Mock Test: WHO Laboratory Quality

Management System
Instructions:

 This mock test comprises 30 multiple-choice questions.

 Choose the most appropriate answer for each question.
 After completing the test, check the provided answer key for your score.

Section 1: Introduction to Quality

1. What is the primary aim of External Quality Assessment (EQA)?
 A. Internal validation
 B. External validation
 C. Internal control
 D. Routine monitoring
2. Which term refers to the formal recognition of competence,
demonstrating adherence to high-quality standards?
 A. Quality Control
 B. Accreditation
 C. Proficiency Testing
 D. Standardization
3. In the history of laboratory quality management, what is the significance
of International Laboratory Standards?
 A. Regional applicability
 B. Global benchmarking
 C. Limited scope
 D. Localized standards

Section 2: Facilities and Safety

 4. What does IQC stand for in laboratory management?
 A. Internal Quality Control
 B. International Quality Certification
 C. Institutional Quality Compliance
 D. Integrated Quality Control
5. In laboratory design, what does "geographic or spatial organization"
refer to?
 A. Safety protocols
 B. Layout planning
 C. Emergency management
 D. Risk identification
6. What is the primary purpose of a Safety Management Programme in a
laboratory?
 A. Equipment calibration
 B. Risk identification
 C. External quality assessment
 D. Staff training

Section 3: Equipment
7. What is the main focus of Section 3-4 in the manual?
 A. Troubleshooting
 B. Equipment retirement
 C. Calibration
 D. Equipment maintenance
8. Which term refers to the systematic evaluation of potential hazards in
laboratory processes?
 A. Risk Assessment
 B. Quality Control
 C. Inventory Management
 D. Equipment Maintenance
9. What does "LIS" stand for in the laboratory context?
 A. Laboratory Inspection System
 B. Laboratory Information System
 C. Laboratory Inventory System
  D. Laboratory Implementation System

Section 4: Purchasing and Inventory

10.What does Section 4-4 of the manual focus on?
 A. Quantification
 B. Forms and logs
 C. Purchasing
 D. Monitoring inventory
11.Which component involves external validation of laboratory
performance?
 A. SOP
 B. IQC
 C. EQA
 D. PT
12.What is the primary function of a laboratory handbook?
 A. Sample processing
 B. Inventory management
 C. Collection and preservation
 D. Quality control

Section 5: Process Control—Introduction to Quality

Control
13.What is the main focus of Section 6-1 of the manual?
 A. Quality Control
 B. Process Improvement
 C. Introduction to Quality Control
 D. Safety Management
14.What is the primary goal of Quality Control for quantitative tests?
 A. Establishing control ranges
 B. Interpreting control data
 C. Using control information
 D. Maintaining equipment
15.What does Section 7-6 of the manual emphasize?
  A. Interpreting quality control data
 B. Using quality control information
 C. Establishing control ranges
 D. Quality control materials

Section 6: Process Control—Quality Control for Qualitative

and Semiquantitative Procedures
16.What is the primary focus of Section 8-2?
 A. Quality control of stains
 B. Quality control materials
 C. Quality control of media
 D. Quality control of equipment
17.Which term refers to a process for systematic review and assessment of
laboratory operations?
 A. Quality control
 B. Process improvement
 C. Internal audit
 D. External audit
18.What is the primary goal of Quality Control for microbiological media
(Section 8-4)?
 A. Assessing customer satisfaction
 B. Establishing control ranges
 C. Quality control materials
 D. Managing inventory

Section 7: Assessment—Audits
19.What is the purpose of Section 9-4 in the manual?
 A. Internal audit programme
 B. Internal audit
 C. Actions as a result of audit
 D. External audit
20.What does an "external audit" primarily assess?
 A. Internal procedures
  B. Customer satisfaction
 C. Laboratory performance
 D. Employee performance
21.What is the key action after an internal audit (Section 9-5)?
 A. Issuing a report
 B. Identifying risks
 C. Taking corrective actions
 D. Conducting a proficiency test

Section 8: Assessment—External Quality Assessment

22.What does Section 10-4 of the manual compare?
 A. External quality assessment methods
 B. Proficiency testing methods
 C. Internal and external audits
 D. Norms and accreditation
23.How is external quality assessment managed in the laboratory (Section
10-5)?
 A. By internal audit
 B. Through quality indicators
 C. By comparison with internal standards
 D. By implementing inventory management
24.What is the primary purpose of proficiency testing (Section 10-2)?
 A. Internal audit
 B. Assessment of competence
 C. External quality assessment
 D. Risk identification

Section 9: Assessment—Norms and Accreditation

25.What is the main focus of Section 11-6?
 A. National standards
 B. Certification and accreditation
 C. Benefits of accreditation
 D. Process of accreditation
26.In laboratory personnel, what does "competency assessment" involve?
  A. Employee performance appraisal
 B. Recruitment and orientation
 C. Training and continuing education
 D. Evaluation of skills and knowledge
27.What do "international standards and standardization bodies" primarily
address (Section 11-2)?
 A. Local standards
 B. Certification
 C. Accreditation
 D. National standards

Section 10: Personnel

28.What is the primary focus of Section 12-5?
 A. Customer service
 B. Personnel records
 C. Employee performance appraisal
 D. Competency and competency assessment
29.In laboratory management, what does "LIMS" stand for?
 A. Laboratory Inventory Management System
 B. Laboratory Information Management System
 C. Laboratory Inspection Management System
 D. Laboratory Improvement Management System
30.What does Section 13-4 of the manual address?
 A. Customer satisfaction surveys
 B. Laboratory clients
 C. Assessing and monitoring customer satisfaction
 D. Occurrence management

Answer Key:
 1. B. External validation
2. B. Accreditation
3. B. Global benchmarking
4. A. Internal Quality Control
5. B. Layout planning
6. B. Risk identification
7. D. Equipment maintenance
8. A. Risk Assessment
9. B. Laboratory Information System
10.D. Monitoring inventory
11.C. EQA
12.B. Inventory management
13.C. Introduction to Quality Control
14.B. Interpreting control data
15.B. Using quality control information
16.B. Quality control materials
17.C. Internal audit
18.C. Quality control of media
19.A. Internal audit programme
20.C. Laboratory performance
21.C. Taking corrective actions
22.A. External quality assessment methods
23.C. By comparison with internal standards
24.B. Assessment of competence
25.C. Benefits of accreditation
26.D. Evaluation of skills and knowledge
27.C. Accreditation
28.C. Employee performance appraisal
29.B. Laboratory Information Management System
30.C. Assessing and monitoring customer satisfaction

WHO Laboratory Quality Management System -

Summary

Introduction to Quality Management

 1. Importance of EQA: External Quality Assessment (EQA) is crucial for external
validation of laboratory performance.
2. Accreditation Significance: Accreditation demonstrates competence and
adherence to high-quality standards on a global scale.
3. International Standards: International Laboratory Standards provide a
benchmark for laboratories globally.

Facilities and Safety

4. IQC in Laboratory Design: Internal Quality Control (IQC) is integral to laboratory

design and risk identification.
5. Spatial Organization: Laboratory design considers geographic or spatial
organization for effective risk management.
6. Safety Management: Safety Management Programs are implemented for risk
identification, personal protective equipment, and emergency management.

Equipment

7. Equipment Maintenance: Section 3-4 emphasizes the importance of

troubleshooting, service, repair, and retiring equipment.
8. Risk Assessment: Systematic evaluation of potential hazards is essential, termed
Risk Assessment.
9. LIS in Laboratories: Laboratory Information System (LIS) plays a vital role in
information management.

Purchasing and Inventory

10. Monitoring Inventory: Section 4-4 focuses on monitoring inventory, ensuring

efficient supply chain management.
11. External Validation: Proficiency Testing (PT) is a component involving external
validation of laboratory performance.
12. Laboratory Handbook: A laboratory handbook guides processes related to
collection, preservation, and processing.

Process Control and Quality Assurance

13. Introduction to QC: Section 6-1 introduces Quality Control (QC) and its role in
laboratory processes.
 14. QC for Quantitative Tests: Focus on establishing control ranges, interpreting
control data, and using control information.
15. QC for Qualitative Procedures: Section 7-6 emphasizes the importance of
quality control for qualitative and semiquantitative procedures.
16. QC for Microbiological Media: Quality control of stains, media, and equipment
is crucial (Section 8-2, 8-4).

Assessment and Audits

17. Internal Audit: Section 9-4 outlines the purpose and process of internal audits.
18. External Audit: External audits assess laboratory performance, providing insights
for improvement.
19. Proficiency Testing (PT): PT involves assessing laboratory competence through
external quality assessment methods.

Personnel and Competency

20. Competency Assessment: Personnel competency is evaluated through

recruitment, orientation, training, and continuing education.
21. Customer Service: Section 13 addresses customer service, assessing and
monitoring customer satisfaction.

Occurrence Management and Process Improvement

22. Occurrence Management: Understanding sources and consequences of

laboratory errors, emphasizing investigation and management.
23. Process Improvement: Continual improvement involves tools, quality indicators,
and selecting indicators for effective process enhancement.

Documents, Records, and Information Management

24. Documentation Overview: The manual emphasizes the importance of

documentation, including the quality manual, SOPs, and record-keeping.
25. Information Management: Information management involves elements, manual
paper-based systems, and computerized laboratory information systems.

Organization and Norms

26. Organizational Requirements: Organizational aspects, including management
role, structure, and functions, are critical for a quality management system.
27. Accreditation Benefits: Section 11-6 highlights the benefits of accreditation,
addressing national and international standards.