ISO 9001-2015 Overview-11-22-16-PACU · ISO 9001 • 1979 – BS 5750 Quality Assurance Standards...
Transcript of ISO 9001-2015 Overview-11-22-16-PACU · ISO 9001 • 1979 – BS 5750 Quality Assurance Standards...
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@CQLBusinessSystemsConsulting(11-2015)
ISO9001:2015PresentedBy:ASEANEng.DEXTERT.CHUA,PIE
November25,2016
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ISO• TheInternationalOrganizationforStandardizationbasedinGeneva,Switzerland
• Worldwidefederationofnationalstandardsbodies(ISOmemberbodies)
• Firstapproachedsubjectofqualityin1979• DerivedfromtheGreekword“isos”meaningequal
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ISO 9001 • 1979 – BS 5750 Quality Assurance Standards• 1987 – ISO 9001, ISO 9002, ISO 9003 QualityAssurance Standards
• 1994 – ISO 9001, ISO 9002, ISO 9003 QualityAssurance Standards Revision
• 2000 - ISO 9001 Quality Management Systems –Series Revisions
• 2008 – ISO 9001 Quality Management Systems -Requirements
2015 - ISO 9001 Quality ManagementSystems - Requirements
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ISO9001:2015• FiftheditionofISO9001standard.
• Based on the Common Framework: Appendix 3 ofISO/IEC Directives, Part 1 Annex SL• “Annex SL” is the generally used shorthand• New Clause numbers
• PublishedonSeptember15,2015.
• DeadlineforthetransitionfromISO9001:2008versionisSeptember14,2018.
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Whatwaschanged?
0.Introduction1. Scope2. Normativereferences3. Termsanddefinitions4. Contextoftheorganization5. Leadership6. Planning7. Support8. Operation9. Performanceevaluation10. Improvement
0.Introduction1. Scope2. Normativereferences3. Termsanddefinitions4. QualityManagementSystem5. ManagementResponsibility6. ResourceManagement7. ProductRealization8. Measurement,Analysisand
Improvement
ISO9001:2008 ISO9001:2015
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ISO9001:2015
Employstheprocessapproach,whichincorporatesthePlan-Do-Check-Act(PDCA)cycleandrisk-basedthinking.
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ISO9001:2015– PDCACycle
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QualityManagementPrinciples1. Customer focus2. Leadership3. Engagement of people4. Process approach5. Improvement6. Evidence-based decision making7. Relationship management
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MajorDifferencesinTerminologyISO9001:2008 ISO9001:2015
Products Productsandservices
Exclusions Notused
Managementrepresentative Notused
Documentation, qualitymanual,documentedprocedures,records
Documented information
Workenvironment Environmentfortheoperationofprocesses
Monitoringandmeasurementequipment
Monitoringandmeasuringresources
Purchased product Externallyprovidedproductsandservices
Supplier Externalprovider
*TableA.1ofISO9001:2015
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KeyChanges• EmphasisonRisk-basedmanagement(PreventiveAction)
• Increaseemphasisonachievingvaluefororganizationanditscustomer
• DocumentedInformation-Decreasedemphasisondocumentation-Expandsconceptofdocumentation-ReplacesDocumentsandRecords
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KeyChanges• OrganizationalContext-Responsivenesstobusinessenvironment
• OutsourcingisnowExternalProvision• Enhancedleadershiprequirements• NorequirementforManagementRepresentative• NorequirementforQualityManual
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UnderstandingISO9001:2015Requirements
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4.ContextoftheOrganization4.1 Understanding the organization and its
context4.2 Understanding the needs and expectations
of interested parties4.3 Determining the scope of the quality
management system4.4 Quality management system and its
processes
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5.Leadership5.1 Leadership and commitment
5.1.1 General5.1.2 Customer focus
5.2 Policy5.2.1 Establishing the quality policy5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities andauthorities
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6.Planning6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achievethem
6.3 Planning of changes
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7.Support7.1 Resources
7.1.1 General7.1.2 People7.1.3 Infrastructure7.1.4 Environment for the operation of
processes7.1.5 Monitoring and measuring resources
7.1.5.1 General7.1.5.2 Measurement traceability
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7.Support7.1.6 Organizational knowledge
7.2 Competence7.3 Awareness7.4 Communication7.5 Documented information
7.5.1 General7.5.2 Creating and updating7.5.3 Control of documented information
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8.Operation8.1 Operational planning and control8.2 Requirements for products and services
8.2.1 Customer communication8.2.2 Determining the requirements for
products and services8.2.3 Review of the requirements for
products and services8.2.4 Changes to requirements for
products and services
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8.Operation8.3Designanddevelopmentofproductsand
services8.3.1 General8.3.2 Design and development planning8.3.3 Design and development inputs8.3.4 Design and development controls8.3.5 Design and development outputs8.3.6 Design and development changes
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8.Operation8.4 Control of externally provided processes,
products and services8.4.1 General8.4.2 Type and extent of control8.4.3 Information for external providers
8.5 Production and service provision8.5.1 Control of production and service
provision
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8.Operation8.5.2 Identification and traceability8.5.3 Property belonging to customers or
external providers8.5.4 Preservation8.5.5 Post-delivery activities8.5.6 Control of changes
8.6 Release of products and services8.7 Control of nonconforming outputs
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9.Performanceevaluation9.1 Monitoring, measurement, analysis and
evaluation9.1.1 General9.1.2 Customer satisfaction9.1.3 Analysis and evaluation
9.2 Internal audit9.3 Management review
9.3.1 General9.3.2 Management review inputs9.3.3 Management review outputs
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10.Improvement10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
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BenefitsofAdoptingISO9001:2015
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Benefits• Enhancingcontinuousimprovement• MoreemphasisonLeadership• Managingriskandopportunities• Performancemeasurement• Integration
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