NABL accreditation – principles, procedures and significance MCQs With Answer

Introduction: NABL accreditation is a recognised quality framework for testing and calibration laboratories, rooted in ISO/IEC 17025 requirements. For B. Pharm students, understanding NABL principles, procedures and significance is essential for ensuring reliable analytical data, compliance in pharmaceutical quality control, and patient safety. Key concepts include technical competence, impartiality, traceability, measurement uncertainty, method validation, proficiency testing and documented procedures for assessments, corrective actions and surveillance. Mastery of these topics helps future pharmacists interpret accredited reports, design compliant analytical workflows and support regulatory submissions. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What does NABL stand for?

• National Accreditation Board for Laboratories
• National Accreditation Board for Testing and Calibration Laboratories
• National Agency for Biological Laboratories
• National Association of Biochemistry Laboratories

Correct Answer: National Accreditation Board for Testing and Calibration Laboratories

Q2. Which international standard forms the foundation of NABL accreditation for testing and calibration labs?

• ISO 9001:2015
• ISO/IEC 17025:2017
• ISO 15189
• ISO 13485

Correct Answer: ISO/IEC 17025:2017

Q3. The primary objective of NABL accreditation is to:

• Increase laboratory profits
• Ensure technical competence and reliable test/calibration results
• Standardize laboratory décor
• Certify individual analysts

Correct Answer: Ensure technical competence and reliable test/calibration results

Q4. Key principles underpinning NABL accreditation include:

• Competence, impartiality and confidentiality
• Speed, secrecy and centralization
• Profitability, branding and publicity
• Hierarchy, rigidity and isolation

Correct Answer: Competence, impartiality and confidentiality

Q5. The first formal step a laboratory takes to obtain NABL accreditation is:

• Purchasing branded stationery
• Submitting an application and quality documentation for review
• Hiring a celebrity auditor
• Publishing results in a journal

Correct Answer: Submitting an application and quality documentation for review

Q6. During an on-site assessment, assessors primarily evaluate:

• Interior decoration of the lab
• The technical competence of personnel and implementation of quality procedures
• Marketing strategies
• Proprietary product formulations

Correct Answer: The technical competence of personnel and implementation of quality procedures

Q7. Proficiency testing (PT) in the context of NABL is used to:

• Train new staff in record keeping
• Assess laboratory performance and comparability with peers
• Replace internal audits
• Calibrate instruments remotely

Correct Answer: Assess laboratory performance and comparability with peers

Q8. Measurement uncertainty is best described as:

• The exact true value of a measurement
• A range around a measured value that is believed to contain the true value with a given level of confidence
• The average of repeated measurements only
• An irrelevant concept for accredited labs

Correct Answer: A range around a measured value that is believed to contain the true value with a given level of confidence

Q9. Traceability in calibration means:

• Keeping equipment locked in a traceable room
• An unbroken chain of calibrations linking measurements to national or international standards
• Tracking staff movements
• Using only traceable consumables

Correct Answer: An unbroken chain of calibrations linking measurements to national or international standards

Q10. Which document typically describes a laboratory’s overall quality management system?

• Staff birthday register
• Quality manual
• Marketing brochure
• Supplier invoice book

Correct Answer: Quality manual

Q11. Which of the following is NOT a typical method validation parameter?

• Accuracy
• Precision
• Linearity
• Calibration certificate

Correct Answer: Calibration certificate

Q12. LOD in analytical validation stands for:

• Limit of Determination
• Level of Detection
• Limit of Detection
• Linearity of Dilution

Correct Answer: Limit of Detection

Q13. LOQ refers to:

• Limit of Qualification
• Limit of Quantitation
• Level of Quality
• Linear Operational Quantifier

Correct Answer: Limit of Quantitation

Q14. Demonstrating impartiality in a laboratory can be achieved by:

• Refusing all external assessments
• Declaring and managing conflicts of interest openly
• Only hiring family members
• Publishing selective favorable results

Correct Answer: Declaring and managing conflicts of interest openly

Q15. Internal audits in an accredited lab should be conducted:

• Only when a customer complains
• At planned intervals defined by the laboratory
• Never, because external assessors do the work
• Only at the time of accreditation application

Correct Answer: At planned intervals defined by the laboratory

Q16. A surveillance visit by NABL is intended to:

• Replace the initial assessment
• Monitor continued compliance between full re-assessments
• Set new national standards
• Conduct commercial inspections

Correct Answer: Monitor continued compliance between full re-assessments

Q17. The purpose of corrective action after a non-conformity is to:

• Punish staff
• Eliminate the root cause and prevent recurrence
• Delay accreditation decisions
• Hide records

Correct Answer: Eliminate the root cause and prevent recurrence

Q18. For pharmaceutical laboratories, NABL accreditation is significant because it:

• Guarantees lower reagent costs
• Enhances credibility of analytical data and regulatory acceptance
• Removes the need for SOPs
• Allows unverified methods to be used

Correct Answer: Enhances credibility of analytical data and regulatory acceptance

Q19. Who typically performs the technical evaluation of a laboratory during NABL assessment?

• Marketing consultants
• An assessment team of technical assessors appointed by NABL
• The laboratory’s CEO alone
• Random customers

Correct Answer: An assessment team of technical assessors appointed by NABL

Q20. The scope of NABL accreditation for a laboratory specifies:

• The financial turnover of the lab
• The specific tests, calibrations and locations covered by accreditation
• The brand of instruments allowed
• The names of the staff members forever

Correct Answer: The specific tests, calibrations and locations covered by accreditation

Q21. Use of the NABL logo by a laboratory is permitted when:

• Displayed on all promotional material regardless of scope
• Used only on accredited test reports and within the granted scope
• Used to endorse unrelated products
• Displayed on staff ID cards without restriction

Correct Answer: Used only on accredited test reports and within the granted scope

Q22. Inter-laboratory comparisons are valuable because they:

• Eliminate the need for method validation
• Help evaluate laboratory accuracy and comparability across peers
• Are primarily marketing exercises
• Replace internal quality control charts

Correct Answer: Help evaluate laboratory accuracy and comparability across peers

Q23. Records retention in an accredited lab should be:

• Random and unplanned
• Defined with specified retention periods for test and calibration records
• Destroyed immediately after reporting
• Only stored on personal devices

Correct Answer: Defined with specified retention periods for test and calibration records

Q24. Essential requirements for equipment calibration under NABL include:

• Calibration traceable to national standards with documented uncertainty
• Calibration performed only when the equipment breaks
• Using stickers without records
• Calibrating only visual appearance

Correct Answer: Calibration traceable to national standards with documented uncertainty

Q25. A major non-conformity during assessment indicates:

• A minor clerical error
• Serious failure that may affect validity of results
• An opportunity for immediate re-accreditation
• A branding issue

Correct Answer: Serious failure that may affect validity of results

Q26. Method transfer between laboratories requires:

• Only verbal agreement
• Verification that the receiving lab can perform the method to required performance criteria
• Changing the method completely
• Replacing SOPs with memos

Correct Answer: Verification that the receiving lab can perform the method to required performance criteria

Q27. A blind sample in proficiency testing is used to:

• Allow the lab to practice before reporting
• Assess laboratory performance without prior knowledge of the expected value
• Train suppliers
• Reduce workload

Correct Answer: Assess laboratory performance without prior knowledge of the expected value

Q28. Components that typically contribute to measurement uncertainty include:

• Repeatability, calibration uncertainty and reference material uncertainty
• Only analyst’s opinion
• Stationary color and brand of gloves
• Office temperature exclusively

Correct Answer: Repeatability, calibration uncertainty and reference material uncertainty

Q29. A primary responsibility of laboratory management in NABL-accredited labs is to:

• Delegate accreditation entirely to an external party
• Provide resources, competent personnel and maintain impartial operations
• Ignore training and rely on luck
• Sell accreditation certificates

Correct Answer: Provide resources, competent personnel and maintain impartial operations

Q30. After receiving an assessment report with non-conformities, the laboratory must:

• Ignore the findings if inconvenient
• Submit a corrective action plan with evidence to the assessor or NABL
• Close the laboratory permanently
• Publicly dispute every finding

Correct Answer: Submit a corrective action plan with evidence to the assessor or NABL

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