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Laboratory Management > History and Organizations > Flashcards

History and Organizations Flashcards

1
Q

This is the series of standards that implements laboratory quality management systems.

A

ISO 9000:2000

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2
Q

These are the people dubbed as the “Innovators of Quality.”

A
  1. Walter Shewhart
  2. W. Edwards Deming
  3. Joseph Juran
  4. Philip Crosby
  5. Robert Galvin
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3
Q

The innovator behind the Statistical Process Control Cycle.

A

Walter A. Shewhart

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4
Q

The innovator behind the Continual Improvement Cycle.

A

W. Edwards Deming

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5
Q

The innovator behind the Quality Toolbox Cycle.

A

Joseph M. Juran

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6
Q

The innovator behind the Quality by Requirement Cycle.

A

Philip B. Crosby

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7
Q

The innovator behind the Microscale Error Reduction Cycle.

A

Robert W. Galvin

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8
Q

The cycle made during 1920’s.

A

Statistical Process Control

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9
Q

The cycle made during the 1940’s.

A

Continual Improvement

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10
Q

The cycle made during the 1950’s.

A

Quality Toolbox

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11
Q

The cycle made during 1970’s.

A

Quality by Requirement

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12
Q

the cycle made during the 1980’s.

A

Microscale Error Reduction

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13
Q

These are the standard organizations.

A

ISO and CLSI

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14
Q

The meaning of the term ISO.

A

International Organization for Standardization

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15
Q

The meaning of the term CLSI.

A

Clinical and Laboratory Standard Institute

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16
Q

This was the former organization name for CLSI.

A

NCCLS

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17
Q

The meaning of the term NCCLS.

A

National Committee for Clinical Laboratory Standards

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18
Q

This is the guidance of quality in manufacturing and service industries.

A

ISO

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19
Q

This has broad applicability; used in many kinds of organizations.

A

ISO

20
Q

This has standards, guidelines, and best practices for quality in medical laboratory testing.

A

CLSI

21
Q

This is detailed; applies specifically to medical laboratories.

A

CLSI

22
Q

This uses a consensus process in developing standards.

A

ISO and CLSI

23
Q

This is the model for QA in design, development, production, installation, and services.

A

ISO 9001:2000 QMS Requirements

24
Q

These are the two ISO documents specifically for clinical laboratories.

A
  1. ISO/IEC 17025:2005
  2. ISO 15189:2007
25
Q

This is the ISO document for general requirements for the competence testing and calibration of laboratories.

A

ISO/IEC 17025:2005

26
Q

This is the ISO document for quality management in the clinical laboratories.

A

ISO 15189:2007

27
Q

This is described as the foundation of international medical laboratory quality management.

A

ISO 15189:2007

28
Q

This is the particular requirement for quality competence among medical laboratories.

A

ISO 15189:2007

29
Q

These are the two CLSI documents health care systems.

A
  1. HS1-A2
  2. GP26-A3
30
Q

This is the CLSI document titled “A Quality Management System Model for Health Care.”

A

HS1-A2

31
Q

This describes the quality system model of 12 essentials.

A

HS1-A2

32
Q

This aligns to the ISO 15189 and is parallel to the ISO 9000.

A

HS1-A2

33
Q

This document is applied to all health care systems.

A

HS1-A2

34
Q

This is the CLSI document titled “Application of Quality Management System Model for Laboratory Services.”

A

GP26-A3

35
Q

This describes the laboratory application of quality system models.

A

GP26-A3

36
Q

This relates to the path of workflow to the quality system essentials.

A

GP26-A3

37
Q

This mainly assists laboratories in their improving processes.

A

GP26-A3

38
Q

This is related to the HS1-A2 and ISO 15189 documents.

A

GP26-A3

39
Q

This is what they used to describe quality management.

A

It’s not new.

40
Q

This grew from the good works of innovators who defined quality.

A

Quality Management

41
Q

It is just as applicable to medical laboratories as it is for manufacturing and industries.

A

Quality Management

42
Q

This is the span of years it took innovators to define quality.

A

80

43
Q

This is a complex system that all aspects must function properly in order to achieve quality.

A

Laboratory

44
Q

These are approaches to be considered within local situations.

A

Varying Approaches

45
Q

This is where we start and how we must implement quality management.

A

We start with the easiest and implemented in a stepwise process.

46
Q

This is what ultimately needs to be addressed.

A

All quality management system elements.

Laboratory Management (11 decks)

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