1. What is the primary goal of laboratory quality management?

 A) Increase laboratory expenses

 B) Ensure the accuracy and reliability of test results
 C) Reduce the number of laboratory personnel
 D) Increase test turnaround times
 Answer: B
2. Which organization defines quality management systems for medical
laboratories?
 A) WHO
 B) ISO
 C) CDC
 D) FDA
 Answer: B
3. What is ISO 15189:2012 known for?
 A) Food safety requirements
 B) Environmental management
 C) Medical laboratories - Requirements for quality and
competence
 D) Information security management
 Answer: C
4. Which of the following is NOT a component of the Quality System
Essentials (QSEs)?
 A) Documents and Records
 B) Occurrence Management
 C) Equipment Maintenance
 D) Marketing Strategies
 Answer: D
5. What is the primary function of a Quality Management System (QMS) in
a laboratory?
 A) To manage the laboratory's financial accounts
 B) To oversee the laboratory's research and development
 C) To ensure quality and consistency in laboratory operations
 D) To handle the laboratory's procurement process
 Answer: C
6. Which standard is specifically focused on the competence of medical
laboratories?
 A) ISO 9001
 B) ISO 14001
 C) ISO 15189
 D) ISO 27001
 Answer: C
7. What is the significance of External Quality Assessment (EQA) in
laboratory quality management?
 A) It assesses the laboratory's exterior environment.
 B) It evaluates the laboratory's performance against standards
through interlaboratory comparisons.
 C) It is used for marketing purposes only.
 D) It focuses on the internal audit processes.
 Answer: B
8. What role does the laboratory information management system (LIMS)
play in quality management?
 A) Managing employee schedules
 B) Tracking test results and ensuring data integrity
 C) Organizing the laboratory's social events
 D) Overseeing the laboratory's building maintenance
 Answer: B
9. Who is responsible for implementing quality management in the
laboratory?
 A) Only the laboratory manager
 B) Only the quality manager
 C) All laboratory personnel
 D) External auditors
 Answer: C
10.What is the first step in establishing a Quality Management System in a
laboratory?
 A) Defining objectives and policies
 B) Purchasing new equipment
 C) Training on specific tests
 D) External accreditation
  Answer: A
11.Which QSE focuses on the corrective actions following the identification
of a problem?
 A) Process Improvement
 B) Occurrence Management
 C) Customer Service
 D) Documents and Records
 Answer: B
12.What is essential for maintaining the accuracy of laboratory
instruments?
 A) Regular calibration and preventive maintenance
 B) Using them as infrequently as possible
 C) Keeping them turned off when not in use
 D) Manual operation by skilled technicians only
 Answer: A
13.The term "proficiency testing" primarily refers to:
 A) A method to evaluate the competency of laboratory staff
 B) A financial audit of the laboratory's spending on tests
 C) An external quality assessment method for comparing
laboratory test results
 D) Testing new laboratory equipment for proficiency
 Answer: C
14.Internal audits are essential for a laboratory because they:
 A) Ensure compliance with external regulations only
 B) Provide an opportunity for staff promotion
 C) Identify areas for improvement within the laboratory's QMS
 D) Focus solely on financial auditing
 Answer: C
15.The principle of "Continuous Quality Improvement" in the laboratory
setting involves:
 A) Regularly increasing test prices
 B) Continuously enhancing processes to improve quality and
performance
 C) Expanding the laboratory space annually
 D) Hiring more staff every quarter
  Answer: B
16.How does document control contribute to laboratory quality
management?
 A) By ensuring all paperwork is filed immediately
 B) Through maintaining up-to-date,