ISO 9001:2008 requirements MCQs With Answer

Introduction: This set of MCQs on ISO 9001:2008 requirements is designed specifically for M.Pharm students studying Quality Management Systems (MQA 102T). The questions emphasize practical understanding of clauses, documented procedures, responsibilities of top management, resource and product realization requirements, measurement, analysis and continual improvement. Each item tests knowledge relevant to pharmaceutical quality systems such as control of documents, records, internal audits, corrective and preventive actions, supplier control, traceability and calibration. Use these questions to reinforce conceptual clarity and prepare for exams or internal QA roles where application of ISO 9001:2008 principles to pharmaceutical processes is critical.

Q1. Which clause of ISO 9001:2008 primarily addresses management commitment and quality policy?

• Clause 4: Quality Management System
• Clause 5: Management Responsibility
• Clause 6: Resource Management
• Clause 7: Product Realization

Correct Answer: Clause 5: Management Responsibility

Q2. ISO 9001:2008 requires documented procedures for certain processes. Which is NOT explicitly required as a documented procedure?

• Control of Documents
• Control of Records
• Internal Audit
• Daily production log for every batch

Correct Answer: Daily production log for every batch

Q3. Under ISO 9001:2008, who is ultimately responsible for ensuring the quality management system is established and maintained?

• Quality Manager
• Top Management
• Production Supervisor
• Internal Auditor

Correct Answer: Top Management

Q4. Which clause focuses on ensuring resources (human, infrastructure, work environment) necessary to implement the QMS?

• Clause 4: Quality Management System
• Clause 5: Management Responsibility
• Clause 6: Resource Management
• Clause 8: Measurement, Analysis and Improvement

Correct Answer: Clause 6: Resource Management

Q5. What is the main objective of the ‘control of documents’ requirement in ISO 9001:2008?

• To ensure documents are written by the Quality Manager only
• To prevent unauthorized changes and ensure current versions are available where needed
• To keep all documents in a single locked cabinet
• To eliminate the use of any electronic records

Correct Answer: To prevent unauthorized changes and ensure current versions are available where needed

Q6. Which process is required by ISO 9001:2008 to determine conformity of product before delivery?

• Management Review
• Product Realization and Monitoring/Measurement of Product
• Supplier Evaluation Only
• Marketing Approval

Correct Answer: Product Realization and Monitoring/Measurement of Product

Q7. ISO 9001:2008 requires internal audits. What is the primary purpose of these audits?

• To punish nonconforming staff
• To provide objective evidence of conformity and effectiveness of the QMS
• To certify products for export
• To generate increased paperwork for the QA department

Correct Answer: To provide objective evidence of conformity and effectiveness of the QMS

Q8. Which action is emphasized by ISO 9001:2008 for preventing recurrence of detected nonconformities?

• Corrective action
• Preventive action
• Management Review only
• External certification audit

Correct Answer: Preventive action

Q9. What is the difference between corrective and preventive action as per ISO 9001:2008?

• Corrective actions address potential nonconformities; preventive actions fix actual nonconformities
• Corrective actions fix actual nonconformities; preventive actions address potential nonconformities
• They are identical and used interchangeably
• Corrective actions are only managerial; preventive actions are only operational

Correct Answer: Corrective actions fix actual nonconformities; preventive actions address potential nonconformities

Q10. Which requirement ensures that purchased product conforms to specified purchase requirements?

• Clause 7.4 Purchasing (Control of Purchased Product)
• Clause 6.2 Human Resources
• Clause 8.2.1 Customer Satisfaction
• Clause 4.1 General Requirements

Correct Answer: Clause 7.4 Purchasing (Control of Purchased Product)

Q11. ISO 9001:2008 requires calibration of monitoring and measuring equipment. The primary purpose is to:

• Guarantee instruments never fail
• Ensure validity and traceability of measurement results
• Reduce the need for training
• Increase production speed

Correct Answer: Ensure validity and traceability of measurement results

Q12. During a management review, which of the following should be considered according to ISO 9001:2008?

• Audit results, customer feedback, process performance and product conformity
• Only financial profit figures
• Individual employee salaries
• Supplier marketing materials

Correct Answer: Audit results, customer feedback, process performance and product conformity

Q13. Clause 8 of ISO 9001:2008 deals mainly with:

• Management responsibility and policy
• Resource allocation and infrastructure
• Measurement, analysis and improvement of the QMS
• Control of documents

Correct Answer: Measurement, analysis and improvement of the QMS

Q14. Which documentation is explicitly required by ISO 9001:2008?

• Quality Manual, documented procedures and records
• Only an internal audit schedule
• Only employee resumes
• Supplier promotional brochures

Correct Answer: Quality Manual, documented procedures and records

Q15. Traceability in product realization refers to:

• The ability to follow the history, application or location of an item
• Tracking employee attendance
• Monitoring financial transactions
• Tracing the origin of office supplies

Correct Answer: The ability to follow the history, application or location of an item

Q16. Which of the following best describes ‘continual improvement’ in ISO 9001:2008?

• A one-time corrective action after a major failure
• An ongoing activity to enhance overall QMS performance
• Only updating the quality manual annually
• Replacing the quality manager regularly

Correct Answer: An ongoing activity to enhance overall QMS performance

Q17. Customer focus as required by ISO 9001:2008 means an organization should:

• Only accept orders from local customers
• Understand customer needs and strive to meet and exceed their requirements
• Prioritize internal convenience over customer requirements
• Delegate all customer interactions to suppliers

Correct Answer: Understand customer needs and strive to meet and exceed their requirements

Q18. For control of nonconforming product, ISO 9001:2008 requires:

• Immediate disposal without documentation
• Identification, documentation, evaluation and disposition
• Sending product to marketing
• No action until customer complains

Correct Answer: Identification, documentation, evaluation and disposition

Q19. Which statistical technique is specifically required by ISO 9001:2008?

• Control charts for every process
• No specific technique is mandated; organizations should use appropriate methods
• Six Sigma certification for all staff
• Only descriptive statistics are allowed

Correct Answer: No specific technique is mandated; organizations should use appropriate methods

Q20. What is the role of ‘quality objectives’ under ISO 9001:2008?

• They replace the need for a quality manual
• They provide measurable goals consistent with the quality policy to improve QMS effectiveness
• They are optional and used only by auditors
• They define employee job descriptions

Correct Answer: They provide measurable goals consistent with the quality policy to improve QMS effectiveness

Download