Awarness of ISO 9001: 2008

December 10

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Awareness ofAwareness of ISO ISO 9001 9001 : : 20082008 (QMS) STANDARD(QMS) STANDARD

Prepared By:Prepared By:

Ashraf S. Youssef, Ph. D.Ashraf S. Youssef, Ph. D.

الدوليةالدوليةالتوعية بنظام إدارة الجودة والمواصفة القياسيةالتوعية بنظام إدارة الجودة والمواصفة القياسيةISO ISO 9001 9001 : : 20082008

June June 2727, , 20092009

QA & Ind. Methods ManagerQA & Ind. Methods Manager

S.M. ASQ, L.A. BSI, M. ELI, M. EMSS.M. ASQ, L.A. BSI, M. ELI, M. EMS

Training Approach

• Focus on Basics

• Interactive

• Exercises

• Case Studies

• Role Plays

• Have Fun !

Learning Objectives

• Learn about Quality Management and How it Applies to EEIC

• Become Familiar with ISO R iRequirements

• Design your own QMS

• Realize the Benefits of ISO at EEIC

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1.1. Introduction to Total Quality Introduction to Total Quality ManagementManagement

2.2. QMS Principles & ISO QMS Principles & ISO 9001 9001 ModelModel

3.3. ISO ISO 9001 9001 Model & ClausesModel & Clauses

AgendaAgenda

٤

4.4. Key Quality ToolsKey Quality Tools

5.5. ISO ISO 9001 9001 Certification Realization Certification Realization ProcessProcess

To keep Customer coming again to you

To keep them satisfied for your product

Provide consistent direction to employee

Increase employee awareness of quality

Why should my organization implement ISO Why should my organization implement ISO 90019001::2008 2008 ??

٥

p y q y

Opportunity for continuous improvement

And that means consistently customercustomersatisfaction & aa Growing OrganizationGrowing Organization

Exercise: What is Quality?

• Use the Japanese brainstorming technique to answer the question.

• After the exercise, each group reads out their ideastheir ideas.

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Dictionary Definitions

• “the degree of excellence which a thing possesses”

• “the feature that makes something h t it i ”what it is”

• “superiority in kind”

Classical Definitions

• “fitness for use” (Juran)

• “conformance to requirements”(Crosby)

• “the totality of features and ycharacteristics of a product or service that bear on its ability to satisfy given needs” (ASQ)

Quality Dimensions

• Meaning of quality cannot be captured in a simple short statement

• Let us define some dimensions of quality for Product

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Quality Dimensions -- Product

PerformancePerformanceFeaturesFeatures

ReliabilityReliabilityConformanceConformance DurabilityDurability

ServiceabilityServiceabilityAestheticAesthetic

Perceived Perceived QualityQualityQualityQuality

ProductProduct

Source: Total quality and organization development by Lindsay and Source: Total quality and organization development by Lindsay and PetrickPetrick

What is ISO 9000:2008 QMS?

• ISO = International Organization for Standards

• 9000 = code to denote QMS Family

• 2008 = year of last revision

• Is a family of standards for implementing a Quality Management System (QMS)

What is a QMS?

• System for managing quality -System: a set of logically related processes that turn input into outputManaging: administering activities and resources to

hi bj tiachieve an objectiveQuality: customer/user satisfaction

InputInput OutputOutputProcessProcess

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ISO is not ...

• a product label

• a product guarantee

• assessed by the ISO organization, but by an independent auditorby an independent auditor

Timeline

• 1945 NATO 6-49• 1959 MIL-Q-9858A• 1975 BS 5179• 1980s TC 176 formed by ISOy• 1987 ISO 9000• 1994 revised ISO 9000:1994• 2000 revised ISO 9000:2000• 2008 revised ISO 9000:2008

ISO 9000 Family

ISO ISO 9000 9000 -- fundamentals, fundamentals, vocabularyvocabularyISO ISO 9001 9001 -- requirementsrequirementsISO ISO 9004 9004 -- continual continual improvement guidelinesimprovement guidelinesISO ISO 19011 19011 -- auditing guidelinesauditing guidelines

only ISO only ISO 9001 9001 can be used forcan be used forcertification purposescertification purposes

December 10

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SSummary of all ummary of all ISOISO guidelinesguidelines

SaySay what you what you DoDo

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DocumentDocument what you what you SaySayDoDo what you what you DocumentDocument

Why ISO QMS?

• Competitors have it

• Required by customers

• Helps manage company records

• Clarifies authority & responsibilitiesClarifies authority & responsibilities

• Improves performance

• Can cut costs

• Global acceptance

ISO 9001:2008 QMS Principles

1. Customer focus2. Leadership3. Involvement of people4. Process approach 5 System approach to management5. System approach to management6. Continual improvement7. Factual approach to decision

making8. Mutually beneficial supplier’s

relationship ISO ISO 90009000::20082008

December 10

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Continual Improvement of the QMSContinual Improvement of the QMS

info. flowinfo. flow

IREM

ENTS

IREM

ENTS

SFA

CTI

ON

SFA

CTI

ONmanagementmanagement

responsibilityresponsibility QMSQMS

QMS Principles & ISO QMS Principles & ISO 9001 9001 ModelModel

InputInput OutputOutputvalue adding value adding

activitiesactivities


CU

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MER

REQ

UC

UST

OM

ER R

EQU

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ISC

UST

OM

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ATIS

productproductrealizationrealization

resourceresourcemanagementmanagement

meas., analysismeas., analysisimprovementimprovement

productproductvalue value

adding activitiesadding activities

1. Customer Focus

• Organizations depend on their customers; therefore they should

Know their current and future needs

Meet their requirements SFA

CTI

ON

SFA

CTI

ON

IREM

ENTS

IREM

ENTS

Meet their requirements

Exceed their expectations

Get their feedback

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2. Leadership

• Leaders create common purpose and direction; therefore they should

Maintain a healthy internal

managementmanagementresponsibilityresponsibility

environment

Inspire workforce to excel

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3. Involvement of People• People are the essence of an

organization; thereforeThey should be fully involved

Their abilities should be used for


organization benefits

4.4. Process ApproachProcess Approach

Manage activities and related Manage activities and related resources as a PROCESSresources as a PROCESS

ReviewReviewPurchasePurchase DesignDesign MakeMake DeliverDeliver

OrderOrder ProductProduct

ReviewReviewPurchasePurchase DesignDesign MakeMake DeliverDeliver

EQU

IREM

ENTS

EQU

IREM

ENTS

ATIS

FAC

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ISFA

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4.4. Process ApproachProcess Approach



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productproductrealizationrealization productproduct

value value adding adding


December 10

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5. System Approach to Management

• Managing interrelated processes as a system helps the organization in achieving its objectives in an effective and efficient manner

QU

IREM

ENTS

QU

IREM

ENTS

TISF

AC

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NTI

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5.5. System ApproachSystem Approach

managementmanagementresponsibilityresponsibility



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productproductrealizationrealization productproduct

value value adding adding





6. Continual Improvement

• A permanent objective of an organization should be to grow and improve over time

December 10

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managementmanagementresponsibilityresponsibilityPlanPlan ActAct

6.6. Continual Improvement:Continual Improvement: PDCA CyclePDCA Cycle





DoDo CheckCheck

7. Factual Approach to Decision-Making

• Effective decisions are based on the analysis of data and information

IREM

ENTS

IREM

ENTS

SFA

CTI

ON

SFA

CTI


responsibilityresponsibilityinfo. flowinfo. flow


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STO

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8. Mutually Beneficial Supplier Relationship

• Interrelated

• Win-Winproductproduct

realizationrealizationSupplierSupplier

December 10

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QU

IREM

ENTS

QU

IREM

ENTS

TISF

AC

TIO

NTI

SFA

CTI


responsibilityresponsibilityclause clause 44

clause clause 55clause clause 66 clause clause 88

QMSQMS

ISO ISO 9001 9001 Model & ClausesModel & Clauses




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SATresourceresource

managementmanagementmeas., analysismeas., analysisimprovementimprovement

productproduct

clause clause 77productproduct

realizationrealizationvalue value adding adding


Clauses/Requirements

Clause 4. Quality Management System

Clause 5. Management Responsibility

Clause 6. Resource Management

Clause 7 Product RealizationClause 7. Product Realization

Clause 8. Measurement, Analysis and Improvement

Count the number of requirement categories.Count the number of requirement categories.

Clause 4: Quality Management System

4.1 General requirements4.2 Documentation requirements

1. General2. Quality manual3. Control of documents4. Control of records

December 10

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Clause 5: Management Responsibility

5.1 Management commitment5.2 Customer focus5.3 Quality policy5.4 Planning

1. Quality objectives2. QMS planning

Clause 5: Management Responsibility (Cont.)

5.5 Responsibility, authority and communication

1. Responsibility and authority2. Management representative3. Internal communication

5.6 Management review1. General2. Review input3. Review output

Clause 6: Resource Management

6.1 Provision of resources6.2 Human resources

1. General2. Competence, awareness and training

6.3 Infrastructure 6.4 Work environment

December 10

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Clause 7: Product Realization

7.1 Planning of product realization7.2 Customer-related processes

1. Determination of requirements related to the product

2. Review of requirements related to the product

3. Customer communication

Clause 7: Product Realization (Cont.)

7.3 Design and development1. Design and development planning2. Design and development inputs3. Design and development outputs4 Design and development review4. Design and development review5. Design and development verification6. Design and development validation7. Control of design and development changes


7.4 Purchasing1. Purchasing process2. Purchasing information3. Verification of purchased productp p

December 10

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7.5 Production and service provision1. Control of production and service provision2. Validation of processes for production and

service provision3. Identification and traceability4. Customer property5. Preservation of product

7.6 Control of monitoring and measuring devices

Clause 8: Measurement, Analysis, and Improvement

8.1 General8.2 Monitoring and measurement

1. Customer satisfaction2. Internal audit3 Monitoring and measurement of3. Monitoring and measurement of

processes4. Monitoring and measurement of product

Clause 8: Measurement, Analysis, and Improvement (Cont.)

8.3 Control of nonconforming product8.4 Analysis of data8.5 Improvement

1. Continual improvementCo ua p o e e2. Corrective action3. Preventive action

December 10

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Key Quality Tools

DocumentationDocumentation AuditingAuditing

Why Document?

Document for ARCA:Document for ARCA:AAccuracyccuracyRRepeatabilityepeatabilityCConsistencyonsistencyAAccountabilityccountability

From Standards to Quality Manual

ISO ISO 90019001StandardStandardOrganizationOrganization

shallshallshallshall

QualityQualityManualManual


shallshall shallshall

December 10

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ISO 9001 Documentation Structure

PoliciesPolicies

ProceduresProcedures(Department)(Department)

The QualityThe QualityManualManual

( p )( p )

Work InstructionsWork Instructions(Job/Task)(Job/Task)

Quality RecordsQuality RecordsExternal DocumentsExternal Documents

ISO 9001 Documentation Cross Referencing

Level Level II

Level Level IIII

PoliciesPolicies

ProceduresProcedures(Department)(Department)

Level Level IIIIII

Level Level IVIV

( p )( p )

Work InstructionsWork Instructions(Job/Task)(Job/Task)

Quality RecordsQuality RecordsExternal DocumentsExternal Documents

Why Audit?

The organization shall continually improve the effectiveness of the QMS through the use of the:

quality policy and objectives

dit ltaudit results

analysis of data

corrective and preventive actions

management review Clause 8.5.1

December 10

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Types of Audits

11stst party party -- audit within your organizationaudit within your organization

22ndnd party party -- auditing your suppliersauditing your suppliers

33rdrd party party -- audit by regulators & audit by regulators & registrarsregistrars

ISO 9001 Certificate Realization Process

DocumentDocumentIdentifyIdentifyGapGap

PlanPlan

QMQM

ImplementImplement

RegisterRegister

EvidenceEvidence

CertificateCertificate

Gap AnalysisIdentifyIdentify

GapGap

ISO ISO 90019001StandardStandard

OrganizationOrganization




PlanPlan

December 10

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From Standards to Quality Manual IdentifyIdentifyGapGap

DocumentDocument


OrganizationOrganization QualityQualityManualManual




Implementing DocumentationIdentifyIdentify

GapGap

DocumentDocument

IdentifyIdentifyGapGap

DocumentDocument

ImplementImplement

ISO ISO 90019001St d dSt d d

OrganizationOrganization Implementing Implementing StandardStandard

gg




Quality ManualQuality Manual

Getting the CertificateIdentifyIdentify

GapGap DocumentDocumentIdentifyIdentify

GapGap DocumentDocument

ImplementImplement

RegisterRegister


OrganizationOrganization



Implementing Implementing Quality ManualQuality Manual

CertificateCertificate


December 10

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ISO ISO 90019001::20082008is not a System for is not a System for

ISO ISO 90019001::20082008is not a System for is not a System for

٥٥

is not a System for is not a System for Documentation!Documentation!

ISO is a Documented SystemISO is a Documented System

is not a System for is not a System for Documentation!Documentation!

ISO is a Documented SystemISO is a Documented System

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Awarness of ISO 9001: 2008

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