History and Organizations Flashcards
This is the series of standards that implements laboratory quality management systems.
ISO 9000:2000
These are the people dubbed as the “Innovators of Quality.”
- Walter Shewhart
- W. Edwards Deming
- Joseph Juran
- Philip Crosby
- Robert Galvin
The innovator behind the Statistical Process Control Cycle.
Walter A. Shewhart
The innovator behind the Continual Improvement Cycle.
W. Edwards Deming
The innovator behind the Quality Toolbox Cycle.
Joseph M. Juran
The innovator behind the Quality by Requirement Cycle.
Philip B. Crosby
The innovator behind the Microscale Error Reduction Cycle.
Robert W. Galvin
The cycle made during 1920’s.
Statistical Process Control
The cycle made during the 1940’s.
Continual Improvement
The cycle made during the 1950’s.
Quality Toolbox
The cycle made during 1970’s.
Quality by Requirement
the cycle made during the 1980’s.
Microscale Error Reduction
These are the standard organizations.
ISO and CLSI
The meaning of the term ISO.
International Organization for Standardization
The meaning of the term CLSI.
Clinical and Laboratory Standard Institute
This was the former organization name for CLSI.
NCCLS
The meaning of the term NCCLS.
National Committee for Clinical Laboratory Standards
This is the guidance of quality in manufacturing and service industries.
ISO
This has broad applicability; used in many kinds of organizations.
ISO
This has standards, guidelines, and best practices for quality in medical laboratory testing.
CLSI
This is detailed; applies specifically to medical laboratories.
CLSI
This uses a consensus process in developing standards.
ISO and CLSI
This is the model for QA in design, development, production, installation, and services.
ISO 9001:2000 QMS Requirements
These are the two ISO documents specifically for clinical laboratories.
- ISO/IEC 17025:2005
- ISO 15189:2007
This is the ISO document for general requirements for the competence testing and calibration of laboratories.
ISO/IEC 17025:2005
This is the ISO document for quality management in the clinical laboratories.
ISO 15189:2007
This is described as the foundation of international medical laboratory quality management.
ISO 15189:2007
This is the particular requirement for quality competence among medical laboratories.
ISO 15189:2007
These are the two CLSI documents health care systems.
- HS1-A2
- GP26-A3
This is the CLSI document titled “A Quality Management System Model for Health Care.”
HS1-A2
This describes the quality system model of 12 essentials.
HS1-A2
This aligns to the ISO 15189 and is parallel to the ISO 9000.
HS1-A2
This document is applied to all health care systems.
HS1-A2
This is the CLSI document titled “Application of Quality Management System Model for Laboratory Services.”
GP26-A3
This describes the laboratory application of quality system models.
GP26-A3
This relates to the path of workflow to the quality system essentials.
GP26-A3
This mainly assists laboratories in their improving processes.
GP26-A3
This is related to the HS1-A2 and ISO 15189 documents.
GP26-A3
This is what they used to describe quality management.
It’s not new.
This grew from the good works of innovators who defined quality.
Quality Management
It is just as applicable to medical laboratories as it is for manufacturing and industries.
Quality Management
This is the span of years it took innovators to define quality.
80
This is a complex system that all aspects must function properly in order to achieve quality.
Laboratory
These are approaches to be considered within local situations.
Varying Approaches
This is where we start and how we must implement quality management.
We start with the easiest and implemented in a stepwise process.
This is what ultimately needs to be addressed.
All quality management system elements.
