5.2 personnel l use competent staff l supervise as necessary l document qualifications and training...
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5.2 Personnel5.2 Personnel
Use competent staffUse competent staff
Supervise as necessarySupervise as necessary
Document qualifications and trainingDocument qualifications and training
Maintain documented training programMaintain documented training program
Define responsibilities and authoritiesDefine responsibilities and authorities
Applies also to contracted workersApplies also to contracted workers
Use competent staffUse competent staff
Supervise as necessarySupervise as necessary
Document qualifications and trainingDocument qualifications and training
Maintain documented training programMaintain documented training program
Define responsibilities and authoritiesDefine responsibilities and authorities
Applies also to contracted workersApplies also to contracted workers
5.3 Accommodation, Environment5.3 Accommodation, Environment
Accommodation & environment to suitAccommodation & environment to suittestingtesting
equipmentequipment
Monitor environment as needed, recordsMonitor environment as needed, records
Control access to laboratoriesControl access to laboratories
Good housekeepingGood housekeeping
Accommodation & environment to suitAccommodation & environment to suittestingtesting
equipmentequipment
Monitor environment as needed, recordsMonitor environment as needed, records
Control access to laboratoriesControl access to laboratories
Good housekeepingGood housekeeping
5.4 Test Methods, Validation5.4 Test Methods, Validation
Use appropriate methodsUse appropriate methods
Methods to meet client needsMethods to meet client needs
Prefer standard methodsPrefer standard methods
Validate any non-standard procedureValidate any non-standard procedure
Various ways to validateVarious ways to validate
Retain validation dataRetain validation data
Use appropriate methodsUse appropriate methods
Methods to meet client needsMethods to meet client needs
Prefer standard methodsPrefer standard methods
Validate any non-standard procedureValidate any non-standard procedure
Various ways to validateVarious ways to validate
Retain validation dataRetain validation data
5.5 Equipment5.5 Equipment
Use appropriate equipmentUse appropriate equipment Authorised personnel operateAuthorised personnel operate Instructions availableInstructions available Unique identification, inventoryUnique identification, inventory Equipment calibration Equipment calibration (also 5.6)(also 5.6) Applies to outside equipmentApplies to outside equipment
Use appropriate equipmentUse appropriate equipment Authorised personnel operateAuthorised personnel operate Instructions availableInstructions available Unique identification, inventoryUnique identification, inventory Equipment calibration Equipment calibration (also 5.6)(also 5.6) Applies to outside equipmentApplies to outside equipment
ISO/IEC 17025 - TechnicalISO/IEC 17025 - Technical
5.65.6 Measurement traceabilityMeasurement traceability
5.75.7 SamplingSampling
5.85.8 Handling test itemsHandling test items
5.95.9 Quality assuranceQuality assurance
5.105.10 ReportingReporting
5.65.6 Measurement traceabilityMeasurement traceability
5.75.7 SamplingSampling
5.85.8 Handling test itemsHandling test items
5.95.9 Quality assuranceQuality assurance
5.105.10 ReportingReporting
5.6 Measurement Traceability5.6 Measurement Traceability
Calibrate equipmentCalibrate equipment Ensure measurement traceabilityEnsure measurement traceability Use interlaboratory comparisons Use interlaboratory comparisons
where possiblewhere possible Calibrate reference materialsCalibrate reference materials Protect reference materialsProtect reference materials
Calibrate equipmentCalibrate equipment Ensure measurement traceabilityEnsure measurement traceability Use interlaboratory comparisons Use interlaboratory comparisons
where possiblewhere possible Calibrate reference materialsCalibrate reference materials Protect reference materialsProtect reference materials
5.7 Sampling5.7 Sampling
Ensure statistical validityEnsure statistical validity Ensure statistical validityEnsure statistical validity
5.8 Handling Test Items5.8 Handling Test Items
Documented handling proceduresDocumented handling procedures
Secure identification of samplesSecure identification of samples
Ensure sample condition acceptableEnsure sample condition acceptable
Protect samplesProtect samples
Documented handling proceduresDocumented handling procedures
Secure identification of samplesSecure identification of samples
Ensure sample condition acceptableEnsure sample condition acceptable
Protect samplesProtect samples
5.9 Quality Assurance5.9 Quality Assurance
Use quality controlUse quality control
Participate in proficiency testingParticipate in proficiency testing
Use statistics if practicableUse statistics if practicable
Use quality controlUse quality control
Participate in proficiency testingParticipate in proficiency testing
Use statistics if practicableUse statistics if practicable
5.10 Reporting5.10 Reporting
Minimum requirements for reportsMinimum requirements for reports
Keep interpretation distinctKeep interpretation distinct
Identify testing by subcontractorsIdentify testing by subcontractors
Apply also to electronic transmissionApply also to electronic transmission
Amendments - supplementary documentsAmendments - supplementary documents
Minimum requirements for reportsMinimum requirements for reports
Keep interpretation distinctKeep interpretation distinct
Identify testing by subcontractorsIdentify testing by subcontractors
Apply also to electronic transmissionApply also to electronic transmission
Amendments - supplementary documentsAmendments - supplementary documents
ISO/IEC 17025 - ManagementISO/IEC 17025 - Management
4.14.1 OrganisationOrganisation
4.24.2 Quality systemQuality system
4.3 Document control
4.4 Contract review
4.5 Subcontracting
4.6 Purchasing
4.7 Service to the client
4.14.1 OrganisationOrganisation
4.24.2 Quality systemQuality system
4.3 Document control
4.4 Contract review
4.5 Subcontracting
4.6 Purchasing
4.7 Service to the client
4.1 Organisation4.1 Organisation
Quality Manager (title irrelevantQuality Manager (title irrelevant))may have other dutiesmay have other dutiesdirect access to top managementdirect access to top management
““defined responsibility and authority for defined responsibility and authority for ensuring that the quality system is ensuring that the quality system is
implemented and followed at all times”implemented and followed at all times”
Quality Manager (title irrelevantQuality Manager (title irrelevant))may have other dutiesmay have other dutiesdirect access to top managementdirect access to top management
““defined responsibility and authority for defined responsibility and authority for ensuring that the quality system is ensuring that the quality system is
implemented and followed at all times”implemented and followed at all times”
4.4 Contract Review4.4 Contract Review
Requirements for any testingRequirements for any testing documenteddocumentedunderstoodunderstood
Appropriate methods usedAppropriate methods used Adequately resourcedAdequately resourced Changes documented & agreedChanges documented & agreed
Requirements for any testingRequirements for any testing documenteddocumentedunderstoodunderstood
Appropriate methods usedAppropriate methods used Adequately resourcedAdequately resourced Changes documented & agreedChanges documented & agreed
4.5 Subcontracting4.5 Subcontracting
Testing subcontracted to another labTesting subcontracted to another labsubcontractor competentsubcontractor competent
also accredited to standard?also accredited to standard?
client advised in writingclient advised in writing
register of subcontractors usedregister of subcontractors usedevidence of suitabilityevidence of suitability
Testing subcontracted to another labTesting subcontracted to another labsubcontractor competentsubcontractor competent
also accredited to standard?also accredited to standard?
client advised in writingclient advised in writing
register of subcontractors usedregister of subcontractors usedevidence of suitabilityevidence of suitability
4.6 Purchasing4.6 Purchasing
Procedures for selection and Procedures for selection and purchasingpurchasingwhere it affects test qualitywhere it affects test quality
Inspected to confirm complianceInspected to confirm compliance Lists of suppliersLists of suppliers
records of evaluationrecords of evaluation
Procedures for selection and Procedures for selection and purchasingpurchasingwhere it affects test qualitywhere it affects test quality
Inspected to confirm complianceInspected to confirm compliance Lists of suppliersLists of suppliers
records of evaluationrecords of evaluation
4.7 Service to the client4.7 Service to the client
Communication and co-operationCommunication and co-operation Communication and co-operationCommunication and co-operation
ISO/IEC 17025 - ManagementISO/IEC 17025 - Management
4.84.8 ComplaintsComplaints
4.94.9 Control of nonconforming testingControl of nonconforming testing
4.104.10 Corrective actionCorrective action
4.114.11 Preventive actionPreventive action
4.124.12 Control of recordsControl of records
4.134.13 Internal AuditsInternal Audits
4.144.14 Management ReviewsManagement Reviews
4.84.8 ComplaintsComplaints
4.94.9 Control of nonconforming testingControl of nonconforming testing
4.104.10 Corrective actionCorrective action
4.114.11 Preventive actionPreventive action
4.124.12 Control of recordsControl of records
4.134.13 Internal AuditsInternal Audits
4.144.14 Management ReviewsManagement Reviews
4.9 Control of Nonconforming Testing
4.9 Control of Nonconforming Testing
When testing or results do not:When testing or results do not:conform with proceduresconform with procedures
meet client requirementsmeet client requirements
Remedial actionsRemedial actionswhat is done - by whomwhat is done - by whom
Client notified if necessaryClient notified if necessary
When testing or results do not:When testing or results do not:conform with proceduresconform with procedures
meet client requirementsmeet client requirements
Remedial actionsRemedial actionswhat is done - by whomwhat is done - by whom
Client notified if necessaryClient notified if necessary
A Documented Quality SystemA Documented Quality System
OutlineOutline
What is a quality system?What is a quality system?
Why documentation is necessaryWhy documentation is necessary
Requirements for documentationRequirements for documentation
Documentation structuresDocumentation structures
Quality manuals, procedures, work instructionsQuality manuals, procedures, work instructions
Guidance on documentationGuidance on documentation
What is a quality system?What is a quality system?
Why documentation is necessaryWhy documentation is necessary
Requirements for documentationRequirements for documentation
Documentation structuresDocumentation structures
Quality manuals, procedures, work instructionsQuality manuals, procedures, work instructions
Guidance on documentationGuidance on documentation
What is a Quality System ?What is a Quality System ?
ISO/IEC Guide 25 (from ISO 8402)ISO/IEC Guide 25 (from ISO 8402)
““The organisational The organisational structurestructure, ,
responsibilitiesresponsibilities, , proceduresprocedures, processes , processes
and and resourcesresources for implementing quality for implementing quality
management”management”
ISO/IEC Guide 25 (from ISO 8402)ISO/IEC Guide 25 (from ISO 8402)
““The organisational The organisational structurestructure, ,
responsibilitiesresponsibilities, , proceduresprocedures, processes , processes
and and resourcesresources for implementing quality for implementing quality
management”management”
Why Document the System?Why Document the System?
For system to functionFor system to function
Define responsibilities and authoritiesDefine responsibilities and authoritieswho does whatwho does what
Ensure compliance with standard(s)Ensure compliance with standard(s)
For system to functionFor system to function
Define responsibilities and authoritiesDefine responsibilities and authoritieswho does whatwho does what
Ensure compliance with standard(s)Ensure compliance with standard(s)
What is Required?What is Required?
CommunicatedCommunicated
AvailableAvailable
UnderstoodUnderstood
ImplementedImplemented
Easily updatedEasily updated
CommunicatedCommunicated
AvailableAvailable
UnderstoodUnderstood
ImplementedImplemented
Easily updatedEasily updated
Verbal InstructionsVerbal Instructions
Often:Often:Not heardNot heard
MisunderstoodMisunderstood
Quickly forgottenQuickly forgotten
IgnoredIgnored
Often:Often:Not heardNot heard
MisunderstoodMisunderstood
Quickly forgottenQuickly forgotten
IgnoredIgnored
What is Required?What is Required?
A quality manualA quality manual
A quality policyA quality policy
Document key areas of activityDocument key areas of activity
A quality manualA quality manual
A quality policyA quality policy
Document key areas of activityDocument key areas of activity
A Typical Documentation Structure
A Typical Documentation Structure
Quality ManualQuality Manual
ProceduresProcedures
Work InstructionsWork Instructions
FormsForms
RecordsRecords
Quality ManualQuality Manual
ProceduresProcedures
Work InstructionsWork Instructions
FormsForms
RecordsRecords
Document DesignDocument Design
Work Work InstructionsInstructions
ProcedureProcedure Manual(s) Manual(s)
QualityQualityManualManual
IncreasingIncreasingIncreasingIncreasing
DetailDetailDetailDetail
Definition of SystemDefinition of System
(Company Policy &(Company Policy &
System Outline)System Outline)
Description of the ProcessesDescription of the Processes
(Defines how the Policy is carried(Defines how the Policy is carried
out in individual work Processes)out in individual work Processes)
Instructions for Individual Instructions for Individual Job FunctionsJob Functions(Defines how specific tasks that are referenced in that are referenced in
procedures are carried out)procedures are carried out)
Work FunctionsWork FunctionsWork FunctionsWork Functions
What is a Quality Manual?What is a Quality Manual?
ISO/IEC Guide 25ISO/IEC Guide 25
““A document stating the quality policy, A document stating the quality policy,
quality system and quality practices of an quality system and quality practices of an
organisation”organisation”
ISO/IEC Guide 25ISO/IEC Guide 25
““A document stating the quality policy, A document stating the quality policy,
quality system and quality practices of an quality system and quality practices of an
organisation”organisation”
Required in Quality ManualRequired in Quality Manual
Quality policyQuality policy Structure of documentationStructure of documentation Cross reference supporting documentsCross reference supporting documents Include or refer to:Include or refer to:
systems, instructionssystems, instructionsresponsibilities and authoritiesresponsibilities and authorities
Quality policyQuality policy Structure of documentationStructure of documentation Cross reference supporting documentsCross reference supporting documents Include or refer to:Include or refer to:
systems, instructionssystems, instructionsresponsibilities and authoritiesresponsibilities and authorities
Quality PolicyQuality Policy
ConciseConcise
Overall objectivesOverall objectives
Authorised by chief executiveAuthorised by chief executive
Commitment to good practiceCommitment to good practice
Commitment to Standard(s)Commitment to Standard(s)
Staff must familiarise and useStaff must familiarise and use
ConciseConcise
Overall objectivesOverall objectives
Authorised by chief executiveAuthorised by chief executive
Commitment to good practiceCommitment to good practice
Commitment to Standard(s)Commitment to Standard(s)
Staff must familiarise and useStaff must familiarise and use
Must Document:Must Document:
Scope of activitiesScope of activities
Document control and reviewDocument control and review
Customer complaintsCustomer complaints
Corrective, preventive actionCorrective, preventive action
Internal auditsInternal audits
Scope of activitiesScope of activities
Document control and reviewDocument control and review
Customer complaintsCustomer complaints
Corrective, preventive actionCorrective, preventive action
Internal auditsInternal audits
Must Document:Must Document:
Management reviewManagement review
Approved signatoriesApproved signatories
Equipment inventoryEquipment inventory
Equipment calibration & maintenanceEquipment calibration & maintenance
Training recordsTraining records
Management reviewManagement review
Approved signatoriesApproved signatories
Equipment inventoryEquipment inventory
Equipment calibration & maintenanceEquipment calibration & maintenance
Training recordsTraining records
Quality Manager Typically:Quality Manager Typically:
Creates documentation structureCreates documentation structure Creates numbering systemCreates numbering system Decides formats and stylesDecides formats and styles Writes Quality ManualWrites Quality Manual Writes some other documentsWrites some other documents
e.g. document controle.g. document controlhow to write a documenthow to write a document
Creates documentation structureCreates documentation structure Creates numbering systemCreates numbering system Decides formats and stylesDecides formats and styles Writes Quality ManualWrites Quality Manual Writes some other documentsWrites some other documents
e.g. document controle.g. document controlhow to write a documenthow to write a document
Quality ManagerQuality Manager
Keeps overview of documentationKeeps overview of documentation
Makes system workMakes system workdocumentationdocumentation
document reviewdocument review
document controldocument control
Keeps overview of documentationKeeps overview of documentation
Makes system workMakes system workdocumentationdocumentation
document reviewdocument review
document controldocument control
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