iso-9001 2k requirements 101003 dep

8/3/2019 ISO-9001 2K Requirements 101003 Dep

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10/10/2003 ISO-9001:2000 Requirements 1

ISOISO--9001:20009001:2000

Quality Management SystemsQuality Management Systems

REQUIREMENTSREQUIREMENTS


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Process Based ApproachProcess Based ApproachMANAGEMENTMANAGEMENT

RESPONSIBILITYRESPONSIBILITY

RESOURCE MANAGEMENTRESOURCE MANAGEMENT

MEASUREMENT, ANALYSIS &MEASUREMENT, ANALYSIS &

IMPROVEMENTIMPROVEMENT

INPUT PROCESSOUTPUT

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PRODUCT REALIZATIONPRODUCT REALIZATION

SatisfactionSatisfaction

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RequirementsRequirements


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THETHE

PDCAPDCACYCLECYCLE

PLANPLAN

DODO

IMPLEMENTIMPLEMENT

CHECKCHECK

STUDYSTUDY

ACTACT

EVALUATEEVALUATE

VERIFYVERIFY

VALIDATEVALIDATE


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ISOISO--9000:2000 Family Structure9000:2000 Family Structure

Quality Management SystemQuality Management System

PROCESS MODELPROCESS MODEL

QualityQualityManagementManagementSystemsSystems --RequirementsRequirements

ISO 9001ISO 9001

REFERENCEREFERENCESTANDARDSTANDARD

QualityQualityManagementManagementSystemsSystems FundamentalsFundamentals& Vocabulary& Vocabulary

ISO 9000ISO 9000

ISO 9004ISO 9004

GuidelinesGuidelinesForForPerformancePerformanceImprovementsImprovements

SUPPORTING STANDARDSSUPPORTING STANDARDS

ISO 10012ISO 10012

RequirementsRequirementsforforMeasurementMeasurementProcesses &Processes &MeasuringMeasuringEquipmentEquipment

OTHER STANDARDSOTHER STANDARDS ISO 19011ISO 19011GuidelinesGuidelineson Qualityon Quality& EMS& EMSAuditingAuditing

ISO/IEC 17025ISO/IEC 17025

Competence ofCompetence ofTesting &Testing &CalibrationCalibrationLabsLabs

ISO/TS 16949ISO/TS 16949

Quality MgmtQuality MgmtSystemsSystems --AutomotiveAutomotive

ISO 13485ISO 13485MedicalMedicalDevicesDevices --Quality MgmtQuality MgmtSystemsSystems

ISO 14001ISO 14001

EnvironmentalEnvironmentalManagementManagementSystemSystem

ISO 15189ISO 15189

Medical LabsMedical Labs Quality &Quality &CompetenceCompetence

ISO 10013ISO 10013

GuidelinesGuidelinesforforDevelopingDevelopingQMSQMSDocumentsDocuments

ISO 10014ISO 10014GuidelinesGuidelinesManagingManagingthetheEconomicsEconomicsof Qualityof Quality

ISO 10017ISO 10017

GuidanceGuidanceononStatisticalStatisticalTechniquesTechniques

ISO 10005ISO 10005

GuidelinesGuidelinesfor Qualityfor QualityPlansPlans

ISO 10006ISO 10006

GuidelinesGuidelinesin Projectin ProjectMgmtMgmt

ISO 10007ISO 10007

GuidelinesGuidelinesfor Config.for Config.MgmtMgmt

ISO 10015ISO 10015

GuidelinesGuidelinesfor Trainingfor Training

PHILOSOPHICAL GUIDELINESPHILOSOPHICAL GUIDELINES


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QMS per ISOQMS per ISO--9001:20009001:2000

4 Quality Management System4 Quality Management System

General RequirementsGeneral Requirements

Documentation RequirementsDocumentation Requirements


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QMS per ISOQMS per ISO--9001:20009001:20004.1 General Requirements4.1 General Requirements

Establish, Document, Implement &

Maintain a QMSQMS and Continually ImproveContinually Improve

its Effectivenessits Effectiveness

Identify the ProcessesProcesses and their application

throughout the organization


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4.1 General Rs Continued

Determine the sequence and interaction ofthese processesthese processes;

Determine criteria and methods to ensure

the operation and control ofthesetheseprocessesprocesses are effective;


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QMS per ISOQMS per ISO--9001:20009001:20004.1 General Rs Continued

Ensure necessary resources and informa-

tion are available to support the operationand monitoring ofthese processesthese processes;

Monitor, Measure and analyze thesethese

processesprocesses;Implement actions necessary to achieve

planned results and continual improvement

ofthese processesthese processes.


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QMS per ISOQMS per ISO--9001:20009001:20004.1 General Rs Continued

Outsourced processes shall beshall beidentified and controlledidentified and controlled

Outside processes that affect productOutside processes that affect product

conformity with requirements;conformity with requirements;


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4.2 Documentation Requirements4.2 Documentation Requirements

A QMS documentation shall include:StatementsStatements of a Quality PolicyQuality Policy and QualityQuality

ObjectivesObjectives;

A Quality ManualQuality Manual;ProceduresProcedures required by ISO (6);

RecordsRecords required by ISO (21);


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4.2 Documentation Requirements-Continued

Quality ManualScopeScope of QMS

Detailed ExclusionsExclusions and their justification;

Documented ProceduresDocumented Procedures, or reference tothem; and

A description of the interactionA description of the interaction between the

QMS processes.


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Exclusions to ISO-9001:20001.2 Application

All Requirements are generic and are intended

to be applicable to all organizations.

Where any requirements cannot be applied

due to the nature of an organization and its

product an exclusion can be considered.Exclusions are limited to requirements within

clause 7 Product Realization.


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Procedures Required by ISOProcedures Required by ISO4.2.3 Control of DocumentsControl of Documents

4.2.4 Control of RecordsControl of Records8.2.2 Internal AuditsInternal Audits

8.3 Control of Nonconforming ProductControl of Nonconforming Product

8.5.2 Corrective ActionCorrective Action

8.5.3 Preventive ActionPreventive Action


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Records Required by ISORecords Required by ISO (21)(21)4.2.4 Records shall be established andRecords shall be established and

maintained to provide evidence of conformity tomaintained to provide evidence of conformity to

requirements and of the effective operation of therequirements and of the effective operation of the

QMS.QMS.

5.6.1 Management Review General, Records fromRecords from

Management ReviewsManagement Reviews shall be maintained ;

6.2.2 (Human Resources) Appropriate records ofrecords of

education, training, skills and experienceeducation, training, skills and experience;

7.1 (Planning of Product Realization) Records to

provide evidence that the realization processes andevidence that the realization processes and

resulting product meet requirementsresulting product meet requirements;


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Records Required by ISORecords Required by ISO7.2.2 (Customer Related Processes - Review of

Requirements related to the Product) Records of theRecords of the

results of the review and actions arising from it shall beresults of the review and actions arising from it shall be

maintainedmaintained;7.3.2 (Design & Development Inputs) Inputs relatingInputs relating

to product requirements shall be determined andto product requirements shall be determined and

records maintainedrecords maintained;

7.3.4 (Design & Development Review) Records ofRecords of

the results of the reviews and any necessary actionsthe results of the reviews and any necessary actionsshall be maintainedshall be maintained;

7.3.5 (Design & Development Verification) RecordsRecords

of the results of the verification and any necessaryof the results of the verification and any necessary

actions shall be maintainedactions shall be maintained.


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Records Required by ISORecords Required by ISO7.3.6 (Design & Development Validation) Records ofRecords of

the results of validation and any necessary actionsthe results of validation and any necessary actions

shall be maintainedshall be maintained;

7.3.7 (Control of Design & Development Changes)Records of the results of the review and any necessaryRecords of the results of the review and any necessary

actions shall be maintainedactions shall be maintained;

7.4.1 (Purchasing Process) Records of the results ofRecords of the results of

evaluations and any necessary actions arising from theevaluations and any necessary actions arising from the

evaluation shall be maintainedevaluation shall be maintained;

7.5.2 ( Validation of Special Processes) The

organization shall establish arrangements for these

processes including requirements for recordsrequirements for records;


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Records Required by ISORecords Required by ISO7.5.3 (Identification & Traceability) Where traceability is

a requirement, the organization shall control and

record the unique identification of the productrecord the unique identification of the product;

7.5.4 (Customer Property) If any customer property islost, damaged or otherwise found to be unsuitable for

use, this shall be reported to the customer and recordsthis shall be reported to the customer and records

maintainedmaintained;

7.6 (Control of Monitoring & Measuring Devices)

If calibrated/verified to nonIf calibrated/verified to non--national or international standardsnational or international standards

the basis shall be recorded.the basis shall be recorded.

Equipment found nonEquipment found non--conformingconforming validity of previousvalidity of previous

measurements shall be assessed & recorded;measurements shall be assessed & recorded;

Records of the results of calibration and verification shall beRecords of the results of calibration and verification shall be



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Records Required by ISORecords Required by ISO8.2.2 (Internal Audit) The responsibilities and

requirements for planning and conducting audits and

for reporting results and maintaining recordsand maintaining records;

8.2.4 (Monitoring & Measurement of Product) Evidence

of conformity with the acceptance criteria shall be

maintained. Records shall indicate the person(s)Records shall indicate the person(s)

authorizing release of productauthorizing release of product;

8.3 (Control of Nonconforming Product) Records of theRecords of thenature of nonconformities and any subsequent actionsnature of nonconformities and any subsequent actions

taken, including concessions obtained, shall betaken, including concessions obtained, shall be



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Records Required by ISORecords Required by ISO8.5.2 (Improvement Corrective Action) Records of theRecords of the

results of action takenresults of action taken;

8.5.3 (Improvement Preventive Action) Records ofRecords of

the results of action takenthe results of action taken.


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QMS per ISOQMS per ISO--9001:20009001:20004.2 Documentation Requirements-Continued

Control of DocumentsControl of Documents

A documented procedure to define the

following controls:

Approve adequacy of documents prior to issueApprove adequacy of documents prior to issue;;

Review and update as necessary & ReReview and update as necessary & Re--approveapprove;

Ensure changes and current revision status ofEnsure changes and current revision status of

documents are identifieddocuments are identified;


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QMS per ISOQMS per ISO--9001:20009001:2000Control of Documents-Contd

A documented procedure to define thefollowing controls: - Continued

Ensure relevant versionsrelevant versions of applicable

documents are available at points of useare available at points of use;

Ensure documents remain legible and readilyremain legible and readily

identifiable;identifiable;

Ensure documents ofexternal originexternal origin areidentified and their distribution controlled; and

Prevent the unintended use of obsoletePrevent the unintended use of obsolete

documentsdocuments, AND apply suitable ID if they areapply suitable ID if they are

retained for any purposeretained for any purpose;


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Control of RecordsControl of RecordsA documented procedure to define the

controls needed for the identificationidentification,,

storagestorage,, protectionprotection,, retrievalretrieval,, retention timeretention time

andand dispositiondisposition of records.of records.


Control of RecordsControl of RecordsA documented procedure to define the

controls needed for the identificationidentification,,

storagestorage,, protectionprotection,, retrievalretrieval,, retention timeretention time

andand dispositiondisposition of records.of records.


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INPUT PROCESSOUTPUT

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Management ResponsibilityManagement Responsibility

per ISOper ISO--9001:20009001:2000

5 Management Responsibility5 Management Responsibility

Management CommitmentManagement Commitment

Customer FocusCustomer Focus

Quality PolicyQuality Policy

PlanningPlanning

Management ReviewManagement Review

5 Management Responsibility5 Management Responsibility

Management CommitmentManagement Commitment

Customer FocusCustomer Focus

Quality PolicyQuality Policy

PlanningPlanning



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per ISOper ISO--9001:20009001:20005.1 Management Commitment5.1 Management Commitment

Evidence of CommitmentEvidence of Commitment

Communicate to the Organization the

Importance of meeting CustomerCustomer, StatutoryStatutory,

and RegulatoryRegulatory RequirementsRequirements

Establish the Quality PolicyQuality Policy

Ensuring Quality ObjectivesQuality Objectives are Established

Conduct Management ReviewsManagement Reviews

Ensure the Availability of ResourcesAvailability of Resources

5.1 Management Commitment5.1 Management Commitment

Evidence of CommitmentEvidence of Commitment

Communicate to the Organization the

Importance of meeting CustomerCustomer, StatutoryStatutory,

and RegulatoryRegulatory RequirementsRequirements

Establish the Quality PolicyQuality Policy

Ensuring Quality ObjectivesQuality Objectives are Established

Conduct Management ReviewsManagement Reviews

Ensure the Availability of ResourcesAvailability of Resources


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per ISOper ISO--9001:20009001:20005.2 Customer Focus5.2 Customer Focus

Ensure Customer Requirements are determinedand met, with the aim of enhancing customeraim of enhancing customer

satisfactionsatisfaction

5.3 Quality Policy5.3 Quality Policy

Established, Appropriate, Framework for QualityFramework for Quality

ObjectivesObjectives, Communicated & UnderstoodCommunicated & Understood, and

Reviewed for Continued Suitability

5.2 Customer Focus5.2 Customer Focus

Ensure Customer Requirements are determinedand met, with the aim of enhancing customeraim of enhancing customer

satisfactionsatisfaction

5.3 Quality Policy5.3 Quality Policy

Established, Appropriate, Framework for QualityFramework for Quality

ObjectivesObjectives, Communicated & UnderstoodCommunicated & Understood, and

Reviewed for Continued Suitability


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per ISOper ISO--9001:20009001:20005.4 Planning5.4 Planning

Establish Quality ObjectivesEstablish Quality Objectives at relevant levelsat relevant levels

and functions within the Organizationand functions within the Organization

Ensure that the planning of the QMS is carriedEnsure that the planning of the QMS is carried

outout to meet the General Requirementsto meet the General Requirements (4.1)(4.1)

Maintain Integrity of the QMSMaintain Integrity of the QMS when changes arewhen changes areplanned & implementedplanned & implemented

5.4 Planning5.4 Planning

Establish Quality ObjectivesEstablish Quality Objectives at relevant levelsat relevant levels

and functions within the Organizationand functions within the Organization

Ensure that the planning of the QMS is carriedEnsure that the planning of the QMS is carried

outout to meet the General Requirementsto meet the General Requirements (4.1)(4.1)

Maintain Integrity of the QMSMaintain Integrity of the QMS when changes arewhen changes areplanned & implementedplanned & implemented


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per ISOper ISO--9001:20009001:20005.5 Responsibility, Authority and CommunicationResponsibility, Authority and Communication

Ensure that responsibilities & authorities are

defined and communicateddefined and communicated within the

organization

Appoint a Management RepresentativeManagement Representative

Ensure appropriate communication processescommunication processesare established and Communication on the

Effectiveness of the QMS takes placeEffectiveness of the QMS takes place

5.5 Responsibility, Authority and CommunicationResponsibility, Authority and Communication

Ensure that responsibilities & authorities are

defined and communicateddefined and communicated within the

organization

Appoint a Management RepresentativeManagement Representative

Ensure appropriate communication processescommunication processesare established and Communication on the

Effectiveness of the QMS takes placeEffectiveness of the QMS takes place


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Management RepresentativeManagement RepresentativeIrrespective of other responsibilities, shall

have the following responsibility & authority

Ensure that processesprocesses needed for the QMS areestablished, implemented & maintained

Reports to Top Management on the performanceperformance

of the QMS and any need for improvementneed for improvement

Ensure the promotion & awarenesspromotion & awareness of Customerrequirements throughout the Organization

Can include being the liaison with external parties

on QMS matters


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per ISOper ISO--9001:20009001:20005.6 Management Review

Review the QMS at planned intervalsat planned intervalsEnsure ContinuedContinued Suitability, Adequacy, &Suitability, Adequacy, &

EffectivenessEffectiveness;

Include Assessing Opportunities forOpportunities for

ImprovementImprovement & the need for changesneed for changes

including the Quality Policy and Quality

Objectives

5.6 Management Review

Review the QMS at planned intervalsat planned intervalsEnsure ContinuedContinued Suitability, Adequacy, &Suitability, Adequacy, &

EffectivenessEffectiveness;

Include Assessing Opportunities forOpportunities for

ImprovementImprovement & the need for changesneed for changes

including the Quality Policy and Quality

Objectives


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Review InputReview Input

Results of AuditsResults of Audits

Customer FeedbackCustomer Feedback

Process Performance & Product ConformityProcess Performance & Product Conformity

Status of Corrective & Preventive ActionsStatus of Corrective & Preventive Actions

FollowFollow--up Actions from Previous Reviewsup Actions from Previous Reviews

Changes that could affect the QMSChanges that could affect the QMS

Recommendations for ImprovementRecommendations for Improvement


Review InputReview Input

Results of AuditsResults of Audits

Customer FeedbackCustomer Feedback

Process Performance & Product ConformityProcess Performance & Product Conformity

Status of Corrective & Preventive ActionsStatus of Corrective & Preventive Actions

FollowFollow--up Actions from Previous Reviewsup Actions from Previous Reviews

Changes that could affect the QMSChanges that could affect the QMS

Recommendations for ImprovementRecommendations for Improvement


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Review OutputReview OutputDecisions & Actions takenDecisions & Actions taken related to:

Improvement on the effectiveness of the QMS & itsImprovement on the effectiveness of the QMS & its

ProcessesProcesses

Improvement of product related to customerImprovement of product related to customerrequirementsrequirements

Resource NeedsResource Needs


Review OutputReview OutputDecisions & Actions takenDecisions & Actions taken related to:

Improvement on the effectiveness of the QMS & itsImprovement on the effectiveness of the QMS & its

ProcessesProcesses

Improvement of product related to customerImprovement of product related to customerrequirementsrequirements

Resource NeedsResource Needs


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Resource ManagementResource Management

per ISOper ISO--9001:20009001:20006 Resource Management6 Resource Management

Provision of ResourcesProvision of Resources

Human ResourcesHuman Resources

InfrastructureInfrastructure

Work EnvironmentWork Environment

6 Resource Management6 Resource Management

Provision of ResourcesProvision of Resources

Human ResourcesHuman Resources

InfrastructureInfrastructure

Work EnvironmentWork Environment


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per ISOper ISO--9001:20009001:20006.1 Provision of Resources6.1 Provision of Resources

Determine and ProvideDetermine and Provide Resources needed to:Resources needed to: Implement & Maintain the QMSImplement & Maintain the QMS

Continually Improve Effectiveness of QMSContinually Improve Effectiveness of QMS

Enhance Customer Satisfaction by meetingEnhance Customer Satisfaction by meetingcustomer requirementscustomer requirements

6.1 Provision of Resources6.1 Provision of Resources

Determine and ProvideDetermine and Provide Resources needed to:Resources needed to: Implement & Maintain the QMSImplement & Maintain the QMS

Continually Improve Effectiveness of QMSContinually Improve Effectiveness of QMS

Enhance Customer Satisfaction by meetingEnhance Customer Satisfaction by meetingcustomer requirementscustomer requirements


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per ISOper ISO--9001:20009001:20006.2 Human Resources6.2 Human Resources

Personnel performing work affecting productPersonnel performing work affecting product

quality shall be competent on the basis ofquality shall be competent on the basis of

appropriate education, training, skills andappropriate education, training, skills and

experienceexperience

6.2 Human Resources6.2 Human Resources

Personnel performing work affecting productPersonnel performing work affecting product

quality shall be competent on the basis ofquality shall be competent on the basis of

appropriate education, training, skills andappropriate education, training, skills and

experienceexperience


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per ISOper ISO--9001:20009001:20006.3 Competence,6.3 Competence,

Awareness and TrainingAwareness and Training

Determine the necessaryDetermine the necessary

competencecompetence

Provide Training or takeProvide Training or take

other actions to satisfyother actions to satisfyEvaluate the EffectivenessEvaluate the Effectiveness

of actions takenof actions taken

6.3 Competence,6.3 Competence,

Awareness and TrainingAwareness and Training

Determine the necessaryDetermine the necessary

competencecompetence

Provide Training or takeProvide Training or take

other actions to satisfyother actions to satisfyEvaluate the EffectivenessEvaluate the Effectiveness

of actions takenof actions taken


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per ISOper ISO--9001:20009001:20006.3 Infrastructure6.3 Infrastructure

Determine, provide and maintain theDetermine, provide and maintain the

infrastructure needed to achieve conformity toinfrastructure needed to achieve conformity to

product requirementsproduct requirements

6.3 Infrastructure6.3 Infrastructure

Determine, provide and maintain theDetermine, provide and maintain the

infrastructure needed to achieve conformity toinfrastructure needed to achieve conformity to

product requirementsproduct requirements

Buildings, Workspace &Buildings, Workspace &

associated utilitiesassociated utilities

Process equipmentProcess equipment

(Hardware & Software)(Hardware & Software)

Supporting services (i.e.Supporting services (i.e.

transport ortransport or

communication)communication)

Buildings, Workspace &Buildings, Workspace &

associated utilitiesassociated utilities

Process equipmentProcess equipment

(Hardware & Software)(Hardware & Software)

Supporting services (i.e.Supporting services (i.e.

transport ortransport or

communication)communication)


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per ISOper ISO--9001:20009001:20006.4 Work Environment6.4 Work Environment

Determine & Manage the workDetermine & Manage the work

environment needed to achieveenvironment needed to achieveconformity to product requirementsconformity to product requirements

[Factors that influence motivation,[Factors that influence motivation,satisfaction, development andsatisfaction, development and

performance of people.]performance of people.]Psychological FactorsPsychological Factors

Physical FactorsPhysical Factors

6.4 Work Environment6.4 Work Environment

Determine & Manage the workDetermine & Manage the work

environment needed to achieveenvironment needed to achieveconformity to product requirementsconformity to product requirements

[Factors that influence motivation,[Factors that influence motivation,satisfaction, development andsatisfaction, development and

performance of people.]performance of people.]Psychological FactorsPsychological Factors



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per ISOper ISO--9001:20009001:2000Work EnvironmentWork Environment -- ContinuedContinued

Psychological FactorsPsychological Factors

Greater Involvement & Understanding ofGreater Involvement & Understanding of

Objectives to be AchievedObjectives to be Achieved

Safety Rules & ProceduresSafety Rules & Procedures

Recognition & Reward for Achievement,Recognition & Reward for Achievement,Improvement & InnovationImprovement & Innovation

Career Planning & DevelopmentCareer Planning & Development

Work EnvironmentWork Environment -- ContinuedContinued

Psychological FactorsPsychological Factors

Greater Involvement & Understanding ofGreater Involvement & Understanding of

Objectives to be AchievedObjectives to be Achieved

Safety Rules & ProceduresSafety Rules & Procedures

Recognition & Reward for Achievement,Recognition & Reward for Achievement,Improvement & InnovationImprovement & Innovation

Career Planning & DevelopmentCareer Planning & Development


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per ISOper ISO--9001:20009001:2000Work EnvironmentWork Environment -- ContinuedContinued


ErgonomicsErgonomics

TemperatureTemperature

LightLight

NoiseNoise CleanlinessCleanliness

Work EnvironmentWork Environment -- ContinuedContinued


ErgonomicsErgonomics

TemperatureTemperature

LightLight

NoiseNoise CleanlinessCleanliness


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Product RealizationProduct Realization

per ISOper ISO--9001:20009001:20007 Product Realization7 Product Realization

Planning of Product RealizationPlanning of Product Realization

CustomerCustomer--related Processesrelated Processes

Design & DevelopmentDesign & Development

PurchasingPurchasing

Production and Service ProvisionProduction and Service ProvisionControl of Monitoring and MeasuringControl of Monitoring and MeasuringDevicesDevices


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per ISOper ISO--9001:20009001:20007.1 Planning of Product Realization7.1 Planning of Product Realization

Plan & Develop the processes needed forPlan & Develop the processes needed forProduct RealizationProduct Realization

Planning shall determine the following asPlanning shall determine the following asappropriate:appropriate:

Quality ObjectivesQuality Objectives && RequirementsRequirements for thefor theProduct;Product;

Need to establish processes, documents andNeed to establish processes, documents andprovide resources specific to the product;provide resources specific to the product;


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per ISOper ISO--9001:20009001:2000Planning shall determine the following:Planning shall determine the following:

ContinuedContinued

RequiredRequired vverification,erification, vvalidation,alidation, mmonitoring,onitoring,

inspection & testinspection & test activities specific to theactivities specific to the

productproduct and the criteria for productand the criteria for product

acceptanceacceptance

RecordsRecords needed to provide evidence thatneeded to provide evidence that

the realization processes and resultingthe realization processes and resulting

product meet requirementsproduct meet requirements


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per ISOper ISO--9001:20009001:2000TheThe outputoutput of this planning shall be in aof this planning shall be in a formform

suitablesuitable for the organizations method offor the organizations method of

operationsoperations

NOTE 1: A document specifying the QMS processesNOTE 1: A document specifying the QMS processes

(including the product realization processes) can be(including the product realization processes) can be

referred to as a Quality Planreferred to as a Quality Plan

NOTE 2: The Design & Development RequirementsNOTE 2: The Design & Development Requirements

(7.3) may also be applied to the development of the(7.3) may also be applied to the development of the

product realization processesproduct realization processes


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per ISOper ISO--9001:20009001:20007.2 Customer7.2 Customer--related Processesrelated Processes

DeterminationDetermination of requirementsof requirements related to therelated to theproductproduct

ReviewReview of requirementsof requirements related to the productrelated to the product

Customer CommunicationCustomer Communication


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per ISOper ISO--9001:20009001:2000Determination of requirementsDetermination of requirements related torelated tothe productthe product

RequirementsRequirements specified by the customer,specified by the customer,including delivery & postincluding delivery & post--delivery activities;delivery activities;

RequirementsRequirements necessary for specified ornecessary for specified orintended use, where known;intended use, where known;

Statutory and regulatory requirementsStatutory and regulatory requirements relatedrelatedto the product;to the product;

Any additional requirementsAny additional requirements determined by thedetermined by theOrganization.Organization.


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per ISOper ISO--9001:20009001:2000Review of requirementsReview of requirements related to therelated to the

productproduct

Shall be conducted prior to the commitment toShall be conducted prior to the commitment to

supply a product to the customer;supply a product to the customer;

Ensure that product requirements are defined;Ensure that product requirements are defined;

Ensure contract or order requirements differingEnsure contract or order requirements differingfrom those previously expressed are resolved;from those previously expressed are resolved;

Ensure capable of meting the definedEnsure capable of meting the defined

requirements.requirements.


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per ISOper ISO--9001:20009001:2000Review of requirementsReview of requirements related to the productrelated to the product

ContinuedContinued

Customer Requirements shall beCustomer Requirements shall be confirmedconfirmed by theby the

organizationorganization before acceptancebefore acceptance, where no, where no

documented statement of requirements isdocumented statement of requirements is

provided by the customerprovided by the customer

Where Product Requirements are changed, theWhere Product Requirements are changed, theorganization shallorganization shall ensure that relevant documentsensure that relevant documents

are amended and that relevant personnel areare amended and that relevant personnel are

made aware of the changed requirementsmade aware of the changed requirements


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Product Realization

per ISO-9001:2000Customer CommunicationCustomer Communication

Determine and ImplementDetermine and Implement effectiveeffective

arrangements for communicatingarrangements for communicating with customerswith customersin relation to:in relation to:

Product information;Product information;

Enquiries, contracts or order handling, includingEnquiries, contracts or order handling, includingamendments;amendments;

Customer feedback, including customerCustomer feedback, including customercomplaints.complaints.


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per ISOper ISO--9001:20009001:20007.3 Design & Development7.3 Design & Development

Design & DevelopmentDesign & Development PlanningPlanning

Design & DevelopmentDesign & Development InputsInputs

Design & DevelopmentDesign & Development OutputsOutputs

Design & DevelopmentDesign & Development ReviewReview

Design & DevelopmentDesign & Development VerificationVerification

Design & DevelopmentDesign & Development ValidationValidation

Control ofControl ofDesign & DevelopmentDesign & Development ChangesChanges


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VVerificationerificationVValidationalidation

7.3.5 & 7.3.67.3.5 & 7.3.6

RRevieweviewat Suitableat Suitable

Stages of DesignStages of Design& Development& Development

7.3.47.3.4

VVerificationerificationVValidationalidation

7.3.5 & 7.3.67.3.5 & 7.3.6

DesignOutpu

t7.3.3

Design &Design &

DevelopmentDevelopmentProcessProcess

End ItemProduct

Design

Input7.3.2

Application of DesignControl in Waterfall or Stair

Step Design Process[with ISO-9001 Clauses]

PlanPlanDesign &Design &

DevelopmentDevelopment

Stages, AND theStages, AND the

VerificationVerification

& Validation for& Validation for

each Stage 7.3.1each Stage 7.3.1

UserNeeds

7.3.2


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Purchasing in ISOPurchasing in ISO--9001:20009001:20007.4 Purchasing7.4 Purchasing

PurchasingPurchasing ProcessProcess

PurchasingPurchasing InformationInformation

VerificationVerification of Purchased Productof Purchased Product


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Purchasing in ISOPurchasing in ISO--9001:20009001:2000PurchasingPurchasing ProcessProcess

Ensure purchased product conforms toEnsure purchased product conforms to

specified requirements.specified requirements.

Type and Extent of control shall be dependentType and Extent of control shall be dependent

upon the effect of the purchased product onupon the effect of the purchased product on

subsequent product realization or the finalsubsequent product realization or the final

product.product.

Suppliers shall be evaluated and selectedSuppliers shall be evaluated and selected

based on their ability to supply product IAW thebased on their ability to supply product IAW the

organizations requirements.organizations requirements.


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Purchasing in ISOPurchasing in ISO--9001:20009001:2000PurchasingPurchasing ProcessProcess -- ContinuedContinued

Criteria for selection, evaluation, & reCriteria for selection, evaluation, & re--

evaluation shall be established.evaluation shall be established.

Records of the results of evaluations and anyRecords of the results of evaluations and any

necessary actions arising from the evaluationnecessary actions arising from the evaluation

shall be maintainedshall be maintained


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Purchasing in ISO-9001:2000PurchasingPurchasing InformationInformation

Shall describe the product to be purchased,Shall describe the product to be purchased,

including where appropriate:including where appropriate:

Requirements for approval of product, procedures,Requirements for approval of product, procedures,

processes and equipment;processes and equipment;

Requirements for qualification of personnel, andRequirements for qualification of personnel, and

Quality Management SystemsQuality Management Systems

The organization shall ensure the adequacy ofThe organization shall ensure the adequacy ofspecified purchase requirementsspecified purchase requirements priorpriorto theirto their

communicationcommunication


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Purchasing in ISO-9001:2000VerificationVerification of Purchased Productof Purchased Product

Shall establish and implement the inspection orShall establish and implement the inspection or

other activities necessary for ensuring theother activities necessary for ensuring theproduct meets specified purchaseproduct meets specified purchaserequirements.requirements.

Where the organization or its customer intendsWhere the organization or its customer intendsto perform verification at the suppliersto perform verification at the suppliers

premises, the intended verificationpremises, the intended verificationarrangements and the method of productarrangements and the method of productrelease shall be stated in the purchasingrelease shall be stated in the purchasinginformation.information.


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per ISOper ISO--9001:20009001:20007.5 Production and Service Provision7.5 Production and Service Provision

Control of Production & Service ProvisionControl of Production & Service ProvisionValidation of Processes for Product &Validation of Processes for Product &

Service ProvisionService Provision

Identification & TraceabilityIdentification & Traceability

Customer PropertyCustomer Property

Preservation of ProductPreservation of Product


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per ISOper ISO--9001:20009001:2000Control of Production & Service ProvisionControl of Production & Service Provision

Plan & carry out provisions under controlledPlan & carry out provisions under controlled

conditions, including as applicable:conditions, including as applicable:

Availability of information that describesAvailability of information that describes thetheproduct characteristicsproduct characteristics ;;

Availability ofAvailability ofWork InstructionsWork Instructions, as necessary;, as necessary;

Use ofUse ofsuitable equipmentsuitable equipment;;

Availability & use ofAvailability & use ofMonitoring and MeasuringMonitoring and MeasuringDevicesDevices;;


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per ISOper ISO--9001:20009001:2000PlanPlan & carry out provisions under controlled& carry out provisions under controlled

conditions, including as applicable:conditions, including as applicable: ContdContd

Implementation ofImplementation ofMonitoringMonitoring andand

MeasurementMeasurement;;

Implementation ofImplementation ofReleaseRelease,, DeliveryDelivery

andand PostPost--Delivery Activities.Delivery Activities.


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per ISOper ISO--9001:20009001:2000Validation of Processes for Product &Validation of Processes for Product &Service ProvisionService Provision

Validate any process for a provision whereValidate any process for a provision wherethe resulting outputthe resulting output cannot be verified bycannot be verified bysubsequent monitoring or measurementsubsequent monitoring or measurementwherewhere deficiencies become apparent onlydeficiencies become apparent only

after the product is in useafter the product is in use or the service hasor the service hasbeen deliveredbeen delivered

ValidationValidation demonstrates the abilitydemonstrates the ability of theof theprocessprocess to achieve planned resultsto achieve planned results


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per ISOper ISO--9001:20009001:2000Validation of ProcessesValidation of Processes ContdContd

Establish Arrangements for these processes (asEstablish Arrangements for these processes (as

applicable):applicable):DefinedDefined Criteria for Review & ApprovalCriteria for Review & Approval of theof theprocess;process;

Approval ofApproval ofEquipmentEquipment & Qualification of& Qualification of

PersonnelPersonnel;;Use ofUse ofSpecific Methods & ProceduresSpecific Methods & Procedures;;

Requirements forRequirements forRecordsRecords; and; and

RevalidationRevalidation..


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per ISOper ISO--9001:20009001:2000Identification & TraceabilityIdentification & Traceability

WhereWhere applicableapplicable,, product shall be identifiedproduct shall be identified

by a suitable means throughout itsby a suitable means throughout itsrealization process.realization process.

It shallIt shall identify the product statusidentify the product status withwithrespect torespect to monitoring & measurementmonitoring & measurement

requirements.requirements.WhereWhere traceabilitytraceability is a requirement, theis a requirement, theunique identification of the product shall beunique identification of the product shall becontrolled and recordedcontrolled and recorded..


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per ISOper ISO--9001:20009001:2000Customer PropertyCustomer Property

Care shall be exercisedCare shall be exercised with customerwith customer

property while under the organizationsproperty while under the organizationscontrol or being used by the organization.control or being used by the organization.

Customer Property shall beCustomer Property shall be identifiedidentified,,verifiedverified,, protected and safeguardedprotected and safeguarded while inwhile in

use or being incorporated into the product.use or being incorporated into the product.IfIflostlost,, damageddamaged or otherwiseor otherwise found to befound to beunsuitableunsuitable, it shall be reported and records, it shall be reported and recordsmaintained.maintained.


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per ISOper ISO--9001:20009001:2000Preservation of ProductPreservation of Product

ConformityConformity of the product shall beof the product shall be preservedpreserved

during internal processing and delivery to theduring internal processing and delivery to the

intended destination.intended destination.

PreservationPreservation shall includeshall include identificationidentification,,

handlinghandling,, packagingpackaging andand protectionprotection..

PreservationPreservation also applies to thealso applies to the constituentconstituent

parts of a productparts of a product..


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per ISOper ISO--9001:20009001:20007.6 Control of Monitoring and Measuring7.6 Control of Monitoring and Measuring

DevicesDevices

Determine theDetermine the monitoringmonitoring andand

measurementmeasurement to be undertaken toto be undertaken to

provideprovide evidence of conformityevidence of conformity toto

determined requirements, AND thedetermined requirements, AND themonitoring and measuringmonitoring and measuring devicesdevices

needed to ensure valid results.needed to ensure valid results.


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per ISOper ISO--9001:20009001:20007.6 Control of Monitoring and Measuring Devices7.6 Control of Monitoring and Measuring Devices ContdContd

EstablishEstablish processesprocesses to ensure thatto ensure that

monitoring and measurement can bemonitoring and measurement can be

carried out and in a mannercarried out and in a manner

consistent with the monitoring andconsistent with the monitoring and

measurement requirements.measurement requirements.


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When necessary, measuring equipmentWhen necessary, measuring equipment

shall:shall:BeBe calibrated or verifiedcalibrated or verified at specified intervals,at specified intervals,

or prior to use,or prior to use, against measurementagainst measurement

standards traceablestandards traceable to international or nationalto international or national

measurement standards;measurement standards;Where no such standards exist, the basis use forWhere no such standards exist, the basis use for

calibration or verification shall be recorded.calibration or verification shall be recorded.


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When necessary, measuring equipmentWhen necessary, measuring equipment

shall:shall: -- ContinuedContinuedBeBe adjustedadjusted ororrere--adjustedadjusted as necessary;as necessary;

BeBe identifiedidentified to enable theto enable the calibration statuscalibration status toto

be determined;be determined;

BeBe safeguardedsafeguarded from adjustments that wouldfrom adjustments that would

invalidate the measurement result;invalidate the measurement result;

BeBe protectedprotected from damage and deteriorationfrom damage and deterioration

during handling, maintenance and storage.during handling, maintenance and storage.


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When the equipment isWhen the equipment is found not tofound not to

conformconform to requirements, theto requirements, the validity of thevalidity of theprevious measuring resultsprevious measuring results shall beshall beassessed and recorded.assessed and recorded.

Appropriate action shall be taken on theAppropriate action shall be taken on the

equipmentequipment and anyand any product affectedproduct affected..

Records of the results of calibration andRecords of the results of calibration andverification shall be maintained.verification shall be maintained.


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per ISOper ISO--9001:20009001:200077.6 Control of Monitoring and Measuring Devices.6 Control of Monitoring and Measuring Devices ContdContd

Computer softwareComputer software to be used in theto be used in the

monitoring and measurement of specifiedmonitoring and measurement of specified

requirements,requirements, shall be confirmedshall be confirmed as to itsas to its

ability to satisfy the intended application.ability to satisfy the intended application.

This confirmation shall be undertaken priorThis confirmation shall be undertaken priorto initial use and reconfirmed asto initial use and reconfirmed as

necessary.necessary.


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Process Based ApproachProcess Based Approach

MANAGEMENTMANAGEMENT





INPUT PROCESSOUTPUT

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Measurement, Analysis &Measurement, Analysis &

Improvement per ISOImprovement per ISO--9001:20009001:2000

8 Measurement, Analysis and Improvement8 Measurement, Analysis and Improvement

GeneralGeneral

Monitoring and MeasurementMonitoring and Measurement

Control of Nonconforming ProductControl of Nonconforming Product

Analysis of DataAnalysis of Data

ImprovementImprovement


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Improvement per ISOImprovement per ISO--9001:20009001:20008.1 General8.1 General

Plan & Implement the monitoring,Plan & Implement the monitoring,

measurement, analysis and improvementmeasurement, analysis and improvementprocesses needed to :processes needed to :

DemonstrateDemonstrate conformity of the product;conformity of the product;

EnsureEnsure conformity of the QMS;conformity of the QMS;

Continually improveContinually improve the effectiveness of the QMSthe effectiveness of the QMS

Determine the applicable methods, includingDetermine the applicable methods, includingstatistical techniques, and the extent of theirstatistical techniques, and the extent of theiruseuse


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8.2 Monitoring and Measurement8.2 Monitoring and Measurement

Customer SatisfactionCustomer Satisfaction

Internal AuditInternal Audit

Monitoring and Measurement of ProcessesMonitoring and Measurement of Processes

Monitoring and Measurement of ProductMonitoring and Measurement of Product


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Customer SatisfactionCustomer Satisfaction

A QMS measurement of performanceA QMS measurement of performanceMonitor information relating toMonitor information relating to customercustomer

perceptionperception as to whether customeras to whether customer

requirements are being met;requirements are being met;Determine the methods for obtaining andDetermine the methods for obtaining and

using this informationusing this information


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Internal AuditInternal Audit

Conduct internal audits at planned intervals toConduct internal audits at planned intervals todetermine whether the QMS:determine whether the QMS:

ConformsConforms to the planned arrangements, toto the planned arrangements, to

the requirements of ISOthe requirements of ISO--9001, and QMS9001, and QMS

requirements established by therequirements established by theorganization;organization;

Is effectively implementedIs effectively implemented and maintainedand maintained


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Improvement per ISOImprovement per ISO--9001:20009001:2000Internal AuditInternal Audit ContCont

An audit program shall be planned,An audit program shall be planned, consideringconsidering

the status and importance of the processes andthe status and importance of the processes andareas to be auditedareas to be audited, as well as the results of the, as well as the results of theprevious audits.previous audits.

The auditThe audit criteriacriteria,, scopescope,, frequencyfrequency andand methodsmethodsshall be defined.shall be defined.

Selection of auditors and conduct of the auditsSelection of auditors and conduct of the auditsshallshall ensure objectivity and impartialityensure objectivity and impartiality of theof theaudit processaudit process

Auditors shall not audit their own workAuditors shall not audit their own work


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Improvement per ISOImprovement per ISO--9001:20009001:2000Internal AuditInternal Audit ContdContd

TheThe management responsible for themanagement responsible for the

areas being auditedareas being audited shall ensure thatshall ensure thatactions are takenactions are taken without undue delaywithout undue delay totoeliminate detected nonconformities andeliminate detected nonconformities andtheir causes.their causes.

FollowFollow--up activitiesup activities shall include theshall include theverification of the actions taken and theverification of the actions taken and thereporting of verification results.reporting of verification results.


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Improvement per ISOImprovement per ISO--9001:20009001:2000Monitoring and Measurement of ProcessesMonitoring and Measurement of Processes

Apply suitable methods for monitoring and,Apply suitable methods for monitoring and,

where applicable, measurement of the QMSwhere applicable, measurement of the QMSprocesses.processes.

These methods shall demonstrate the ability ofThese methods shall demonstrate the ability ofthe processes to achieve planned results.the processes to achieve planned results.

When planned results are not achieved,When planned results are not achieved,correction and corrective action shall be takencorrection and corrective action shall be takenas appropriate to ensure conformity of theas appropriate to ensure conformity of theproduct.product.


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Monitoring and Measurement of ProductMonitoring and Measurement of Product

Monitor and measure theMonitor and measure the productproductcharacteristicscharacteristics to verify thatto verify that productproduct

requirementsrequirements have been met.have been met.

This is to be carried out at appropriateThis is to be carried out at appropriate

stages of the product realization processstages of the product realization process

IAW the planned arrangementsIAW the planned arrangements


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Improvement per ISOImprovement per ISO--9001:20009001:2000Monitoring and Measurement of ProductMonitoring and Measurement of Product ContCont

Evidence of conformityEvidence of conformity with thewith the acceptanceacceptance

criteriacriteria shall be maintainedshall be maintainedRecords shall indicate theRecords shall indicate the person(s)person(s)authorizing release of productauthorizing release of product

Product Release and Service DeliveryProduct Release and Service Delivery shall notshall not

proceedproceed until the planned arrangements haveuntil the planned arrangements havebeen satisfactorily completed, unlessbeen satisfactorily completed, unless otherwiseotherwiseapproved by a relevant authorityapproved by a relevant authority and whereand whereapplicable by the customer.applicable by the customer.


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Improvement per ISOImprovement per ISO--9001:20009001:20008.3 Control of Nonconforming Product8.3 Control of Nonconforming Product

Ensure that product whichEnsure that product which does not conformdoes not conform

to product requirements isto product requirements is identifiedidentified andandcontrolledcontrolled to prevent its unintended use orto prevent its unintended use ordelivery.delivery.

The controls and related responsibilities andThe controls and related responsibilities and

authorities for dealing with nonconformingauthorities for dealing with nonconformingproduct shall be defined in a documentedproduct shall be defined in a documentedprocedure.procedure.


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Improvement per ISOImprovement per ISO--9001:20009001:20008.3 Control of Nonconforming Product8.3 Control of Nonconforming Product ContdContd

Nonconforming product shall be dealt with inNonconforming product shall be dealt with in

one or more of the following ways:one or more of the following ways:TakingTaking action to eliminateaction to eliminate the detectedthe detectednonconformity;nonconformity;

Authorizing its useAuthorizing its use, release or acceptance under, release or acceptance under

concession by a relevant authority and, whereconcession by a relevant authority and, whereapplicable, by the customer;applicable, by the customer;

TakingTaking action to preclude its original intended useaction to preclude its original intended useor applicationor application


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Improvement per ISOImprovement per ISO--9001:20009001:20008.3 Control of Nonconforming Product8.3 Control of Nonconforming Product ContdContd

When nonconforming productWhen nonconforming product is correctedis corrected itit

shall beshall be subject to resubject to re--verificationverification totodemonstrate conformity todemonstrate conformity to the requirements.the requirements.

When detected after delivery or use hasWhen detected after delivery or use hasstarted,started, actions shall be takenactions shall be taken with thewith the

nonconforming product , appropriate to thenonconforming product , appropriate to theeffects, or potential effects, of theeffects, or potential effects, of thenonconformity.nonconformity.


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8.3 Control of Nonconforming Product8.3 Control of Nonconforming Product

ContdContd

RecordsRecords of the nature of nonconformitiesof the nature of nonconformities

and any subsequent actions taken,and any subsequent actions taken,

including concessions obtained, shall beincluding concessions obtained, shall be

maintainedmaintained


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Improvement per ISOImprovement per ISO--9001:20009001:20008.4 Analysis of Data8.4 Analysis of Data

Determine, collect and analyze appropriateDetermine, collect and analyze appropriate

datadata to demonstrateto demonstrate thethe suitabilitysuitability andandeffectivenesseffectiveness of the QMS andof the QMS and to evaluateto evaluatewherewhere continual improvementcontinual improvement of theof theeffectiveness of the QMS can be madeeffectiveness of the QMS can be made

This shall include data generated as a result ofThis shall include data generated as a result ofmonitoring and measurement and from othermonitoring and measurement and from otherrelevant sourcesrelevant sources


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Improvement per ISOImprovement per ISO--9001:20009001:20008.4 Analysis of Data8.4 Analysis of Data ContdContd

Analysis of Data shall provide informationAnalysis of Data shall provide information

relating to:relating to:Customer satisfaction;Customer satisfaction;

Conformity to product requirements;Conformity to product requirements;

Characteristics and trends of processes andCharacteristics and trends of processes and

products including opportunities for preventiveproducts including opportunities for preventive

action;action;

SuppliersSuppliers


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8.5 Improvement8.5 Improvement

Continual ImprovementContinual ImprovementCorrective ActionCorrective Action

Preventive ActionPreventive Action


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Improvement per ISOImprovement per ISO--9001:20009001:2000Continual ImprovementContinual Improvement

Continually improve the effectiveness of theContinually improve the effectiveness of the

QMS through the use of the:QMS through the use of the:Quality PolicyQuality Policy;;

Quality ObjectivesQuality Objectives;;

Audit ResultsAudit Results;;

Analysis of DataAnalysis of Data;;Corrective & Preventive ActionsCorrective & Preventive Actions



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Corrective ActionCorrective Action

Actions takenActions taken to eliminate the causeto eliminate the cause ofof

nonconformity in order tononconformity in order to preventprevent

recurrencerecurrence

They shall be appropriate to the effects ofThey shall be appropriate to the effects of

the nonconformities encountered.the nonconformities encountered.


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Improvement per ISOImprovement per ISO--9001:20009001:2000Corrective ActionCorrective Action-- ContdContd

A documented procedure shall be establishedA documented procedure shall be established

to define requirements for:to define requirements for:Reviewing nonconformities (including CustomerReviewing nonconformities (including CustomerComplaints);Complaints);

Determining the causes of nonconformities;Determining the causes of nonconformities;

Evaluating the need for action to ensure thatEvaluating the need for action to ensure that

nonconformities do not recur;nonconformities do not recur;Determining & implementing action needed;Determining & implementing action needed;

Reviewing corrective action taken;Reviewing corrective action taken;

Records of results of action taken.Records of results of action taken.


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Preventive ActionPreventive Action

Actions takenActions taken to eliminate the causeto eliminate the cause ofof

potentialpotential nonconformities in order tononconformities in order to

prevent their occurrenceprevent their occurrence

They shall be appropriate to the effects ofThey shall be appropriate to the effects of

thethe potential problemspotential problems..


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Improvement per ISOImprovement per ISO--9001:20009001:2000Preventive ActionPreventive Action ContdContd

A documented procedure shall be establishedA documented procedure shall be established

to define requirements for:to define requirements for:Determining potential nonconformities and theirDetermining potential nonconformities and theircauses;causes;

Evaluating the need for action to prevent occurrenceEvaluating the need for action to prevent occurrence

of nonconformities;of nonconformities;Determining & implementing action needed;Determining & implementing action needed;

Reviewing preventive action taken;Reviewing preventive action taken;

Records of the results of action taken.Records of the results of action taken.