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