ISO 9000ImplementationTridash Chopra

ISO 9000: 1994 ClausesManagement ResponsibilityQuality SystemContract ReviewDesign ControlDocument ControlPurchasingPurchaser Supplied ProductProduct Identification and TraceabilityProcess ControlInspection and Testing

ISO 9000: 1994 ClausesInspection Measuring and Test EquipmentInspection and Test StatusControl of Non-Conforming ProductCorrective ActionHandling, Storage, Packaging and DeliveryQuality RecordsInternal Quality AuditsTrainingServicingStatistical Techniques

ISO 9000:2000 ClausesQuality Management SystemResource ManagementProduct or Service RealizationManagement ResponsibilityMeasurement, Analysis and Improvement

ISO 9000: 2000Quality Management System

Quality Management SystemDocumentation

StandardISO 9000Quality ManualQuality System ProceduresWork InstructionsFormsLEVEL 1LEVEL 2LEVEL 3LEVEL 4Policy Statement, Commitment, Organisation, ResponsibilitiesCompany Practices, InterfacesWritten Instructions to Control TasksQuality RecordsSalesDesignPurchasingManufacturingAccountsPersonnelAfter Sales

Why have a Quality Policy?

Need for Quality PolicyAll organizations have in mind some principles, beliefs which are their broad guides to managerial conductThese guides rest on a philosophical and ethical baseThey concern important issues and are intended to have a long life, i.e. to act as a stabilizerSuch principles and beliefs are referred to as a Quality Policy

Need for Quality PolicyWhen organizations grow, there are different managers working under which various employees are workingThings need to be defined at that stage as things start becoming ambiguousAs the unwelcome incidents accumulate, there arises a growing urge to think through, write out, and publish quality policies to serve as guides to managerial action

Advantages of PoliciesIt provides insiders and outsiders with a new, superior form of predictability, i.e. a written guide to managerial actionIt forces the organization to think about quality problems to a depth never before achieved. before you write it down, you must think it outIt establishes legitimacy and can be communicated in an authoritative, uniform mannerIt permits practices to be audited against that policy

Disadvantages of PoliciesMajor disadvantage is work involvedSome managers think that written policies tend to restrict innovation and to narrow the range of action available to adapt to changing conditions

Corporate Quality PoliciesAs a company grows, it becomes evident that no one set of quality policies can fit all company activitiesThis problem is solved by creating several levels of quality policy out of which one is corporate policy which usually consists ofThe purpose of writing and publishing quality policiesA brief statement of corporate intentThe minimal actions to be taken by the company divisions with respect to qualityInterdivisional relationships concerning qualityRelationship of quality policies to other company policies

Corporate Quality PoliciesA delegation of authority to subordinate company organization units to establish subsidiary quality policies appropriate to their needsSummary statementIt is the policy of the company to provide products and services of a quality that meet the initial and continuing needs and expectations of customers in relation to the price paid and to the nature of competitive offerings, and in doing so, to be the leader in product quality reputation

Corporate Quality PoliciesImportance of qualityLeadership in quality has top priorityQuality shall be given equal priority to costs and deliveryQuality competitivenessEqual or exceed competitive qualityBe of the highest qualityCustomer relationsProvide customer satisfactionMeet customer perception of good quality

Corporate Quality PoliciesInternal CustomersWe regard the receivers of our work results as customers whose needs are important to understand and satisfyWork Force InvolvementOur policy is to foster a spirit of pride among employees regarding the companys quality performanceQuality improvementResources will be allocated primarily to the prevention of defects and corrective action will be focused on rot-cause identification and elimination

Divisional Quality PoliciesThe same design shall be used in all factories making a specific product.Quality of design shall be used in all factories making a specific product

Quality Policies for Functional AreasMany of the policies are prepared to provide guidance to managers in specific functional departments such as product development, manufacturing and marketingNew product introductionDesign reviews shall be conducted with customer, market and regulatory bodies in order to ensure the compliance of the design for qualitySuppliersWe seek to establish long-term, open relations with our suppliers

Quality Policies for Functional AreasManufacturingManufacturing process capability must be verified during the product development cycleProductionInvolvement and a spirit of pride will be fostered among employees by encouraging ideas and resolutions regarding the companys quality performanceCustomer serviceService operations shall be conducted so as to minimize customers shutdowns

Quality ObjectivesAn objective is an aimed-at-target an achievement toward which effort is extended. Quality objective is an aimed-at-quality targetQuality objectives should be quantifiable in nature (measurable) - SMART

Objectives vs. Policies

Objectives vs. Standards

Implementing ISO 9000:2000Awareness TrainingEstablish a TeamEstablish ISO 9000 StatusPrepare Action PlanTrack Action PlanPresent Status of Action PlanISO 9000 Readiness AssessmentContact Registrar (Certification Body)Official ISO 9000 AuditContinuous ImprovementCelebrate!

ISO 9000:2000 ClausesQuality Management SystemResource ManagementProduct or Service RealizationManagement ResponsibilityMeasurement, Analysis and Improvement

Quality Management System (QMS)Concerned with the documentation and management of the QMSSub-clauses:Quality ManualControl of documentsControl of records

Management ResponsibilityConcerned with the responsibility of management in the implementation of the quality systemSub-clauses:Management commitmentCustomer focusQuality policyPlanningResponsibility, authority, and communicationManagement review

Resource ManagementConcerned with the provision of resources needed to implement the QMSSub-clauses:Provision of resourcesHuman resourcesInfrastructureWork environment

Product or Service RealizationConcerned with the provision of processes to implement the product or serviceSub-clauses:Planning of product realizationCustomer related processesCustomer requirementsCustomer communicationDesign and developmentControl of changesPurchasing processProduction and service provisionValidation of processesIdentification and traceabilityCustomer propertyPreservation of productControl of measuring and monitoring devices

Measurement, Analysis and ImprovementConcerned with the establishment of a measurement program to measure QMS performance and to identify problemsSub-clauses:Measurement of customer satisfactionInternal auditsMeasurement and monitoring of processesMeasurement and monitoring of productControl of nonconformityAnalysis of dataContinual improvementCorrective actionPreventive action