iso 9000 lecture

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QMS Standard

ISO 9000:2000QMS Standard

ISO 9000:2000

Pakistan Institute of Quality Control

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Principles of Auditing

Audit Terms and Definitions

CONTENTSCONTENTSCONTENTSCONTENTS1

5

4

ISO 9000 New Family of Standards

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3

What’s New in ISO 9000:2000 (Outline)

ISO 9001:2000 New/Modified Requirements

Competence of Auditors6

Managing an Audit Program7

3

Evolution of Quality FieldEvolution of Quality Field

TQM+ TQM+ 6 Sigma

KnowledgeMgt.

IT

TQMTQMHRM

GROUPDYNAMICS

Teams

Efficiency

BPR

TPM

JIT/MRP

QAQAISO9000

JAR 145

OPR MGT.

QCQCSPC

QualityCirclesPerformance

Measure

ProcessControl

SystemOpr Mgt.

Culture /Performance

OverallCompetitiveness

ProductInspection

4

Quality Control

RootcauseAnalysis &ProblemSolving

RootcauseAnalysis &ProblemSolving

PROCESSFlight

ServicesMarketing

AirportServices

ReworkRework

Cycle B

Cycle A

OK

Errors

MIS Performance

5

CorrectionCorrection

OK

Errors

OUTCOMEPROCESSES

Root-Cause Analysis &

Problem solving

Root-Cause Analysis &

Problem solving

Customers

Quality Assurance

data

FIELDPerformance

Root-Cause Analysis &Problem solving

Root-Cause Analysis &Problem solving

data

PROCESSMeasures

6

PURCHASINGPURCHASING

PLANNINGPLANNING

ENGG.ENGG.

HRDHRD

FINANCEFINANCE

MISMIS

MkgFlightOperations

Airport ServicesAirport ServicesFlight ServicesFlight Services

QA in PIA means QA in every Dept.

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Performance Measures for Quality

1AppropriatenessThe degree to which the service provided is relevant to The passenger needs

1AppropriatenessThe degree to which the service provided is relevant to The passenger needs

4 EffectivenessThe degree to which the service is provided in the correct manner

4 EffectivenessThe degree to which the service is provided in the correct manner

6 Efficiency The relationship between theoutcome(s) andthe resources used to deliverservice

6 Efficiency The relationship between theoutcome(s) andthe resources used to deliverservice

3 Continuity The degree to which the service for the passenger iscoordinated among providers among organizations, and overtime

3 Continuity The degree to which the service for the passenger iscoordinated among providers among organizations, and overtime

2 AvailabilityThe degree to which the appropriate service is available to meet the passenger’s needs

2 AvailabilityThe degree to which the appropriate service is available to meet the passenger’s needs

5 Safety The degree to which the risk ofan intervention and the risk in theservice environment are reduced for passengers and others

5 Safety The degree to which the risk ofan intervention and the risk in theservice environment are reduced for passengers and others

8 Respect & CaringThe degree to which the patientor designee is involved in his orher own travel decisions and towhich those providing service do so with sensitivity andrespect for the passengers needs, expectations, and Individual differences

8 Respect & CaringThe degree to which the patientor designee is involved in his orher own travel decisions and towhich those providing service do so with sensitivity andrespect for the passengers needs, expectations, and Individual differences

7 Timeliness The degree to which service is provided to the Passenger at themost beneficial or necessarytime

7 Timeliness The degree to which service is provided to the Passenger at themost beneficial or necessarytime

9 ReliabilityErrors during service 9 ReliabilityErrors during service

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ISO 9000 QMSISO 9000 QMSIntroduction to

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ISO 9000:2000 Family of Standards

• CORE STANDARDSCORE STANDARDS– ISO 9000:2000 Fundamentals and Vocabulary

– ISO 9001:2000 QMS Requirements

– ISO 9004:2000 Guidelines for Performance Improvement

• SUPPORTING STANDARDSSUPPORTING STANDARDS– ISO 10005:1995 Guidelines for Quality Plans

– ISO 10006:1997 Guidelines for Project Management

– ISO 10007:1995 Guidelines for Configuration Mgt

– ISO 19011 on Auditing

– ISO 10012-1 & -2, Quality Assurance for Measuring Eqpt.

– ISO 10013:1995 Guidelines for Quality manuals

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– ISO/TR 10014:1998 Guidelines for managing economics of quality

– ISO 10015 Guidelines for Training– ISO/TR 10017:1999 Guidelines on Statistical techniques

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Process Approach Model

Management Management responsibilityresponsibility

Measurement, Measurement, analysis and analysis and improvementimprovement

Resource Resource managementmanagement

Service Service realizationrealization

OutputInput

ProductProduct

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

CUSTOMER

CUSTOMER

Satisfaction

Satisfaction

CUSTOMER

CUSTOMER

Requirements

Requirements

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Contents

Scope 1.1 General1.2 Application

1

Terms and Definitions3

Normative Reference2

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Contents (cont.)

Quality Management System 4.1 General Requirements

4.2 Documentation Requirements

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Management Responsibility

5.1 Management Commitment5.2 Customer focus5.3 Quality Policy5.4 Planning5.5 Responsibility, authority and communication5.6 Management Review

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Resource Management 6.1 Provision of resources6.2 Human resources6.3 Infrastructure6.4 Work environment

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Product Realization 7.1 Planning of product realization7.2 Customer-related processes7.3 Design and development7.4 Purchasing7.5 Production and service provision7.6 Control of monitoring and measuring devices

7

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Contents (cont.)

Measurement, Analysis and Improvement 8.1 General

8.2 Monitoring and measurement8.3 Control of nonconforming product8.4 Analysis of data8.5 Improvement

8

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1. Scope (applicability)

• Product meets customer and applicable regulatory requirements

• to enhance customer satisfaction, including continual improvement of the system and assurance of conformity to customer and applicable regulatory requirements

1.1 General1.1 General

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• Generic requirements; applicable to all organizations, regardless of type, size and product provided

1.2 Application1.2 Application

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Documentation Structure (Example)

QUALITYQUALITYMANUALMANUAL(SUMMARY)

RelevantRecords

RelevantRecords

RelevantRecords

RelevantRecords

RelevantRecords

QMSDept B

Procedures

QMSDept C

Procedures

QMSDept D

Procedures

QMSDept E

Procedures

Supporting Documentse.g. standards, ManualsSupporting Documentse.g. standards, Manuals

QMSDept A

Procedures

What How

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• Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction

Examples

• Customer needs identification procedure?(e.g. surveys, focus groups, contracts)

• Top management verification (through 1st, 2nd, 3rd party tests etc., that such requirements are fulfilled

Examples

• Customer needs identification procedure?(e.g. surveys, focus groups, contracts)

• Top management verification (through 1st, 2nd, 3rd party tests etc., that such requirements are fulfilled

5.2 Customer Focus5.2 Customer Focus

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Top management shall ensure that the quality policy:

• is appropriate to the purpose of the organization

• includes a commitment to comply with the requirements and continually improve the effectiveness of the QMS

• provides a framework for establishing and reviewing quality objectives

• communicated and understood in the organization

• is reviewed for continuing suitability

What broad Quality aspects should be Covered in the Quality Policy?

1. Fulfillment of Customer needs

2. Fulfillment of applicable national laws and regulations

3. Minimization of waste,errors and nonconforming

4. Continual improvement

5. Employees quality and organizational culture

What broad Quality aspects should be Covered in the Quality Policy?

1. Fulfillment of Customer needs

2. Fulfillment of applicable national laws and regulations

3. Minimization of waste,errors and nonconforming

4. Continual improvement

5. Employees quality and organizational culture

5.3 Quality Policy5.3 Quality Policy

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• Quality Objectives: – are established at relevant functions

and levels, and are measurable and consistent with the quality policy

• QMS Planning: – How to achieve the objectives

• What does Quality objectives for each function means?

• What does Quality objectives for each level means?

• What does Quality objectives for each function means?

• What does Quality objectives for each level means?

5.4 QMS Planning5.4 QMS Planning

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• Responsibility and Authority:– defined and communicated within the

organization

• Management Representative: appoint a QMS Coordination role to a

management member– ensure QMS is established,

implemented and maintained– report the performance and the need

for improvement– promote awareness– liaison with external parties

Examples• Job Descriptions• QMR’s clear role

Examples• Job Descriptions• QMR’s clear role

5.5 Responsibility, Authority and Communication5.5 Responsibility, Authority and Communication

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• Internal Communication:ensure effective communication regarding the effectiveness of the QMS

Examples• Team briefing and

meetings• notice boards• newsletter• intranet• employees surveys

Examples• Team briefing and

meetings• notice boards• newsletter• intranet• employees surveys

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5.6 Management Review5.6 Management Review

ManagementManagementReviewsReviews

QUALITY REPORT covering•Audit results•Customer feedback•process performance•product conformity•C/P Action•follow-ups•changes / follow-ups•recommendationsfor improvements

QUALITY REPORT covering•Audit results•Customer feedback•process performance•product conformity•C/P Action•follow-ups•changes / follow-ups•recommendationsfor improvements

Improvements in QMSImprovements in QMS

Improvements in Products/Processes

Improvements in Products/Processes

Resource NeedsResource Needs

OUTPUTSOUTPUTSOUTPUTSOUTPUTS

INPUTSINPUTSINPUTSINPUTSQUALITYQUALITYPROCESSPROCESSQUALITYQUALITYPROCESSPROCESS

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6.2 Human Resources

6.2.1 General6.2.1 General

Right person for the right jobRight person for the right job

qualified managers?qualified supervisors?appropriate workers?

Qualified / Qualified / Appropriate means Appropriate means

1. Education1. Education2. Training2. Training3. Skills3. Skills4. Experience4. Experience

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• Provide necessary infrastructure for the QA program, e.g.

– building, workspace, utilities– process equipment (hardware/

software)– supporting services, e.g. transport,

communication,

6.3 Infrastructure6.3 Infrastructure

Examples• suitable machines,

workspaces, software, hardware, information

Examples• suitable machines,

workspaces, software, hardware, information

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• The organization shall determine and manage the work environment needed to achieve conformity to product requirements

Examples

• work space• heat, humidity, light

airflow,• hygiene, cleanliness,

noise, vibration and pollution, etc.

Examples

• work space• heat, humidity, light

airflow,• hygiene, cleanliness,

noise, vibration and pollution, etc.

6.4 Work Environment6.4 Work Environment

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7. Service Realization

7.1Planning 7.2

CustomerRelated

Processes

7.3Design &

Development

7.5Service

Provision7.4

Purchasing

7.6Monitoring &

MeasuringDevices PROCESS

MANAGEMENTPROCESS

MANAGEMENT

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7.1 Planning

• Quality objectives and requirements for the services

• establish processes, documents, and provide resources specific to the services

• required verification, validation, monitoring, inspection and test activities specific to the service and the criteria for service acceptance

• identification of relevant records

• Service Quality Plans?

• Service Quality Plans?

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7.2 Customer-related Processes

• Determine:– customer’s requirements– unstated but necessary requirements– statutory and regulatory product req’t– any additional requirement

determined by the organization

7.2.1 Determination of requirements related to the Services7.2.1 Determination of requirements related to the Services

Examples• contracts• customer surveys,

focus groups• applicable national

regulations

Examples• contracts• customer surveys,

focus groups• applicable national

regulations

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• review contract before acceptance• ensure service reqts are defined• resolve issues before acceptance• confirm organization capability• maintain records• ensure amendments properly

Examples• Contract review• review of results of

surveys and focus groups, etc.

Examples• Contract review• review of results of

surveys and focus groups, etc.

7.2.2 Review of requirements related to the Services7.2.2 Review of requirements related to the Services

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• Make effective arrangements for communicating with customers in relation to:– service information– inquiries, order handling, including

changes, and– customer feedback, including

customer complaints

Examples• Printed information• Telephonic info• Mail info• Web info• Airport

announcements.• Aircraft

announcements

Examples• Printed information• Telephonic info• Mail info• Web info• Airport

announcements.• Aircraft

announcements

7.2.3 Customer Communication7.2.3 Customer Communication

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CustomerRegulatory

ProfessionalReqts.

CustomerRegulatory

ProfessionalReqts.

7.3 Development of New Services

InputsInputs ReviewReview Designing Output

VerificationVerification

ValidationValidation

Development ReviewDevelopment Review

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7.4 Purchasing

PURCHASINGPURCHASINGPURCHASINGPURCHASING

Pur

chas

ing

Proc

ess Purchasing Information

Verification of Purchased Product/Services

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7.5 Service Provision

7.5.1Control of

Service Provision

7.5.1Control of

Service Provision

7.5.2Validation ofProcesses

7.5.2Validation ofProcesses

7.5.6Control of

Monitoring andMeasuring

Devices

7.5.6Control of

Monitoring andMeasuring

Devices

7.5.4CustomerProperty

7.5.4CustomerProperty

7.5.5Preservation of Luggage& products

7.5.5Preservation of Luggage& products

7.5.3Identification

andTraceability

7.5.3Identification

andTraceability

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8. Measurement, Analysis and Improvement

8.38.3Control of Control of

non-conformingnon-conformingserviceservice

8.38.3Control of Control of

non-conformingnon-conformingserviceservice

8.58.5ImprovementImprovement

8.58.5ImprovementImprovement

8.28.2Monitoring &Monitoring &MeasurementMeasurement

8.28.2Monitoring &Monitoring &MeasurementMeasurement

8.48.4Analysis ofAnalysis of

DataData

8.48.4Analysis ofAnalysis of

DataData

8.18.1GeneralGeneral

8.18.1GeneralGeneral

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8 Measurement, Analysis and Improvement

• Ensure conformity of the service• ensure conformity of the QMS• ensure effectiveness and

continually improving the QMS

8.1 General8.1 General

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• Customer Satisfaction– device a method to measure and

monitor customer satisfaction from customer perception point of view

• Internal Audit– regularly carry out internal audit to

check conformity and effectiveness of the QMS

– design an effective audit program and plan, criteria

– competent auditors

– audit results and records

– follow-ups and timely C/A

Examples of CS:• Direct interfaces• focus groups• surveys• sector and industry

studies

Examples of IA:• Main objective is to

check the correctness and performance of functions and processes

Examples of CS:• Direct interfaces• focus groups• surveys• sector and industry

studies

Examples of IA:• Main objective is to

check the correctness and performance of functions and processes

8.2 Monitoring and Measurement8.2 Monitoring and Measurement

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• Processes– apply suitable monitoring of processes

where required– C/A when deviation occurs

• Services– measure service characteristics to

confirm fulfillment of quality– at appropriate stages in accordance

with the quality plans– define acceptance criteria– authorize release and records

8.2 Monitoring and Measurement8.2 Monitoring and MeasurementExamples

• use of SPC, especially control charts

• monitoring and supervision of process parameters

• daily morning reviews of quality by workers and their supervisors

• Appropriate product measurement scheme

Examples

• use of SPC, especially control charts

• monitoring and supervision of process parameters

• daily morning reviews of quality by workers and their supervisors

• Appropriate product measurement scheme

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• Determine, collect and analyze appropriate data from measurement sources to check conformance and analysis for improvement in:– customer satisfaction– service conformance– process– suppliers

8.4 Analysis of Data8.4 Analysis of Data

• Analysis is not compiling of data

• Analysis is after compiling of quality data

• Analysis is part of Quality Report

• Sources of data?

• Analysis is not compiling of data

• Analysis is after compiling of quality data

• Analysis is part of Quality Report

• Sources of data?

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• Continual Improvement– identify opportunities of improvement

from quality policy, objectives, audit results, analysis of data, C/P actions, and management reviews

– mobilize improvement programs

8.5 Improvement8.5 Improvement

• Clear evidence of improvement processes

• Clear evidence of improvements

• Clear evidence of improvement processes

• Clear evidence of improvements

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• Corrective Action– take timely action to eliminate the

cause of nonconformities.– Review nonconformities– determine causes– evaluate – determine and implement action– records of results– review and confirm results


• What is the difference between Correction, Corrective Action and Preventive Action?

• Corrective Action Form

• Control of Corrective Actions

• What is the difference between Correction, Corrective Action and Preventive Action?

• Corrective Action Form

• Control of Corrective Actions

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• Preventive Action– determine potential nonconformities

current mistakes and future planning– determine their causes– device actions– implement actions– record results– review action taken


• Outputs of management reviews or corrective actions

• Outputs of management reviews or corrective actions

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System Maturity Logic

SYS

TEM

1ST Year 2nd Year 3rd Year

Em

bryo

nic

Mat

urit

yImpr

ovem

ent

An S-Curve

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System Maturity

C

A

B

3 6 9 12 18 Time (months)

Mat

urit

y

Acceptable

Satisfactory

Good

Excellent

After 1 1/2 years

45

Poor

60%

Satisfactory

40%

Good

Satisfactory

25%15%

QUALITY ASSURANCE (ISO 9000)

1998 Survey Result by KM

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ISO

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Thank You

Lets Create Lets Create

QUALITYQUALITYTRADITIONSTRADITIONS

The End