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Questions and Answers
Which component of the Quality Management System (QMS) involves acquisition, installation, validation, maintenance, calibration, and records?
Which component of the Quality Management System (QMS) involves acquisition, installation, validation, maintenance, calibration, and records?
What aspect of the QMS covers quality control, sample management, method validation, and method verification?
What aspect of the QMS covers quality control, sample management, method validation, and method verification?
Which component of QMS relates to job qualifications, job descriptions, orientation, training, competency assessment, and professional development?
Which component of QMS relates to job qualifications, job descriptions, orientation, training, competency assessment, and professional development?
What part of the QMS includes vendor qualifications, supplies and reagents management, contract review, and inventory management?
What part of the QMS includes vendor qualifications, supplies and reagents management, contract review, and inventory management?
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Which element of the QMS encompasses responsibilities, authorities, quality policy provision, and resources?
Which element of the QMS encompasses responsibilities, authorities, quality policy provision, and resources?
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Which part of the QMS addresses complaints handling, mistakes documentation, root cause analysis, corrective actions, and preventive actions?
Which part of the QMS addresses complaints handling, mistakes documentation, root cause analysis, corrective actions, and preventive actions?
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Which aspect is NOT considered an essential component of a Quality Management System?
Which aspect is NOT considered an essential component of a Quality Management System?
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What is a key component of a Quality Management System that focuses on preventing, detecting, and correcting problems?
What is a key component of a Quality Management System that focuses on preventing, detecting, and correcting problems?
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Which of the following is NOT one of the 12 essential components of a Quality Management System?
Which of the following is NOT one of the 12 essential components of a Quality Management System?
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Which component of a Quality Management System addresses the management of incidents and non-conformities?
Which component of a Quality Management System addresses the management of incidents and non-conformities?
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Which is a crucial part of a Quality Management System that focuses on acquiring and managing necessary resources?
Which is a crucial part of a Quality Management System that focuses on acquiring and managing necessary resources?
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Which component of a Quality Management System involves evaluating both internal and external processes for quality assurance?
Which component of a Quality Management System involves evaluating both internal and external processes for quality assurance?
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What are the basic components of Quality Assurance?
What are the basic components of Quality Assurance?
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Which component involves opportunities for improvement, stakeholder feedback, problem resolution, and risk assessment?
Which component involves opportunities for improvement, stakeholder feedback, problem resolution, and risk assessment?
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What is the role of an External Quality Assessment (EQA) in Quality Assurance?
What is the role of an External Quality Assessment (EQA) in Quality Assurance?
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Which of the following is NOT a part of the basic components of QA?
Which of the following is NOT a part of the basic components of QA?
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What is the primary focus of Internal Quality Assessment (IQA) in QA?
What is the primary focus of Internal Quality Assessment (IQA) in QA?
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Who needs to collaborate closely for successful Total Quality Management (TQM)?
Who needs to collaborate closely for successful Total Quality Management (TQM)?
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Study Notes
Quality Management System (QMS)
- QMS involves acquisition, installation, validation, maintenance, calibration, and records in the Facilities and Equipment component.
Quality Control and Method Validation
- Quality control, sample management, method validation, and method verification are covered under the Quality Control aspect of QMS.
Human Resource Management
- Job qualifications, job descriptions, orientation, training, competency assessment, and professional development are related to the Personnel component of QMS.
Vendor Management and Supply Chain
- Vendor qualifications, supplies and reagents management, contract review, and inventory management fall under the Purchasing and Inventory part of QMS.
Quality Policy and Management
- The Quality Management element of QMS encompasses responsibilities, authorities, quality policy provision, and resources.
Corrective and Preventive Actions
- Complaints handling, mistakes documentation, root cause analysis, corrective actions, and preventive actions are addressed in the Corrective and Preventive Actions part of QMS.
Non-Essential Components of QMS
- Quality Research is NOT considered an essential component of a Quality Management System.
Problem Prevention and Correction
- A key component of a Quality Management System that focuses on preventing, detecting, and correcting problems is Corrective and Preventive Actions.
Non-Essential Components of QMS (continued)
- Quality Research is NOT one of the 12 essential components of a Quality Management System.
Incident and Non-Conformity Management
- The management of incidents and non-conformities is addressed in the Corrective and Preventive Actions component of QMS.
Resource Management
- A crucial part of a Quality Management System that focuses on acquiring and managing necessary resources is Quality Management.
Internal and External Process Evaluation
- Evaluating both internal and external processes for quality assurance is part of the Quality Assurance component.
Quality Assurance Components
- The basic components of Quality Assurance include Quality Policy, Quality Control, Quality Assurance, and Quality Improvement.
Opportunities for Improvement
- Opportunities for improvement, stakeholder feedback, problem resolution, and risk assessment are involved in the Quality Improvement component.
External Quality Assessment (EQA)
- The role of an External Quality Assessment (EQA) in Quality Assurance is to evaluate the quality of processes and systems.
Non-Essential Components of QA
- Quality Research is NOT a part of the basic components of QA.
Internal Quality Assessment (IQA)
- The primary focus of Internal Quality Assessment (IQA) in QA is to evaluate internal processes and systems.
Total Quality Management (TQM)
- For successful Total Quality Management (TQM), top management and employees need to collaborate closely.
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Description
Learn about the coordinated activities, organizational structure, and resources needed to implement quality management in laboratory operations. Understand why the quality system is crucial for patient sample testing and how it ensures the foundation of quality in all processes.
