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Ashraf S. Youssef, Ph.D., Quality Assurance Manager, Senior Member ASQ, Member EMS.
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December 10
١
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
December 10
٢
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.
December 10
٣
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
December 10
٤
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
December 10
٥
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
٦
SSummary of all ummary of all ISOISO guidelinesguidelines
SaySay what you what you DoDo
١٦
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
٧
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
info. flowinfo. flow
CU
STO
MER
REQ
UC
UST
OM
ER R
EQU
CU
STO
MER
SAT
ISC
UST
OM
ER S
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
CU
STO
MER
SAT
ISC
UST
OM
ER S
ATIS
CU
STO
MER
REQ
UI
CU
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MER
REQ
UI
2. Leadership
• Leaders create common purpose and direction; therefore they should
Maintain a healthy internal
managementmanagementresponsibilityresponsibility
environment
Inspire workforce to excel
December 10
٨
3. Involvement of People• People are the essence of an
organization; thereforeThey should be fully involved
Their abilities should be used for
resourceresourcemanagementmanagement
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
TIO
NAT
ISFA
CTI
ON
4.4. Process ApproachProcess Approach
InputInput OutputOutputvalue adding value adding
activitiesactivities
CU
STO
MER
RE
CU
STO
MER
RE
CU
STO
MER
SA
CU
STO
MER
SA
productproductrealizationrealization productproduct
value value adding adding
activitiesactivities
December 10
٩
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
TIO
NTI
SFA
CTI
ON
5.5. System ApproachSystem Approach
managementmanagementresponsibilityresponsibility
InputInput OutputOutputvalue adding value adding
activitiesactivities
CU
STO
MER
REQ
CU
STO
MER
REQ
CU
STO
MER
SAT
CU
STO
MER
SAT
productproductrealizationrealization productproduct
value value adding adding
activitiesactivities
productproductrealizationrealization
resourceresourcemanagementmanagement
meas., analysismeas., analysisimprovementimprovement
6. Continual Improvement
• A permanent objective of an organization should be to grow and improve over time
December 10
١٠
managementmanagementresponsibilityresponsibilityPlanPlan ActAct
6.6. Continual Improvement:Continual Improvement: PDCA CyclePDCA Cycle
Continual Improvement of the QMSContinual Improvement of the QMS
productproductrealizationrealization
resourceresourcemanagementmanagement
meas., analysismeas., analysisimprovementimprovement
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
ONmanagementmanagement
responsibilityresponsibilityinfo. flowinfo. flow
info. flowinfo. flow
CU
STO
MER
REQ
UC
UST
OM
ER R
EQU
CU
STO
MER
SAT
ISC
UST
OM
ER S
ATIS
meas., analysismeas., analysisimprovementimprovement
productproductrealizationrealization
8. Mutually Beneficial Supplier Relationship
• Interrelated
• Win-Winproductproduct
realizationrealizationSupplierSupplier
December 10
١١
Continual Improvement of the QMSContinual Improvement of the QMS
info. flowinfo. flow
QU
IREM
ENTS
QU
IREM
ENTS
TISF
AC
TIO
NTI
SFA
CTI
ONmanagementmanagement
responsibilityresponsibilityclause clause 44
clause clause 55clause clause 66 clause clause 88
QMSQMS
ISO ISO 9001 9001 Model & ClausesModel & Clauses
InputInput OutputOutputvalue adding value adding
activitiesactivities
info. flowinfo. flow
CU
STO
MER
REQ
CU
STO
MER
REQ
CU
STO
MER
SAT
CU
STO
MER
SATresourceresource
managementmanagementmeas., analysismeas., analysisimprovementimprovement
productproduct
clause clause 77productproduct
realizationrealizationvalue value adding adding
activitiesactivities
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
١٢
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
١٣
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
Clause 7: Product Realization (Cont.)
7.4 Purchasing1. Purchasing process2. Purchasing information3. Verification of purchased productp p
December 10
١٤
Clause 7: Product Realization (Cont.)
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
١٥
Key Quality Tools
DocumentationDocumentation AuditingAuditing
Why Document?
Document for ARCA:Document for ARCA:AAccuracyccuracyRRepeatabilityepeatabilityCConsistencyonsistencyAAccountabilityccountability
From Standards to Quality Manual
ISO ISO 90019001StandardStandardOrganizationOrganization
shallshallshallshall
QualityQualityManualManual
shallshallshallshall
shallshall shallshall
December 10
١٦
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
١٧
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
shallshallshallshall
shallshallshallshall
shallshall shallshall
PlanPlan
December 10
١٨
From Standards to Quality Manual IdentifyIdentifyGapGap
DocumentDocument
ISO ISO 90019001StandardStandard
OrganizationOrganization QualityQualityManualManual
shallshallshallshall
shallshallshallshall
shallshall shallshall
Implementing DocumentationIdentifyIdentify
GapGap
DocumentDocument
IdentifyIdentifyGapGap
DocumentDocument
ImplementImplement
ISO ISO 90019001St d dSt d d
OrganizationOrganization Implementing Implementing StandardStandard
gg
shallshallshallshall
shallshallshallshall
shallshall shallshall
Quality ManualQuality Manual
Getting the CertificateIdentifyIdentify
GapGap DocumentDocumentIdentifyIdentify
GapGap DocumentDocument
ImplementImplement
RegisterRegister
ISO ISO 90019001StandardStandard
OrganizationOrganization
shallshallshallshall
shallshall shallshall
Implementing Implementing Quality ManualQuality Manual
CertificateCertificate
shallshall shallshall
December 10
١٩
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
كرًا كرًاش ش٥٦
شــــكراشــــكرا
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