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Questions and Answers
What is the primary focus of the Clinical and Laboratory Standards Institute (CLSI)?
What is the primary focus of the Clinical and Laboratory Standards Institute (CLSI)?
How many quality system essentials (QSE) form the basis of the CLSI quality management system model?
How many quality system essentials (QSE) form the basis of the CLSI quality management system model?
Which document outlines the application of a quality management system model for laboratory services by CLSI?
Which document outlines the application of a quality management system model for laboratory services by CLSI?
What type of standards is the CLSI quality management system model compatible with?
What type of standards is the CLSI quality management system model compatible with?
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Which organization has established standards for specific programs and areas in laboratories?
Which organization has established standards for specific programs and areas in laboratories?
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Which major contribution is attributed to Shewhart in the context of quality management?
Which major contribution is attributed to Shewhart in the context of quality management?
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What does ISO 9000 primarily provide guidance for?
What does ISO 9000 primarily provide guidance for?
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What is the focus of ISO 15189:2007?
What is the focus of ISO 15189:2007?
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Which of the following innovators is known for contributing to the quality management concepts beyond the statistical process control?
Which of the following innovators is known for contributing to the quality management concepts beyond the statistical process control?
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What are the two ISO standards that are specifically related to laboratory requirements?
What are the two ISO standards that are specifically related to laboratory requirements?
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How is quality management defined according to ISO 9000?
How is quality management defined according to ISO 9000?
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What is the significance of quality assessment in quality management?
What is the significance of quality assessment in quality management?
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Galvin's work in quality management primarily focuses on which area?
Galvin's work in quality management primarily focuses on which area?
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Study Notes
Definition of Quality Management
- Quality management involves coordinated activities to direct and control an organization regarding quality.
- A quality system encompasses the organizational structure, resources, processes, and procedures needed for quality management.
Historical Context of Quality Management
- The origins of quality management concepts date back to the 20th century, evolving from manufacturing practices.
- Early emphasis on quality control focused on product quality, with Shewhart establishing statistical process control in the 1920s as a foundation for laboratory quality control procedures.
- Quality control practices in laboratories did not emerge until the 1940s.
Principal Innovators and Contributions
- Arman Feigenbaum contributed to the quality management movement through his philosophies on total quality control.
- Kaoru Ishikawa introduced the concept of quality circles and fishbone diagrams for problem-solving.
- Genichi Taguchi is known for robust design and methods to improve quality and reduce variation.
- Galvin’s research focuses on micro-scale error reduction, providing modern insights applicable in laboratory settings.
International Laboratory Standards
- The establishment of international laboratory standards was driven by the need for quality assessment and benchmarking.
- ISO (International Organization for Standardization) developed standards for industrial manufacturing, influential in laboratory quality management.
Key ISO Standards
- ISO 9000 provides guidance for quality assurance in both manufacturing and service industries.
- ISO 9001:2000 outlines general quality management system requirements applicable to laboratories.
- ISO 15189:2007 specifies particular requirements for medical laboratory quality and competence.
- ISO/IEC 17025:2005 lays out general requirements for testing and calibration laboratories.
Clinical and Laboratory Standards Institute (CLSI)
- CLSI, formerly NCCLS, focuses on developing laboratory quality standards through a consensus process involving multiple stakeholders.
- Important CLSI documents include:
- CLSI/NCCLS Quality Management System Model for Health Care (Approved Guideline—Second Edition).
- CLSI/NCCLS Application of a Quality Management System Model for Laboratory Services (Approved Guideline—Third Edition).
- The CLSI model incorporates twelve quality system essentials (QSE) compatible with ISO laboratory standards.
Other Standards and Regulations
- Various countries may have national laboratory quality standards which apply specifically to their laboratories.
- Laboratory standards can be specialized to certain areas or specific tests within a laboratory.
- The World Health Organization has set specific standards for various programs and laboratory practices.
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Description
Explore the history and definition of laboratory quality management. This quiz covers key principles, significant innovators, and their contributions to the development of quality systems as defined by ISO 9000. Test your knowledge on how these concepts shape organizational practices today.
