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Achieveobjectives

D o

Ch eck

Act

Plan

QualityManagementSystem:support toachieve theobjectives

Achieve

objectives

Movingtarget

Continual improvement

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C orrectionAction taken to eliminate a detected nonconformity

C orrective Action(Reactive)Action taken to eliminate t h e cause of a detectednonconformity or ot h er undesirable situation

Preventive Action(Proactive)

Action take to eliminate t h e cause of a potentialnonconformity or ot h er potentially undesirablesituation

TERMINOLOGY & CONCEPTS (ISO 9000)

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specified wayto carry out

an activity or a process

Procedure

TERMINOLOGY & CONCEPTS (ISO 9000)

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ISO9001 : RequirementsISO9004 : Guidelines for performance

improvements

ISO9001 & ISO9004 ( a consistent pair )

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ISO9001 : focuses on t h e effectivenessof t h e system in meetingcustomer requirements

ISO9004 : guide for moving beyondISO9001(not intended for certificationor contractual purposes)

ISO9001 & ISO9004 ( a consistent pair )

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compre h ensive and fundamental rule or

belief, for leading and operating anorganisation, aimed at continually

improving performance over t h e long termby focusing on customers w h ile

addressing th

e needs of all oth

er stake h olders

ISO/T C 176/WG15

QUALITY MANAGEMENT PRINCIPLE

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QUALITY M A NAGEMENT PRINCIPLES

Customer-Focused OrganisationLeadership

Involvement of PeopleProcess ApproachSystem Approach by ManagementContinual Improvement

Factual approach to decision makingMutually beneficial supplier relationships

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14

Process Approach

Input Output

Resources Product

Monitoring & Measurement Opportunities(Before, During, and After the Process)

PROCESS(set of interrelated or interacting activities)

PROCEDURE(Specified way to carry out an activity or process may be documented or not)

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15

Process Approach

The process approach emphasizes the importanceof:

Understanding and meeting requirementsLooking at processes in terms of added valueObtaining results of process performance

Continual improvement of processes

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ResourceManagement

ManagementResponsibility

Measurement,Analysis andImprovement

ProductRealisation Product

Input Output

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C ustomer

R equirements

C ustomer

Satisfaction

Value Adding ActivitiesInformation Flow

C ONTINUAL IMPROVEMENT OF THEQUALITY MANAGEMENT SYSTEM

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4.2 DOCUMENT ATION RE QUIREMENTS

Policy & Objectives

Quality Manual

Procedures

Other Documents

Records

Control of documents

Control of Records

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Provide Evidence of C ommitment to D evelopment &Improvement of Effectiveness

of QMS

C ommunicating Importance of Meeting Requirements

Establish

ing Quality Policy & ObjectivesC onducting Management Reviews

Providing Necessary Resources

5 .1 M A NAGEMENT COMMITMENT

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ensure customer requirements(needs and expectations as defined

in ISO 9000:2000) are

DeterminedandFulfilled

Aim : to en h ance customer satisfaction

5.2 CUSTOMER FOCUS

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Appropriate to purpose of organisation

Commitment to comply wit

hrequirements

C ommitment to continually improve effectiveness

Framework for setting and reviewing quality objectives

C ommunicated and understood

Reviewed for continuing suitability

5.3 QUALITY POLICY

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Establis h ed at relevant functions and levels

Measurable

C onsistent wit h Policy

(th is is t h e place we h ave to focus for a systemto be effectively designed and is t h e greatestoppurtunity as well as a c h allenge)

5.4 PLANNING

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Responsibilities, Aut h orities and Interrelation

D efined & C ommunicated

5.5.1 Responsibility and Authority

5.5 RESPONSIBILITY, AUTHORITY &COMMUNICATION

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Processes Establis h ed, Implemented & MaintainedReport on Performance

Report on Need for Improvement

Ensuring Awareness of C ustomer Requirements

5.5.2 Management Representative


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C ommunication Processes establis h ed

including

Effectiveness of QMS

5.5.3 Internal Communications


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5.6.1 General

5.6.2 : Review Inputs

5.6.3 : Review Out puts

5.6 MANAGEMENT REVIEW

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6.1 : provision of resources6.2 : Human resources

D etermine necessary competence (competence of inspectors, operators, trainers, auditors, but w h atabout managers?)Satisfy needs (training or ot h er actions)Evaluate effectiveness of actionsAwareness of relevance/importance of activitiesRecords

6.3 : Infrastructure6.4 : Work Environment

6 .0 R esource Management

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Quality O bjectives and R equirements for ProductsProcessesDocumentationR esourcesVerification/Validation/ Monitoring/ Inspection/ Test

activitiesR ecords

7.1 PL A NNING OF PRODUCT

REALIS ATION

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7 .2.1 Determination of requirements related to theproductSpecified by customer Necessary for specified, known, intended useStatutory/Regulatory

Additional

7 .2.2 Review of requirements related to the product

7 .2.3 Customer CommunicationProduct informationEnquiries, contracts, order handlingCustomer feedback (inc complaints)

7.2 CUSTOMER REL ATED PROCESSES

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77..33..11 PlanningPlanning

7.3 DESIGN A ND DE VELOPMENT

Planning

Design Inputs

Design outputs

Design review

Verification

Control of changes

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7.4 PURCH ASING

77..44..11 Purc h asingPurc h asing ProcessProcess

Evaluate, Select, Re-evaluate suppliers

Basis of ability to supply

Define criteria to be employed

Records

7 .4.2 Purchasing Information

7 .4.3 Verification of Purchased product

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77..55 ..11 ControlControl of of ProductionProduction andand ServiceService ProvisionProvision

7.5 PRODUCTION A ND SER VICE

PRO VISION

Controlled Conditions

InformationWork Instructions

Suitable Equipment

Availability & Use of Monitoring & Measuring Devices

Implement Monitoring & Measurement Activities

Release, Delivery & Post Delivery Activities

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77..55 ..22 ValidationValidation of of ProcessProcess


PRO VISION

Special Processes

Criteria for review and approval

Equipment and personnel

Specific methods and procedures

Requirements for recordsRevalidation

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77..55 ..33 IdentificationIdentification andand TraceabilityTraceability


PRO VISION

Where appropriate, identify product

Identify Measurement and Monitoring status

Control and record traceability when required

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77..55 ..44 Customer Customer PropertyProperty


PRO VISION

Exercise care

IdentifyVerify

Protect

SafeguardReport and record problems

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77..55 ..55 PreservationPreservation of of ProductProduct

Products and C omponent Parts


PRO VISION

Identification

HandlingPackaging

Storage

Protection

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7.6 CONTROL OF MONITORING &ME ASURING

Determine measurements to be madeSelect and use suitable equipmentWhere necessary

Calibrate (traceable) AdjustIdentify (calibration status)Safeguard from invalidationProtectRecords

Validity of previous resultsIncludes software

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88..11 GeneralGeneral

8 ME ASUREMENT, A NALYSIS &IMPRO VEMENT

Plan & Implement Processes

Demonstrate Product Conformity

Ensure Conformity of QMS

Continually Improve Effectiveness of

QMS

Statistical Techniques

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D etermine Met h ods

Monitoring and Use of Information

C ustomer Perception (interesting?)

Fulfilling C ustomer Requirements

88..22..11 C ustomer C ustomer SatisfactionSatisfaction

Proactive not Reactive

8 .2 MONITORING & ME ASUREMENT

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88..22..22 InternalInternal AuditAudit


Planned Intervals

Conformity to ISO 9001:2000

Effective Implementation &Maintenance

Programme (Status & Importance)

Auditor ObjectivityCorrective Actions (no undue delay)

Follow-up Verification

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88..22..33 MonitoringMonitoring & & MeasurementMeasurement of of ProcessesProcesses


Suitable Methods

Ability of Process Achieve Planned Results

Correction & Corrective Action, whereappropriate

Release of records

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88..22..44 MonitoringMonitoring & & MeasurementMeasurement of of ProductProduct


Product CharacteristicsPlanned Arrangements

Appropriate StagesVerify Requirements Fulfilled

RecordsEvidence of ConformityID of person authorising release

No release if not successful (exceptconcession)

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8 .3 CONTROL OF NONCONFORMINGPRODUCT

Identify & Control (prevent use/delivery)Documented Procedure

Deal with nonconformityEliminate it (rectify/scrap)

Accept it (concession)Preclude original use (regrade)

RecordsRe-verification (where corrected)

Appropriate action if found after delivery

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8 .4 A NALYSIS OF D ATA

Determine, Collect, Analyse Data to

Demonstrate Suitability &Effectiveness of QMSEvaluate Improvement Opportunities

Analysis to provide information on

Customer SatisfactionProduct ConformanceProcess Characteristics/TrendsSuppliers

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88..55..11 C ontinualC ontinual ImprovementImprovement

8 .5 IMPRO VEMENT

Continually Improve Effectiveness of QMS

through use of Quality PolicyQuality Objectives

Audit Results

Analysis of DataCorrective & Preventive ActionManagement Review

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88..55..22 C orrectiveC orrective ActionAction

8 .5 IMPRO VEMENT

Eliminate cause of nonconformities to preventrecurrence

Documented ProcedureReview (inc Customer Complaints)Determine Cause

Evaluate Need for ActionTake ActionRecord ResultsReview Action

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88..55..33 PreventivePreventive ActionAction

8 .5 IMPRO VEMENT

Eliminate cause of potential nonconformities toprevent ocurrence

Documented ProcedureDetermine Potential Problems &Causes

Evaluate Need for ActionTake ActionRecord Results

Review Action