25 Questions
What is one of the benefits of equipment management?
Lowers repair costs
What should you do if you come across equipment that does not function properly?
Report it and do not use it
What is a benefit of equipment management in terms of customer satisfaction?
It increases customer satisfaction
What happens to the lifespan of equipment when it is properly managed?
It increases
Why is it important to have properly functioning equipment?
To reduce safety risks
What type of audit reviews one or more elements in the quality system?
Horizontal audit
Which of the following is an example of an element that may be reviewed in a horizontal audit?
Equipment
What is the primary focus of a vertical audit?
Random selection of tests that have passed through the laboratory
Which of the following is NOT an example of an element that may be reviewed in a horizontal audit?
Employee salaries
What is the main difference between horizontal and vertical audits?
Horizontal audits review multiple elements, while vertical audits review a single element
What decade is associated with the contribution of Walter A. Shewhart in quality management?
1920s
Who is credited with a significant contribution to quality management in the 1920s?
Walter A. Shewhart
Which decade is associated with the concept of Micro Scale Error Reduction?
1980s
What is the primary focus of Walter A. Shewhart's contribution to quality management?
Statistical Process Control
Which standard is concerned with the competence of testing and calibration laboratories?
ISO/IEC 17025:2005
What is the theme of the text that mentions Walter A. Shewhart's contribution?
A Brief History of Quality Management
What is the primary focus of ISO 15189:2007?
Quality management in the clinical laboratory
What is the author of the text that mentions Walter A. Shewhart's contribution?
Brown
Who is associated with the concept of Quality by Requirement?
Crosby
What is the primary focus of ISO 9001:2015?
Quality management system requirements
What is the main purpose of Quality Control (QC) in quality management?
To fulfill quality requirements
What type of materials are examined in the Quality Control (QC) process?
Control materials of known substances
What is the primary focus of the Quality Control (QC) process?
To monitor the accuracy and precision of the examination process
What is the difference between documents and records?
Documents communicate information, while records capture information
What is the characteristic of records?
They are permanent and do not change
Study Notes
Brief History of Quality Management
- Quality Management is not new, with innovators contributing to its development throughout history
- Walter A. Shewhart introduced Statistical Process Control in the 1920s
- W. Crosby introduced Quality by Requirement in the 1970s
- Robert W. Galvin introduced Micro Scale Error Reduction in the 1980s
ISO Documents
- ISO 9001:2015 specifies requirements for a Quality Management System
- ISO/IEC 17025:2005 outlines general requirements for the competence of testing and calibration laboratories
- ISO 15189:2007 provides a Quality Management System for clinical laboratories
Accreditation
- Accreditation involves horizontal audits, reviewing specific elements in the quality system
- Horizontal audits may focus on training, equipment, quality control activities, test methods, complaints, and corrective actions
- Accreditation also involves vertical audits, reviewing a random selection of tests that have passed through the laboratory
Equipment Management
- Effective equipment management lowers repair costs and lengthens equipment lifespan
- Benefits include improved performance, increased safety, reduced service interruptions, and greater customer satisfaction
- Equipment that does not function properly should not be used
Documents and Records
- Documents communicate information on policies, processes, and procedures
- Records capture information on worksheets, forms, labels, and charts
- Documents need to be updated, while records are permanent and do not change
This quiz covers the history of quality management, including its innovators and milestones. Learn about the key contributors and their contributions to the field.
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