QMS Overview - Minimal Version



Example Only273050058420YOUR LOGO00YOUR LOGO300228068580This document is a MINIMAL template for an organisation that uses Qudos 3 software for its QMS (Quality management system). It assumes the QMS is designed to comply with ISO 9001:2015, and is based on the FINAL DRAFT (FDIS) version of that standard.To remove this note, click on its border and press the DELETE key00This document is a MINIMAL template for an organisation that uses Qudos 3 software for its QMS (Quality management system). It assumes the QMS is designed to comply with ISO 9001:2015, and is based on the FINAL DRAFT (FDIS) version of that standard.To remove this note, click on its border and press the DELETE keyOrganisation NameQMS Overview An introduction to our Quality Management System.IntroductionAbout us MACROBUTTON NoMacro [ Click here & insert an introduction to your organisation]About our QMSWe have established a QMS (quality management system) based on the requirements of the ISO 9001:2015 standard. Top management are committed to maintaining, and continually improving this system. This commitment is expressed in our Quality Policy, and further evidenced by the leadership and active involvement of top management. All workers and vendors are invited and expected to share in this commitment. Objectives are set for key processes, and also at corporate level. Top management considers our corporate objectives at management review meetings, and plans how to achieve them. Process objectives are set by the process owner in conjunction with the CEO. These are noted in Process plans.The following illustrates how elements of our QMS helps us to achieve continuous improvement:PLAN Legal & regulatory requirements Quality Policy Objectives Process PlansProceduresClient briefProject plansContractsJob descriptionsJob descriptionsDO Human resourcesTraining / competence Work as per procedures and plans Use of equipment and tools Infrastructure Work environment ProcurementVendor management Record keepingACT Reporting nonconformity Dealing with problems Root cause analysis Corrective action Management review Responses to feedback -1276350-118237000CHECK Monitoring Measuring Customer surveys Internal auditsExternal auditsThis QMS Overview does the following:Describes the system and its scope of applicationExplains how the clauses of the ISO 9001 quality standard are addressedEach of our key work processes is described in a Process Plan. These documents play an important role in the management of our work processes – they bring together consideration of various attributes of the process. Each process has an ‘owner’ who will review the plan at least annually. The plan and any related procedures and other documents will be updated in line with our business plan and corporate objectives.We have implemented a programme of Internal audits to ensure that we are consistently doing what we set out to, and we are achieving the desired management reviews the system at least once a year to ensure its continued suitability for purpose, and effectiveness in satisfying requirements (including those of ISO 9001).The Qudos 3 software application performs a key role in automating and enabling the efficient administration of our QMS.ScopeThe QMS applies to…MACROBUTTON NoMacro [ Click here & note applicable location, unit or all of your business]Make reference to products / services, relevant interested parties and their relevant needs and expectations.State any limits to its application.Process MapThis process map indicates our major operational processes. We maintain Process Plans for these and also for a range of support processes – such as HR and IT functions.192338175782Customer orderInternal requirementDesign / developmentBooking in customer itemsPurchasingWarehouseDeliveryCustomer accountsProject managementOperations controlEXAMPLE ONLY00Customer orderInternal requirementDesign / developmentBooking in customer itemsPurchasingWarehouseDeliveryCustomer accountsProject managementOperations controlEXAMPLE ONLY15113039370The process map shown is an example only and should be replaced with one to reflect your own business. With dedicated flow chart software applications, hyperlinks may be made directly from the components in the flow chart to other documents. An alternative is to add a text box like this one for detailed information and hyperlinks.To remove this note, click on its border and press the DELETE key00The process map shown is an example only and should be replaced with one to reflect your own business. With dedicated flow chart software applications, hyperlinks may be made directly from the components in the flow chart to other documents. An alternative is to add a text box like this one for detailed information and hyperlinks.To remove this note, click on its border and press the DELETE key41057ISO 9001 Clause Matrix The following table describes where various clauses of the standard are addressed, and justifies why any clause is excluded from our system. 5432425305435This table is populated with sample information - replace with and add your information as necessary.To delete this Tip – click on its border and press DELETE key.00This table is populated with sample information - replace with and add your information as necessary.To delete this Tip – click on its border and press DELETE key.ClauseNo.Clause How we address the requirements 4Context of the OrganizationUnderstanding the organization and its contextSituational analysis as part of our Business PlanUnderstanding the needs and expectations of interested partiesEmployee Surveys.Customer feedback – including surveys.Legal review.Determining the scope of the QMSScope statement in this QMS OverviewThe QMS and its processesProcess Map in this QMS Overview. A series of Process Plans in the Qudos 3 Master Document List.5LeadershipLeadership and commitmentA ‘hands-on approach’ by top management demonstrated by involvement in certification audits and management reviews.Regular communications on quality mattersBusiness Planning - including consideration and provision of the necessary resourcesPolicyQuality Policy Included in the Master Document List Published on our web site.The policy is also displayed in reception, and brought to the attention of new workers as part of the induction process. Any change to the policy is communicated to all workers via team meetings or anizational roles, responsibilities and authoritiesOrganisation chart.Job descriptions describe responsibilitiesList of authoritiesThe above documents are included in the Master Document ListCommunications via team meetings, intranet and email6Planning Actions to address risks and opportunitiesRisk Assessment process utilizing Qudos 3 Risk moduleRisk Assessment procedureBusiness Continuity planQuality objectives and planning to achieve themObjectives established for the overall organization, individual business units, and processes. These are managed in Qudos 3 Objectives module.Planning of changesChange management process. Business rules for managing major changes are described in a procedure included in the Master Document List7SupportResourcesResources considered as part of process planning, project planning, and at management review meetingsCompetenceRequired competencies are expressed as selection criteria in our Job descriptions. We operate a program of Individual Development Planning to direct people towards achieving required competencies. Training is planned and recorded in the Qudos 3 Training module.Considered at Management reviewAwarenessQMS included in the induction process - recorded in the Qudos 3 Training moduleQMS included as agenda item in team meetings - recorded in the Qudos 3 Meetings moduleCommunicationInternal Communications via team meetings, intranet and emailCommunications with external parties regarding our QMS is primarily via our web site and emailCommunications scope and arrangements considered at Management ReviewDocumented informationImportant documents are available in the Master Document ListDocument management utilizing the Qudos 3 Documents module in accordance with our Document management process planRecords management is largely electronic utilizing the following software applications:Qudos 3 for Compliance & Risk management activities(List others e.g. ERP, Accounting, HR applications etc.)Records management matrixData backup proceduresRegular Information Security Audits to consider issues such as confidentiality, access, and data integrity. Sheduled, planned and recorded utilizing the Qudos 3 - Audits & Actions modules8OperationOperational planning and controlBusiness plan Project plansVarious Process plansRequirements for products and servicesEnquiries & Orders process planCustomer accounts process planPrice listStandard quotation formsStandard terms and conditionsWeb site (product information, company information)Customer feedbackLegal reviewCorporate style guideContracts / Service Level AgreementsThe above documents are included in the Master Document ListDesign and development of products and servicesCustomer brief / specificationSubscription to industry guides Design process planCorporate style guideSpecific project plansThe above documents are included in the Master Document List Qualified designersDesign softwareControl of externally provided processes, products and servicesContracts / Service Level AgreementsSupplier benchmarking assessments in Qudos 3 Benchmark moduleNew supplier risk assessments in Qudos 3 Risk moduleSupplier audits in Qudos 3 Audit moduleProduction and service provisionOperations and Service Delivery process plansInfrastructure and working environment considered at management reviewRelease of products and servicesApproval processesControl of nonconforming outputsQuarantine areasRecall procedure9Performance evaluationMonitoring, measurement, analysis and evaluationApproval processesCustomer Care SurveyChecklistsMonitoring & measuring plansUse, Calibration & Maintenance of monitoring and measurement equipmentInternal auditInternal audits process planTeam of trained Internal auditorsThe Internal Audit programme is scheduled, planned and recorded utilizing the Qudos 3 - Audits & Actions modulesManagement reviewManagement review meeting held every 6 months – attending by top managementMeetings are planned and recorded utilizing the Qudos 3 Meetings and Actions modules10ImprovementNonconformity and corrective actionIssues management procedureActions are planned and recorded utilizing the Qudos 3 Actions moduleConsidered at management reviewContinual improvementActions are planned and recorded utilizing the Qudos 3 Actions moduleBright Ideas scheme Considered at Team meetings and management review ................
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