ISO 9001:2015 Revision - TÜV Nord

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ISO 9001:2015 RevisionTÜV UK Ltd – Guidance & Self Evaluation ChecklistWhy ISO 9001 is changingAll ISO management system standards are subjectto a periodic review under the rules by which theyare written. Following a user survey the ISOCommittee responsible for ISO 9001 determined thata review was appropriate and created the followingobjectives to maintain its relevance in today’s marketplace: Integrate with other management systems Provide an integrated approach to organisationalmanagement Provide a consistent foundation for the next 10years Reflect the increasingly complex environments inwhich organisations’ operate Ensure the new Standard reflects the needs of allpotential user groups Enhance an organisation’s ability to satisfy itscustomers.The key changes in the proposed standard for 2015are: Context of the organisationThis document providesan overview of the key changesbetween the 2008 and 2015 version ofISO 9001 and has been designed to help youassess your company’s readiness for an ISO9001:2015 certification audit.You will need to prepare for change and adaptyour quality management system to meet the newrequirements and transitional timelines.TÜV UK are encouraging clients to do early gapanalysis and be able to interpret standardrequirements.TÜV UK will offer transition audits after thepublication and certificates after successfulaccreditation (expectedtowardstheendof 2015).If you would like us to conduct a GAP analysis orreview your self evaluation form for you, pleasecomplete the questionnaire (including your contactdetails), and email it to us addition to ISO 9001 auditing TÜV UK offer thefollowing ISO 9001:2015 related services The emphasis on leadership The focus on risk managementGAP Analysis Emphasis on objectives, measurement and changeChecklist Review Communication and awareness Fewer prescriptive requirements

GuidanceISO 9001:2015 CLAUSESISO 9001:2008 CLAUSESGUIDANCE4 Context of the organisation4.1 Understanding the organisationand your contextNew requirement!This new concept relates to the factors andconditions affecting organisational operationE.g. regulation, governance and stakeholders.4.2 Understanding the needs andexpectations of interested partiesNew requirement!Consider who the interested parties might be andwhat their relevant interests might be, e.g.customers, shareholders, board members,competitors, regulators.4.3 Determining the scope of the QMS1 ScopeReference to “exclusions” has been removed.Elements which do not apply can and should bejustified under Clause 4.3 of 9001:2015.4.4 Quality management system and yourprocesses4.1, 5.4.2, 7.1, 8.1 and 8.2.3An elevated focus on processes. Adoption of theprocess approach is now mandatory and willbe audited accordingly.5.1 Leadership and commitment5 Management ResponsibilityEnhances 5.1, Management commitment, fromthe 2008 Standard. The 2015 FDIS repositionssome requirements to “leadership”, notmanagement. The emphasis has shifted fromensuring to “engaging”.5.2 Quality policy5.3 Quality policyEnhanced requirements from the 2008 version:more attention to be paid to the application of thepolicy across the organisation. There is a needfor “documented information”, as opposed to adocumented statement.5.3 Organisational roles,responsibilities and authorities5.5 Responsibility, authority andcommunicationThe role of the Management Representativehas disappeared; however the requirements ofthe 2008 clause 5.5.2 still need to be met. Thereis a new requirement that someone is taskedwith preserving the integrity of the QMS while it isin the process of change.6.1 Actions to address risksand opportunitiesNew requirement!Organisations must determine its context, and thearising risks and opportunities. Actions to addressrisk must be proportional to the potential impact.6.2 Quality objectives and planning toachieve them5.4 PlanningExtension of 2008 clauses, 5.4.1, and5.4.2.Stronger emphasis on the importance ofobjectives, which should be set for processes. Theorganisation must retain documented informationon quality objectives.5.4.2 Quality management systemplanningAn extension of the existing requirement:organisations must identify the purpose and likelyconsequences of change, and the necessaryresources and responsibilities.5 Leadership6 Planning for the QMS6.3 Planning of changes

Guidance7. Support7.1 Resources7.1.1General6.1 Provision of resourcesNeed to evidence external as well as internalresource requirements.7.1.2People6.2 Human Resources, 6.2.1GeneralNo significant change7.1.3Infrastructure6.3 InfrastructureEnhanced reference to examples, e.g. hardware,software, transportation7.1.4Environment for theoperation of processes6.4 Work environmentMore prescriptive than before with a requirementto determine, provide and maintain a suitableenvironment. There is a note in the new clausethat examples of “environment for the operationof processes” include social, psychological andenvironmental7.1.5Monitoring and measuringResources7.6 Control of monitoring andmeasuring equipmentMeasuring “equipment” becomes measuring“resource”, acknowledging that professionaljudgment and human senses may also be ameasuring resource, e.g. tea tasting.7.1.6Organisational knowledgeNew Requirement!Examples of such knowledge could be intellectualE.g. design or software and external sourcesof knowledge e.g. academia or conferences7.2 Competence6.2 Human resourcesThe requirement has been extended to includepeople performing work under the organisation’scontrol, i.e. outsourced resource such asagencies.7.3 Awareness6.2.2 Competence, training andawarenessThis is more expansive and now applies to allpersons doing work under the organisation’scontrol. People must be aware of policy, objectives,how they contribute and the implications of notconforming to the QMS.7.4 Communication5.5.3 Internal communicationThis is now much more prescriptive and includesexternal communications. Organisations mustnow determine what, when, with whom and howcommunications should take place.7.5 Documented information4.2 Documentation requirementsThe FDIS does not mention manual, proceduresor records. Documented information must becontrolled but there is no longer a requirement tohave a documented procedure for this process.Requirements now extend to access and usage,recognising that electronic information can beaccessed as read only, without authority to change.

Guidance8. Operation8.1 Organisational planning and control7.1 Planning of product realisationThis is a reworking and reorganising of the 2008Clause 7.1 requirements. The requirement to planand develop processes is not new, but has beenextended to include implementation and control.8.2 Determination of requirementsforproducts & services7.2 Customer related processesA subtle change in the supplier customerrelationship: the FDIS starts from the position thatthe organisation has already determined theproducts and services it intends to offer, reflecting amore common business environment for certificationcustomers. Requirements should include those frominterested parties and also include statutory andregulatory requirements relating to the product.New requirement!This new clause mandates the introduction ofa design and development process where thisactivity is required.7.3 Design and developmentBuilds on existing 2008 clauses 7.3.1 - 7.3.6.Design and development needs to be approachedas a process.8.4 Control of externally provided productsand services7.4 Purchasing8.5 Production and service provision7.5 Production and serviceProvisionEnhanced emphasis on external providersand the extent of employment of contractors incurrent commercial practice. Extent of controlsneeds to take account of the potential impacton the organisation’s ability to consistently meetrequirements. Risk assessment will be applicablehere.No significant changes.8.6 Release of products and services8.2.4 Monitoring and measurementof product8.7 Control of nonconforming processoutputs, products and services8.3 Control of nonconformingproduct8.3 Design and development of productsand services.8.3.1General8.3.2-8.3.6 Design and developmentprocess requirements:planning, inputs,controls,outputs,changesNo substantive change needed. Note refreshedterminology referring to services in addition toproduct.Some minor changes. There is no longer arequirement for a documented procedure, but thereis a requirement to maintain documentedinformation onactions taken,includingconcessions and authorisations.9 Performance evaluation9.1 Monitoring, measurement, analysisandevaluation9.2 Internal audit9.3 Management review8.2.1 Customer satisfaction, and 8.4 An enhanced emphasis on evaluation of results, inAnalysis of dataaddition to measurement and analysis. Monitoringshould be based on risk. Customer perceptionnow includes soliciting perceptions about theorganisation and its products and services.Preventive action and statistical techniques are nolonger referenced.8.2.2 Internal auditThere is no longer a need for a documentedprocedure. Internal audit programme shalltake into consideration changes to theorganisations.5.6 Management ReviewOverall purpose remains the same, howeverinputs should now include strategic items relatingto context, risk and opportunities. Trends andindicators should be usedto monitor qualityperformance.

Guidance10. Improvement10.1 GeneralNew requirement!The requirement for a documented preventiveaction procedure has gone.10.2 Nonconformity and corrective action5.2 Corrective actionWhen corrective action has been completed, theorganisation can move on to consider whetherany further action is required to prevent a similarnonconformity occurring in future.This requires the organisation to determine whatcaused the nonconformities and then to considerwhether the potential for a similar problemremains.The organisation is then required to implementany actions identified as needed, review theireffectiveness and make changes to the qualitymanagement system if necessary.10.3 Continual improvement8.5.1 Continual improvementOrganisations will now need to demonstrate thatthey are using the outputs from their analysisand evaluation processes to identify areas ppropriate tools and methodologies shouldbe employed by the organisation to support thisactivity.Major differences in terminologyYou will find that some of the familiar terminology of ISO 9001:2008 has either been changed or removed. Here are thehighlights:ISO 9001:2008ISO 9001:2015ProductsProducts and servicesSupplierExternal providerDocumentation and recordsDocumented informationWork environmentEnvironment for the operation of processesPurchased productExternally provided products and servicesExclusionsTerm not usedManagement representativeTerm not usedDocumented procedureTerm not usedQuality manualTerm not usedPreventive actionTerm not usedTerm not usedLeadershipTerm not usedRisk

Self Evaluation ChecklistSelf Evaluation ChecklistContext of the organisationPlanningHave you determined the external and internal issues thatare relevant to your organisation’s purpose and theachievement of customer satisfaction and the organisation’sstrategic direction?Have the risks and opportunities that need to beaddressed to give assurance that the QMS can achieveits intended result(s) been established?Has the organisation planned actions to address theserisks and opportunities and integrated them into thesystem processes?Do you have a way of reviewing and monitoring these ona regular basis?Have you determined the needs and expectations ofinterested parties that are relevant to the QualityManagement System (QMS)?Is there a defined process for the determining the need forchanges to the QMS and managing their implementation?Has the scope of the QMS been determined taking intoaccount the external and internal issues, interested partiesand your products and services?SupportHas your QMS been established including theprocesses needed and their sequence and interaction?Have the criteria for managing these been establishedtogether with responsibilities, methods, measurements andrelated performance indicators needed to ensure theeffective operation and control?LeadershipHas top management taken accountability foreffectiveness of the QMS?theHave the policy and objectives for the QMS, which arecompatible with the strategic direction of the organisation,been established and communicated?Have the objectives been established at relevantdepartmental and individual levels with the business?Have the requirements for the QMS been integrated into thebusiness processes and have management promotedawareness of the process approach?Have customer requirements and applicable statutory andregulatory requirements been determined, met andcommunicated throughout the organisation?Have the risks and opportunities that are relevant to the QMSbeen established?Has the organisation established and communicated theresponsibilities and authorities for the effective operation ofthe QMS?Has the organisation determined and provided theresources needed for the establishment, implementation,maintenance and continual improvement of the QMS(including people, environmental and infrastructurerequirements)?If monitoring or measuring is used for evidence ofconformity of products and services to specifiedrequirements, has the organisation determined theresources needed to ensure valid and reliable monitoringand measuring of results?Has the organisation determined the knowledgenecessary for the operation of its processes andachievement of conformity of products and services andimplemented a lessons learnt process?Has the organisation ensured that those persons who canaffect the performance of the QMS are competent on thebasis of appropriate education, training, or experience ortaken action to ensure that those persons can acquire thenecessary competence?Has the documented information required by the standardand necessary for the effective implementation andoperation of the QMS been established?

Self Evaluation ChecklistOperationIs there a defined process for the provision of products andservices that meet requirements defined by the customer?When changes are planned are they carried out in a controlledway and actions taken to mitigate any adverse effects?Are any outsourced processes managed and controlled?Is there a defined process for reviewing and communicatingwith customers in relation to information relating to productsand services, enquiries, contracts or order handling?If there is a requirement for post-delivery activitiesassociated with the products and services such aswarranty, maintenance services, recycling or finaldisposal, are these defined and managed?Are any nonconforming process outputs managed soas to prevent their unintended use?Performance evaluationHas the organisation determined what needs to be monitored and measured andIs this review conducted prior to the organisation’scommitment to supply products and services?If you design and develop products or services, are theseprocesses established and implemented in line with therequirements of the standard?Do you ensure that externally provided processes, products,and services conform to specified requirements?Do you have criteria for the evaluation, selection, monitoring ofperformance and re-evaluation of external providers?Is the provision of products and services carried out incontrolled conditions which include: the availability of documented information that defines thecharacteristics of the products and services; the availability of documented information that defines theactivities to be performed and the results to be achieved? the methods for monitoring, measurement, analysisand evaluation, to ensure valid results?Has it established when the results from monitoring andmeasurement shall be analyzed and evaluated?Have methods of monitoring customer perceptions ofthe provision of products and services beenestablished?Has it determined the need or opportunities forimprovements within the QMS and how these will be fedinto management reviews?Has the organisation established a process for aninternal audit of the QMS?Has an approach to perform management reviewsbeen established and implementedImprovement monitoring and measurement activities at appropriatestages to verify that criteria for control of processes andprocess outputs, and acceptance criteria for products andservices, have been met? the people carrying out the tasks are competent?Has the organisation determined and selectedopportunities for improvement and implemented thenecessary actions to meet customer requirements andenhance customer satisfaction?Do you have effective methods of ensuring traceabilityduring the operation process?Has the organisation appropriate processes formanaging nonconformities and the related correctiveactions?Where property belonging to customers or externalproviders is used in the provision of the product or service,is this controlled effectively?Has the organisation decided on how it will address therequirement to continually improve the suitability,adequacy, and effectiveness of the QMS?

Contact FormCertification processProposalacceptance byclientTÜV UKproposal issuedStage 1Pre-AuditStage 2CertificationAuditIssue ofcertificate(validity: 3 years)AnnualsurveillanceauditsI’m interested in the following ISO 9001:2015 services:Why TÜV UKFounded in 1979 TÜV UK Ltd. forms part of the TÜVNORD GROUP.Self Evaluation Form reviewOnsite Gap AnalysisThe TÜV NORD GROUP is a technical serviceprovider with worldwide activities, founded in 1 8 6 9and headquartered in Hanover, Germany; the Groupemploys more than 14,000 people in more than 70countries across Europe, Asia, America and Africa.Transition trainingI’d like someone to callISO 14001OHSAS 18001 (ISO 45001)Contact information:Contact name:Position:Company:Address:ISO 9001 is designed to complement and integratewith other management Email:Company information:Employees:ISO14001Number of Sites:Nature of business:Continual ImprovementTÜV UK LtdAMP House, Suites 27-29, Fifth FloorDingwall Road, Croydon, CR9 1XZPhone: 44 (0) 20 8680 7711Fax: 44 (0) 20 8680 4035E-mail:’d also like information on the upcoming revisions forOur approach:TÜV UK can audit and certify your QMS system toISO 9001 as a standalone, or if you wish to reduceyour overall costs and audit durations, as part of anIntegrated Management System (IMS), by combiningyour ISO 9001 audits with new or existing ISO 14001and OHSAS 18001 management system

2015). If you would like us to conduct a GAP analysis or review your self evaluation form for you, please complete the questionnaire (including your contact details), and email it to us at: In addition to ISO 9001 auditing TÜV UK offer the following ISO 9001:2015 related services GAP Analysis Checklist Review

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