QMS requirement does this violate?

Accepted Answer

The need to apply criteria and methods to ensure effective operation and control (Clause 4.4.1c)

Answer

The need to assign process owners (Clause 5.3)

Answer

The requirement to maintain documented information (Clause 7.5)

Answer

The requirement to perform management review (Clause 9.3)

Question 6

In PDCA terms, which phase corresponds to determining process performance against objectives and reporting results to management?

Accepted Answer

Check

Answer

Plan

Answer

Do

Answer

Act

Question 7

An organization outsources its warehousing process. Under the process-based approach, what must the organization ensure according to ISO 9001:2015?

Accepted Answer

Control of the outsourced process is retained within the QMS

Answer

The outsourced process is excluded from the QMS scope

Answer

A separate QMS is established for the outsourced provider

Answer

The outsourced process is audited only during supplier qualification