ACCURATE EXAM APPROVED QUESTIONS AND CORRECT DETAILED
ANSWERS WITH RATIONALES (100% EXPERT VERIFIED SOLUTIONS)
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|FULL REVISED QSP APPROVED EXAM
Which clause of ISO 9001:2015 addresses the requirements for determining the
context of the organization?
A) Clause 4.1
B) Clause 5.2
C) Clause 6.1
D) Clause 7.1
CORRECT ANSWER: A
Rationale: Clause 4.1 of ISO 9001:2015 specifically requires the organization to
determine external and internal issues that are relevant to its purpose and strategic
direction, establishing the context of the organization.
What is the primary purpose of a corrective action request (CAR)?
A) To document a minor deviation without further analysis
B) To identify the root cause of a nonconformity and prevent recurrence
C) To approve a temporary change in production
D) To assign blame for a quality failure
CORRECT ANSWER: B
Rationale: A corrective action request is a formal document that initiates the
process of investigating a nonconformity, determining its root cause, and
implementing actions to eliminate the cause and prevent recurrence, as required by
quality management systems.
,Which tool is most effective for identifying the most frequent cause of a problem
in a process?
A) Scatter diagram
B) Control chart
C) Pareto chart
D) Fishbone diagram
CORRECT ANSWER: C
Rationale: A Pareto chart is based on the 80/20 rule and displays categories of
defects in descending order of frequency, helping teams focus on the most
significant causes of a problem.
In the PDCA cycle, what is the primary activity of the "Check" phase?
A) Implement the solution on a small scale
B) Define the problem and set objectives
C) Monitor and measure processes against policies and objectives
D) Standardize successful improvements
CORRECT ANSWER: C
Rationale: The Check phase involves monitoring and evaluating the results of the
implemented plan by measuring process performance against established
objectives and reporting the findings.
Which type of audit is conducted by an organization to evaluate its own quality
management system?
A) Supplier audit
B) Second-party audit
C) Third-party audit
D) First-party audit
,CORRECT ANSWER: D
Rationale: A first-party audit, also known as an internal audit, is performed by the
organization itself to assess the effectiveness of its own quality management
system and identify areas for improvement.
What does the acronym CAPA stand for in quality management?
A) Corrective and Preventive Action
B) Control and Process Assessment
C) Continuous Audit and Product Approval
D) Customer Acceptance and Product Assurance
CORRECT ANSWER: A
Rationale: CAPA stands for Corrective and Preventive Action, a systematic
approach to eliminating the causes of existing nonconformities (corrective) and
preventing potential nonconformities (preventive).
Which statistical process control (SPC) chart is most appropriate for monitoring
the number of defects per unit?
A) X-bar and R chart
B) p-chart
C) u-chart
D) c-chart
CORRECT ANSWER: C
Rationale: A u-chart is used when the sample size varies and you are tracking the
number of defects per unit, making it suitable for monitoring defect density.
According to ISO 9001:2015, top management must demonstrate leadership and
commitment with respect to the quality management system by:
A) Delegating all quality responsibilities to a quality manager
, B) Promoting the use of process approach and risk-based thinking
C) Eliminating all customer feedback channels
D) Reducing documentation to a single page
CORRECT ANSWER: B
Rationale: Clause 5.1 of ISO 9001:2015 requires top management to demonstrate
leadership by promoting the process approach, risk-based thinking, and ensuring
the integration of QMS requirements into the organization's business processes.
What is the recommended minimum sample size for a valid process capability
study assuming a normal distribution?
A) 10 samples
B) 30 samples
C) 50 samples
D) 100 samples
CORRECT ANSWER: B
Rationale: A sample size of at least 30 is generally accepted in statistics to
approximate a normal distribution and obtain a reliable estimate of process
capability indices such as Cp and Cpk.
Which document provides detailed instructions for carrying out a specific activity
or test in a quality system?
A) Quality manual
B) Work instruction
C) Quality policy
D) Nonconformance report
CORRECT ANSWER: B