ISO 9001:2008

ISO 9001:2008AWARNESS TRAININGTraining objectiveTo create a basic awareness about Quality Management System (QMS) based on ISO 9001:2008 standard.Content:Introduction DefinitionsBenefits of ISO 9001Overview of ISO 9001:2008 ClauseintroductionWhat is ISO ? Stands for, International Organization for Standardization (ISO) Founded in 1947Independent, non-governmental organizationMade up of member from the National Standard bodies of 163 countries and 3368 technical bodies.Central Secretariat in Geneva, SwitzerlandPublished over 19, 500 international standards covering almost all aspects of Technology and BusinessThe ISO story began in 1946 when delegates from 25 countries met at the Institute of Civil Engineers in London and decided to create a new international organization to facilitate the international coordination and unification of industrial standards. In February 1947 the new organization, ISO, officially began operations.

3IntroductionNAMEThe International Organization for Standardization (ISO) would have different acronyms in different Language (IOS in English, OIN in French for Organization Internationale de Normalisation)Decided to give it short form ISOISO is derived from the Greek word ISOS meaning Equal

Whatever the Country, whatever the language, short form is always ISO

4ISO 9000 SERIES- Quality Management

ISO 9000:2005 QMS Fundamental and VocabularyISO 9001:2008 QMS Requirements (For Certification)ISO 9004:2009 Guideline (Beyond ISO 9001)ISO 19011:20011 For Auditing (Internal and External Audits)Familyof relatedinternational standardsandguidelinesonQuality ManagementandQuality assurance. Firstpublishedin 1987 (and continually updated) by theISOStandards are not specific to anyindustryorproduct.5ISO 9000 SERIES- Quality Management

What is ISO 9001:2008 ?This is a comprehensive set of standards and guideline for Quality Management Systems.ISO 9000 series of standards are developed by Technical Committee ISO/TC 176, Quality management and quality assurance.It is System-Based not Product Based.This is a distillation of Quality System that have been tried and proven by the industry.

National Bodies represent the Technical Committee7Criticism of ISO 9001?Amount of money, time and paperwork required.Poor process selection and/or poor technical solutions might result in poor quality performance. (Garbage in and Garbage Out).Having concept that we just need to satisfy the Auditor.Prone to failure when a company is interested in certification before Quality.Mislead companies into thinking that certification means better Quality.

National Bodies represent the Technical Committee89Certification/ REGISTRATIONCertification is known in some countries as registration.It means that an independent, external body has audited an organization's management system and verified that it conforms to the requirements specified in the standard (ISO 9001).ISO does not carry out certification and does not issue or approve certificates,Certification bodies themselves operate under another quality standard, ISO/IEC 1702110Certification/ REGISTRATIONAccreditation is like certification of the certification body.It means the formal approval by a specialized body - an accreditation body - that a certification body is competent to carry out ISO 9001:2008 certification in specified business sectors.Certificates issued by accredited certification bodies - and known as accredited certificates - may be perceived on the market as having increased credibility.ISO does not carry out or approve accreditation.Accreditation bodies operate under ISO/IEC 17011.11

What is Quality Management System ?A common sense way of ORGANIZING & MANAGING THE BUSINESS PROCESSES that affect the quality of our products and services

13Why have A qmsWe gain a common understanding of how the important things get doneWe have a chance to capture our Best PracticesOur Internal audit system ensures we stay on trackOur Corrective Action system helps to fix problemsContinual Improvement becomes a way of lifeA Quality Management System keeps us from moving backwards and losing important knowledge that we gain over timeChanges are controlled

Documented QMS14Why is Certification NeededMARKET PRESSURETangible proof that the quality management system established by our organization meets the requirements of and internationally recognized standard.Provide marketing edge over competitorsIt enhanced customers satisfaction an loyalty; because it is assured that their requirements are met.Increased competitiveness and profitability as quality products are being delivered and operational cost are reduced.15What we must doOnce our system is developed and documented , all members of the organization should follow the procedures or rules and make improvements to the system.Document our work procedures / systems What we doWho does do it When we do it How we do it Ensure that the procedures are being followed in actual PRACTICE.Keep RECORDS, minutes of what you practice

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Participating in our Improvement ProcessEveryone is welcome!Improve your processMeasure performance (see your procedure)Look for ways to improve efficienciesLook for ways to prevent errorsSuggest changes to procedures and work instructionsHelp finding solutions to problems written in Corrective Action Requests and Preventive Action Requests

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Say what youll do!Do what you say!(Disciplined Use of System)Prove It!Improve It!Everyone!Everywhere!Every Time!The Spirit of the QMS Way18What is your ROLE Do What You Say!!!!!Follow the established system (documented information)Ask for clarification if confusingHelp other people to understand the systemImprove your job, your process, the system!What Do You Do If a Process Is Wrong?StopGet the process changedParticipate in Quality Improvement Opportunities

19The degree to which a set of inherent characteristic fulfills requirements.

What is Quality ?Fitness for the PurposeConformance to RequirementsCustomer SatisfactionHow well does this set ofinherent characteristics comply with this set of requirements?Thequalityof something can be determined by comparinga set of inherent characteristics with a set of requirements.If those inherent characteristics meet all requirements, high or excellent quality is achieved.

Category | Grade | QualityCategory: Same functional Use but different requirementGrade: Just change in SpecificationQuality: How well the product satisfies needs

20All activities of overall Management functionthat determine Quality Policy, Objectives &Responsibility, & Implement them by meansof Quality Planning, Quality Control, QualityAssurance & Quality Improvement.A common sense way of ORGANIZING & MANAGING THE BUSINESS PROCESSES that affect the quality of our products and servicesWhat is Quality Management System ?21Quality Assurance vs. Quality ControlQuality AssuranceQuality Assuranceis a set of activities intended to establish confidence that quality requirements will be met. Quality in Process Proactive in natureExample: Process checklists, Audits, Methodology etc.Quality ControlQuality controlis a set of activities intended to ensure thatquality requirements are actually being met.Quality in Product Reactive in NatureExample: Inspection, Testing Process etc.Quality Management System Uses both Quality Assurance and Quality Control228 Principle of Quality Management

23Customer FocuxOrganizations depend on their Customers and therefore should:

Understand current and future customer Needs;Meet customer Requirements andStrive to exceed customer Expectations.LeadershipLeaders should:

Establish unity of purpose and Direction of the organization & Create and maintain the internal environment in which people can become fully Involved in achieving the organizations objectives.Involvement of PeoplePeople at all levels are the essence of an organization andTheir full involvement enables their abilities to be used for the organizations benefit.Process ApproachOrganizations need to do more than simply monitor process outputs (typically through inspection activities):They must also control all process inputs, (people, facilities, equipment, material & methods) &They must establish appropriate controls over the transformation activities (if desired results are to be achieved consistently and efficiently).Process The Steps You Do to Accomplish SomethingOutputSupplierCustomerInputA Simple Process Model- Activity that transforms Input into OutputWhat is a Process?Resources:PeopleFacilities/EquipmentMaterialMethodsResult:ProductServicesPerformanceInput:

OutPutProductsServicesPerformance28YourProcessActDoPlanCheckContinualImprovementThe Plan-do-Check-Act (PDCA) methodology applies to all processesDeploy and conform with planActivitiesControlsDocumentationResourcesObjectivesAnalyze/reviewDecide/changeImprove effectivenessMeasure and monitor for conformity and effectivenessPDCA (Plan-Do-Check-Act)

System ApproachOrganizations must understand a system is a set of interrelated processes, and the output of one process is the input to one or more subsequent processes, so ...It is critical to manage the white space (or interface) between processes to ensure that the overall system is effectiveQuality Management System is a key part of the entire business systemAsset-creating ProcessesFinanceAcquisition IT, Facilities, EquipmentHRCustomersBusiness ProcessesCore Processes(create customer value)Support ProcessesMaintenanceManage InformationHR MaintenanceFinancial Transactions

Environmental ManagementManage External RelationsManage PerformanceManage Improvement & Change

Business SystemSalesProcessDesignProcessPurchasingProcessReceivingProcessDeliveryProcessProductionProcessProcess Combined to Make a System31System ApproachProcess AProcess CInput AOutput AControlOutput AControlOutput CControlProcess BOutput BInput BInput C32

Continual ImprovementContinual improvement of the organizations overall performance should be a permanent objective;Improvement must be a planned activity if the organization desires to improve overall performance and capabilities.Factual Approach To Decision MakingEffective decisions are:

Based on the analysis of data and information.Mutually Beneficial Supplier RelationshipAn organization and its suppliers are truly inter-dependent andA mutually beneficial relationship enhances the ability of both to create value.Iso 9001:2008 Standard RequirementsISO 9001:2008 requirement4. Quality Management System6. Resource Management7.Product Realization8. Measurement Analysis & Improvement5. Management ResponsibilityGeneral RequirementDocumentation RequirementManagement CommitmentCustomer FocusQuality PolicyPlanningResponsibility, Authority & CommunicationProvision of ResourcesHuman ResourcesInfrastructureWork EnvironmentPlanningCustomer Related ProcessesDesign and DevelopmentPurchasingProduction and Service ProvisionGeneralMonitoring and MeasurementControl of NCPAnalysis of DataImprovementsManagement ReviewControl of Measuring and Monitoring Equipment37Question ?END Of PresentationThank you 1.SCOPE1.1 General Applicable, where an organization:Needs to demonstrate its ability to provide product that meets customer and applicable statutory and regulatory requirements, andAims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to the customer and applicable regulatory requirements.

401.SCOPE1.2 ApplicationTailoring permitted subject to following condition: Exclusions should not affect the organizations ability or responsibility, to provide product that fulfills customer and applicable regulatory requirementsExclusions permitted only in clause 7.

412. Normative ReferenceISO 9000 : Quality management system - Fundamentals and Vocabulary

423. Terms and DefinitionsTerms and definitions given in ISO 9000 shall applyProduct also means service

434. QUALITY Management System4.1. General RequirementEstablish, document, implement and maintain quality management system andContinually improve the effectiveness of the quality management system.

444. QUALITY Management System4.1. General RequirementThe organization shall:Identify the processes (Include processes related clause 5, 6, 7 and 8, consider clause 1.2)Determine the sequence and their interactionDetermine criteria and methods required to ensure that both operation and control of these processes are effective.

454. QUALITY Management System4.1. General RequirementThe organization shall:Ensure availability of resources and information to support their operation and monitoringMonitor, measure and analyze these processesImplement actions necessary to achieve planned results and continual improvement

46RememberIdentify and ensure control over outsourced processes affecting product conformity, within Quality Management System

(In 2008 two notes are added to clarify outsourcing)47

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4.2 Documentation Requirements

4.2.1 General Quality policy and its objectives ( See 5.3, 5.4.1)A quality manual (See 4.2.2)Documented procedures Documents required by the organization Quality records required by the standard

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4.2 Documentation Requirements

4.2.2 Quality ManualStandard requires organizations to prepare Quality Manual detailing:Scope, exclusions (see 1.2) and their justification Documented procedures or reference to them Descriptions of interaction between the processes

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4.2 Documentation Requirements

4.2.3 Control of documents:Documented procedure is required for control of documents. Standard requires:Approve documents for adequacy prior to issueReview, update and re-approveIdentify changes and current revision statusEnsure availability of relevant versions at points of use51

4.2 Documentation Requirements

4.2.3 Control of documents:Ensure that documents are legible and identifiableidentify and control distribution of documents of external originidentify obsolete copies to prevent unintended use if retained.

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4.2 Documentation Requirements

4.2.4 Control of Records:Documented procedure is required for Identification, Storage, Protection, Retrieval, Retention Time and Disposition of quality records.Records should provide evidence of conformityRecords should evidence effectiveness of QMS.Records should be legible, identifiable and retrievable. Legible: Clear, Comprehensive and Understandable (and not simply readable)

535. Management responsibility

5.1 Management commitment: Top management to provide evidence of its commitment to the development, implementation and its continual improvement by:communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements (see 7.2.1)545. Management responsibility5.1 Management commitment: Establishing Quality Policy (see 5.3),Ensuring that Quality Objectives are established (see 5.4.1 and 7.1a),Conducting management reviews (see 5.6),Ensuring the availability of resources (see 6.1)

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5.2 Customer Focus

Objective : Enhance Customer Satisfaction

What to do:Determine customer requirements.Fulfill customer requirements.

Note :See 7.2.1 Product related requirementsSee 8.2.1 Customer satisfaction

565.3 Quality PolicyResponsibility : Top management

Top management should ensure that Quality Policy:is appropriate to purpose of organizationincludes a commitment to comply with requirements and for continual improvement of effectiveness of processes of quality management system.

575.3 Quality PolicyResponsibility : Top managementprovides a framework for establishing and reviewing quality objectivesis communicated and understood within the organization, and is reviewed for its continuing suitability.

585.4 Planning5.4.1 Quality ObjectivesQuality Objectives are required:at relevant functions and levelsto be measurable (not necessarily quantifiable)to be consistent with quality policyto include product requirements (See 7.1a)

595.4 Planning5.4.2 Quality Management System PlanningPlanning of QMS to meet the requirements given in clause 4.1 Establish, document, implement and maintain quality management system, andContinually improve the effectiveness of the quality management system.Integrity of QMS should be maintained, when changes are planned and implemented.

605.5 Responsibility, Authority and Communication5.5.1 Responsibility and authorityDefine and communicate : ResponsibilitiesAuthoritiesInterrelations between various authorities within the organization

615.5.2 Management RepresentativeAppoint a Management Representative for :Ensuring that processes of QMS are established, implemented and maintained.Reporting to top management on performance and need for improvement.Ensuring the promotion of awareness of customer requirements throughout the organization.

625.5.3 Internal communicationProcesses to be established for communication within the organization.Internal communication may be documented, verbal or through electronic media.For example : a. Amendment in customer requirements,b. Purchasing information.

635.6 Management Review5.6.1 GeneralBy top management, maintain records (See 4.2.4):QMS should be reviewed at planned intervalsVerify continuing suitability of QMSVerify adequacy of QMSVerify effectiveness of QMS Evaluate need for changes in QMS

645.6 Management Review5.6.2 Review inputManagement review inputs should include:Results of audits (internal quality audits, customer audits and third party audits).Customer feedback (including customer complaints) .Process performance and product conformity.Status of corrective and preventive actions.Follow-up actions from previous management reviews.Planned changes that could affect QMSRecommendations for improvement

655.6 Management Review5.6.2 Review inputNotes:Define periodicity of some or all the inputs. Based on need, short reviews can be conducted for just one or two points.MR should submit report of performance of QMS and suggestions for improvement prior to review.Trends of process performance and product conformity should form a part of review.

665.6 Management Review5.6.3 Review OutputRecord (see 4.2.4) the decisions and actions finalized during review. It may be relating to:improvement of QMS and its processes.improvement of product related to customer requirementsresource needsNote : Record actions and follow-ups.

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6. RESOURCE MANAGEMENT6.1 Provision of resourcesDetermine and provide the resources needed.To implement and maintain QMS and continually improve effectiveness of QMS

Enhance customer satisfaction by meeting customer requirements.

686.2 Human resources6.2.1 GeneralPersonnel performing work affecting conformity to product requirement shall be competent on the basis of:EducationTrainingSkillsExperience

696.2.2 Competence, Awareness and TrainingThe organization should:Determine the necessary competence for personnel performing work affecting product qualityProvide training or take other actions to satisfy these needsEvaluate the effectiveness of actions takenEnsure that employees are aware of the relevance and importance of their activities and how they contribute to achievement of quality objectives.Maintain appropriate records of education, training, skills and experience (see 4.2.4).

706.3 InfrastructureDetermine, provide and maintain infrastructure required to achieve product conformity.

What to consider:Buildings, workspace and associated utilities.Process equipment (hardware and software).Supporting services (transportation, communication, information system etc.)

716.4 Work environmentDetermine and manage work environment required to achieve product conformity.

What to consider:Ambient temperature of workspaceAvailability of fresh airLighting, etc.

727.Product Realization7.1 Planning of product realizationProcess: An activity that transforms inputs into outputs.

Product realization:Sequence of processes and sub-processes required to achieve the product is called product realization.

73Quality Plan:

A document which describes how the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred as quality plan.

747.1 Planning of realization processesOrganization should determine followingsQuality objectives and requirements for the product,Need to establish processesDocumentation requiredResources neededVerification and validation requirementMonitoring, inspection and test requirementsCriteria for product acceptance Records necessary to provide evidence of conformity of realization processes and conformity of product (See 4.2.4)

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7.2 Customer-related processes

7.2.1 Determination of requirements related to the productSpecified by customer (including delivery and post delivery activities)Not specified by the customer but necessary for specified use or known and intended use.

* Post delivery includes recycling, final disposal

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7.2 Customer-related processes

7.2.1 Determination of requirements related to the productStatutory and regulatory requirements related to the product andany additional requirement determined by the organization.

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7.2 Customer-related processes

7.2.2 Review of requirements related to productEnsure thatProduct requirements are defined.Contract or order requirements differing from those previously expressed are resolved, andOrganization has ability to meet the requirements.When: submitting tender or quotation, accepting contract or order, accepting changes to orders

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7.2 Customer-related processes

7.2.2 Review of requirements related to productEnsure thatRecord results of the review and actions arising from the review.In case of amendments (changes) in the requirements, amend relevant documentsinform relevant personnelConfirm, in case of verbal communication

797.2 Customer-related processes7.2.3 Customer communicationEffective arrangements for communication required with customer on following mattersProduct InformationEnquiries, contracts or order handling, amendments to ordersCustomer feedback, including customer complaints

807.3 Design and development7.3.1 Design and development planning Plan and control to determine:Stages of design and developmentRequirement of review, verification and validation as appropriate to each stageResponsibilities and Authorities Manage interfaces between different groups involved in design and development to ensure communication (see 5.5.3) and clear assignment of responsibility (see 5.5.1)Update planning output document, as appropriate, with progress in design and development

817.3 Design and Development7.3.2 Design and development inputsObjective : To determine inputs relating to product requirements.Determine and maintain records (See. 4.2.4)to be reviewed for adequacyto be complete and unambiguousshould not conflict with each other

827.3 Design and Development7.3.2 Design and development inputsInputs should includeFunctional and performance requirementsApplicable statutory and regulatory requirements.Information derived from previous similar designsOther essential requirements.

837.3 Design and Development7.3.2 Design and development outputsObjectiveTo meet input requirementsProvide appropriate information for purchasing, production and for service provisionProvide product acceptance criteriaSpecify characteristics essential for its safe and proper use, preservation.Outputs Shall be approved prior to release

847.3 Design and Development7.3.4 Design and development reviewObjectiveTo evaluate the ability of the results to fulfill requirements, andTo identify any problems and propose necessary actions

857.3 Design and Development7.3.4 Design and development reviewWhen and How ?At suitable stages, in a systematic mannerReview team to include functions concerned with stage of being reviewedRecord result of review and actions (see 4.2.4)

867.3 Design and Development7.3.5 Design and development VerificationObjective: Verification To Verify that output satisfies input requirementRequirement:Records result of verification and necessary action (see 4.2.4)

877.3 Design and Development7.3.6 Design and development VerificationObjective: Validation To ensure product capability to meet specified or known intended useHow and When ?To be planned (see 7.3.1)Prior to delivery or prior to implementationRecord result of validation and necessary actions.

887.3 Design and Development7.3.7 Design and development ChangesObjectiveTo identified and recorded (See 4.2.4)To be reviewed, verified and validated (see 7.3.6)To be approved before implementationTo include evaluation of effect of changes on constituent parts and delivered productsRecord result of review of changes and necessary actions (See 4.2.4)

897.4 Purchasing7.4.1 Purchasing processEnsure that purchased product conforms to specified purchase requirements.Select suppliers based on their abilityDocument criteria for selection, evaluation and re-evaluation.Define type and extent of control on supplier.

907.4 Purchasing7.4.1 Purchasing processType and extent of control exercised on supplier should depend on effect of purchased product on next process (see 7.1) or final productResults of evaluation and necessary actions arising from evaluation to be recorded (See 4.2.4).

917.4 Purchasing7.4.2 Purchasing processPurchasing information normally consists of:Requirement of approval of product, procedures, processes and equipment, as appropriate.Requirement of qualification of personnel, if required. Quality management system requirements.Product verification arrangements (see 7.4.3)

927.4 Purchasing7.4.3 Verification of purchased productEstablish and implement arrangements (inspection etc.) for verification of purchased product.This may consists of :1. Total verification after receipt of product2. Partial or total verification at suppliers premises by organization or its customer.

937.5 Production and service provision7.5.1 Control of production and service provisionPlan and carry out under controlled conditions, that includes:Availability of information that describes the characteristics of product,Availability of work instructions, (Refer clause 4.2.1, Note 2)

947.5.1 Control of Production and service provisionControlled Conditionuse of suitable equipment,availability and use of measuring and monitoring equipment,Implementation of monitoring and measurement processesImplementing release, delivery and post-delivery activity.

7.5 Production and service provision957.5 Production and service provision7.5.2 Validation of processes for production and service provision Applicable only on those processes where :Quality of output can not be verified by subsequent monitoring and measurement.Deficiency will become apparent only when product is in use or service is delivered.

967.5 Production and service provision7.5.2 Validation of processes for production and service provisionThe Validation should demonstrateAbility to provide conforming productEvidence of consistency in resultAchieve planned resultCriteria to decide about a process to be considered as Special process depends on resources availability in an organization.

977.5 Production and service provision7.5.2 Validation of process for production and service provisionProcess Validation may includeDefined criteria for review and approval of processesApproval of equipment and qualification of personnelUse of specific methods and proceduresProcess parameters and other details to be recorded (see 4.2.4)Re-validation (Frequency of validation)

987.5.3 Identification and TraceabilityIdentify the product (See 7.5.1)Identify status with respect to monitoring and measurement requirements (i.e. inspection and test status)Control and record the identification of product, if traceability is a requirement (See 4.2.4).

7.5 Production and service provision997.5.4 customer property What is customer property ?Any product received from the customer or made available by the customer to the organization or its representative for production and service provision.1007.5.4 customer property What is customer property ?Any product received from the customer or made available by the customer to the organization or its representative for production and service provision.1017.5.4 customer property What is customer property ?Products to be incorporated in to the final product.Products to enable processing or delivery of final product.Tools and equipment provided by the customer.Products received from customer for post delivery service operation.1027.5.4 customer property What is customer property ?Products (including tools) provided by customer at customer premises to enable delivery of final product or post-delivery operation.Any type of intellectual property including concepts, designs (or drawings) provided by customer. (Personal data)1037.5.4 customer property Identifying, Verifying, Protecting and Safe guarding customer property.Recording the occurrence of lost, damage or otherwise finding un-suitability of use (See 4.2.4)Reporting to customer, occurrence of lost, damage or otherwise finding un-suitability of use1047.5.5 Preservation of productApply suitable techniques for preserving the conformity of product.Also applicable to constituent parts of the product,Requirement covers product identification, handling, packaging, storage and protection.105

7.6 Control of monitoring and measuring equipment

What are monitoring and measurement equipment:PhysicalSoftware Question paper, Checklist or questionnaire used for measurement of competence of personnel, customer satisfaction, effectiveness of QMS, used during internal audit, etc.

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7.6 Control of monitoring and measuring equipment

Determine monitoring and measurements to be undertaken. Determine monitoring and measurement devices needed.Determine calibration (or verification) requirements based on use, Calibrate, traceable to national or international standards if such standards exists, else record basis used for calibration or verification. (See 4.2.4)107

7.6 Control of monitoring and measuring equipment

Identify calibration status.Safeguard the devices from adjustments that could invalidate the result.Protect the devices from damage and deterioration during handling, maintenance and storage.Record the resultsValidate conformity of previous results if device is found out of calibration and take appropriate action on the equipment and product affected.108

8 Measurement, Analysis and Improvement

8.1 GeneralWhat to doPlan and implement monitoring, measurement, analysis and improvement processes needed.Include applicable methods and extent of their use.

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8 Measurement, Analysis and Improvement

8.1 GeneralObjective:To demonstrate conformity of productTo ensure conformity of QMS, andTo continually improve the effectiveness of quality management system.

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8 Measurement, Analysis and Improvement

8.2.1 Customer SatisfactionAn objective of QMSOne of the measurement of performance of QMS.Monitor customer perception regarding fulfillment of requirements.Determine the methods for obtaining and using the information on customer satisfaction.

1118 Measurement, Analysis and Improvement8.2.2 Internal AuditObjectiveQMS conforms to planned arrangements (see7.1)QMS conforms to the requirement of the standardQMS conforms to the requirements of the organizationQMS: Effectively implemented and maintained

1128 Measurement, Analysis and Improvement8.2.2 Internal AuditRequirement:Ensure objectivity and impartiality of audit.Auditors shall not audit their own work.Actions to be taken without undue delay.Follow-up actions to verify actions taken and report verification results (See 8.5.2).Results of audit to be reported for management review (See 5.6).

113a. Audit Planning b. Audit criteriac. Audit scoped. Audit frequencye. Audit methodf. Responsibilitiesg. Reporting resultsh. Maintain records (4.2.4)

Documented procedure is required to definea. status of processesb. importance of processesc. results of previous audits.8.2.2 Internal Audit8 Measurement, Analysis and Improvement1148 Measurement, Analysis and Improvement8.2.3 Monitoring and Measuring of processes:

Objective: Monitor and Measure ProcessApply suitable methods for monitoring and, where applicable, for measurement.Demonstrate ability of processes to achieve planned results.Make corrections, if required.Take corrective action, if required,Applicable to all the processes (see 4.1 & 7.1)

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8.2.4 Monitoring and Measurement of ProductMonitor and measure product characteristicsAt appropriate stages of product realization (7.1)Record evidence of conformity against acceptance criteria.Records to indicate authority responsible for release.Product release and service delivery to proceed only when all specified activities (see 7.1) have been completed, else approval is required by relevant authority or customer.

8 Measurement, Analysis and Improvement1168.3 Control of Nonconforming ProductObjectiveTo prevent unintended use or delivery of products which does not conform to requirements.To take appropriate action on consequences if non conformity is detected after delivery.

8 Measurement, Analysis and Improvement1178.3 Control of Nonconforming ProductDisposition could be:To eliminate the detected nonconformityUse, release or acceptance under concession (to be authorized by relevant authority and, where applicable, by customer)Preclude its original intended use

8 Measurement, Analysis and Improvement1188.3 Control of Nonconforming ProductDocumented Procedure should cover:Identifying nonconforming product Recording the nature of nonconformities and subsequent actions taken (See 4.2.4)Responsibilities and authoritiesRe-verification, when non-conformity is corrected, as per specified requirements (see 8.2.4)

8 Measurement, Analysis and Improvement1198.3 Control of Nonconforming ProductDocumented Procedure should cover:Allowing concessionsObtaining concessions from the customerActions needed when nonconformity is detected after delivery (these actions should be appropriate to the effects, or potential effects of nonconformity)

8 Measurement, Analysis and Improvement1208.3 Analysis of DataObjective To determine suitability and effectiveness of QMSTo identify areas of improvements and opportunities for preventive action.Requirement:Determine, Collect and Analyze data

8 Measurement, Analysis and Improvement1218.3 Analysis of DataArea of Application ( not exhaustive list)Customer satisfaction (see 8.2.1)Conformance to product requirements (See 7.2.1)Characteristics and trends of processes and products Suppliers

8 Measurement, Analysis and Improvement1228.4 Analysis of DataArea of Application ( not exhaustive list)Customer satisfaction (see 8.2.1)Conformance to product requirements (See 7.2.1)Characteristics and trends of processes and products Suppliers

8 Measurement, Analysis and Improvement1238.5 Improvement8.5.1 Continual ImprovementQuality Policy (see 5.3)Quality Objectives (see 5.4.1)Audit results (see 8.2.2)Analysis of data (see 8.4)corrective action (see 8.5.2)Preventive action (see 8.5.3)Management review (see 5.6)

8 Measurement, Analysis and Improvement124Correction: Elimination of nonconformities.Corrective action:Actions taken to prevent the recurrence of nonconformities.Preventive action: Actions taken to prevent the potential occurrence of nonconformities.125Review non conformities (including customer complaints),Determine the causes of non conformity,Evaluate the need for actions to prevent recurrence of nonconformities,Determining and implementing the actions needed (appropriate to their effects)Recording results of action taken (see 4.2.4)Reviewing the effectiveness of action taken

8.5.2 Corrective action126Determine potential non conformitiesDetermine the causesEvaluate the need for action to prevent occurrence of nonconformities.Determining and implementing the actions needed (appropriate to their effects)Recording results of action taken (see 4.2.4)Reviewing the effectiveness of action taken

8.5.3 preventive action127Documented procedure requiredOnly six documented procedures are MandatoryControl of documents (See 4.2.3)Control of quality records (See 4.2.4)Internal quality audit (See 8.2.2)Control of nonconforming product (See 8.3)Corrective action (See 8.5.2)Preventive action (See 8.5.3)

128Quality records requiredManagement review (clause 5.6.1)Education, training, skills and experience (clause 6.2.2 e) Evidence that the realization processes and resulting product fulfill requirements (clause 7.1 d)Results of the review of product requirements and actions arising from the review (clause 7.2.2)Design and development inputs (clause 7.3.2)

129Quality records requiredResult of design and development review and any necessary actions (clause 7.3.4)Result of design and development verification and any necessary actions (clause 7.3.5)Result of design and development validation and any necessary actions (clause 7.3.6)Result of design and development changes and any necessary actions (clause 7.3.7)

130Quality records requiredResults of supplier evaluations and actions arising from the evaluations (clause 7.4.1)Validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement (clause 7.5.2 d)The unique identification of the product, where traceability is a requirement (clause 7.5.3)131Quality records requiredCustomer property that is lost, damaged or otherwise found to be unsuitable for use (clause 7.5.4)Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist (clause 7.6a)Validity of previous results when measuring equipment is found not to conform with its requirements (clause 7.6)

132Quality records requiredResults of calibration and verification of measuring equipment (clause 7.6) Internal audit results (clause 8.2.2)Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product (clause 8.2.4)

133Quality records requiredNature of the product nonconformities and any subsequent actions taken, including concessions obtained (clause 8.3)Results of corrective action (clause 8.5.2)Results of preventive actions (clause 8.5.3)

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