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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
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
Effect of Quality Management on Costs
Effect of Quality Management on Costs
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
Implementing a QMSImplementing a QMSImplementing a QMSImplementing a QMS
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”
Implementing a QMSImplementing a QMSImplementing a QMSImplementing a QMS
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
Implementing a QMSImplementing a QMSImplementing a QMSImplementing a QMS
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
Implementing a QMSImplementing a QMSImplementing a QMSImplementing a QMS
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
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
Management versus Laboratory Standards
Management versus Laboratory Standards
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