CPM ISO 9001 & QMS Deployment 3 — Questions and Answers
Question 1: What is the purpose of a 'scope statement' in an ISO 9001 QMS?
- To list all documented procedures
- To define the boundaries and applicability of the QMS (Correct answer)
- To describe the organizational chart
- To summarize audit findings
Correct answer: To define the boundaries and applicability of the QMS
The scope statement defines what products, services, locations, and processes are covered by the QMS, setting its boundaries.
Question 2: During an ISO 9001 internal audit, the auditor finds no documented evidence of management reviews for 18 months. This constitutes a:
- Minor observation
- Major nonconformity (Correct answer)
- Opportunity for improvement
- Surveillance finding
Correct answer: Major nonconformity
Failure to conduct management reviews at planned intervals is a major nonconformity because it violates a mandatory ISO 9001:2015 Clause 9.3 requirement.
Question 3: Which of the following BEST describes 'documented information' as used in ISO 9001:2015?
- Only paper-based records and manuals
- Information required to be controlled and maintained by the organization (Correct answer)
- Electronic databases only
- Customer-facing quality certificates
Correct answer: Information required to be controlled and maintained by the organization
ISO 9001:2015 uses the term 'documented information' to cover both documents (maintained) and records (retained), in any medium or format.
Question 4: A plant experiences a recurring defect rate spike every Monday morning. What QMS tool is BEST suited to identify the root cause?
- Gauge R&R study
- Fishbone (Ishikawa) diagram (Correct answer)
- Pareto chart
- Control plan
Correct answer: Fishbone (Ishikawa) diagram
A fishbone diagram systematically explores all potential causes (people, methods, machines, materials, environment, measurement) tied to a specific effect.
Question 5: In ISO 9001:2015, 'interested parties' (stakeholders) are addressed in which clause?
- Clause 4.2 (Correct answer)
- Clause 5.1
- Clause 7.4
- Clause 8.4
Correct answer: Clause 4.2
Clause 4.2 requires organizations to determine relevant interested parties and their requirements relevant to the QMS.
Question 6: Which metric is MOST directly used to measure customer satisfaction under ISO 9001?
- First-pass yield
- On-time delivery rate
- Net Promoter Score or customer complaint rate (Correct answer)
- Internal audit nonconformity count
Correct answer: Net Promoter Score or customer complaint rate
ISO 9001 Clause 9.1.2 requires monitoring customer perception, commonly measured via surveys, NPS, or tracking complaint frequency and resolution.
Question 7: What is the key difference between 'correction' and 'corrective action' in ISO 9001 terminology?
- Correction eliminates root cause; corrective action contains the defect
- Correction addresses the immediate nonconformity; corrective action eliminates the root cause (Correct answer)
- Correction applies to suppliers; corrective action applies internally
- There is no difference — the terms are interchangeable
Correct answer: Correction addresses the immediate nonconformity; corrective action eliminates the root cause
A correction fixes the specific nonconforming item (containment), while corrective action investigates and eliminates the underlying root cause to prevent recurrence.
CPM ISO 9001 & QMS Deployment 3
What is the purpose of a 'scope statement' in an ISO 9001 QMS?