This document introduces laboratory quality management systems. It discusses the 12 essential elements of a quality management system including organization, personnel, equipment, purchasing, process control, and more. It provides an overview of the history and development of quality principles from innovators like Shewhart, Deming, and Juran. Standards organizations that guide quality systems for laboratories are also examined, including ISO and CLSI. The document emphasizes that a quality system is necessary to detect and prevent errors in the laboratory testing process.

1. Introduction-
Laboratory Quality
Management System

2. Introduction Laboratory Quality Management System-Module 1 2
At the end of this activity, participants will be
able to:
 Explain the importance of a quality
management system
 List the quality system essential elements
 Describe the history of development of
quality principles
 Discuss relationship of this quality model to
ISO and CLSI standards
Learning Objectives

3. Introduction Laboratory Quality Management System-Module 1 3
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety
The Quality Management System

4. Introduction Laboratory Quality Management System-Module 1 4
What is Quality?

5. Introduction Laboratory Quality Management System-Module 1 5
5
Achieving a 99% level of quality
means
accepting a 1% error rate
1%

6. Introduction Laboratory Quality Management System-Module 1 6
In France a 1% error rate
would mean everyday
 14 minutes without water or electricity
 50,000 parcels lost by postal services
 22 newborns falling from
midwives’ hands
 600,000 lunches contaminated
by bacteria
 3 bad landings at Orly Paris airport

7. Introduction Laboratory Quality Management System-Module 1 7
7
Result: 1% failure

8. Introduction Laboratory Quality Management System-Module 1 8
Essential to all aspects of
health care are laboratory
results that are
 accurate,
 reliable, and
 timely

9. Introduction Laboratory Quality Management System-Module 1 9
Laboratory errors cost in
time
personnel
effort
patient
outcomes

10. Introduction Laboratory Quality Management System-Module 1 10
How do we
achieve
excellent
performance
in the
laboratory?
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety

11. Introduction Laboratory Quality Management System-Module 1 11
Quality Management System Definition
Coordinated activities to direct and
control an organization with regard
to quality (ISO,CLSI).
All aspects of the laboratory operation
need to be addressed to assure
quality; this constitutes
a quality management system.

12. Introduction Laboratory Quality Management System-Module 1 12
Complexity of a Laboratory System
•Data & Laboratory
Management
•Safety
•Customer Service
Patient/Client Prep
Sample Collection
Sample Receipt and
Accessioning
Sample Transport
Quality Control
Testing
Record Keeping
Reporting
Personnel Competency
Test Evaluations

13. Introduction Laboratory Quality Management System-Module 1 13
Path of Workflow
THE PATIENT Test selection Sample Collection
Sample Transport
Laboratory Analysis
Examination Phase
Report Creation
Report Transport
Preexamination Phase
Result Interpretation Postexamination Phase

14. Introduction Laboratory Quality Management System-Module 1 14
WHY is the Path of Workflow essential
to consider in health laboratories?
The entire process of managing a
sample must be considered:
 the beginning: sample collection
 the end: reporting and saving of results
 all processes in between.

15. Introduction Laboratory Quality Management System-Module 1 15
Laboratory tests are influenced by
 laboratory environment
 knowledgeable staff
 competent staff
 reagents and equipment
 quality control
 communications
 process management
 occurrence management
 record keeping

16. Introduction Laboratory Quality Management System-Module 1 16
Twelve Quality System Essentials
set of
coordinated
activities that
function as
building blocks
for
quality
management
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety

17. Introduction Laboratory Quality Management System-Module 1 17
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety
Path of Workflow

18. Introduction Laboratory Quality Management System-Module 1 18
Organization
Responsibilities, Authorities
Communication
Provision
of
resources
Quality
Policy

19. Introduction Laboratory Quality Management System-Module 1 19
Personnel
human resources
job qualifications
job descriptions
orientation
training
competency assessment
professional development
continuing education

20. Introduction Laboratory Quality Management System-Module 1 20
Equipment
acquisition
installation
validation
maintenance
calibration
troubleshooting
service and repair
records

21. Introduction Laboratory Quality Management System-Module 1 21
Purchasing and Inventory
vendor qualifications
supplies and reagents
critical services
contract review
inventory management

22. Introduction Laboratory Quality Management System-Module 1 22
Process Control
quality control
sample management
method validation
method verification

23. Introduction Laboratory Quality Management System-Module 1 23
Information Management
 confidentiality
 requisitions
 logs and records
 reports
 computerized laboratory
information systems (LIS)

24. Introduction Laboratory Quality Management System-Module 1 24
Documents Records
creation collection
revisions and review review
control and distribution storage
retention

25. Introduction Laboratory Quality Management System-Module 1 25
Occurrence Management
complaints
mistakes and problems
documentation
root cause analysis
immediate actions
corrective actions
preventive actions

26. Introduction Laboratory Quality Management System-Module 1 26
Laboratory Assessment
External
Proficiency
testing (EQA)
Inspections
Accreditations
Internal
Internal

27. Introduction Laboratory Quality Management System-Module 1 27
Process Improvement
opportunities for improvement (OFIs)
stakeholder feedback
problem resolution
risk assessment
preventive actions
corrective actions

28. Introduction Laboratory Quality Management System-Module 1 28
Customer Service
customer group identification
customer needs
customer feedback

29. Introduction Laboratory Quality Management System-Module 1 29
Facilities and Safety
safe working environment
transport management
security
containment
waste management
laboratory safety
ergonomics

30. Introduction Laboratory Quality Management System-Module 1 30
Implementing
Quality Management
does not
guarantee
an
ERROR-FREE
Laboratory
But it detects
errors that may
occur and
prevents them
from recurring

31. Introduction Laboratory Quality Management System-Module 1 31
Organizatio
n
Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Manageme
nt
Assessmen
t
Process
Improvement
Customer
Service
Facilities
&
Safety
Laboratories not
implementing a
quality management
system guarantees
UNDETECTED
ERRORS

32. Introduction Laboratory Quality Management System-Module 1 32
Laboratory
Quality Management System
Coordinated activities to direct
and control an organization
with regard to quality.
ISO 9000:2000

33. Introduction Laboratory Quality Management System-Module 1 33
Innovators of Quality
Walter
Shewhart
1891-1967
W. Edwards
Deming
1900-1993
Joseph Juran
1904-2008 (103 years)
Philip Crosby
1926-2001
Robert Galvin
b. 1922

34. Introduction Laboratory Quality Management System-Module 1 34
A Brief History of Quality Management
Innovator Date Cycle
Walter A.Shewhart 1920s Statistical Process
Control
W. Edwards Deming 1940s Continual
Improvement
Joseph M. Juran 1950s Quality Toolbox
Philip B. Crosby 1970s Quality by
Requirement
Robert W. Galvin 1980s Micro Scale Error
Reduction
Quality Management is not new.

35. Introduction Laboratory Quality Management System-Module 1 35
Standards Organizations
ISO
International Organization
for Standardization
CLSI
Clinical and Laboratory
Standards Institute
(formerly known as NCCLS)
Guidance for quality in
manufacturing and service
industries
Standards, guidelines, and
best practices for quality in
medical laboratory testing
Broad applicability; used
by many kinds of
organizations
Detailed; applies
specifically to medical
laboratories
Uses consensus process in
developing standards
Uses consensus process in
developing standards

36. Introduction Laboratory Quality Management System-Module 1 36
ISO Documents - Laboratory
ISO 9001:2000 Quality Management
System Requirements
Model for QA in design, development
production, installation, and servicing
ISO/IEC 17025:2005 General
requirements for the competence of
testing and calibration laboratories
ISO 15189:2007 Quality management
in the clinical laboratory

37. Introduction Laboratory Quality Management System-Module 1 37
ISO 15189:2007
 The foundation of international
medical laboratory quality
management
 Medical laboratories–Particular
requirements for quality
and competence

38. Introduction Laboratory Quality Management System-Module 1 38
CLSI Quality Documents
HS1-A2 A Quality Management System Model
for Health Care
describes quality system model, 12 essentials
aligns to ISO 15189 and parallels ISO 9000
applies to all health care systems
GP26-A3 Application of Quality Management
System Model for Laboratory Services
describes laboratory application of quality system model
relates the path of workflow to the quality system essentials
assists laboratory in improving processes
relates to HS1-A2 and ISO 15189

39. Introduction Laboratory Quality Management System-Module 1 39
In summary
 Quality management is not new.
 Quality management grew from the
good works of innovators who defined
quality over a span of 80 years.
 Quality management is as applicable
for the medical laboratory as it is for
manufacturing and industry.

40. Introduction Laboratory Quality Management System-Module 1 40
 A laboratory is a complex system and
all aspects must function properly to
achieve quality.
 Approaches to implementation will vary
with local situation.
 Start with the easiest, implement in
stepwise process.
 Ultimately, all quality management
system elements must be addressed.
Key Messages

41. Introduction Laboratory Quality Management System-Module 1 41
Questions?
Comments?
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety