Introduction to ISO 9000 series of quality system standards MCQs With Answer

Introduction to ISO 9000 series of quality system standards MCQs With Answer

The ISO 9000 series provides international guidance on quality management systems (QMS), defining terms, principles and the framework used by organizations worldwide. For B.Pharm students, understanding ISO 9000, ISO 9001 requirements, quality assurance, documentation, process approach, risk-based thinking, continual improvement and audit principles is essential for regulatory compliance, GMP alignment and reliable pharmaceutical manufacturing. This concise guide focuses on core concepts such as clauses, management responsibility, control of records, supplier control, calibration, validation and corrective actions, tailored to pharmacy practice. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of the ISO 9000 series for a pharmaceutical company?

• To set specific drug potency limits
• To provide an international framework for a quality management system
• To replace Good Manufacturing Practices (GMP)
• To certify individual employees

Correct Answer: To provide an international framework for a quality management system

Q2. Which ISO standard in the 9000 family specifies requirements for a QMS that organizations can be certified against?

• ISO 9000
• ISO 9001
• ISO 9004
• ISO 19011

Correct Answer: ISO 9001

Q3. In ISO 9001:2015, which clause addresses ‘Leadership’ and top management responsibilities?

• Clause 4
• Clause 5
• Clause 7
• Clause 10

Correct Answer: Clause 5

Q4. What does the ‘process approach’ promoted by ISO 9001 emphasize?

• Focusing only on final product testing
• Managing activities as interrelated processes to achieve objectives
• Replacing documentation with verbal instructions
• Outsourcing all quality activities

Correct Answer: Managing activities as interrelated processes to achieve objectives

Q5. Which concept introduced in ISO 9001:2015 requires organizations to consider external and internal issues and interested parties?

• Preventive action
• Context of the organization
• Calibration planning
• Product realization

Correct Answer: Context of the organization

Q6. ‘Risk-based thinking’ in ISO 9001 primarily helps to:

• Eliminate the need for audits
• Identify, prioritize and control risks to product quality and processes
• Increase documentation without practical use
• Guarantee zero defects

Correct Answer: Identify, prioritize and control risks to product quality and processes

Q7. Which document typically states an organization’s commitment to quality and compliance with ISO 9001?

• Quality policy
• Batch manufacturing record
• Audit checklist
• Supplier invoice

Correct Answer: Quality policy

Q8. Under ISO 9001, which activity ensures planned results are achieved and nonconformities are corrected?

• Management review
• Corrective action
• Preventive maintenance
• Purchasing approval

Correct Answer: Corrective action

Q9. Which clause of ISO 9001 covers ‘Support’ including resources, competence, and documented information?

• Clause 6
• Clause 7
• Clause 8
• Clause 9

Correct Answer: Clause 7

Q10. For pharmaceutical laboratories, why is calibration emphasized in ISO 9001?

• To improve staff morale only
• To ensure measurement accuracy and traceability of test and inspection equipment
• To speed up production without checks
• To reduce documentation requirements

Correct Answer: To ensure measurement accuracy and traceability of test and inspection equipment

Q11. What is the role of internal audits in an ISO 9001 QMS?

• To conduct marketing research
• To verify conformance of the QMS to planned arrangements and standard requirements
• To replace external regulatory inspections
• To train new employees only

Correct Answer: To verify conformance of the QMS to planned arrangements and standard requirements

Q12. Which of the following best describes ‘documented information’ in ISO 9001?

• Only paper documents stored in a filing cabinet
• Information required to be controlled and maintained, in any medium
• Unofficial notes kept by staff
• Only electronic spreadsheets

Correct Answer: Information required to be controlled and maintained, in any medium

Q13. How does ISO 9001 relate to GMP in the pharmaceutical industry?

• ISO 9001 replaces GMP regulations
• ISO 9001 complements GMP by strengthening QMS and process control
• GMP is irrelevant if ISO 9001 is implemented
• They are identical in content

Correct Answer: ISO 9001 complements GMP by strengthening QMS and process control

Q14. Which activity is NOT explicitly required by ISO 9001 but is often practiced in pharma for continual improvement?

• Management review
• Process validation
• Continual improvement
• Monitoring and measurement

Correct Answer: Process validation

Q15. What is a ‘nonconformity’ according to ISO 9001 principles?

• A planned improvement action
• A failure to meet a requirement
• An internal memo
• A supplier promotional offer

Correct Answer: A failure to meet a requirement

Q16. Which clause addresses ‘Operation’ including production and service provision in ISO 9001?

• Clause 4
• Clause 8
• Clause 10
• Clause 5

Correct Answer: Clause 8

Q17. Why is control of externally provided processes, products and services important under ISO 9001?

• Because suppliers are solely responsible for final product quality
• To ensure purchased items meet specified requirements and do not compromise quality
• To reduce purchasing costs only
• To eliminate the need for incoming inspection

Correct Answer: To ensure purchased items meet specified requirements and do not compromise quality

Q18. What is the significance of ‘quality objectives’ in a QMS?

• They are vague mission statements with no measurement
• They set measurable targets aligned with the quality policy to drive improvement
• They replace the need for internal audits
• They refer only to financial goals

Correct Answer: They set measurable targets aligned with the quality policy to drive improvement

Q19. Which activity should be performed before releasing a pharmaceutical batch to the market under a robust QMS?

• Random marketing survey
• Review of batch records and release by authorized personnel
• Immediate dispatch without checks
• Supplier audit

Correct Answer: Review of batch records and release by authorized personnel

Q20. In ISO 9001:2015, what replaced the specific requirement for ‘preventive action’ found in earlier versions?

• Risk-based thinking embedded throughout the standard
• Stricter documentation rules
• Elimination of corrective action
• Mandatory external audits every month

Correct Answer: Risk-based thinking embedded throughout the standard

Q21. What is the role of management review in an ISO 9001 QMS?

• To train shop-floor staff weekly
• To evaluate QMS performance, adequacy and opportunities for improvement
• To perform routine equipment calibration
• To issue product certificates to customers

Correct Answer: To evaluate QMS performance, adequacy and opportunities for improvement

Q22. Which of the following is a key principle in the ISO 9000 family?

• Focus on external advertising
• Customer focus
• Exclusion of employee involvement
• Prioritizing speed over quality

Correct Answer: Customer focus

Q23. How should a pharmaceutical company handle nonconforming product according to QMS practices?

• Release it immediately to reduce inventory
• Identify, segregate, document and decide on disposition
• Destroy without records
• Return to supplier without investigation

Correct Answer: Identify, segregate, document and decide on disposition

Q24. Which record would be considered ‘documented information’ in a pharmaceutical QMS?

• Quality manual, procedures, batch records and calibration logs
• Employee social media posts
• Supplier marketing brochures
• Unapproved draft notes kept privately

Correct Answer: Quality manual, procedures, batch records and calibration logs

Q25. What does continual improvement mean in the context of ISO 9001?

• Making one-time changes only
• An ongoing effort to improve products, processes and the QMS
• Only expanding market share
• Reducing staff to cut costs

Correct Answer: An ongoing effort to improve products, processes and the QMS

Q26. Which activity ensures that personnel are capable of performing tasks affecting product quality?

• Supplier selection
• Competence, training and awareness programs
• Advertising campaigns
• Financial auditing

Correct Answer: Competence, training and awareness programs

Q27. In ISO 9001 auditing, what is the primary focus of an audit checklist for pharmaceutical manufacturing?

• Assessing QMS conformity, process control, documentation and regulatory compliance
• Counting employee birthdays
• Designing new products
• Negotiating supplier prices

Correct Answer: Assessing QMS conformity, process control, documentation and regulatory compliance

Q28. How does traceability support quality in pharmaceutical production under ISO 9001?

• By hiding production records
• By enabling identification of materials, processes and batches for investigation and recall
• By reducing training requirements
• By eliminating the need for supplier evaluation

Correct Answer: By enabling identification of materials, processes and batches for investigation and recall

Q29. Which of the following best describes the relationship between ISO 9000 and ISO 9001?

• ISO 9000 contains requirements for certification, ISO 9001 provides definitions
• ISO 9000 provides fundamentals and vocabulary; ISO 9001 contains QMS requirements for certification
• They are the same document with different titles
• ISO 9001 is obsolete and replaced by ISO 9000

Correct Answer: ISO 9000 provides fundamentals and vocabulary; ISO 9001 contains QMS requirements for certification

Q30. Which outcome is expected when a pharmaceutical organization effectively implements ISO 9001?

• Improved process control, reduced errors, regulatory readiness and enhanced customer confidence
• Immediate elimination of all manufacturing costs
• Guaranteed absence of any inspections
• Removal of all documentation

Correct Answer: Improved process control, reduced errors, regulatory readiness and enhanced customer confidence

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com