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What Is The Primary Goal of Laboratory Quality Management

The document discusses key aspects of laboratory quality management. It addresses the primary goals of quality management as ensuring accurate and reliable test results. International Organization for Standardization (ISO) standards define quality management systems for medical laboratories, including ISO 15189 which sets requirements for quality and competence specifically. Quality management systems encompass components like document control, occurrence management, and equipment calibration to ensure consistent and high quality operations. All laboratory personnel are responsible for implementing quality management.

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mariam zameer
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320 views

What Is The Primary Goal of Laboratory Quality Management

The document discusses key aspects of laboratory quality management. It addresses the primary goals of quality management as ensuring accurate and reliable test results. International Organization for Standardization (ISO) standards define quality management systems for medical laboratories, including ISO 15189 which sets requirements for quality and competence specifically. Quality management systems encompass components like document control, occurrence management, and equipment calibration to ensure consistent and high quality operations. All laboratory personnel are responsible for implementing quality management.

Uploaded by

mariam zameer
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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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,

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