Process-Based QMS Approach Flashcards
7 cards from real ISO AUDITOR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Process-Based QMS Approach flashcards as text
In a process-based QMS, what does the 'turtle diagram' tool primarily help an auditor analyze?
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.
Which ISO 9001:2015 clause specifically requires the organization to determine the sequence and interaction of QMS processes?
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.
An auditor finds that a process owner cannot identify the internal customer for their process output. What ISO 9001 requirement is most likely unmet?
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).
What is the primary distinction between a 'process' and a 'procedure' in ISO 9001 terminology?
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.
During an audit, you discover that a support process for calibration has no defined performance indicator. Which process-based QMS requirement does this violate?
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.
In PDCA terms, which phase corresponds to determining process performance against objectives and reporting results to management?
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.
An organization outsources its warehousing process. Under the process-based approach, what must the organization ensure according to ISO 9001:2015?
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.