iso lab introduction slides

8/18/2019 ISO Lab Introduction Slides

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Introduction-

Laboratory Quality

Management System


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Introduction Laboratory Quality Management System-Module 1 2

At the end of this activity, participants will beable 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

I! and "LI standards

Learning !b#ectives


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Organization Personnel Equipment

Purchasing

&

Inventory

Process

Control

Information

Management

Documents

&

Records

Occurrence

Management ssessment

Process

Improvement

Customer

!ervice

"acilities

&

!afety

$he %uality &anagement ystem


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'hat is %uality(


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Achieving a 99% level of quality

means

accepting a 1% error rate

1%


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In )rance a 1% error rate would mean everyday

*+ minutes without water or electricity

-,--- parcels lost by postal services

.. newborns falling from

midwives/ hands

0--,--- lunches contaminated

by bacteria

1 bad landings at !rly 2aris airport


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3esult: 1% failure


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Essential to all aspects of

health care are laboratoryresults that are

accurate,

reliable, and

timely


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Laboratory errors cost in

time

personnel effort

patientoutcomes


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How do weachieveexcellenter!ormancein thelaboratory"


Purchasing

&

Inventory

Process

Control

Information

Management

Documents

&

Records

Occurrence

Managementssessment

Process

Improvement

Customer

!ervice

"acilities

&

!afety


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%uality &anagement ystem Definition

"oordinated activities to direct andcontrol an organi4ation with regardto quality 5I!,"LI67

#ll asects o! the laboratory oeration

need to be addressed to assure$uality this constitutes

a $uality management system&


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'ath o! (or)!low

)E PIE* est selection !ample Collection

!ample ransport

#a$oratory nalysis

E+amination Phase

Report CreationReport ransport

Pree+amination Phase

Result Interpretation Poste+amination Phase


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(H* is the 2ath of 'or8flow essential

to consider in health laboratories(

$he entire rocess of managing asample must be considered:

the beginning: sample collection

the end: reporting and saving of results

all processes in between7


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Laboratory tests are influenced by

laboratory environment

8nowledgeable staff

competent staff

reagents and equipment

quality control

communications

process management

occurrence management

record 8eeping


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+welve Quality System ,ssentials

set ofcoordinated

activities thatfunction as

building bloc8sfor

quality

management


Purchasing

&

Inventory

Process

Control

Information

Management

Documents

&

Records

Occurrence

Managementssessment

Process

Improvement

Customer

!ervice

"acilities

&

!afety


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Purchasing

&

Inventory

Process

Control

Information

Management

Documents

&

Records

Occurrence

Managementssessment

Process

Improvement

Customer

!ervice

"acilities

&

!afety

Path of Worflo!


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!rgani4ationesonsibilities. #uthorities

/ommunication'rovisiono!

resources

Quality'olicy


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2ersonnel

human resources #ob qualifications

#ob descriptions

orientationtraining

competency assessment

professional developmentcontinuing education


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Equipmentacquisition

installation

validation

maintenance calibration

troubleshooting

service and repair

records


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2urchasing and Inventory

vendor qualifications

supplies and reagents

critical services

contract review

inventory management


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2rocess "ontrol

quality control

sample management

method validation

method verification


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Information &anagement

confidentiality

requisitions

logs and records

reports

computeri4ed laboratoryinformation systems 5LI6


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!ccurrence &anagement

complaints

mista8es and problems

documentationroot cause analysis

immediate actions

corrective actionspreventive actions


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Laboratory Assessment ,xternal

'ro!iciencytesting ,Q#2

Insections

#ccreditations

InternalInternal


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2rocess Improvement

opportunities for improvement 5!)Is6sta8eholder feedbac8

problem resolution

ris8 assessment

preventive actions

corrective actions


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"ustomer ervice

customer group identificationcustomer needs

customer feedbac8


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)acilities and afety

safe wor8ing environmenttransport management

security

containment

waste management

laboratory safetyergonomics


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Organization

Personnel Equipment

Purchasing

&

Inventory

Process

Control

Information

Management

Documents

&

Records

Occurrence

Manageme

nt

ssessmen

t

Process

Improvement

Customer

!ervice

"acilities

&

!afety

Laboratories not

implementing a

quality management

system guarantees

9DE$E"$ED

E33!3


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Laboratory

%uality &anagement ystem"oordinated activities to direct and

control an organi4ation with regard to

quality7

IS4 955567555


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Innovators of %uality

(alterShewhart*;


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A ?rief @istory of %uality &anagement

Innovator 0ate /ycle'alter A7hewhart 1975s tatistical 2rocess

"ontrol

'7 Edwards Deming

19:5s"ontinual

Improvement

oseph &7 uran 19;5s %uality $oolbox

2hilip ?7 "rosby 19


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tandards !rgani4ations

IS4 International !rgani4ationfor tandardi4ation

/LSI "linical and Laboratorytandards Institute

5formerly 8nown as ""L6

Buidance for quality inmanufacturing and serviceindustries

tandards, guidelines, andbest practices for quality inmedical laboratory testing

?road applicabilityC used

by many 8inds oforgani4ations

DetailedC applies

specifically to medicallaboratories

9ses consensus process in

developing standards

9ses consensus process in

developing standards


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I! Documents = LaboratoryIS4 955167555 Quality Management

System e$uirements &odel for %A in design, developmentproduction, installation, and servicing

IS4>I,/ 1


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I! **;

$he foundation of internationalmedical laboratory quality

management&edical laboratories2articular

requirements for quality

and competence


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"LI %uality Documents

HS1-#7 # Quality Management System Model!or Health /are

describes quality system model, *. essentials

aligns to I! **;< and parallels I!


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In summary %uality management is not new7

%uality management grew from the good wor8s ofinnovators who defined quality over a span of ;-years7

%uality management is as applicable for the medicallaboratory as it is for manufacturing and industry7


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A laboratory is a complex system and allaspects must function properly to achievequality7

Approaches to implementation will vary withlocal situation7

tart with the easiest, implement instepwise process7

9ltimately, all quality management system

elements must be addressed7

ey &essages


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I t d ti L b t Q lit M t S t M d l 1 41

%uestions(

"omments(


Purchasing

&

Inventory

Process

Control

Information

Management

Documents

&

Records

Occurrence

Managementssessment

Process

Improvement

Customer

!ervice

"acilities

&

!afety