ISO AUDITOR Quality Management Systems & Principles 2 — Questions and Answers
Question 1: Which ISO 9001:2015 clause specifically addresses the concept of 'context of the organization'?
- Clause 4 (Correct answer)
- Clause 5
- Clause 6
- Clause 7
Correct answer: Clause 4
Clause 4 of ISO 9001:2015 covers 'Context of the Organization,' including understanding internal/external issues and interested parties.
Question 2: An organization identifies a supplier as an 'interested party.' Under ISO 9001:2015, what must the organization determine about this party?
- Their financial stability
- Their relevant requirements and expectations (Correct answer)
- Their ISO certification status
- Their market share
Correct answer: Their relevant requirements and expectations
ISO 9001:2015 Clause 4.2 requires organizations to determine the relevant requirements and expectations of interested parties.
Question 3: The PDCA cycle in the context of ISO 9001:2015 maps most directly to which pair of clauses for 'Do'?
- Clauses 4 and 5
- Clauses 8 and 9
- Clauses 6 and 7
- Clauses 7 and 8 (Correct answer)
Correct answer: Clauses 7 and 8
In the PDCA mapping, 'Do' corresponds to Clauses 7 (Support) and 8 (Operation), where work is actually carried out.
Question 4: Which quality management principle underpins the ISO 9001:2015 requirement to use data and information for decision making?
- Customer focus
- Engagement of people
- Evidence-based decision making (Correct answer)
- Relationship management
Correct answer: Evidence-based decision making
The principle of 'Evidence-based decision making' underpins the requirement to analyze data and information before making decisions.
Question 5: A company's QMS scope excludes the design and development of products. Under ISO 9001:2015, this exclusion must be:
- Approved by a certification body before implementation
- Documented and justified with reasons it cannot be applied (Correct answer)
- Reported to all interested parties in writing
- Approved by top management and reviewed annually
Correct answer: Documented and justified with reasons it cannot be applied
ISO 9001:2015 Clause 4.3 requires that any exclusion be documented within the scope statement with justification for why it cannot be applied.
Question 6: Which of the following best describes 'risk-based thinking' as applied throughout ISO 9001:2015?
- Creating a formal risk register for every process
- Considering risks and opportunities to ensure the QMS achieves intended results (Correct answer)
- Eliminating all identified risks before proceeding
- Applying a probability-impact matrix to all business activities
Correct answer: Considering risks and opportunities to ensure the QMS achieves intended results
Risk-based thinking means considering potential risks and opportunities as preventive action to ensure the QMS can achieve its intended results.
Question 7: Under the 'leadership' principle of ISO 9001:2015, top management demonstrates commitment by:
- Delegating all quality responsibilities to the Quality Manager
- Ensuring a Management Representative is appointed in writing
- Taking accountability for the effectiveness of the QMS (Correct answer)
- Publishing a quality policy signed by all department heads
Correct answer: Taking accountability for the effectiveness of the QMS
ISO 9001:2015 Clause 5.1 requires top management to take accountability for the effectiveness of the QMS, integrating it into business processes.
ISO AUDITOR Quality Management Systems & Principles 2
Which ISO 9001:2015 clause specifically addresses the concept of 'context of the organization'?