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ISO 9000ISO 9000IntroductionIntroduction
Imran HussainImran Hussain
Why have a Quality Why have a Quality Standard?Standard?
Customer
Supplier
Vendor Subcontractor
contract
subcontract
Motivation for ISO 9000Motivation for ISO 9000
Helps in selection of suppliers and Helps in selection of suppliers and vendorsvendors
Places onus of proving quality on Places onus of proving quality on suppliersupplier ControlsControls ProcessesProcesses ProceduresProcedures Quality recordsQuality records
What’s the difference What’s the difference between TQM and ISO between TQM and ISO
9000?9000?
Benefits to customers Benefits to customers and _____ ?and _____ ?
Benefits of ISO 9000Benefits of ISO 9000
Customers and users will benefit by Customers and users will benefit by receiving the products that are:receiving the products that are: Conforming to the requirements Conforming to the requirements Dependable and reliable Dependable and reliable Available when needed Available when needed MaintainableMaintainable
Benefits to Benefits to employees?employees?
Benefits of ISO 9000Benefits of ISO 9000
People in the organization will People in the organization will benefit by:benefit by: Better working conditions Better working conditions Increased job satisfaction Increased job satisfaction Improved health and safety Improved health and safety Improved morale Improved morale Improved stability of employmentImproved stability of employment
Benefits to owners Benefits to owners and investors?and investors?
Benefits of ISO 9000Benefits of ISO 9000
Owners and investors will benefit by:Owners and investors will benefit by: Increased return on investment Increased return on investment Improved operational results Improved operational results Increased market share Increased market share Increased profitsIncreased profits
Benefits to suppliers Benefits to suppliers and partners?and partners?
Benefits of ISO 9000Benefits of ISO 9000
Suppliers and partners will benefit Suppliers and partners will benefit by:by: Stability Stability Growth Growth Partnership and mutual understandingPartnership and mutual understanding
Benefits to society?Benefits to society?
Benefits of ISO 9000Benefits of ISO 9000
Society will benefit by:Society will benefit by: Fulfillment of legal and regulatory Fulfillment of legal and regulatory
requirements requirements Improved health and safety Improved health and safety Reduced environmental impact Reduced environmental impact Increased securityIncreased security
Does ISO have anything Does ISO have anything to do with Quality to do with Quality
Management?Management?
ISO 9000 and Quality ISO 9000 and Quality Management (QM)Management (QM)
ISO standards based on the following ISO standards based on the following QM principles:QM principles:
1.1. Customer focus Customer focus
2.2. Leadership Leadership
3.3. Involvement of people Involvement of people
4.4. Process approach Process approach
5.5. System approach to management System approach to management
6.6. Continual improvement Continual improvement
7.7. Factual approach to decision making Factual approach to decision making
8.8. Mutually beneficial supplier relationshipsMutually beneficial supplier relationships
ISO 9000 and SQA GroupISO 9000 and SQA Group
Responsibility lies with managementResponsibility lies with management SQA groupSQA group
implements standardsimplements standards Monitors effectiveness in organizationMonitors effectiveness in organization
Responsibilities of SQA Responsibilities of SQA GroupGroup
Perform auditsPerform audits Promote awarenessPromote awareness Communicate Quality System to staffCommunicate Quality System to staff Support implementation of ISO 9000Support implementation of ISO 9000 Perform customer satisfaction surveysPerform customer satisfaction surveys Facilitate improvement following Facilitate improvement following
customer feedbackcustomer feedback Review project quality at milestonesReview project quality at milestones Act as partner in quality projectAct as partner in quality project
Responsibilities of SQA Responsibilities of SQA GroupGroup
Facilitate improvement and defect Facilitate improvement and defect prevention activitiesprevention activities
Monitor and verify process complianceMonitor and verify process compliance Monitor effectiveness of processesMonitor effectiveness of processes Monitor institutionalisation of processesMonitor institutionalisation of processes Chair organization quality reviewsChair organization quality reviews Facilitate external auditsFacilitate external audits Test planning, execution, reporting and Test planning, execution, reporting and
recommendationrecommendation Test lab managementTest lab management Support a metrics cultureSupport a metrics culture
ISO 9000 History and ISO 9000 History and BackgroundBackground
BS 5750 (forerunner to ISO 9000)BS 5750 (forerunner to ISO 9000) ISO 9000: 1987ISO 9000: 1987 ISO 9000: 1994ISO 9000: 1994 ISO 9000: 2000ISO 9000: 2000
ISO 9000: 1994ISO 9000: 1994
Family of standardsFamily of standards Applicable to manufacturing Applicable to manufacturing
organizations, servicing organizations organizations, servicing organizations and software organizationsand software organizations
Different flavoursDifferent flavours ISO 9001 (full product lifecycle) - supersetISO 9001 (full product lifecycle) - superset ISO 9002 (production, installation, ISO 9002 (production, installation,
servicing)servicing) ISO 9004 (inspection and testing)ISO 9004 (inspection and testing)
Quality Management Quality Management System DocumentationSystem Documentation
Quality Manual
Quality Manual Quality
System Procedure
s
Quality System
Procedures
Work Instructio
ns
Work Instructio
nsFormsForms
Quality ManualQuality Manual
Quality PolicyQuality Policy ObjectivesObjectives OverviewOverview OrganisationOrganisation ResponsibilitiesResponsibilities Requirements Requirements
Policy/Responsibility/Procedure Policy/Responsibility/Procedure ReferenceReference
Quality System Quality System ProceduresProcedures
A set of procedures which detail how A set of procedures which detail how the requirements of the quality the requirements of the quality manual are to be implementedmanual are to be implemented
Detailed procedures which define Detailed procedures which define how the processes are to be how the processes are to be performed and controlledperformed and controlled
Specifying who is responsible for Specifying who is responsible for whatwhat
Work InstructionsWork Instructions
Detailed instructions for the Detailed instructions for the performance of specific tasksperformance of specific tasks
Such instructions may coverSuch instructions may cover MaterialsMaterials ProcessesProcesses VerificationVerification
FormsForms
Records that provide proof that Records that provide proof that specified activities were carried outspecified activities were carried out
A.k.a. quality recordsA.k.a. quality records
Quality Management Quality Management SystemSystemStandard
ISO 9000
Quality Manual
Quality System Procedures
Work Instructions
Forms
LEVEL 1
LEVEL 2
LEVEL 3
LEVEL 4
Policy Statement, Commitment, Organisation,
Responsibilities
Company Practices, Interfaces
Written Instructions to Control Tasks
Quality Records
Sales Design
Purchasing
Manufacturing
Accounts Personnel
After Sales
Documenting ProceduresDocumenting Procedures
Say what you doSay what you do
Do what you sayDo what you say
And where necessaryAnd where necessary
Show what you didShow what you did
ISO 9000: 1994 ClausesISO 9000: 1994 Clauses
1.1. Management ResponsibilityManagement Responsibility2.2. Quality SystemQuality System3.3. Contract ReviewContract Review4.4. Design ControlDesign Control5.5. Document ControlDocument Control6.6. PurchasingPurchasing7.7. Purchaser Supplied ProductPurchaser Supplied Product8.8. Product Identification and TraceabilityProduct Identification and Traceability9.9. Process ControlProcess Control10.10. Inspection and TestingInspection and Testing
ISO 9000: 1994 ClausesISO 9000: 1994 Clauses
11.11. Inspection Measuring and Test EquipmentInspection Measuring and Test Equipment12.12. Inspection and Test StatusInspection and Test Status13.13. Control of Non-Conforming ProductControl of Non-Conforming Product14.14. Corrective ActionCorrective Action15.15. Handling, Storage, Packaging and DeliveryHandling, Storage, Packaging and Delivery16.16. Quality RecordsQuality Records17.17. Internal Quality AuditsInternal Quality Audits18.18. TrainingTraining19.19. ServicingServicing20.20. Statistical TechniquesStatistical Techniques
ReferencesReferences
Software Quality Management and Software Quality Management and ISO 9001, by Michael Jenner, Ch. 1, ISO 9001, by Michael Jenner, Ch. 1, 22
A Practical Approach to Software A Practical Approach to Software Quality, by Gerard O’Regan, Ch. 3Quality, by Gerard O’Regan, Ch. 3
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