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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

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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

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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

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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 )

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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

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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

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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

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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

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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

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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

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Cost of QualityCost of Quality

Appraisal

Failure

Prevention

Appraisal

Failure

Prevention

Before After

gain

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Demings chain

Improvement of quality Improvement of productivity

Cost-reductionPrice-reductionMarket-share

Secure position Secure jobs

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Demings chain in Laboratory Service

Improvement of quality Improvement of productivity

Cost-reductionPrice-reductionMarket-share

Secure position Secure jobs

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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 ?

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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.

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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.

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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”

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Should’nt we achieve Should’nt we achieve excellence ?excellence ?

Quality = ExcellenceQuality = Excellence

Excellence begins in your mindExcellence begins in your mind

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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

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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 !!

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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

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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

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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 )

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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

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Organization and PersonnelOrganization and Personnel

Quality management systemQuality management system

On AccountabilityOn Accountability

-Responsibilities-Responsibilities

-Authorities-Authorities

TrainingTraining

- Competency based- Competency based

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FacilitiesFacilities

Appropriate infrastructureAppropriate infrastructure Safety measuresSafety measures Hygiene measuresHygiene measures

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EquipmentEquipment

ValidatedValidated

- Does it do what you want it to do ?- Does it do what you want it to do ?

MaintainedMaintained

CalibratedCalibrated

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Reagents / Test KitsReagents / Test Kits

EvaluatedEvaluated Methodology validatedMethodology validated Test run validatedTest run validated

- Kit / reagent controls- Kit / reagent controls

- Internal control- Internal control

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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

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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

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Inter-laboratory comparisonInter-laboratory comparison

External Quality Assurance SchemeExternal Quality Assurance Scheme

( Proficiency Test , P.T. )( Proficiency Test , P.T. )

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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 )

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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

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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.

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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:

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Nine DimensionNine Dimension EfficacyEfficacy AppropriatenessAppropriateness AvailabilityAvailability TimelinessTimeliness EffectivenessEffectiveness ContinuityContinuity SafetySafety EfficiencyEfficiency Care and RespectCare and Respect

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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

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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

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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

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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

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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.

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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

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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

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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

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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)

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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.

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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 ) ??

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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

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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

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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

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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

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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

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PrepareDocuments as

Required inStandard Format

Authority Use OnlyValid &

ControlledDocuments

RegularReview,Revise

Easy Accessible to All

Obsolete Document

Authority

Return &Destroy

DistributionRetrieval

Document ControlDocument Control

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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

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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

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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

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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

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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

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Continual ImprovementContinual Improvement

Check

Do

Act

Plan

Benchmarkingor Beyond TQM

Objective of Changes

Quality Management System

Time

Improvement

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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

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Seven Determinants in TQMSeven Determinants in TQM

¾÷

Information

5M1E1I

Methods Environment

Monitoring &MeasuringMan

MaterialsMachine

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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)

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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

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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

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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

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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

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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

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Quality Standard Compliance Triangle & Quality Standard Compliance Triangle & Quality System Accreditation/CertificationQuality System Accreditation/Certification

QMSCertificationAccreditation

Documentation

Training Audit

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““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