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ISO 9001: 2015Quality ManagementSystem CertificationAwareness Training

ISO 9001: 2015 STRUCTUREThe new standard ismodeled around the ISODirective Annex SL, a highlevel structure (HSL) basedon the Plan-Do-Check-Actmethodology andcommon languagedeveloped by ISO for usein all new managementsystem standards.

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ISO 9001: 2015 STRUCTURE Cont.The new9001:2015standardcomprises of tenclauses instead ofthe previous eightused in the ISO9001:2008.

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ISO 9001: 2015 STRUCTURE Cont.1.Scope2.Normative Reference3.Terms and Definitions4.Quality ce Management7.Product Realization8.Measurement, Analysisand Improvement1. Scope2. Normative References3. Terms and Definitions4. Context of theOrganization5. Leadership6. Planning7. Support8. Operation9. Performance Evaluation10. Improvement

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ISO 9001: 2015 STRUCTURE Cont.The use of Annex SL across all management systemstandards will aid in the integration of differentsystems as almost a third of text is common acrossall standards under Annex SL.

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ISO 9001: 2015 STRUCTURE Cont.The use of Annex SL across all management systemstandards will aid in the integration of differentsystems as almost a third of text is common acrossall standards under Annex SL.

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ISO 9001: 2015 STRUCTURE Cont.CLAUSE:1. Scope2. Normative References3. Terms and DefinitionsSAME

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ISO 9001: 2015 STRUCTURE Cont.Context of TheOrganizationClause 4

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ISO 9001: 2015 STRUCTURE Cont.4.1 UnderstandingThis clause is looking to require companies toidentify, monitor and review issues that arerelevant to the organization in terms of itsperformance that could have an impact on itsquality management system.Most successful businesses will already bemonitoring such issues; however they are nowrequired to provide evidence of this for assessmentpurposes.

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ISO 9001: 2015 STRUCTURE Cont.4.2 Understanding The Needs and Expectations ofInterested PartiesOrganizations are being asked to identify ‘relevantrequirements’ or ‘relevant interested parties’ and,once identified, monitor and review suchinformation.

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ISO 9001: 2015 STRUCTURE Cont.Interested parties could be groups or individuals,(such as suppliers, employees, shareholders,neighbors, etc.) who could impact on theorganization’s ability to provide the product and/orservice that meet their customer’s requirements, aswell as those of any legal and regulatory nature.As with the Clause above most successfulbusinesses will already be monitoring theirinterested parties, but they are now required toprovide evidence of this for assessment purposes.

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ISO 9001: 2015 STRUCTURE Cont.4.3 Determining The Scope of The QualityManagement SystemThe scope of the quality management system (QMS)sets its boundaries, identifying what requirementsof the QMS are applicable to and what are not. Itshould be done with consideration of theorganization’s context (what your company does,what it wants to achieve, who you supply to, etc.) aswell as the products and/or services it supplies; thescope shall be documented.

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ISO 9001: 2015 STRUCTURE Cont.4.4 Quality Management System and Its ProcessesThis clause requires organizations to establishprocesses that, once established, are maintainedand continually improved. Organizations are alsoasked to set performance indicators that enable theeffective operation and control of the processesestablished by the organization.

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ISO 9001: 2015 STRUCTURE Cont.Leadership andCommitmentClause 5

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ISO 9001: 2015 STRUCTURE Cont.5.1.1 Leadership and Commitment to The QualityManagement SystemThis clause will require management to demonstratetheir leadership and commitment to the qualitymanagement system by taking responsibility for theeffective running of the organization’s qualitymanagement system.

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ISO 9001: 2015 STRUCTURE Cont.They can do this by ensuring that the organization’squality policy, quality objectives and commitment isconsistent with the organization’s overall businessplan.Top management shall also ensure that therequirements of the quality management system arealigned with the organization’s business practicesand they should promote awareness of the systemthroughout their organization.

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ISO 9001: 2015 STRUCTURE Cont.5.1.2 Customer FocusTop management are required to take the lead indemonstrating customer commitment within theorganization by ensuring that all applicablestatutory, regulatory and customer requirementsare identified and achieved while, at the same time,ensuring that the organization continues to providethe products and services expected by theircustomer.

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ISO 9001: 2015 STRUCTURE Cont.5.2 Quality Policy5.2.1Top management are required to establish a qualitypolicy that is in line with the purpose and context ofthe organization (see clause 4.1) while, at the sametime, providing a framework for the organization’squality objectives and the basis on which theimprovements in the quality management systemcan be achieved.

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ISO 9001: 2015 STRUCTURE Cont.5.2.2The policy shall be available as documentedinformation and communicated and understoodthroughout the organization and by relevantinterested parties.

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ISO 9001: 2015 STRUCTURE Cont.5.3 Organizational Roles, Responsibilities andAuthoritiesTop management need to ensure that individuals aregiven the responsibility and authority to enable themto carry out their duties in line with the requirementsof the quality management system.

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ISO 9001: 2015 STRUCTURE Cont.PlanningClause 6

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ISO 9001: 2015 STRUCTURE Cont.6.1 Actions to Address Risks and Opportunities6.1.1Organizations are required to think about theinternal and external issues they face and therelevant requirements of their interested partiesand how this may impact on their qualitymanagement system. The organization must thendetermine the risks and opportunities that need tobe addressed. This is in order to provideconfidence that the quality management systemcan achieve its intended outcomes and to achievecontinual improvement.

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ISO 9001: 2015 STRUCTURE Cont.6.1.2Once the organization has identified the risks andopportunities it faces, it must then determine howit wishes to address these; however theorganization may take an informed decision to keepthe risk, in effect taking no action beyondidentifying and evaluating the risk or opportunity.

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ISO 9001: 2015 STRUCTURE Cont.6.2 Quality Objectives and Planning to AchieveThem6.2.1This Clause requires an organization to set qualityobjectives for relevant areas within its qualitymanagement system. It is for the organization todecide which areas are relevant. The qualityobjectives must be consistent with theorganization’s quality policy and be relevant toproducts and services it provides, and theenhancement of customer satisfaction.

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ISO 9001: 2015 STRUCTURE Cont.Quality objectives must be measurable, take intoaccount applicable customer, statutory andregulatory requirements and be monitored in orderto determine whether they are being met. Theymust also be communicated across the organizationand be updated as and when the need arises.

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ISO 9001: 2015 STRUCTURE Cont.6.2.2The organization must undertake planning in orderto determine how its quality objectives will beachieved.

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ISO 9001: 2015 STRUCTURE Cont.6.3 Planning of ChangesWhen the organization decides that there is a needto change the quality management system, theyare to be carried out in a controlled manner.Changes need to be planned and then acted upon.The organization needs to be clear as to what it isattempting to achieve.

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ISO 9001: 2015 STRUCTURE Cont.SupportClause 7

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ISO 9001: 2015 STRUCTURE Cont.7.1 Resources7.1.1 GeneralRequires an organization initially to determine andthen subsequently provide the resources necessaryto establish, implement, maintain and continuallyimprove its quality management system.

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ISO 9001: 2015 STRUCTURE Cont.7.1.2 PeopleThis requires an organization to provide thosepeople necessary for the effective operation of itsquality management system and its processes inorder that it can consistently meet customer,statutory and regulatory requirements.

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ISO 9001: 2015 STRUCTURE Cont.7.1.3 InfrastructureRequires an organization to identify, provide andmaintain the infrastructure necessary to enableprocesses to operate effectively.7.1.4 Environment for The Operation of ProcessesRequires an organization to “determine, provideand maintain” a suitable environment for thebusiness to operate.

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ISO 9001: 2015 STRUCTURE Cont.7.1.5 Monitoring and Measuring ResourcesWhere an organization uses monitoring ormeasuring to demonstrate that its products andservices conform to requirements, it must makesure that it provides the necessary resources toensure that its monitoring and measuring resultsare valid.

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ISO 9001: 2015 STRUCTURE Cont.7.1.6 Organizational KnowledgeThis requires an organization to ensure that it hasor obtains the knowledge necessary to respond tochanging business environments, changingcustomer needs and expectations and, whereapplicable, related improvement initiatives.

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ISO 9001: 2015 STRUCTURE Cont.7.2 CompetenceThe organization must determine the competencylevels necessary for those people performing workunder its control. Once these competency levelshave been determined, the organization must thenensure that those people possess the necessarycompetencies, either on the basis of theireducation, training or experience.

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ISO 9001: 2015 STRUCTURE Cont.7.3 AwarenessThe requirements apply to all “persons doing workunder the organization’s control” – this can includecontractors. People doing work under theorganization’s control are to be aware of theorganization’s quality policy, any quality objectivesthat are relevant to them, how they arecontributing to the effectiveness of the QMS andthe implications for not conforming to the QMSrequirements

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ISO 9001: 2015 STRUCTURE Cont.7.4 CommunicationAn Organization must determine how it wishes tocommunicate on QMS matters, to whom it willcommunicate and when such communications willbe made.

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ISO 9001: 2015 STRUCTURE Cont.7.5 Documented information7.5.1 GeneralAn Organization’s quality management systemshould include documented information requiredby the standard and that identified by theorganization as being necessary for the effectiveoperation of their quality management system.

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ISO 9001: 2015 STRUCTURE Cont.7.5.2 Creation and UpdatingWhen documented information is created orupdated, the organization must ensure that it isappropriately identified and described andreviewed and approved for suitability andadequacy.

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ISO 9001: 2015 STRUCTURE Cont.7.5.3 Control of documented information7.5.3.1An Organization is required to control documentedinformation in order to ensure that it is availablewhere needed and that it is suitable for use.7.5.3.2The organization must determine how it willdistribute, access, retrieve and use documentedinformation.

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ISO 9001: 2015 STRUCTURE Cont.OperationClause 8

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ISO 9001: 2015 STRUCTURE Cont.8.1 Operational Planning & ControlRequires an organization to plan, implement andcontrol processes identified in clause 4.4 in order tomeet requirements for the delivery of theirproducts and services and to put into place theactions determined as a result of risk assessment

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ISO 9001: 2015 STRUCTURE Cont.8.2 Determination of Requirements for Products &ServicesRequires an organization to put processes in place toenable communication with clients on matters relating totheir products and services. To put in place processes toensure product or service requirements are known andthat any statutory and regulatory requirements includingcustomer requirements are also known. To review therequirements related to their products and services andthose specified by their customer, including any statutoryand regulatory requirements.

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