NABL certification and accreditation MCQs With Answer

NABL certification and accreditation MCQs With Answer

This quiz set is designed specifically for M.Pharm students studying Quality Management Systems (MQA 102T) to deepen understanding of NABL accreditation and laboratory certification principles. It covers key concepts such as ISO/IEC 17025 requirements, traceability, measurement uncertainty, proficiency testing, impartiality, documentation, audit types, and the accreditation process. Each question links practical laboratory quality management elements to the theoretical framework used by auditors and assessors. These MCQs will help you prepare for exams, internal assessments, and practical applications in pharmaceutical laboratories seeking or maintaining NABL accreditation.

Q1. What is the primary international standard used by NABL for accrediting testing and calibration laboratories?

• ISO 9001
• ISO/IEC 17025
• GLP (Good Laboratory Practice)
• ISO/IEC 17020

Correct Answer: ISO/IEC 17025

Q2. In the context of NABL accreditation, what does ‘traceability of measurements’ primarily ensure?

• That test reports are stored indefinitely
• That measurement results are linked to national or international standards through an unbroken chain of calibrations
• That all staff qualifications are documented
• That the laboratory uses only branded equipment

Correct Answer: That measurement results are linked to national or international standards through an unbroken chain of calibrations

Q3. Which document is typically required by NABL to describe the overall quality management system of a laboratory?

• Quality Manual
• Procedure for procurement
• Equipment logbook
• Customer feedback form

Correct Answer: Quality Manual

Q4. Which of the following best describes ‘measurement uncertainty’ as required by NABL/ISO 17025?

• The difference between two successive measurements
• A parameter that characterizes the dispersion of the values that could reasonably be attributed to the measurand
• The error recorded on calibration certificates
• The bias corrected by an internal control sample

Correct Answer: A parameter that characterizes the dispersion of the values that could reasonably be attributed to the measurand

Q5. During a NABL assessment, which activity evaluates the technical competence of staff and validity of test results?

• Management review
• Surveillance audit
• Technical assessment including witness testing and review of competence records
• Environmental monitoring

Correct Answer: Technical assessment including witness testing and review of competence records

Q6. What is the role of proficiency testing (PT) in NABL accredited laboratories?

• To calibrate instruments annually
• To provide external verification of a laboratory’s analytical performance compared to peers
• To replace internal QC procedures
• To certify staff qualifications

Correct Answer: To provide external verification of a laboratory’s analytical performance compared to peers

Q7. Which principle is critical for NABL to avoid bias in accreditation decisions?

• Confidentiality
• Impartiality
• Economy
• Efficiency

Correct Answer: Impartiality

Q8. For a pharmaceutical testing lab seeking NABL accreditation, what is the significance of ‘method validation’?

• It demonstrates that a method meets specified performance requirements for the intended use
• It records when the reagent batches were purchased
• It is only required for new instruments
• It replaces the need for calibration

Correct Answer: It demonstrates that a method meets specified performance requirements for the intended use

Q9. Which of the following is a mandatory element of corrective action under NABL/ISO 17025 when a nonconformity is found?

• Immediate dismissal of responsible staff
• Root cause analysis and implementation of actions to prevent recurrence
• Only documenting the nonconformity without action
• Informing only the client affected

Correct Answer: Root cause analysis and implementation of actions to prevent recurrence

Q10. How often does NABL typically conduct reassessment for continuing accreditation after initial accreditation?

• Every year
• Every two to five years depending on scope and policies
• Only when laboratory requests
• Every ten years

Correct Answer: Every two to five years depending on scope and policies

Q11. What does NABL expect regarding laboratory records and retention?

• Records should be kept only in electronic form
• Records must be legible, traceable, and retained for a period defined in the laboratory’s procedures or regulatory requirements
• All raw data should be destroyed after issuing the report
• Only summary reports need retention

Correct Answer: Records must be legible, traceable, and retained for a period defined in the laboratory’s procedures or regulatory requirements

Q12. Which of these describes a ‘witnessed test’ during a NABL technical assessment?

• An assessor observing the laboratory perform a routine test to verify competence and proper method application
• A customer witnessing a test for promotional purposes
• A staff member demonstrating instrument cleaning
• An external vendor calibrating equipment

Correct Answer: An assessor observing the laboratory perform a routine test to verify competence and proper method application

Q13. What does NABL require concerning the calibration status of measuring equipment used for accredited tests?

• Calibration is optional if instrument is new
• Equipment must be calibrated or verified at specified intervals against traceable standards
• Instruments can be used without records if results look reasonable
• Only critical instruments need calibration

Correct Answer: Equipment must be calibrated or verified at specified intervals against traceable standards

Q14. Which document typically contains the scope of accreditation granted by NABL to a laboratory?

• Purchase order
• Scope of Accreditation certificate or schedule listing methods and matrices
• Employee handbook
• Calibration certificate

Correct Answer: Scope of Accreditation certificate or schedule listing methods and matrices

Q15. Under NABL requirements, what is the purpose of management review?

• To review laboratory’s performance, adequacy of the QMS, resource needs, and opportunities for improvement
• To train new recruits
• To issue test reports
• To perform equipment maintenance

Correct Answer: To review laboratory’s performance, adequacy of the QMS, resource needs, and opportunities for improvement

Q16. What is the importance of ‘impartiality policy’ in an NABL accredited laboratory?

• It ensures the lab charges competitive prices
• It documents measures to identify and minimize conflicts of interest that could affect the integrity of results
• It states opening hours of the laboratory
• It describes sample disposal methods

Correct Answer: It documents measures to identify and minimize conflicts of interest that could affect the integrity of results

Q17. Which of the following is a typical cause for suspension or withdrawal of NABL accreditation?

• Failure to participate in agreed proficiency testing or persistent nonconformities not addressed
• Changing the laboratory logo
• Relocating the canteen
• Hiring additional staff

Correct Answer: Failure to participate in agreed proficiency testing or persistent nonconformities not addressed

Q18. For analytical results reporting under NABL, what information is commonly expected on a test report?

• Only the final numerical result without units
• Sample identification, method used, results with units, uncertainty (if applicable), accreditation mark and scope reference
• Confidential internal comments only
• Only the analyst’s name and signature

Correct Answer: Sample identification, method used, results with units, uncertainty (if applicable), accreditation mark and scope reference

Q19. When a laboratory extends its scope of accreditation to include a new test, what is generally required by NABL?

• No action is needed; scope updates automatically
• Application for scope extension, demonstration of competence, method validation, and possibly an onsite technical assessment
• Only a phone call to NABL
• Replacement of all laboratory personnel

Correct Answer: Application for scope extension, demonstration of competence, method validation, and possibly an onsite technical assessment

Q20. Which element helps demonstrate the reliability of archived raw data for NABL assessments?

• Random deletion of obsolete files
• Controlled access, version control, time-stamped entries, and traceability between raw data and issued reports
• Storing data only on personal devices
• Only keeping signed summaries without raw data

Correct Answer: Controlled access, version control, time-stamped entries, and traceability between raw data and issued reports

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