Roderick Chappel, Sandy Walker and Elizabeth M. Dax nrl.au

Quality Management Systems (QMS)for Laboratories

Preparation and Implementation

Requirements of ISO/IEC 17025 and ISO 9000

Elizabeth M. DaxNational Serology Reference

Laboratory, Australiawww.nrl.gov.au

Quality Management Systems (QMS)for Laboratories

Preparation and Implementation

Requirements of ISO/IEC 17025 and ISO 9000

Elizabeth M. DaxNational Serology Reference

Laboratory, Australiawww.nrl.gov.au

Roderick Chappel, Sandy Walker and Roderick Chappel, Sandy Walker and Elizabeth M. Dax Elizabeth M. Dax

www.nrl.gov.auwww.nrl.gov.au

Roderick Chappel, Sandy Walker and Roderick Chappel, Sandy Walker and Elizabeth M. Dax Elizabeth M. Dax

www.nrl.gov.auwww.nrl.gov.au

From the National Serology Reference Laboratory,

Australia41 Victoria Parade, Fitzroy, Vic Australia

3065WHO Collaborating Centre on HIV/AIDS since 1985

From the National Serology Reference Laboratory,

Australia41 Victoria Parade, Fitzroy, Vic Australia

3065WHO Collaborating Centre on HIV/AIDS since 1985

Aims of the QMS SectionAims of the QMS Section

To clarify the requirements of a Quality To clarify the requirements of a Quality

Management System (QMS)Management System (QMS)

To clarify the requirements of a Quality To clarify the requirements of a Quality

Management System (QMS)Management System (QMS)

Objectives of the QMS Section (1)Objectives of the QMS Section (1)

Define aims, costs and benefits of a QMS Define aims, costs and benefits of a QMS

Share NRL’s experience in preparing for Share NRL’s experience in preparing for

and implementing a QMS and implementing a QMS

Define requirements of ISO/IEC 17025 and Define requirements of ISO/IEC 17025 and

the overlap with ISO 9001the overlap with ISO 9001

Define aims, costs and benefits of a QMS Define aims, costs and benefits of a QMS

Share NRL’s experience in preparing for Share NRL’s experience in preparing for

and implementing a QMS and implementing a QMS

Define requirements of ISO/IEC 17025 and Define requirements of ISO/IEC 17025 and

the overlap with ISO 9001the overlap with ISO 9001

Objectives of the QMS Section (2)Objectives of the QMS Section (2)

To train in the more ‘difficult’ elements of ISO/IEC 17025 To train in the more ‘difficult’ elements of ISO/IEC 17025

and ISO 9001, including and ISO 9001, including

Requirements of a documented quality systemRequirements of a documented quality system

Document controlDocument control

Internal auditsInternal audits

Corrective actionCorrective action

Equipment Equipment

Management reviewManagement review

To train in the more ‘difficult’ elements of ISO/IEC 17025 To train in the more ‘difficult’ elements of ISO/IEC 17025

and ISO 9001, including and ISO 9001, including

Requirements of a documented quality systemRequirements of a documented quality system

Document controlDocument control

Internal auditsInternal audits

Corrective actionCorrective action

Equipment Equipment

Management reviewManagement review

Aims in Achieving QualityAims in Achieving Quality

To ensure that outputs and outcomes areTo ensure that outputs and outcomes are

consistentconsistent

reproducible reproducible

traceable traceable

efficaciousefficacious

To ensure no harmTo ensure no harm

To ensure that outputs and outcomes areTo ensure that outputs and outcomes are

consistentconsistent

reproducible reproducible

traceable traceable

efficaciousefficacious

To ensure no harmTo ensure no harm

The Value of StandardsThe Value of Standards

Help us do things betterHelp us do things better

Necessary complianceNecessary compliance

Learning from others' experiencesLearning from others' experiences

Encourage continuous improvementEncourage continuous improvement

Help us do things betterHelp us do things better

Necessary complianceNecessary compliance

Learning from others' experiencesLearning from others' experiences

Encourage continuous improvementEncourage continuous improvement

Effect of Quality Management on Costs


Initial costsInitial costs

internal costs of failureinternal costs of failuree.g. testing errors, reworkinge.g. testing errors, reworking

external costs of failureexternal costs of failuree.g. complaints, losing customerse.g. complaints, losing customers

Initial costsInitial costs

internal costs of failureinternal costs of failuree.g. testing errors, reworkinge.g. testing errors, reworking

external costs of failureexternal costs of failuree.g. complaints, losing customerse.g. complaints, losing customers



Implementation costsImplementation costs

Ongoing costsOngoing costspreventionpreventionappraisalappraisalfailure costs (reduced)failure costs (reduced)

Implementation costsImplementation costs

Ongoing costsOngoing costspreventionpreventionappraisalappraisalfailure costs (reduced)failure costs (reduced)

Effect of Quality Management on CostsEffect of Quality Management on Costs

External CostsExternal Costs

Internal costsInternal costs

Implementation CostsImplementation Costs

Ongoing CostsOngoing CostsAppraisalAppraisal

PreventionPrevention

External CostsExternal Costs

Internal costsInternal costs

Co

st $

Co

st $

TimeTime

The BenefitsThe Benefits

Independent endorsement of Independent endorsement of competencecompetence

Improved service to stakeholdersImproved service to stakeholders

Increased awareness of qualityIncreased awareness of quality

Organisational stabilityOrganisational stability

Independent endorsement of Independent endorsement of competencecompetence

Improved service to stakeholdersImproved service to stakeholders

Increased awareness of qualityIncreased awareness of quality

Organisational stabilityOrganisational stability

Accreditation and CertificationAccreditation and Certification

Laboratory AccreditationLaboratory AccreditationNATA/RCPA Medical TestingNATA/RCPA Medical TestingNATA - ISO/IEC Guide 25:1990NATA - ISO/IEC Guide 25:1990NATA - ISO 17025:2000NATA - ISO 17025:2000

Laboratory AccreditationLaboratory AccreditationNATA/RCPA Medical TestingNATA/RCPA Medical TestingNATA - ISO/IEC Guide 25:1990NATA - ISO/IEC Guide 25:1990NATA - ISO 17025:2000NATA - ISO 17025:2000

Accreditation and CertificationAccreditation and Certification

Quality CertificationQuality Certification

ISO 9001, ISO 9002:1994ISO 9001, ISO 9002:1994

ISO 9001:2000ISO 9001:2000

Quality CertificationQuality Certification

ISO 9001, ISO 9002:1994ISO 9001, ISO 9002:1994

ISO 9001:2000ISO 9001:2000

Requirements SimplifiedRequirements Simplified

Technical Management

NATA/RCPA yes no

Guide 25 yes yes

ISO 17025 yes yes

ISO 9000 no yes

Quality Assurance SystemsWhy Both NATA & ISO 9000?

Quality Assurance SystemsWhy Both NATA & ISO 9000?

ISO 9000Management

NATATechnical

Implementing the GuidelinesImplementing the GuidelinesImplementing the GuidelinesImplementing the Guidelines

Design a systemDesign a system

Implement the systemImplement the system

Verify the system meets the Verify the system meets the guidelines (audits, reviewguidelines (audits, review))

Finalise implementationFinalise implementation

Design a systemDesign a system

Implement the systemImplement the system

Verify the system meets the Verify the system meets the guidelines (audits, reviewguidelines (audits, review))

Finalise implementationFinalise implementation QU

AL

ITY

SY

ST

EM

QU

AL

ITY

SY

ST

EM

Developing a Quality SystemIn a Quality System, work activities are described in written procedures and carried out in a planned way. The structure of a Quality System conforms to the relevant standards.

Developing a Quality SystemIn a Quality System, work activities are described in written procedures and carried out in a planned way. The structure of a Quality System conforms to the relevant standards.

Quality Policy

Quality Strategy

Quality Manual

Procedures

Work Instructions

Mission StatementMission Statement

How policy implemented.How policy implemented.

QP + QS + description of quality system, how standards are applied.

QP + QS + description of quality system, how standards are applied.

Describe how processes which affect quality are carried out.

Describe how processes which affect quality are carried out.

Additional detail on how specific jobs are carried out.

Additional detail on how specific jobs are carried out.

1. Management1. Management Management and staff commitmentManagement and staff commitment

““Management & leadership is for Management & leadership is for

everyone”everyone”

Appoint Quality Manager to establish, Appoint Quality Manager to establish,

implement and maintain the quality implement and maintain the quality

systemsystem

1. Management1. Management Management and staff commitmentManagement and staff commitment

““Management & leadership is for Management & leadership is for

everyone”everyone”

Appoint Quality Manager to establish, Appoint Quality Manager to establish,

implement and maintain the quality implement and maintain the quality

systemsystem

Implementing a QMSImplementing a QMSImplementing a QMSImplementing a QMS

2. Quality System Planning2. Quality System Planning

Training of appropriate personnelTraining of appropriate personnel

Visit other organisationsVisit other organisations

2. Quality System Planning2. Quality System Planning

Training of appropriate personnelTraining of appropriate personnel

Visit other organisationsVisit other organisations


3. Quality System Design3. Quality System Design

Identify core processesIdentify core processes

Create an organisation process mapCreate an organisation process map

Structure documentation around the processesStructure documentation around the processes

““Allow standard to fit organisation”Allow standard to fit organisation”

3. Quality System Design3. Quality System Design

Identify core processesIdentify core processes

Create an organisation process mapCreate an organisation process map

Structure documentation around the processesStructure documentation around the processes

““Allow standard to fit organisation”Allow standard to fit organisation”


4. Format of Documents4. Format of Documents

Determine format of quality system Determine format of quality system

documentsdocuments

Document this in a procedureDocument this in a procedure

4. Format of Documents4. Format of Documents

Determine format of quality system Determine format of quality system

documentsdocuments

Document this in a procedureDocument this in a procedure


5. Successful implementation requires:5. Successful implementation requires:

planning, management,planning, management,

belief in systembelief in system

understanding the “spirit” of the standardunderstanding the “spirit” of the standard

understanding organisation’s aimsunderstanding organisation’s aims

having staff involved at all levelshaving staff involved at all levels

look for real process improvementslook for real process improvements

setting realistic time framessetting realistic time frames

5. Successful implementation requires:5. Successful implementation requires:

planning, management,planning, management,

belief in systembelief in system

understanding the “spirit” of the standardunderstanding the “spirit” of the standard

understanding organisation’s aimsunderstanding organisation’s aims

having staff involved at all levelshaving staff involved at all levels

look for real process improvementslook for real process improvements

setting realistic time framessetting realistic time frames

Implementing a QMS cont.Implementing a QMS cont.Implementing a QMS cont.Implementing a QMS cont.

5. Implementation 5. Implementation

Set out the program for Implementation in Set out the program for Implementation in

stages: Gantt chart format is most appropriatestages: Gantt chart format is most appropriate

5. Implementation 5. Implementation

Set out the program for Implementation in Set out the program for Implementation in

stages: Gantt chart format is most appropriatestages: Gantt chart format is most appropriate


Implementation at NRLImplementation at NRL

ID Task Name

1 NRL CERTIFICATION2 Quality system planning3 Training - P & WI preparation4 Produce Ps & WIs 5 Implementation 6 Prepare Quality Manual 7 Schedule audits 8 NATA assessment 9 Produce Ps & WIs 10 Implementation 11 Update Quality Manual12 Schedule audits13 ISO assessment

MarMayJul SepNovJanMarMayJul SepNov1996 1997

ISO Guide 25/ISO Guide 17025ISO Guide 25/ISO Guide 17025

ISO Guide 25 now ISO Guide 17025

ISO Guide 25 now ISO Guide 17025

ISO/IEC 17025 draws on ISO 9000:1994ISO/IEC 17025 draws on ISO 9000:1994

Accreditation and certificationAccreditation and certificationdifferent historiesdifferent histories

on convergent pathson convergent paths

With ISO/IEC Guide 25, close to ISO With ISO/IEC Guide 25, close to ISO

90019001

ISO/IEC 17025 draws on ISO 9000:1994ISO/IEC 17025 draws on ISO 9000:1994

Accreditation and certificationAccreditation and certificationdifferent historiesdifferent histories

on convergent pathson convergent paths

With ISO/IEC Guide 25, close to ISO With ISO/IEC Guide 25, close to ISO

90019001

Management versus Laboratory Standards


A large A large overlapoverlap between betweenISO 9000ISO 9000

andandISO Guide 25 - ISO/IEC 17025ISO Guide 25 - ISO/IEC 17025

Much of what follows applies directly Much of what follows applies directly to ISO 9000to ISO 9000

A large A large overlapoverlap between betweenISO 9000ISO 9000

andandISO Guide 25 - ISO/IEC 17025ISO Guide 25 - ISO/IEC 17025

Much of what follows applies directly Much of what follows applies directly to ISO 9000to ISO 9000



ISO/IEC 17025 includes:ISO/IEC 17025 includes:

almost all of ISO 9000 management almost all of ISO 9000 management

requirementsrequirements

technical requirementstechnical requirements

ISO/IEC 17025 includes:ISO/IEC 17025 includes:

almost all of ISO 9000 management almost all of ISO 9000 management

requirementsrequirements

technical requirementstechnical requirements

ISO/IEC 17025 & ISO/IEC Guide 25ISO/IEC 17025 & ISO/IEC Guide 25

Basically similar - structural changeBasically similar - structural change

More prescriptive in partsMore prescriptive in parts

More emphasis on:More emphasis on:Method validationMethod validation

Basically similar - structural changeBasically similar - structural change

More prescriptive in partsMore prescriptive in parts

More emphasis on:More emphasis on:Method validationMethod validation

Using Structure of ISO/IEC 17025

Using Structure of ISO/IEC 17025

Limited differencesLimited differences

NewerNewer

Better structureBetter structure

Guide 25 versus NATA requirementsGuide 25 versus NATA requirements

Limited differencesLimited differences

NewerNewer

Better structureBetter structure

Guide 25 versus NATA requirementsGuide 25 versus NATA requirements

ISO/IEC 17025ISO/IEC 17025

4.4. Management requirementsManagement requirements

5.5. Technical requirementsTechnical requirements

4.4. Management requirementsManagement requirements

5.5. Technical requirementsTechnical requirements

ISO/IEC 17025 - TechnicalISO/IEC 17025 - Technical

5.15.1 GeneralGeneral

5.25.2 PersonnelPersonnel

5.35.3 Accommodation and environmentAccommodation and environment

5.45.4 Selecting & validating test methodsSelecting & validating test methods

5.55.5 EquipmentEquipment

5.15.1 GeneralGeneral

5.25.2 PersonnelPersonnel

5.35.3 Accommodation and environmentAccommodation and environment

5.45.4 Selecting & validating test methodsSelecting & validating test methods

5.55.5 EquipmentEquipment

Roderick Chappel, Sandy Walker and Elizabeth M. Dax nrl.au

Documents

Transcript of Roderick Chappel, Sandy Walker and Elizabeth M. Dax nrl.au