ISO AUDITOR Quality Management Systems & Principles 3 — Questions and Answers
Question 1: During an audit, you find the organization has no documented procedure for handling nonconforming outputs. Which ISO 9001:2015 clause is most directly violated?
- Clause 8.7 (Correct answer)
- Clause 9.1
- Clause 10.2
- Clause 6.1
Correct answer: Clause 8.7
Clause 8.7 specifically requires documented information about actions taken on nonconforming outputs and the authority deciding how to deal with them.
Question 2: The 'continual improvement' principle differs from 'continuous improvement' in that it:
- Requires daily incremental changes without pause
- Allows for breakthrough improvements as well as incremental ones (Correct answer)
- Applies only to manufacturing processes
- Must be measured using statistical process control
Correct answer: Allows for breakthrough improvements as well as incremental ones
Continual improvement encompasses both breakthrough and incremental improvements, whereas continuous implies an uninterrupted, steady pace of change.
Question 3: An auditor reviews an organization's quality objectives. Which characteristic is REQUIRED by ISO 9001:2015?
- They must be expressed as measurable KPIs with numerical targets
- They must be consistent with the quality policy (Correct answer)
- They must be approved by the certification body
- They must be reviewed every six months
Correct answer: They must be consistent with the quality policy
ISO 9001:2015 Clause 6.2.1 requires that quality objectives be consistent with the quality policy, among other criteria.
Question 4: Which scenario best illustrates the 'process approach' as defined in ISO 9001:2015?
- Each department manages its own activities independently to optimize departmental efficiency
- Interrelated processes are managed as a system with defined inputs, outputs, and interactions (Correct answer)
- Processes are documented in detailed work instructions before any activity begins
- All processes are mapped using a single unified flowchart approved by top management
Correct answer: Interrelated processes are managed as a system with defined inputs, outputs, and interactions
The process approach involves managing interrelated processes as a coherent system, understanding how inputs and outputs link across the organization.
Question 5: ISO 9001:2015 requires organizations to retain documented information as evidence of competence. This falls under which clause?
- Clause 7.1.2
- Clause 7.2 (Correct answer)
- Clause 7.3
- Clause 7.4
Correct answer: Clause 7.2
Clause 7.2 (Competence) requires retaining documented information as evidence that people are competent to perform work affecting quality.
Question 6: A certified organization changes its manufacturing location. According to ISO 9001:2015, the FIRST action regarding the QMS should be:
- Notify the certification body immediately and suspend the certificate
- Assess whether the change affects the QMS scope and processes (Correct answer)
- Issue a new quality manual for the new location
- Conduct a full internal audit of the new facility before operations begin
Correct answer: Assess whether the change affects the QMS scope and processes
ISO 9001:2015 Clause 6.3 requires the organization to assess the potential consequences of planned changes on the QMS before implementing them.
Question 7: Which of the following is NOT one of the seven quality management principles of ISO 9000:2015?
- Customer focus
- Zero defect manufacturing (Correct answer)
- Continual improvement
- Engagement of people
Correct answer: Zero defect manufacturing
Zero defect manufacturing is not one of the seven QMPs; the principles focus on customer focus, leadership, engagement, process approach, improvement, evidence-based decisions, and relationship management.
ISO AUDITOR Quality Management Systems & Principles 3
During an audit, you find the organization has no documented procedure for handling nonconforming outputs.
Which ISO 9001:2015 clause is most directly violated?