ISO 9001:2015 requirements MCQs With Answer

Introduction: This quiz set on ISO 9001:2015 requirements is designed specifically for M.Pharm students studying Quality Management Systems (MQA 102T). It focuses on the standard’s structure, key clauses (4–10), and concepts such as context of the organization, leadership, risk-based thinking, documented information, operation, validation, monitoring and measurement, internal audit, and continual improvement. Questions link ISO requirements to pharmaceutical practices like process validation, calibration, supplier control, and deviation management. Use these MCQs to test conceptual understanding and practical application of ISO 9001:2015 in pharmaceutical quality systems and to prepare for exams and professional practice.

Q1. Which clause of ISO 9001:2015 requires an organization to determine external and internal issues that are relevant to its purpose and affect its ability to achieve quality objectives?

• Clause 4 — Context of the organization
• Clause 5 — Leadership
• Clause 6 — Planning
• Clause 7 — Support

Correct Answer: Clause 4 — Context of the organization

Q2. In ISO 9001:2015, the requirement to address risks and opportunities is best described as:

• A separate mandatory ‘preventive action’ clause
• Integrated, risk-based thinking across the management system
• Optional guidance that organizations may ignore
• Only relevant for financial risks

Correct Answer: Integrated, risk-based thinking across the management system

Q3. Which of the following is considered ‘documented information’ under ISO 9001:2015?

• Only formal hard-copy procedures
• Records, procedures, and digital files that the organization controls
• Personal notes of employees not used for process control
• External marketing brochures

Correct Answer: Records, procedures, and digital files that the organization controls

Q4. Which clause emphasizes top management commitment, customer focus, and establishing a quality policy?

• Clause 4 — Context of the organization
• Clause 5 — Leadership
• Clause 8 — Operation
• Clause 10 — Improvement

Correct Answer: Clause 5 — Leadership

Q5. For pharmaceutical process validation, which ISO 9001:2015 requirement is most directly applicable when ensuring process capability and control?

• Clause 6 — Planning for actions to address risks and opportunities
• Clause 7 — Support only
• Clause 8 — Operation, including requirements for production and service provision
• Clause 9 — Performance evaluation only

Correct Answer: Clause 8 — Operation, including requirements for production and service provision

Q6. Which activity is a mandatory input to management review under ISO 9001:2015?

• Marketing campaign effectiveness
• Results of internal audits and customer feedback
• Individual employee performance appraisals
• Supplier financial statements

Correct Answer: Results of internal audits and customer feedback

Q7. How does ISO 9001:2015 treat preventive action compared with older versions?

• Prevents preventive actions; they are no longer allowed
• Eliminates the term ‘preventive action’ and integrates prevention via risk-based thinking
• Requires a separate documented preventive action procedure
• Maintains preventive action as a mandatory separate clause

Correct Answer: Eliminates the term ‘preventive action’ and integrates prevention via risk-based thinking

Q8. Which requirement ensures measurement results are reliable and comparable in pharmaceutical QC laboratories?

• Process approach only
• Calibration and traceability of measuring equipment
• Marketing approval
• Customer satisfaction surveys

Correct Answer: Calibration and traceability of measuring equipment

Q9. What is the primary purpose of internal audits in ISO 9001:2015?

• To punish nonconforming employees
• To determine conformity of the QMS to requirements and effectiveness of implementation
• To replace management review
• To perform routine maintenance tasks

Correct Answer: To determine conformity of the QMS to requirements and effectiveness of implementation

Q10. Which clause focuses on monitoring, measurement, analysis and evaluation of the QMS?

• Clause 7 — Support
• Clause 9 — Performance evaluation
• Clause 6 — Planning
• Clause 10 — Improvement

Correct Answer: Clause 9 — Performance evaluation

Q11. In the pharmaceutical context, controlling nonconforming product requires which of the following actions according to ISO 9001:2015?

• Immediate release with manager approval
• Identification, segregation, evaluation, and disposition of the nonconforming product
• Discard without documentation
• Return to the supplier without investigation

Correct Answer: Identification, segregation, evaluation, and disposition of the nonconforming product

Q12. Which element is NOT explicitly required by ISO 9001:2015 for supplier controls?

• Evaluation and selection based on the supplier’s ability to provide product in accordance with requirements
• Maintaining documented information of supplier performance
• Certifying suppliers to ISO 9001 regardless of product criticality
• Monitoring and re-evaluating suppliers

Correct Answer: Certifying suppliers to ISO 9001 regardless of product criticality

Q13. Which of the following best describes the ‘process approach’ required by ISO 9001:2015?

• Managing the organization as a set of interrelated processes with inputs, outputs, controls and interactions
• Focusing only on production activities
• Documenting every activity in minute detail
• Isolating departments to avoid interaction

Correct Answer: Managing the organization as a set of interrelated processes with inputs, outputs, controls and interactions

Q14. Which requirement addresses competence of personnel in ISO 9001:2015?

• Clause 7.1 — Resources only
• Clause 7.2 — Competence, requiring the organization to determine necessary competence and ensure it
• Clause 8 — Operation only
• Clause 10 — Improvement only

Correct Answer: Clause 7.2 — Competence, requiring the organization to determine necessary competence and ensure it

Q15. Which of the following is a required output of a corrective action under ISO 9001:2015?

• Evidence of root cause analysis and actions taken to eliminate causes and prevent recurrence
• Only a short-term containment action with no follow-up
• No documentation is needed if the issue seems small
• Immediate staff termination

Correct Answer: Evidence of root cause analysis and actions taken to eliminate causes and prevent recurrence

Q16. Annex SL is important for ISO 9001:2015 because it:

• Provides specific pharmaceutical testing methods
• Establishes the high-level structure and common language for ISO management system standards
• Is a mandatory technical annex to be implemented verbatim
• Replaces the standard’s requirements

Correct Answer: Establishes the high-level structure and common language for ISO management system standards

Q17. Which activity is essential to ensure traceability of pharmaceutical batches according to ISO 9001:2015 concepts?

• Maintaining identification and documented information linking raw materials, processing steps and finished batches
• Only verbal batch records maintained by operators
• Discarding batch records after release
• Relying on supplier batch numbers without internal records

Correct Answer: Maintaining identification and documented information linking raw materials, processing steps and finished batches

Q18. Which of these is an appropriate performance indicator (KPI) in a pharmaceutical QMS aligned with ISO 9001:2015?

• Number of marketing emails sent
• Percentage of on-time release of batches and rate of deviations closed on time
• Personal attendance at social events
• Quantity of office supplies ordered

Correct Answer: Percentage of on-time release of batches and rate of deviations closed on time

Q19. When a nonconformity is detected, ISO 9001:2015 requires the organization to:

• Take action to control and correct it and evaluate the need for corrective action to eliminate causes
• Ignore it if production is under pressure
• Blame staff and not record the event
• Delay action until annual review

Correct Answer: Take action to control and correct it and evaluate the need for corrective action to eliminate causes

Q20. Which statement best describes ‘documented information retention’ under ISO 9001:2015?

• Organizations must retain documented information only if requested by customers
• Organizations determine what documented information is necessary for the effectiveness of the QMS and maintain appropriate retention and disposal controls
• All records must be kept permanently in paper form
• No records are required under ISO 9001:2015

Correct Answer: Organizations determine what documented information is necessary for the effectiveness of the QMS and maintain appropriate retention and disposal controls

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