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ISO 9001 and ISO 9000-3ISO 9001 and ISO 9000-3
StandardsStandards
Cybermate Infotek Limited
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ISO 9001 Quality systemISO 9001 Quality system
Model for quality assurance in design,development, production, installation andservicing
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ISO 9000-3 QualityISO 9000-3 Qualitymanagement and qualitymanagement and quality
assurance standardsassurance standardsPart 3 Guidelines for the application of ISO9001 : 1994 to the development, supply,installation and maintenance of computer software.
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Quality system requirementsQuality system requirements
Management responsibilityQuality systemContract reviewDesign control
Document and data controlPurchasingControl of customer supplied product
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Quality system requirementsQuality system requirements
(contd)(contd)Product identification and traceabilityProcess control
Inspection and testingControl of inspection, measuring and testequipment
Inspection and test statusControl of non conforming productCorrective and preventive action
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4.2 Quality system (contd)4.2 Quality system (contd)
Quality planning consistsQuality requirementsLife cycle model to be usedCriteria for start and end of phase
Verification and validation activities -reviews, tests etc.,
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4.3 Contract review4.3 Contract review
Before submission of tender or acceptanceof order, reviews are done to ensure that -
Requirements are defined and documentedAny differences between contract andtender are resolved
Supplier has the capability to meetcontractual requirementsContract review records
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4.3 Contract review (contd)4.3 Contract review (contd)
Contract review issues -Customer relatedTechnicalManagerial
Legal, security and confidentiality
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4.4 Design control (contd)4.4 Design control (contd)
Design inputSoftware Requirements Specification may
be provided by the customer or prepared bythe supplier.SRS to cover functionality, reliability,
usability, efficiency, maintainability, portability etc.,Hardware and software aspects.
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4.4 Design control (contd)4.4 Design control (contd)
Design outputShall meet design input requirementsRefer to the acceptance criteriaConsist of architectural design, detaileddesign, source code, user manual etc.,
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4.4 Design control (contd)4.4 Design control (contd)
Design reviewDesign verificationDesign validationDesign changes
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4.5 Document and data4.5 Document and data
controlcontrolDocuments - Quality system documents,Project documents (SRS, SDD, Test plan
etc.,)Document preparation, review and approvalRight documents at the right place.Document change control
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4.7 Control of customer 4.7 Control of customer
supplied productsupplied productVerification, storage and maintenance of customer supplied products like software,
tools, test data, design documents etc.,
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4.8 Product identification and4.8 Product identification and
traceabilitytraceabilityIdentification of software items duringdevelopment phases
Configuration management plan for each projectVersion controlBuild status and BaselineChange control
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4.9 Process control4.9 Process control
ReplicationBackups and disaster recovery plans
Network controlHardware maintenance
Virus control
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4.10 Inspection and testing4.10 Inspection and testing
Test plans for unit, integration, system andacceptance tests.
Receiving inspection and testingUnit testingModule testingIntegration testingSystem testing
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4.10 Inspection and testing4.10 Inspection and testing
(contd)(contd)Tests to be performed - functional,
boundary, performance, usability etc.,
Acceptance testing as per acceptancecriteriaInspection and tests records
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4.11Control of inspection,4.11Control of inspection,
measuring and test equipmentmeasuring and test equipmentEnvironment used for testing softwareValidation of test tools used in testing
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4.12 Inspection and test status4.12 Inspection and test status
Untested, tested with error, testedsuccessfully or approved for release
Movement of software betweendevelopment and testing.
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4.13 Control of nonconforming4.13 Control of nonconforming
productproductTransfer non conforming product to aseparate environment
Review and disposition of non conforming product
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4.14 Corrective and4.14 Corrective and
preventive actionpreventive actionCorrective action
Handling of customer complaintsInvestigate causes of non conformitiesrelating to product, process and qualitysystem.Corrective action to eliminate cause of actual non conformities.
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4.14 Corrective and4.14 Corrective and
preventive action (contd)preventive action (contd)Preventive action
Analyse test, review, audit, service reportsto identify and eliminate potential causes of non conformities.Root cause analysis
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4.15 Handling, storage,4.15 Handling, storage,packaging, preservation andpackaging, preservation and
deliverydeliveryAvoid damage to mediaVirus controlStorage in protected environmentDelivery by physical media or electronictransfer.
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4.16 Control of quality records4.16 Control of quality records
Identification, collection, indexing, access,filing, storage, maintenance and disposition
of quality records.Quality records demonstrate conformanceto specified requirements and effective
operation of quality system.
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4.17 Internal quality audits4.17 Internal quality audits
Plan and implement internal quality auditsAuditors are independent of the area being
audited.Results of audits are recorded and broughtto the notice of the auditee.
Corrective action taken to closedeficiencies.Follow up audits
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4.18 Training4.18 Training
Training to enhance skills and knowledgeTraining needs are identifiedTraining provided as per plans
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4.19 Servicing4.19 Servicing
Maintenance and customer supportProblem resolutionInterface modificationsFunctional expansionPerformance improvement
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4.20 Statistical techniques4.20 Statistical techniques
Establishing, controlling and verifying process capability and product
characteristicsProduct characteristics - testability,usability, reliability, maintainability,
availability
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4.20 Statistical techniques4.20 Statistical techniques
(contd)(contd)Process capability - process maturity, defectdensity, defect removal efficiency,
milestone slippageMetric reporting and actions for improvement.
