ISO AUDITOR Process-Based QMS Approach 2 — Questions and Answers
Question 1: In a process-based QMS, what does the 'turtle diagram' tool primarily help an auditor analyze?
- The organization's quality objectives hierarchy
- The inputs, outputs, resources, and controls of a single process (Correct answer)
- The sequence of all processes across the entire organization
- The risk register associated with nonconformities
Correct answer: The inputs, outputs, resources, and controls of a single process
A turtle diagram maps a single process by examining inputs, outputs, resources (with whom, with what), methods/controls (how), and measurements — making it ideal for process auditing.
Question 2: Which ISO 9001:2015 clause specifically requires the organization to determine the sequence and interaction of QMS processes?
- Clause 4.1
- Clause 4.4 (Correct answer)
- Clause 6.1
- Clause 8.1
Correct answer: Clause 4.4
Clause 4.4 (Quality Management System and its processes) requires the organization to determine and manage the sequence and interaction of required processes.
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?
- Determining interested parties under Clause 4.2
- Defining process sequence and interaction under Clause 4.4 (Correct answer)
- Establishing quality objectives under Clause 6.2
- Controlling externally provided processes under Clause 8.4
Correct answer: Defining process sequence and interaction under Clause 4.4
Clause 4.4 requires organizations to understand process interactions, which inherently includes knowing who receives each process's outputs (the internal customer).
Question 4: What is the primary distinction between a 'process' and a 'procedure' in ISO 9001 terminology?
- A process describes what is done; a procedure describes who does it
- A process transforms inputs to outputs using resources; a procedure is a specified way to carry out an activity (Correct answer)
- A process is mandatory; a procedure is optional
- A process applies to manufacturing; a procedure applies to services
Correct answer: A process transforms inputs to outputs using resources; a procedure is a specified way to carry out an activity
ISO 9000:2015 defines a process as a set of interrelated activities transforming inputs to outputs, while a procedure is a specified way to carry out a process or activity.
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?
- The need to assign process owners (Clause 5.3)
- The need to apply criteria and methods to ensure effective operation and control (Clause 4.4.1c) (Correct answer)
- The requirement to maintain documented information (Clause 7.5)
- The requirement to perform management review (Clause 9.3)
Correct answer: The need to apply criteria and methods to ensure effective operation and control (Clause 4.4.1c)
Clause 4.4.1(c) requires organizations to determine and apply criteria and methods — including monitoring, measurement, and related performance indicators — to ensure processes are effective.
Question 6: In PDCA terms, which phase corresponds to determining process performance against objectives and reporting results to management?
- Plan
- Do
- Check (Correct answer)
- Act
Correct answer: Check
The 'Check' phase involves monitoring and measuring processes against quality objectives and reporting results — which then feed into the 'Act' phase for improvement.
Question 7: An organization outsources its warehousing process. Under the process-based approach, what must the organization ensure according to ISO 9001:2015?
- The outsourced process is excluded from the QMS scope
- Control of the outsourced process is retained within the QMS (Correct answer)
- A separate QMS is established for the outsourced provider
- The outsourced process is audited only during supplier qualification
Correct answer: Control of the outsourced process is retained within the QMS
ISO 9001:2015 Clause 4.4 and 8.4 require that outsourced processes remain under the organization's QMS control — outsourcing does not remove the responsibility.
ISO AUDITOR Process-Based QMS Approach 2
In a process-based QMS, what does the 'turtle diagram' tool primarily help an auditor analyze?