1
From Good Laboratory Practice From Good Laboratory Practice to Total Quality Management in to Total Quality Management in Medical Laboratories : Medical Laboratories :
The PerspectiveThe Perspective
October, 2002 S ChengOctober, 2002 S Cheng
2
What is QualityWhat is Quality
Quality is the entity of a product ( service ) Quality is the entity of a product ( service ) which fulfils the defined and expected which fulfils the defined and expected requirementrequirement
The customer checks if the product meet the The customer checks if the product meet the requirementsrequirements
3
Quality in Medical Laboratory TestingQuality in Medical Laboratory Testing
The right test resultThe right test result, at the, at the Right time, on theRight time, on the Right specimen, from the right patient, withRight specimen, from the right patient, with
result interpretation based onresult interpretation based on Correct reference dataCorrect reference data, and at the, and at the Right priceRight price
4
Evolution of Quality Evolution of Quality Management PhilosophyManagement Philosophy
1930 – 60, 1930 – 60, Q.C. ( Cure )Q.C. ( Cure )
1970 – 80, Q.A. ( Preventive )1970 – 80, Q.A. ( Preventive )
To-day, TQM ( Holistic involvement )To-day, TQM ( Holistic involvement )
5
Evolution of Quality SystemsEvolution of Quality Systems
QualityControl
GoodManufacturing
Practice
Quality Assurance
Quality ManagementSystem
Total Quality Managment
Beyond TQM
1975-90 West1962-75 Japan
1950-62 TQCDeming, Juran,Ishikawa
1942-45 TPC
1930 SPCShewart
1920-1945 QC Depts1915 Gilbreth1890's Taylor
>2000
1980's ISO9000
1988 EEC1972 EPIC1969 WHO1968 UK1962 USA
ISO9004:1994ISO9001:1994
ISO9001:2000
6
Overview on the Functions of Overview on the Functions of The Medical LaboratoryThe Medical Laboratory
Reference Standardsand/or Statutory Requirements
SubcontractingLaboratories
(Tests & Calibration)
Hospital,Clinicians &
Clients
MedicalLaboratory
GLP/ISO/TQM
7
Tissue
MaterialSuppliers
Equipment
Process orTechniques
Environment
PersonnelPatient or Client(sample sources)
Physical Damageor Contamination
MicrobialContamination
Result: Accuracy Precision Reliability Efficiency Confidentiality
Information
Clinical Specimen AdulterationClinical Specimen Adulteration
8
Quality Management SystemQuality Management System
Achieving customer satisfaction by Achieving customer satisfaction by meeting customer’s expectation and meeting customer’s expectation and preventing non-conformity at all stage of preventing non-conformity at all stage of process from design to service.process from design to service.
Enhance the performance of the Enhance the performance of the organization through internal and external organization through internal and external auditaudit
9
Quality Management
Quality System
Quality Assurance
QualityControl
Policy, Objective,Committent & Direction
Organization Structure,Responsibility, Accoutability
Operational & TechnicalActivities on Fulfilling Quality
Requirements
External QAInternal QA
QM, QA and QC inter-QM, QA and QC inter-relationshipsrelationships
10
Why Quality Management is Why Quality Management is everybody’s darlingeverybody’s darling
Quality costs, but poor Quality Quality costs, but poor Quality costs morecosts more
Regulator : reduces workload, ( manpower )Regulator : reduces workload, ( manpower ) Blood Industry Officials: makes the Blood Industry Officials: makes the
environment transparentenvironment transparent Hospitals : reduces responsibility to patientsHospitals : reduces responsibility to patients
11
Cost of QualityCost of Quality
Appraisal
Failure
Prevention
Appraisal
Failure
Prevention
Before After
gain
12
Demings chain
Improvement of quality Improvement of productivity
Cost-reductionPrice-reductionMarket-share
Secure position Secure jobs
13
Demings chain in Laboratory Service
Improvement of quality Improvement of productivity
Cost-reductionPrice-reductionMarket-share
Secure position Secure jobs
14
My problems with the definitions My problems with the definitions of qualityof quality
Does the customer have all the information Does the customer have all the information he needs to qualify the products? Service?he needs to qualify the products? Service?
Is it his responsibility to check the quality Is it his responsibility to check the quality or standards?or standards?
Is’nt there a discrepancy between Is’nt there a discrepancy between customer’s expectations and requirements ?customer’s expectations and requirements ?
15
It is our ethical responsibility to It is our ethical responsibility to define the level of qualitydefine the level of quality
A patient is not able to figure all transfusion A patient is not able to figure all transfusion risks. He might be unconscious on intensive risks. He might be unconscious on intensive care.care.
We know all about transfusion risk and We know all about transfusion risk and must be responsible for the safety.must be responsible for the safety.
A perfect balance is the major support for a A perfect balance is the major support for a good quality management.good quality management.
16
Flawless quality management:Flawless quality management:( Error Management )( Error Management )
Quality management has to be flawless. Quality management has to be flawless. Discovery of errors in documents, or Discovery of errors in documents, or problems must lead to the consideration to problems must lead to the consideration to end, or change the process.end, or change the process.
17
Quality LayersQuality Layers
1.1. Minimal requirements “ Bad Quality”Minimal requirements “ Bad Quality”
2.2. Functional Requirement “Quality”Functional Requirement “Quality”
3.3. Non-functional requirements “Good Non-functional requirements “Good Quality”Quality”
4.4. Far ahead of customer expectations Far ahead of customer expectations “Excellence”“Excellence”
18
Should’nt we achieve Should’nt we achieve excellence ?excellence ?
Quality = ExcellenceQuality = Excellence
Excellence begins in your mindExcellence begins in your mind
19
Quality PlanningQuality Planning
Part of Quality management focused on Part of Quality management focused on setting quality objectives and specifying setting quality objectives and specifying necessary processes and related resources to necessary processes and related resources to fulfil the quality objectivefulfil the quality objective
20
3 3 E in qualityE in quality
Effectiveness Effectiveness ( ( doing the right thingsdoing the right things)) - extent to which planed activities are realized and planed - extent to which planed activities are realized and planed
results achievedresults achieved Efficiency Efficiency ( ( doing things rightdoing things right ) ) - relationship between the result achieved and the resources - relationship between the result achieved and the resources
usedused ExcellenceExcellence - Doing the right things right !!- Doing the right things right !!
21
The 8 columns of excellenceThe 8 columns of excellence
Orientation on results
Orientation of customers
Leadership & consequences of goals
Management ofprocesses & facts
Involvement ofemployees
Continuous learning
Building partnerships
Responsibility forthe community
22
Achieved By Good PracticesAchieved By Good Practices
GLP – Good Laboratory PracticeGLP – Good Laboratory Practice GCL – Good Clinical PracticeGCL – Good Clinical Practice GMP – Good Manufacturing PracticeGMP – Good Manufacturing Practice GTP – Good Transportation PracticeGTP – Good Transportation Practice GDP – Good Distribution PracticeGDP – Good Distribution Practice GAMP – Good Automated Manufacturing GAMP – Good Automated Manufacturing
PracticePractice GRP- Good Regulatory PracticeGRP- Good Regulatory Practice
23
Medical laboratory quality Medical laboratory quality systemsystem
A quality system is essential in the A quality system is essential in the laboratory to ensure the correct results laboratory to ensure the correct results for the correct patient / donorfor the correct patient / donor
By Good Laboratory PracticeBy Good Laboratory Practice
( GLP )( GLP )
24
Good Laboratory Practice( GLP )Good Laboratory Practice( GLP )
Main areas of GLPMain areas of GLP - Organization and personnel- Organization and personnel- FacilitiesFacilities- EquipmentEquipment- Reagent / test kitsReagent / test kits- DocumentationDocumentation- Inter-laboratory comparisonInter-laboratory comparison
25
Organization and PersonnelOrganization and Personnel
Quality management systemQuality management system
On AccountabilityOn Accountability
-Responsibilities-Responsibilities
-Authorities-Authorities
TrainingTraining
- Competency based- Competency based
26
FacilitiesFacilities
Appropriate infrastructureAppropriate infrastructure Safety measuresSafety measures Hygiene measuresHygiene measures
27
EquipmentEquipment
ValidatedValidated
- Does it do what you want it to do ?- Does it do what you want it to do ?
MaintainedMaintained
CalibratedCalibrated
28
Reagents / Test KitsReagents / Test Kits
EvaluatedEvaluated Methodology validatedMethodology validated Test run validatedTest run validated
- Kit / reagent controls- Kit / reagent controls
- Internal control- Internal control
29
Documentation (1)Documentation (1)
Testing strategies / protocolsTesting strategies / protocols - Specimen identification- Specimen identification - Confidentiality- Confidentiality SOPsSOPs - Sample processing- Sample processing - Test performance and result interpretation- Test performance and result interpretation - Inspection of incoming goods- Inspection of incoming goods - Validation- Validation - Equipment maintenance and calibration- Equipment maintenance and calibration - Safety- Safety
30
Documentation (2)Documentation (2)
RecordsRecords
- Test results- Test results
- Equipment maintenance- Equipment maintenance
- Equipment calibration- Equipment calibration
- Control charts- Control charts
- Validation- Validation
- Training- Training
31
Inter-laboratory comparisonInter-laboratory comparison
External Quality Assurance SchemeExternal Quality Assurance Scheme
( Proficiency Test , P.T. )( Proficiency Test , P.T. )
32
By Other Quality Management By Other Quality Management SystemSystem
International StandardsInternational Standardse.g. e.g. ISO 9000 series,ISO 9000 series,
ISO/IEC 17025:1999ISO/IEC 17025:1999
( General Requirements for the Competence of ( General Requirements for the Competence of Testing and Calibration Laboratories ) Testing and Calibration Laboratories )
33
ISO1/IEC 17025, ISO15189 ISO1/IEC 17025, ISO15189 Development History Development History
ISOGuide 25
1978
ISO/IECGuide 25 1st Ed.
1982
ISO/IECGuide 25 2nd Ed.
1990
ISO/IEC 17025:1999(Standard)
ISO/DIS 15189 (2002)Medical Laboratories
Particular Requirements for Quality& Competance
Beyond TQM
ISO9000-2000
ISO9000-1994
ISO9000-1987
NATA ILAC(1947) (1945)
>2000
Guideline(Testing)
Requirement(Testing)
Requirement(Testing/Calibration)
Requirements forCompetence of
Testing & Calibration
Standards
34
InIn 1985 JCAHO published its 10-step 1985 JCAHO published its 10-step QA monitoring process.QA monitoring process.
1.1. Assign responsibility for QA plan.Assign responsibility for QA plan.
2.2. Define scope of patient care.Define scope of patient care.
3.3. Identify important aspects of care.Identify important aspects of care.
4.4. Construct indicators.Construct indicators.
5.5. Define thresholds for evaluation.Define thresholds for evaluation.
6.6. Collect and organize data.Collect and organize data.
7.7. Evaluate data.Evaluate data.
8.8. Develop corrective action plan.Develop corrective action plan.
9.9. Assess action; document improvement.Assess action; document improvement.
10.10. Communicate relevant information.Communicate relevant information.
35
JCAHO has also established JCAHO has also established nine nine dimensions of performance that dimensions of performance that must be included and measured in must be included and measured in the design of the organization’s the design of the organization’s quality assessment and performance quality assessment and performance improvement plan:improvement plan:
36
Nine DimensionNine Dimension EfficacyEfficacy AppropriatenessAppropriateness AvailabilityAvailability TimelinessTimeliness EffectivenessEffectiveness ContinuityContinuity SafetySafety EfficiencyEfficiency Care and RespectCare and Respect
37
National Accreditation SchemeNational Accreditation Scheme
CAP Laboratory Accreditation Programm CAP Laboratory Accreditation Programm ( LAP ), USA( LAP ), USA
CPA , Clinical Pathology AccreditationCPA , Clinical Pathology Accreditation
( UK) Ltd., Standards for the Medical ( UK) Ltd., Standards for the Medical LaboratoryLaboratory
38
ISO/IEC 17025:1999- General Requirements ISO/IEC 17025:1999- General Requirements for the Competence of Testing & Calibration for the Competence of Testing & Calibration Laboratories Laboratories ( Based on ISO9001:1994 )( Based on ISO9001:1994 )
An international standard for An international standard for recognising competence in testing & recognising competence in testing & calibration laboratoriescalibration laboratories
39
ISO/IEC 17025:1999- General Requirements ISO/IEC 17025:1999- General Requirements for the Competence of Testing & Calibration for the Competence of Testing & Calibration Laboratories con’t Laboratories con’t
Sets out basic quality system requirements Sets out basic quality system requirements in accordance with ISO9001 or 9002in accordance with ISO9001 or 9002
Laboratories carrying out calibration and Laboratories carrying out calibration and testing activities and meeting the testing activities and meeting the requirements will therefore also operate requirements will therefore also operate accordance with the ISO 9000 series quality accordance with the ISO 9000 series quality systemsystem
40
ISO9001:1994 – The Role and ISO9001:1994 – The Role and Function of 20 ElementsFunction of 20 Elements
4.8 4.13
4.104.12 4.11
4.20
4.3 4.194.154.94.6/74.4Q
4.14.2
4.5 4.16 4.184.14 4.17
Policy & OrganisationStructure
Control Management &Training
Measuring, Identification& Traceability
Essential Processes
41
Management and Technical Management and Technical criteria for Accreditationcriteria for Accreditation
Compliance with criteria in Section 4, Compliance with criteria in Section 4, Management Requirements;Management Requirements;
Compliance with the criteria in Section 5, Compliance with the criteria in Section 5, Technical Requirements of Technical Requirements of Technical Criteria Technical Criteria for Laboratory Accreditation HKLAS 003for Laboratory Accreditation HKLAS 003
Compliance with HKLAS 002 – regulations Compliance with HKLAS 002 – regulations governing the administration of HOKLAS and governing the administration of HOKLAS and the obligations of accredited laboratories.the obligations of accredited laboratories.
42
UNCERTAINTY OF UNCERTAINTY OF MEASUREMENTMEASUREMENT
Calibration LaboratoriesCalibration Laboratories Accredited for calibrations under the Accredited for calibrations under the
“Calibration Service” Test category“Calibration Service” Test category Refer to ISO “Guide to Expression of Refer to ISO “Guide to Expression of
Uncertainty in Measurement” (GUM)Uncertainty in Measurement” (GUM) Refer to EA-4/02, for application of GUM Refer to EA-4/02, for application of GUM
website:www.european-accreditation.orgwebsite:www.european-accreditation.org
43
Testing LaboratoriesTesting Laboratories
Required to estimate the uncertainty of Required to estimate the uncertainty of measurement in accordance with 5.4.6.2 of measurement in accordance with 5.4.6.2 of the HKLAS 003the HKLAS 003
44
Asia Pacific Laboratory Accreditation Asia Pacific Laboratory Accreditation Cooperation (APLAC)Cooperation (APLAC)
Established in 1992, Secretary Office in AustraliaEstablished in 1992, Secretary Office in Australia MRA, Mutual Recognition AgreementMRA, Mutual Recognition Agreement Members consisted of 7 countries, 13 Laboratory Members consisted of 7 countries, 13 Laboratory
accredition bodies (December, 1999 figure)accredition bodies (December, 1999 figure)1.1. China, China Taipei, China Hong KongChina, China Taipei, China Hong Kong2.2. AustraliaAustralia3.3. New ZealandNew Zealand4.4. KoreaKorea5.5. SingaporeSingapore6.6. United StateUnited State7.7. JapanJapan
45
The Hong Kong Laboratory The Hong Kong Laboratory Accreditation Scheme (HOKLAS)Accreditation Scheme (HOKLAS)
Found in 1985Found in 1985 Function : identifying and recognising Function : identifying and recognising
competent testing & calibration laboratories competent testing & calibration laboratories in Hong Kongin Hong Kong
Expanded in 1998, forming Hong Kong Expanded in 1998, forming Hong Kong Accreditation Service (HKAS)Accreditation Service (HKAS)
46
HKLAS – Scope of HKLAS – Scope of AccreditationAccreditation Electrical and Electronic ProductsElectrical and Electronic Products Textiles and GarmentsTextiles and Garments Toys and children productToys and children product FoodFood Calibration serviceCalibration service Construction materialsConstruction materials Environmental testingEnvironmental testing Chemical testingChemical testing MiscellaneousMiscellaneous
Other Test Categories may be added when Other Test Categories may be added when significant needs are identified.significant needs are identified.
47
Pathology Laboratory Pathology Laboratory Accreditation in Hong KongAccreditation in Hong Kong
In year 2003In year 2003 Mandatory orMandatory or
Voluntary ??Voluntary ??
Based on which standard (S ) ?? Based on which standard (S ) ??
48
Technical Criteria – ISO/IEC17025:1999 Technical Criteria – ISO/IEC17025:1999 4. Management Requirements4. Management Requirements
4.1 4.1 OrganizatonOrganizaton4.2 Quality system4.2 Quality system4.3 Document control4.3 Document control4.4 Review of request, 4.4 Review of request,
tenders or contracttenders or contract4.5 Subcontracting of tests 4.5 Subcontracting of tests
and calibrationsand calibrations4.6 Purchasing services and 4.6 Purchasing services and
suppliessupplies4.7 Service to the client4.7 Service to the client
4.8 4.8 ComplaintsComplaints
4.9 Control of NC Testing 4.9 Control of NC Testing and/or calibration workand/or calibration work
4.10 Corrective action4.10 Corrective action
4.11 Preventive action4.11 Preventive action
4.12 Control of records4.12 Control of records
4.13 Internal audits4.13 Internal audits
4.14 Management Reviews4.14 Management Reviews
49
5. 5. Technical RequiremntsTechnical Requiremnts
5.1 5.1 GeneralGeneral
5.2 Personnel5.2 Personnel
5.3 Accommodation & 5.3 Accommodation & environment conditionsenvironment conditions
5.4 Tests & calibration 5.4 Tests & calibration methods and methods methods and methods validationvalidation
5.5 Equipment5.5 Equipment
5.6 5.6 Measurement traceabilityMeasurement traceability
5.7 Sampling5.7 Sampling
5.8 Handling of test and 5.8 Handling of test and calibration itemscalibration items
5.9 Assuring the quality of 5.9 Assuring the quality of testtest
5.10 Reporting the results5.10 Reporting the results
50
Quality Policy – determined and Quality Policy – determined and issued by the Top Managementissued by the Top Management
Objectives
Policy Statement, Vision, Mission &Quality Planning:Commitment to Quality of Professional Standards Quality Standard Requirements e.g. ISO9000; ISO/IEC17025 etc
Understanding,Implementation &
Review
Service Standardsand / or Statutory
Requirements
Communication
51
Documentation Structure : hierarchyDocumentation Structure : hierarchy
WI
Records
QP
Quality Manual(Policy, Vision, Mission, Objectives
and Commitment to Quality)Structure, Responsibility &
AuthorityQM
Quality Procedure(Guidelines to perform quality
related activities)SOP
Forms, Results, ReferenceStandards &
Equipment Manuals
52
Documentation SystemDocumentation SystemQualityPolicy
Maintenance
Calibration
Distribution
Training
Quality PolicyManual
Computer
QualityRecords
Patient / Client
QC/QA Testing
Registers / Log
Other Records
Production
Codes ofProfession
Specifications Directions
Critical Materials
Labels
Process
Quality Control
Reagents / Kits
Equipment
Management QPs
Workplace WIs
Management QMs
CollectionProcessingTesting/ExamStorageLabelling
Personal Data and Testing
AuditIncident and ComplaintSurveillance QADisposalSystem Reviews
Organization ReviewsInternational Standards (ISO
9000)
Service Standards
(ISO 17025)
OS&H Ordinance
Calibration Device
Chemicals (MSDS)
Materials
Organization Background,Vision, Mission, Objectives, Plans
Responsibilty, Authority
53
PrepareDocuments as
Required inStandard Format
Authority Use OnlyValid &
ControlledDocuments
RegularReview,Revise
Easy Accessible to All
Obsolete Document
Authority
Return &Destroy
DistributionRetrieval
Document ControlDocument Control
54
Benefits of Quality SystemsBenefits of Quality Systems
Consistently achieve ‘customers’ requirementsConsistently achieve ‘customers’ requirements Minimize errors, “waste” and complaintsMinimize errors, “waste” and complaints Improve efficiencyImprove efficiency ReducesReduces
- negative impact on customers- negative impact on customers
- likelihood of litigation- likelihood of litigation
- communication breakdown- communication breakdown
55
Con’tCon’t
Improve safety and moraleImprove safety and morale StandardizationStandardization Ensure adequacy of resourcesEnsure adequacy of resources Build-in improvement toolsBuild-in improvement tools Facilitates changes & easier problem Facilitates changes & easier problem
solvingsolving
56
ISO 15189ISO 15189 Medical Laboratories – Medical Laboratories – Particular requirements for quality and Particular requirements for quality and competence competence ( Based on ISO9001:2000)( Based on ISO9001:2000)
4 4 Management requirementManagement requirement
4.1 Organisation and management4.1 Organisation and management
4.2 Quality management system4.2 Quality management system
4.3 Document control4.3 Document control
4.4 Review of requests and contracts4.4 Review of requests and contracts
4.5 Examination by referral laboratories4.5 Examination by referral laboratories
4.6 External services and supplies4.6 External services and supplies
4.7 Advisory services4.7 Advisory services
57
Medical Laboratories – Particular Medical Laboratories – Particular requirements for quality and requirements for quality and competence (con’t)competence (con’t)
4.8 4.8 Resolution of complaintsResolution of complaints4.9 Identification and control of nonconformities4.9 Identification and control of nonconformities4.10 Continual improvement4.10 Continual improvement4.11 Corrective action4.11 Corrective action4.12 Preventive action4.12 Preventive action4.13 Quality and technical records4.13 Quality and technical records4.14 Internal audits4.14 Internal audits4.15 Management review4.15 Management review
58
Medical Laboratories – Particular Medical Laboratories – Particular requirements for quality and competence requirements for quality and competence (con’t)(con’t)
5 5 Technical requirementsTechnical requirements5.1 Personnel5.1 Personnel5.2 Accommodation and environmental conditions5.2 Accommodation and environmental conditions5.3 Laboratory equipment5.3 Laboratory equipment5.4 Pre-examination procedures5.4 Pre-examination procedures5.5 Examination procedures5.5 Examination procedures5.6 Assuring the quality of examination procedures5.6 Assuring the quality of examination procedures5.7 Post-examination process5.7 Post-examination process5.8 Reporting of results5.8 Reporting of results5.9 Alterations and amendments of reports5.9 Alterations and amendments of reports
59
Continual ImprovementContinual Improvement
Check
Do
Act
Plan
Benchmarkingor Beyond TQM
Objective of Changes
Quality Management System
Time
Improvement
60
Deming CycleDeming Cycle (Plan, Do, Check & Act)(Plan, Do, Check & Act)
Act
(Head & Manager)
Do(Operator)
Check(Monitor & Auditor)
Plan(Manager & Supervisor)
P-D-C-A
61
Seven Determinants in TQMSeven Determinants in TQM
¾÷
Information
5M1E1I
Methods Environment
Monitoring &MeasuringMan
MaterialsMachine
62
Appropriate Choice ofTests
Laboratory-clinicInterface
Testing Sample Transport
Registration (Reconciliation)
Laboratory-clinicInterface
Patient during at afterHealth Service
Dispensing / Archive
Analysis & Testing
Analytical Test Result
Result Verification
ISO15189 (Basedon ISO9001:2000)
NO
N-C
OM
FO
RM
ITY
CO
NT
RO
LS
Feedback
Feedback
Co
mm
un
ication
Handling of Testand Calibration
ItemsStorage Security
DisposalManagement
INFORMATION SYSTEM Security Control
Patient & Laboratory DataUp-Date, & Storage
Authorization To Release
Patient/Client SeekingHealth Service
Material ControlAcceptance,Quarantine &
StorageInventory
Management
DOCUMENTATION,RECORD, DATA
CONTROL
HygieneSterilityControlOS&H
QUALITY SYSTEM
Laboratory
Medical
Testing
ISO17025 (Basedon ISO9001:1994)
StructureObjective
Policies
Management Review
Personnel
Responsibilities
Corrective Preventive Action
Resources
Accommodation & Environmental Conditions
QualityPlanning
Requirements &Specifications
ClinicalDiagnosis
ResultDistribution
Logistics
Confirmatory Test
Purchasing
Logistics
Use ofLaboratory Data
Reporting
Request, Tenders & Contract Review
History
File
CollectionLogistics
Monitoring,Measuring & Testing
Test/CalibrationResults AssuranceQ.C., Q.A.EQASProficiency Test(ISO/IEC Guide 43)MeasurementTraceability
STAFFTRAINING &COMPETENCE
ISO17025 (ISO15189) GENERAL LAYOUTMedical Questioning
& Supplies
SYSTEMVALIDATION
EQUIPMENTMAINTENANCE &CALIBRATION
ContractedLaboratoriesfor tests andcalibrations
Re-test
ISO15189Ethics in Laboratory Medicine
Complaint Audit
ISO15189(Continual
Improvement)
63
Model for Medical Laboratories with Model for Medical Laboratories with Patient / Client as “Customer”Patient / Client as “Customer”
Patient/ClientSeekingClinical
PathologyService
PATIENTduring &after
Health Service
sampling
testing
MANAGE
result analysis
END-USERS
SUPPLIERShardware software consumables
SUBCONTRACTORS(tests & calibration)
REGULATORY AGENCYLEGISLATURE
FUNDING AGENCYMedical
Laboratory
reporting
PERSONNELEducation and Competency
SUPPORT
64
New Rules of the Game…..New Rules of the Game…..
Diminishing ResourcesDiminishing Resources Lowering of staff levelLowering of staff level Increasing AccountabilityIncreasing Accountability Increasing RegulationIncreasing Regulation Complex RelationshipsComplex Relationships Rate of changesRate of changes New value SystemsNew value Systems
The Age of Innocence is overThe Age of Innocence is over
65
The Drive for Public Sector The Drive for Public Sector EfficienciesEfficiencies
The quest for balanced BudgetsThe quest for balanced Budgets Monopolies and monopsoniesMonopolies and monopsonies PrivatisationPrivatisation RegionlizationRegionlization Price signalsPrice signals
66
Some Common GoalsSome Common Goals
Standardize Business SystemStandardize Business System Standardize System PerformanceStandardize System Performance Strengthen the Skills of our PeopleStrengthen the Skills of our People
67
Customers Focus and Customers Focus and Expectation continue forExpectation continue for
Good Price for Best QualityGood Price for Best Quality
Model of process-based quality management systemModel of process-based quality management systemOverview of ISO 9001:2000Overview of ISO 9001:2000
Resourcemanagement
Measurement,analysis & improvement
ProductProductRealization
Continual Improvement of the Quality Management System
Input Output
Management responsibility
Customers(and other interested
parties)
Requirements
Customers(and other interested
parties)
Satisfaction
69
Quality Standard Compliance Triangle & Quality Standard Compliance Triangle & Quality System Accreditation/CertificationQuality System Accreditation/Certification
QMSCertificationAccreditation
Documentation
Training Audit
70
““The system approach begins The system approach begins when first you see the world when first you see the world through the eyes of another”through the eyes of another”
C.W. ChurchmanC.W. Churchman
19681968
Top Related