Qu 4
Qu 4
f) Clause 6: Planning
Planning is central to ISO 9001. Organizations are required to establish quality
objectives and determine the actions needed to address risks and opportunities. This
Questions
Q1. Which of the following is NOT a requirement for leadership under ISO 9001:2015?
Q2. ISO 9001:2015 requires organizations to use which type of approach for decision-making?
a) Intuition-based approach
b) Risk-based approach
c) Experience-based approach
d) Analytical approach
Q4. Which of the following activities is NOT part of the 'Support' clause of ISO 9001:2015?
Q5. In ISO 9001:2015, which clause requires organizations to define their quality policy?
a) Clause 4
b) Clause 5
c) Clause 6
d) Clause 7
Q6. What is the main objective of Clause 10: Improvement in ISO 9001?
Q8. Which of the following would typically be considered a nonconformity in ISO 9001:2015?
Q9. In ISO 9001:2015, which of the following best describes the role of management reviews?
b) To evaluate the effectiveness of the QMS and identify areas for improvement
Q10. Which of the following activities should be considered when assessing customer
satisfaction in ISO 9001:2015?
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Q.1 What is the purpose of Clause 4 (Context of the Organization) in ISO 9001:2015?
Q2. What does the term "documented information" in ISO 9001:2015 refer to?
b) All records and documents necessary for the effective operation of the QMS
Q3. In the context of ISO 9001:2015, what is the role of risk-based thinking?
c) To identify and address risks that could affect the QMS’s ability to achieve objectives
Q4. How often is an external audit required for ISO 9001 certification?
Every 2 years
b) Every 3 years
c) Annually
d) Every 5 years
Q5. Which of the following is a direct benefit of performing an internal audit in the ISO
9001:2015 standard?
Q6. What is the primary purpose of the management review in ISO 9001?
To ensure the quality policy is updated
b) To assess whether the quality management system is operating effectively
c) To evaluate employee performance
d) To conduct risk analysis for business opportunities
Q7. Which of the following is NOT a requirement for documented information in ISO
9001:2015?
It must be controlled and maintained
b) It must be readily available for use
c) It must be updated at least annually
d) It must be protected from unauthorized access
Q8. In ISO 9001:2015, what is the term for a formal review of the QMS to ensure it is
compliant and effective?
Internal audit
b) Risk assessment
c) Management review
d) Performance evaluation
Q9. Which clause of ISO 9001:2015 requires organizations to ensure they have the
necessary resources for their QMS?
Clause 6: Planning
b) Clause 7: Support
c) Clause 8: Operation
d) Clause 9: Performance Evaluation
Q10. Under ISO 9001:2015, what should an organization do if they identify
nonconformities during the internal audit?
Conduct a risk assessment
b) Take immediate corrective actions and document the findings
c) Notify customers
d) Ignore the findings if they are minor
Explanation of Options:
2. Answer: b) All records and documents necessary for the effective operation of the QMS
Explanation of Options:
a) Only the quality policy: Incorrect. Documented information refers to more than just the
quality policy.
b) All records and documents necessary for the effective operation of the QMS:
Correct. Documented information includes procedures, records, and other documentation
required to manage and operate the QMS.
c) The final product design specifications: This is specific to product design, not all the
required documentation under ISO 9001.
d) The cost of quality reports: Cost of quality reports are not part of "documented
information" as defined by ISO 9001.
3. Answer: c) To identify and address risks that could affect the QMS’s ability to achieve
objectives
Explanation of Options:
a) To eliminate risks in the production process: This is not the objective of risk-based
thinking. Risks may be managed rather than eliminated.
b) To ensure all risks are avoided: While some risks may be avoided, the objective is to
address risks to ensure the QMS remains effective, not to avoid all risks.
4. Answer: c) Annually
Explanation of Options:
a) Every 2 years: Incorrect. Audits are typically required annually to ensure ongoing
compliance.
b) Every 3 years: Incorrect. Annual audits are required for certification maintenance.
c) Annually: Correct. Organizations with ISO 9001 certification must undergo surveillance
audits annually.
d) Every 5 years: Incorrect. Surveillance audits are required annually, not every 5 years.
Explanation of Options:
a) Identify and correct nonconformities: Correct. Internal audits help identify areas
where the QMS is not conforming to requirements and facilitate corrective actions.
b) Assess customer satisfaction: This is part of performance evaluation but not a direct
goal of internal audits.
d) Increase product sales: Sales are impacted by many factors, but internal audits
themselves do not directly influence sales.
Explanation of Options:
a) To ensure the quality policy is updated: The management review may discuss quality
policy but its primary purpose is to evaluate the QMS's effectiveness.
d) To conduct risk analysis for business opportunities: While risk analysis may be part
of the review, the primary goal is to evaluate the QMS.
Explanation of Options:
b) It must be readily available for use: Correct. Documented information must be easily
accessible to those who need it for operational purposes.
Explanation of Options:
a) Internal audit: While audits help ensure compliance, they are not formal reviews of the
entire QMS like management reviews.
b) Risk assessment: This process is about identifying risks, not formally reviewing the
QMS’s effectiveness.
Explanation of Options:
c) Clause 8: Operation: This clause addresses the operation and delivery of the product or
service, not resources.
10. Answer: b) Take immediate corrective actions and document the findings
Explanation of Options:
a) Conduct a risk assessment: While a risk assessment might help in some situations, the
main requirement is to take corrective actions for nonconformities.
d) Ignore the findings if they are minor: Nonconformities should never be ignored, even
if they seem minor.
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