Presentation on theme: "4. Quality Management System (QMS)"— Presentation transcript:
1 4. Quality Management System (QMS) ISO 9001:2008 Requirements4. Quality Management System (QMS)5. ManagementResponsibility7. Product RealisationProcesses6. Resource Mgmt8. Measurement,Analysis &ImprovementISO 9001 Std: 1) Scope & application, 2) References, 3) Terms & DefinitionsThere are four key elements forming the QMSMgmt ResponsibilityResource MgmtProduct Realisation ProcessesMeasurements, Analysis & ImprovementMgmt Responsibility is very important for ISO 9001 implementationMgmt to provide adequate Resource for the establishment, implementation and improvement of the QMS / Product Realisation ProcessesThe major portion of the QMS should cover the Product Realisation processes or the organisation’s business activitiesMeasurements & Monitoring is required for effective QMS implementation; Many of the procedures in such a QMS will not be followed and are used merely as guidelines if there is no regular monitoring or auditAfter the monitoring process, deficiencies are analysed and improvements are recommended to top mgmt for implementationTop mgmt will then allocate the resources for the improvements (& changes to the QMS) and the cycle continues.
2 4 Quality Mgmt System (QMS) Requirements ISO 9001:2008 Requirements4 Quality Mgmt System (QMS) RequirementsKey processes documented4.2.3 Control of Document4.2.4 Control of Records8.2 Internal Audit8.3 Control of Non-conforming Products8.5.2 Corrective Actions8.5.3 Preventive ActionsKey business processes / activitiesDocument control in placeRecords properly maintained & retrievableTo cover why various ISO 9001 requirements are present and common deficiencies encounteredExternal training ISO 9001 requires 2 full days – Can only summarise the key requirements during today’s briefingThe basic QMS requirements are toHave the processes for key business activities documentedDocumented procedures are also under proper document controlDocumented procedures have been reviewed and approved by appropriate mgmt staffProper versioning and effective implementation date have been establishedRecords also have to be properly filed and easily retrievableKey business process activities may include purchasing, training, infrastructure supt activities, etc.
3 5 Management Responsibility ISO 9001:2008 Requirements5 Management ResponsibilityCommitment to development, implementation and improvement of QMSCustomer-focusEstablish quality policy / mission for organisationQuality objectives & planningEnsure responsibility & authorities are definedAppoint mgmt representative (member of orgn mgmt *) for the implementation and improvement of the QMSEnsure QMS requirements are communicatedMgmt review of QMS deficiencies & possible improvementsTop mgmt has many responsibility for effective QMS implementationQuestion: Who has the ultimate responsibility of the final quality of the delivered product/servicetop mgmt (answer)middle mgmtstaff leveleveryoneThe quality of the final delivered product / service is dependent on the top mgmt direction and emphasisQuality policy and objectives to be established by top mgmt staff to provide direction to staffTop mgmt have to ensure roles and responsibility are clearly defined to reduce the level of ambiguity in the required scope of work (although quite difficult in today’s complex world)The mgmt representative is accountable for the successful and effective implementation of the QMSRegular mgmt review is required to ensure the suitability and effectiveness of the QMS.
4 ISO 9001:2008 Requirements 6 Resource Mgmt Provide adequate manpower resourcesStaff or personnel* are competent & properly trained for assigned dutiesAdequate supporting infrastructure & facilitiesWork environment does not affect performanceLighting, noise, temperature, humidity, weather*Resource mgmt is important in the context of ISO 9001 implementationStaff needs adequate resources to get their work doneFor example, it is considered a non-conformance to have a staff who consistently work 20% over-time over a period of more than 6 months as this is likely tp affect the quality of the work done by the staffStaff or other personnel (temp staff, supplier, etc.) also have to be properly trained to performed their assigned tasksAdequate facilities, equipment and supporting services also have to be provided for the employeeThe work environment must also be managed to enable the employee to work productively / effectively (e.g. furnace inspection: appropriate protective clothings and materials to be provided; safety boots to be provided at warehouse, etc.)These requirements will benefit each employee in the organisation
5 7 Product Realisation Processes ISO 9001:2008 Requirements7 Product Realisation ProcessesProduct realisation planning (mainly for projects)Determine product/customer requirementsPost-delivery activities include 1) Actions under warranty provisions, 2) Contractual obligations such as maintenance activities and 3) Supplementary services such as recycling or final disposal*Channels for customer communicationDesign and development processesPlanning, inputs, outputs, review, verification, validation*, changesPurchasingProduction and service operationsInclude handling of customer property (include intellectual properties & personal data*)Control of measuring and monitoring devicesDocumentation of key business processesProduct realisation planning are more applicable for one-time projects where customised product requirements and processes are adopted (e.g. e.g. Project Document, Work Instruction documents, etc.)Post-delivery activities include 1) Actions under warranty provisions, 2) Contractual obligations such as maintenance activities and 3) Supplementary services such as recycling or final disposalThis new ISO 9001:2008 requirement is meant more for the application teamsAlso need to consider recycling or final disposal requirements for procured IT equipmentChannels for customer communications include helpdesk phone number, fax number, address, web-site, etc.Purchasing process will also have to be controlled if it affects the final quality of the delivered product or serviceProduction and service operations will have to be performed under controlled conditions - meaning the same production or servicing operations can be repeated with minimal varianceMonitoring and measuring devices also have to be verified to ensure that they are working properly (otherwise they may give us problems; e.g. pressure gauge at oil refinery not working properly, giving rise to explosion which could otherwise be prevented
6 8 Measurement, Analysis & Improvement ISO 9001:2008 Requirements8 Measurement, Analysis & ImprovementMeasurement and Analysis PlanningMeasures on customer satisfactions*, internal audits and other process/product measures*Control of non-conformityAnalysis of data (determine characteristics or trends)QMS Improvements, corrective and preventive actionsVerify effectiveness*Measurement, analysis and improvement is an important part of the QMS implementationEnsure QMS is suitable and effective for current useMeasurements to be collected and analysed must be pre-defined. The statistical technique for analysing the measures should also be pre-determinedIt is mandatory to collect and analyse measures on customer satisfaction and internal auditsThere must also be mechanism to ensure that non-conforming products are prevented from inadvertent use or delivery (e.g. through segregation)Appropriate data should be analysed to determine characteristics or trends of products or processesQMS improvements, correvtive and prevetive actions are usually derived from the analysis of data
7 4 QMS Requirements (Document Key Processes) ISO 9001:2008 Requirements4 QMS Requirements (Document Key Processes)4.1 General QMS RequirementsDocument sequence/interaction of key processesDocument criteria & methods to ensure effective operationThe type & extend of controls to be applied for outsourced processes shall be defined within the Quality Mgmt System*QMS documentationQuality policy & objectives, Quality ManualControl documents such as checklists & work instructionsRequired procedures and recordsLevels of details depends on competence of staff, size of organisation & complexity of processesQuality ManualScope of QMS, including details of and justifications for any exclusionsOne of the key ISO 9001 requirements is ensure that all key business activities are properly documented in terms of sequence / interactions of key processesA business process is normally documented from start to endThe following should be used to guide the documentation of the business process:WHO perform the activityWHEN is the activity performedWHAT record is producedFor important situation, the following areas can be covered:HOW is the activity performedWHY is the activity performedAny exclusion to the ISO 9001 implementation must be justified (partial ISO 9001 certification is discouraged)in the past, partial ISO 9001 certification is allowed through the use of the ISO 9001, 9002 and 9003 standardthis is no longer allowed and most companies do not make use of partial certification anywaya complete product or service must be certified (partial not allowed)
8 ISO 9001:2008 Requirements 4.2.3 Control of Documents Review & approve document before issueChanges & current revision status identifiedRelevant versions are available at point of useDocuments are legible & IdentifiableDocuments of external origins are identified and distribution controlledDocument control is important because we need toensure that staff are following only approved and the correct version of the proceduresNormal a document will need to have aunique title for unique identificationan issue date and/or issue numberpage numbering and total page numbering to eliminate possibility of not being aware of missing pagesapproval signature/record indicating that the document has been approved for useSuperceded documents must also be indicated as such
9 ISO 9001:2008 Requirements 4.2.4 Control of Records Are records legible, readily identifiable & retrievableE.g. mgmt review records, training records, purchase evaluation records, audit records, customer complaints and other process related recordsAll records should have a title and a date to make it readily identifiableFiled records should also be indexed to make the records readily retrievable (through through use of the File Index form)All important records provide evidence that the business processes have been properly carried out should be maintained (e.g. end-products and intermediate end-products)product mkg plansquotationscustomer ‘s POinvoices and delivery notes, etc.
10 5.1 Management Commitment ISO 9001:2008 Requirements5.1 Management CommitmentDevelopment, implementation & improvement of QMSEstablish quality policyEnsure quality objectives are metConduct mgmt review of QMS deficiencies / improvementsEnsure availability of resources for QMS implementation and improvementsAs emphasized earlier, top mgmt commitment is very important for effective ISO 9001 implementationTop mgmt is required to provide evidence of their commitment to the development, implementation & improvement of the QMS through their actions (e.g. send staff for training, directing staff on relevant corrective/preventive actions, etc.)Top mgmt also to establish the quality policy or company mission statement so that staff know their key work objective the moment they step into the companyE.g. To continually improve all business processes so as to meet changing requirements and expectations of all internal and external customersTo provide customers with quality and cost-effective solutions (product/service) in a timely mannerTop mgmt should be set quality related objectives for middle mgmt to achieve (e.g. based on efficiency and effectiveness measures)Efficiency: Amount of work done per unit timeEffectiveness: Number of mistakes made per monthTop mgmt should allocate resources to areas that can improve the capability of the organisationIt is easy to increase revenues or production level by elimination all long term measures such as maintenance, R&D, continual improvementsIt is more difficult to improve the capability of the organisation
11 ISO 9001:2008 Requirements 5.2 Customer Focus Top mgmt ensure customer requirements are determined and fulfilledCustomer satisfaction is also achieved / enhancedBeing customer-focus is important to the survival of an organisationThe customer is the reason which a company existsOld Trend: Let the customer bewareBuy the goods at your own riskSupplier takes no responsibility for poor quality goods producedCustomers have little choice as there are limited suppliers for the same product / serviceNew Trend: Let the Suppliers BewareMany suppliers can now provide the same product/servicesThe supplier that provide poor quality product/services have to be careful; It will steadily lose its market share if nothing is done
12 ISO 9001:2008 Requirements 5.3 Quality Policy Appropriate to purpose of organisation (e.g. mission)Include commitment to meet customer and regulatory requirementsInclude commitment for continual improvement & meeting quality objectivesIs communicated to all staffIs reviewed for continuing suitabilityRegulatory requirements is emphasised or given more attention in the new ISO 9001:2000 standardQuality policy must include commitment for continual improvementstatus quo is no longer okay in the new ISO 9001:2000 standardThe rest are implied in the old ISO 9001 standard
13 5.4 Quality Objectives / QMS Planning ISO 9001:2008 Requirements5.4 Quality Objectives / QMS PlanningQuality objectives set at relevant functions & levelsQuality objectives measurable and consistent with quality policyQMS Planning:Ensure QMS requirements & quality objectives are metEnsure integrity of QMS is maintained when changes are implementedQuality objectives now have to be set at all functions and level (high level objectives no longer adequate)Objectives should be SMART to meet the ISO 9001 requirementsQMS planning refers more on resource and schedule planning for improvement activities
14 5.5 Responsibility, Authority & Communication ISO 9001:2008 Requirements5.5 Responsibility, Authority & CommunicationResponsibility and authorities for various staff definedMgmt Representative (shall be a member from within organisation’s management*) appointed to:Ensure QMS is established, implemented & maintainedReport to top mgmt on the performance of the QMS and any need for improvementPromote awareness of customer requirements throughout the organisationEffectiveness of QMS communicated through established channelsResponsibility and authorities for all staff to be definedGood to have a job specification for all job designation; Job specification can contain:Educational, job experience, skill and/or training requirementsKey required work activitiesMgmt representative is accountable for the successful implementation of the ISO 9001 standardmember of top mgmt should be appointed for this to improve chances of successful ISO 9001 implementationCommunication channels must be established to highlight quality problems and required follow-up actions
15 ISO 9001:2008 Requirements 5.6 Mgmt Review Conducted at planned intervals to ensure continuing suitability, adequacy and effectiveness of the QMSReview inputs include:Audit results, customer complaint, customer satisfaction, process performance & product conformity, follow-up actions, changes / improvement to QMSReview Outputs:Improvement of the effective of the QMS & its processesImprovement of productsResource needsMgmt review is an important process to facilitate continual improvement of the QMSMany measures (e.g. customer satisfaction, complaints, audit results, etc.) are analysed to identify required corrective and preventive actions to improve the QMSThe review process will highlight key QMS deficiencies and required corrective and preventive actionsstrengths of QMS are also sometimes highlighted to inform staff to continue to do what we have done wellResource and schedule plan for improvements should also be made
16 ISO 9001:2008 Requirements 6 Resource Mgmt 6.1 Provision of Resources Determine & provide resources to implement, maintain, improve the QMS & enhance customer satisfaction6.2 Human ResourcesEnsure staff or other personnel* are adequately competent & trained for assigned rolesMaintain training records6.3 Infrastructure:Determine, provide & maintain infrastructure (include bldg, workspace, equipment and supporting services) needed to achieve conformity to product requirements6.4 Work EnvironmentDetermine & manage the work environment (include factors such as noise, lighting, temperature, humidity and weather*) needed to achieve conformity to product requirements
17 7.1 Planning of Product Realisation ISO 9001:2008 Requirements7.1 Planning of Product RealisationPlan & develop the product realisation processesDetermine quality objectives & requirements for productEstablish product-specific processes, documents, resourcesDocument required verification, validation and criteria for product acceptance
18 7.2 Customer Related Processes ISO 9001:2008 Requirements7.2 Customer Related ProcessesDetermine product requirementsPost-delivery activities include 1) Actions under warranty provisions, 2) Contractual obligations such as maintenance activities and 3) Supplementary services such as recycling or final disposal*Review product requirementsRequirements are definedRequirements differing from what customer wants are resolvedOrganisation has ability to fulfilled defined requirementsCustomer CommunicationCommunication channels available to provide product information, answer queries, taking orders and amendments, customer feedback
19 7.3 Design and Development ISO 9001:2008 Requirements7.3 Design and DevelopmentDesign and development planningUpdate plan as design and development progressesDesign and Development Review, Verification, Validation have distinct purposes*They can be conducted and recorded separately or in any combination, as suitable for the product and the organization*Design and development inputsFunctional, performance and regulatory requirements to be documented and reviewedDesign and development outputsIn form suitable for verification against for design & dev. Inputs*Include details for preservation of products*Design and development review, verification, validation and changesProcedures to be defined
20 ISO 9001:2008 Requirements 7.4 Purchasing Evaluate and select suppliers based on their ability to meet purchase requirementsPurchasing information to contain level of adequate purchasing requirementsVerification of purchased productsKey Records:Purchase specificationsSupplier evaluation recordsEvidence of satisfaction receipt
21 7.5 Production & Service Provision ISO 9001:2008 Requirements7.5 Production & Service Provision7.5.1 Control of Production & Service ProvisionPlan and carry out production and service provision under controlled conditions - repeatable processesEnsure availability of work instructions, as necessary7.5.2 Validation of processes for production and service provisionRequired when resulting output cannot be verified or tested (e.g. packing of parachutes)Processes, equipment, personnel needs to be qualified
22 7.5 Production & Service Provision ISO 9001:2008 Requirements7.5 Production & Service Provision7.5.3 Identification & TraceabilityIdentify product by suitable means throughout the product realisationAlso know as configuration mgmt for some industry sector7.5.4 Customer propertyExercise care of customer property (include intellectual property and personal data*)Identify, verify, protect and safeguard customer propertyIf lost, damaged or otherwise found unsuitable for use, this shall be reported to the customer & records maintained
23 7.5 Production & Service Provision ISO 9001:2008 Requirements7.5 Production & Service Provision7.5.5 Preservation of productPreserve conformity of product during internal processing and delivery to intended destinationInclude identification, handling, packaging, storage & protection
24 7.6 Monitoring and Measuring Devices ISO 9001:2008 Requirements7.6 Monitoring and Measuring DevicesMeasuring devices to be calibrated at specific intervalsCalibration records to be maintainedEquipment IDCalibration dateCalibration accuracyNext calibration dateCalibration to be safeguarded from adjustmentsE.g. seal for taxi meter
25 8 Measurement, Analysis & Improvement ISO 9001:2008 Requirements8 Measurement, Analysis & Improvement8.1 Monitoring and Measurement PlanningRequired to demonstrate product conformity, conformity to QMS and continually improve the QMS8.2 Monitoring and Measurements8.2.1 Methods for obtaining measures on customer satisfaction shall be determined which may be derived fromCustomer satisfaction surveyCustomer dataUser opinionLost business analysisComplimentsWarranty claimsDealer reports*
26 8 Measurement, Analysis & Improvement ISO 9001:2008 Requirements8 Measurement, Analysis & Improvement8.2.2 Internal auditConducted at planned interval to determine if QMS requirements have been implementedAudit programme to be plannedAudit criteria, scope and methods shall be definedAuditors shall not audit their own workAudit results & follow-up actions to be recorded
27 8 Measurement, Analysis & Improvement ISO 9001:2008 Requirements8 Measurement, Analysis & Improvement8.2.3 Monitoring & measurement of processesTo monitor QMS processes, to verify conformity to product requirements & the effectiveness of the quality mgmt systems*8.2.4 Monitoring & measurement of productTo monitor characteristics of product to verify if the product requirements have been met8.3 Control of non-conforming productEnsure that product which does not conforms to product requirements is identified and prevented from unintended use or deliveryE.g. segregation of non-conforming products
28 8 Measurement, Analysis & Improvement ISO 9001:2008 Requirements8 Measurement, Analysis & Improvement8.4 Analysis of DataDetermine, collect and analyse appropriate data to demonstrate suitability and effectiveness of the QMSEvaluate where continual improvement can be made through trend analysis8.5.1 Continual ImprovementContinually improve the QMS through quality policy, objectives, audit results, analysis of data, corrective / preventive actions and mgmt review
29 8 Measurement, Analysis & Improvement ISO 9001:2008 Requirements8 Measurement, Analysis & Improvement8.5.2 Corrective ActionDetermine root cause of non-conformities in order to prevent recurrenceEffort should be proportionate to the effects of the non-conformitiesCorrective actions taken to be recorded & their effectiveness* verified8.5.3 Preventive ActionDetermine root cause of potential non-conformities to prevent their occurrenceEffort should be proportionate to the effects of the potential non-conformitiesPreventive actions taken to be recorded & their effectiveness* verified