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