The ISO 9000 series provides internationally recognized standards for quality management systems (QMS) used across industries, including pharmaceuticals. For B.Pharm students, understanding ISO 9001 principles, documentation, risk-based thinking, internal and external audits, and the registration process is essential to ensure product quality, regulatory compliance, and alignment with Good Manufacturing Practice (GMP). This overview explains benefits such as improved customer satisfaction, reduced errors, supplier control, and market access, plus steps to achieve certification: gap analysis, documentation, internal audits, stage 1 and 2 certification audits, surveillance, and recertification. Practical pharma examples—batch records, validation, calibration, and CAPA—help link theory to practice. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is ISO 9001 primarily concerned with?
- Quality management systems for consistent product and service quality
- Environmental management and sustainability
- Occupational health and safety requirements
- Information security controls
Correct Answer: Quality management systems for consistent product and service quality
Q2. Which document gives fundamental terminology and principles of the ISO 9000 family?
- ISO 9000
- ISO 9001
- ISO 9004
- ISO 14001
Correct Answer: ISO 9000
Q3. Which clause structure does ISO 9001:2015 follow that is common across many management standards?
- Annex SL high-level structure (clauses 4 to 10)
- Process-based unique structure with 20 clauses
- Risk-only structure with no clauses
- Product-focused annexes only
Correct Answer: Annex SL high-level structure (clauses 4 to 10)
Q4. In ISO 9001, “context of the organization” requires organizations to:
- Identify internal and external issues and interested parties relevant to the QMS
- Only focus on supplier contracts
- Eliminate documentation requirements
- Outsource all quality functions
Correct Answer: Identify internal and external issues and interested parties relevant to the QMS
Q5. Which principle is central to ISO 9001 and emphasizes continual improvement?
- Customer focus
- Leadership
- Continual improvement
- Evidence-based decision making
Correct Answer: Continual improvement
Q6. For a pharmaceutical company, which benefit of ISO 9001 most directly supports compliance with GMP?
- Improved process documentation and controlled records
- Lowering energy consumption
- Improved public relations
- Tax incentives
Correct Answer: Improved process documentation and controlled records
Q7. Which step typically comes first in the ISO 9001 registration process?
- Gap analysis and preparation of required documentation
- Stage 2 certification audit
- Surveillance audit
- Recertification audit
Correct Answer: Gap analysis and preparation of required documentation
Q8. What are “stage 1” and “stage 2” audits in certification?
- Stage 1 assesses readiness and documentation; stage 2 audits implementation and effectiveness
- Stage 1 is always conducted after certification; stage 2 is surveillance
- Stage 1 audits suppliers; stage 2 audits customers
- Stage 1 is for ISO 9000; stage 2 is for ISO 9001
Correct Answer: Stage 1 assesses readiness and documentation; stage 2 audits implementation and effectiveness
Q9. Which element is NOT a required output of a management review under ISO 9001?
- Decisions related to resource allocation
- Actions to address risks and opportunities
- Confidential employee medical records
- Opportunities for improvement
Correct Answer: Confidential employee medical records
Q10. In ISO 9001, “risk-based thinking” requires organizations to:
- Identify and address risks and opportunities that can affect product conformity and QMS performance
- Only document risks but take no actions
- Eliminate all risks completely
- Rely solely on inspections for quality
Correct Answer: Identify and address risks and opportunities that can affect product conformity and QMS performance
Q11. Which document is essential to define the scope of the QMS in a pharmaceutical company?
- Quality manual or documented scope statement
- Employee payroll register
- Supplier price list
- Marketing brochure
Correct Answer: Quality manual or documented scope statement
Q12. Which is a common nonconformity category found during certification audits?
- Major nonconformity related to system failure affecting product quality
- Minor improvement suggestion unrelated to QMS
- Business opportunity recommendation
- Marketing material preference
Correct Answer: Major nonconformity related to system failure affecting product quality
Q13. CAPA in a pharmaceutical QMS stands for:
- Corrective and Preventive Action
- Calibration and Performance Assessment
- Customer Approval Process Always
- Control and Production Audit
Correct Answer: Corrective and Preventive Action
Q14. Which record is most relevant for traceability in pharmaceutical batch production?
- Batch manufacturing record with raw material lot numbers and equipment IDs
- Company annual social media posts
- Employee lunch attendance sheet
- Office supplies purchase receipts
Correct Answer: Batch manufacturing record with raw material lot numbers and equipment IDs
Q15. Which of the following best describes “competence” requirement in ISO 9001?
- Employees must have appropriate education, training, skills and experience for assigned tasks
- All employees must hold a doctoral degree
- Only external consultants need competence records
- Competence is optional for non-production staff
Correct Answer: Employees must have appropriate education, training, skills and experience for assigned tasks
Q16. How often are surveillance audits by a certification body typically conducted after initial certification?
- Annually (usually once per year) between certification cycles
- Every month without exception
- Only at recertification after three cycles
- Never, certification body conducts no follow-ups
Correct Answer: Annually (usually once per year) between certification cycles
Q17. Which practice helps a pharma company demonstrate “evidence-based decision making”?
- Using statistical process control and trend analysis of quality data
- Making decisions based on rumors
- Choosing procedures by seniority only
- Ignoring monitoring and measurement results
Correct Answer: Using statistical process control and trend analysis of quality data
Q18. Supplier evaluation under ISO 9001 should include:
- Assessment of supplier ability to provide conforming materials and ongoing performance monitoring
- Only price comparisons without quality checks
- Hiring suppliers based on geographical origin only
- Outsourcing all quality controls to suppliers without verification
Correct Answer: Assessment of supplier ability to provide conforming materials and ongoing performance monitoring
Q19. Which quality document provides specific instructions for a process, such as aseptic filling?
- Standard Operating Procedure (SOP)
- Company mission statement
- Annual financial report
- Marketing plan
Correct Answer: Standard Operating Procedure (SOP)
Q20. What role does internal audit play in ISO 9001 compliance?
- Verify QMS conformity and effectiveness and identify improvements before external audits
- Replace the need for external certification audits entirely
- Serve only as a disciplinary tool for employees
- Be optional for certified organizations
Correct Answer: Verify QMS conformity and effectiveness and identify improvements before external audits
Q21. Recertification audit for ISO 9001 is normally performed every:
- Three years
- Six months
- Ten years
- On demand only
Correct Answer: Three years
Q22. Which is a direct business benefit of ISO 9001 certification for pharmaceutical manufacturers?
- Improved regulatory inspections and increased customer trust
- Automatic approval of all new drug applications
- Exemption from GMP requirements
- Free export licenses
Correct Answer: Improved regulatory inspections and increased customer trust
Q23. Which activity demonstrates control of monitoring and measuring equipment?
- Calibration and maintenance records with identification and schedule
- Keeping equipment unmarked to avoid theft
- Sharing instruments between unrelated processes without logs
- Not performing any checks to save time
Correct Answer: Calibration and maintenance records with identification and schedule
Q24. During an external audit, objective evidence is required. Which is an example of objective evidence?
- Completed quality records showing actual measurements and signatures
- Manager’s verbal assurance without records
- Employee opinion survey results only
- Marketing promises in a brochure
Correct Answer: Completed quality records showing actual measurements and signatures
Q25. How does ISO 9001 interface with Good Manufacturing Practice (GMP) in pharma?
- ISO 9001 complements GMP by strengthening QMS elements like documentation, change control, and CAPA
- ISO 9001 replaces the need for GMP inspections entirely
- GMP and ISO 9001 are unrelated and cannot be used together
- ISO 9001 prohibits validation activities required by GMP
Correct Answer: ISO 9001 complements GMP by strengthening QMS elements like documentation, change control, and CAPA
Q26. What is the primary purpose of a quality policy in ISO 9001?
- Provide a statement of the organization’s commitment to quality and continual improvement
- Describe all operational procedures in detail
- Serve as a marketing slogan only
- Replace the quality manual entirely
Correct Answer: Provide a statement of the organization’s commitment to quality and continual improvement
Q27. Which is considered an “interested party” in ISO 9001 for pharmaceutical companies?
- Regulatory authorities, customers, suppliers, and patients
- Only the CEO and board members
- Only foreign governments
- None — interested parties are not relevant
Correct Answer: Regulatory authorities, customers, suppliers, and patients
Q28. What action should be taken when a major nonconformity is raised by a certification auditor?
- Implement corrective actions, root cause analysis, and provide evidence to the certification body within the agreed timeframe
- Ignore it because it will not affect certification
- Delete the audit report to avoid evidence
- Only promise to do better without documented evidence
Correct Answer: Implement corrective actions, root cause analysis, and provide evidence to the certification body within the agreed timeframe
Q29. Which metric is most useful to monitor customer satisfaction in a pharmaceutical company?
- Complaint rate and trend analysis relating to product quality
- Number of social media likes
- Office cafeteria usage
- Employee parking occupancy
Correct Answer: Complaint rate and trend analysis relating to product quality
Q30. Who issues the ISO 9001 certificate after successful audits?
- An accredited certification body (registrar)
- The local hospital authority
- Any supplier to the company
- The company self-issues without external audit
Correct Answer: An accredited certification body (registrar)
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