Quality Auditor Certification Quality Systems 2 — Questions and Answers
Question 1: Which ISO 9001:2015 clause specifically addresses the context of the organization?
- Clause 4 (Correct answer)
- Clause 5
- Clause 6
- Clause 7
Correct answer: Clause 4
Clause 4 of ISO 9001:2015 requires organizations to determine internal and external issues relevant to their purpose and strategic direction.
Question 2: In a quality management system, what is a 'nonconformity'?
- A customer complaint about delivery time
- Non-fulfillment of a requirement (Correct answer)
- A suggestion for process improvement
- A deviation from scheduled production
Correct answer: Non-fulfillment of a requirement
A nonconformity is the non-fulfillment of a requirement, whether it relates to a product, process, or system specification.
Question 3: What does the Plan-Do-Check-Act (PDCA) cycle's 'Check' phase involve?
- Implementing process changes
- Setting quality objectives
- Monitoring and measuring results against policies and objectives (Correct answer)
- Documenting corrective actions
Correct answer: Monitoring and measuring results against policies and objectives
The Check phase involves monitoring, measuring, and evaluating actual results against planned objectives and requirements.
Question 4: Which document defines the scope, objectives, and criteria of a quality audit?
- Audit report
- Audit plan (Correct answer)
- Corrective action request
- Quality manual
Correct answer: Audit plan
The audit plan defines the scope, objectives, audit criteria, methods, and schedule for conducting the audit.
Question 5: Under ISO 9001:2015, 'documented information' replaces which older terminology?
- Records and procedures only
- Documents and records (Correct answer)
- Work instructions and forms
- Policies and guidelines
Correct answer: Documents and records
ISO 9001:2015 replaced the older terms 'documents' and 'records' with the unified term 'documented information'.
Question 6: What is the primary purpose of a management review in a QMS?
- To train new employees on quality procedures
- To ensure the QMS remains suitable, adequate, and effective (Correct answer)
- To conduct supplier evaluations
- To review customer satisfaction surveys only
Correct answer: To ensure the QMS remains suitable, adequate, and effective
Management reviews ensure the QMS remains suitable, adequate, and effective by evaluating performance data and making strategic decisions.
Question 7: Which of the following best describes 'quality assurance'?
- Inspecting finished products before shipment
- Part of quality management focused on providing confidence that requirements will be fulfilled (Correct answer)
- Correcting defects found during production
- Setting product specifications and tolerances
Correct answer: Part of quality management focused on providing confidence that requirements will be fulfilled
Quality assurance is the part of quality management focused on providing confidence that quality requirements will be fulfilled, emphasizing prevention over detection.
Quality Auditor Certification Quality Systems 2
Which ISO 9001:2015 clause specifically addresses the context of the organization?