Introduction- Laboratory

Quality Management
System

Learning Objectives

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
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The Quality Management System

Organization

Personnel

Purchasing
&
Inventory

Process
Control

Documents
&
Records

Occurrence
Management

Process
Improvement

Customer
Service

Equipment

Information
Management

Assessment

Facilities
&
Safety

What is Quality?

Achieving a 99% level of quality

means
accepting a 1%
1% error rate

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

Result:

1% failure

Essential to all aspects of

health care are laboratory
results that are

accurate,
reliable, and
timely
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Laboratory errors cost in

time

personnel
effort
patient
outcomes

Complexity of a Laboratory System

Reporting

Patient/Client Prep
Sample Collection
Personnel Competency
Test Evaluations
Data

& Laboratory
Management
Safety
Customer Service

Sample Receipt and

Accessioning

Record Keeping
Quality Control
Testing

Sample Transport

10

Path of Workflow
THE PATIENT

Test selection

Sample Collection

Preexamination Phase
Sample Transport

Laboratory Analysis
Examination Phase

Report Transport
Result Interpretation

Report Creation

Postexamination Phase
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Laboratory tests are influenced by

laboratory environment
knowledgeable staff
competent staff
reagents and equipment
quality control
process management
occurrence management
record keeping
12

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.
13

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

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Organization
Responsibilities, Authorities

Quality
Policy
Provision
of
resources

Communication

15

Personnel
human resources
job qualifications
job descriptions
training
competency assessment
professional development

16

Equipment

acquisition
installation
maintenance
calibration
troubleshooting
service and repair

17

Purchasing and Inventory

vendor qualifications
supplies and reagents
critical services
inventory management

18

Process Control

sample management
method validation and
method verification

19

Information Management

confidentiality
logs and records
reports
computerized laboratory

information systems (LIS)

20

Documents
creation
revisions and review
control and distribution

Records
collection
review
storage
retention

21

 Documents are written policies, process

descriptions, and procedures used to
communicate information. They provide
written instructions for HOW TO do a specific
task.
Blank forms are also considered documents.
Forms are used to capture data or
information from performing a procedure.

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 Records are generated when written

instructions are followed. In other
words, after data, information, or
results are recorded onto a form, label,
etc, then it becomes a record.

23

Occurrence Management

complaints
mistakes and problems
documentation
root cause analysis
immediate actions
corrective actions

24

Laboratory Assessment
Internal
External
Internal
Proficiency
testing (EQA)
Accreditations
Inspections

25

Process Improvement

26

Customer Service
customer group identification
customer needs
customer feedback

27

Facilities and Safety

safe working environment
security
waste management
laboratory safety

28

Implementing
Quality Management
does not
guarantee
an
ERROR-FREE
Laboratory

But it detects
errors that may
occur and
prevents them
from recurring

29

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

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Innovators of Quality
Walter
Shewhart
1891-1967

W. Edwards
Deming
1900-1993

Joseph Juran
1904-2008 (103 years)
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A Brief History of Quality Management

Quality Management is not new.

Innovator

Date

Cycle

Walter A.Shewhart

1920s

Statistical Process
Control

W. Edwards Deming

1940s

Continual Improvement

Joseph M. Juran

1950s

Quality Toolbox
(matrices and

flowcharts, data
collection, analysis
techniques, )
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Standards Organizations
ISO

International Organization
for Standardization
Guidance for quality in
manufacturing and service
industries
Broad applicability; used
by many kinds of
organizations
Uses consensus process in
developing standards

CLSI

Clinical and Laboratory

Standards Institute

(formerly known as NCCLS)

Standards, guidelines, and

best practices for quality in
medical laboratory testing
Detailed; applies
specifically to medical
laboratories
Uses consensus process in
developing standards
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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
34

ISO 15189:2007
The

foundation of international
medical laboratory quality
management
Medical laboratoriesParticular
requirements for quality
and competence
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CLSI Quality Documents

HS1-A2 A Quality Management System Model
for Health Care
describes quality system model, 12 essentials
applies to all health care systems
GP26-A3 Application of Quality Management
System Model for Laboratory Services
describes laboratory application of quality system model
assists laboratory in improving processes

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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.

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Key Messages

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.

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