Presentation on theme: "Preparing for Quality System Certification"— Presentation transcript:
1 Preparing for Quality System Certification U.S. Senator Byron Dorgan’sAerospace & Defense Manufactures RoundtablePreparing for Quality System Certification
2 Discussion Topics Quality system development Certification process ISO 9001 myths and misconceptionsISO 9001 interpretation of requirements
3 Quality System Development Establish unity of purpose throughout the organizationWhat are we try to achieve with ISO 9001?How do we want to improve our business performance?Eight Quality Management Principles(ISO 9000:2000)Customer focusLeadershipInvolvement of peopleProcess approachSystems approach to managementContinual improvementFactual approach decision makingMutually beneficial supplier relationships
4 Quality System Development Prepare a project plan to manage implementationEstablish scope for the quality management system“Design and manufacture of fluid power controls”Establish quality policyIdentify processes required to satisfy the scopeCustomer orientatedProduct realization processesSupport processesManagement processesStart defining process details, resources and implementation actions (See 4.1 General requirements)Monitor, measure and analyze process performanceSet initial quality objectives, plans and communicationMonitor the project progress at the management level
5 Quality Systems Development Tips for developing your quality systemEstablish awareness that the QMS is the foundation for managing the businessNo single business related activity should exist outside of the scope of the systemInclude the management staff in the initial development of the systemInclude the internal auditors in the system developmentWork according to a project planIdentify information technology (IT) needs up front
6 Quality Systems Development Tips for developing your quality systemKeep the documentation light, easy to use and to the point.Use mix of text and graphical formatsUse simple systems to control the documentationA picture says a thousand words
7 Quality Systems Development Build “working engines” before building documentationEngines are vital and essential work processes that make the ISO 9001 system workManagement processesInformation collection and analysis processesSupplier management processesImprovement processes (C/A, P/A, auditing)Employee development processes
8 Quality Systems Development Establish a culture for planning and execution of improvement actionsPlanQualityImprovementActDoCheckQuality PolicyPlanProductivityImprovementActDoCheck
9 Quality Systems Development Critically examine legacy documentationMay not contain vital informationSee ISO 9001: General requirementsMay not be user friendlyMay cause challenges for internal auditorsDon’t be afraid to start over!
10 Quality System Development (ISO 9001:2000) ISO 9001:2000 promotes the PDCA methodology for processes(See ISO 9001:2000 page VI)PLAN: establish the objectivesand processes necessary to deliverresults in accordance with customerrequirements and organizational policiesPlanDO: implement the processesActDoCHECK: monitor and measureprocesses and product againstpolicies, objectives and requirementsCheckACT: take actions to continuallyimprove process performance.
11 Quality System Development The Process ApproachISO 9001:2000 promotes the adoption of a process approach to manage the organization. (see ISO 9001:2000 page V)Provides a focus on inputs, process, and outputsEnables a systems view by looking at the interconnection and interaction of individual processesProcesses are planned, resourced, implemented and validated/verified.InputProcessOutput
12 Quality System Development The Process Approach4.1 General requirementsThe organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International StandardThe organization shall;Identify the processes needed for the QMS and their applicationDetermine the sequence and interaction of these processesDetermine criteria and methods needed to ensure both the operation and control of processes are effectiveEnsure the availability of resources and information as necessaryMonitor, measure and analyze these processesImplement actions necessary to achieve planned results and continual improvement of these processes
13 ISO 9001 Myths and Misconceptions Documentation efforts will cripple my company!Quality manualQuality policy and objectivesSix required proceduresOther documents needed by the organizationThe organization is responsible to determine the level of documentation requiredDocument format and media is company choice
14 ISO 9001 Myths and Misconceptions ISO 9001 will require us to change the way we manage our business!ISO 9001 provides a frameworkManagement determines the methods and manner of operationsHelps management to mitigate risksBased on Plan-Do-Check-Act cycle
15 ISO 9001 Myths and Misconceptions We’ll spend all of our time filling out records!Twenty (20) record categoriesRecords are determined by the organizationUsed as “collectors” for process performance informationChannels information into analysis processesEnables management to make improvements
16 ISO 9001 Myths and Misconceptions We’ll I have to hire more employees to manage the system?The ISO 9001 requires management to provide resources necessary to achieve customer satisfactionResources are a business case decisionThe resources are an investment in achieving the organization’s goals and customer satisfaction
17 Certification Process Selection of a registrarInitial visit and document reviewPre-auditRegistration auditPost audit corrective actionsVerification of actionsCertificate released, registered in public listingSurveillance auditing begins at appropriate intervals
18 What is ISO 9001:2000? ISO 9001:2000 is a quality management system Interconnected and interdependent processesProvides a systematic approach to delivering products or services meeting customer requirementsEnables continuous improvement in achieving defined objectives
19 Overview of ISO 9001:2000 ISO 9001:2000 is focused on processes Product realization processesSupport processesCustomer orientated processesManagement processes
21 ISO 9001:2000 OverviewISO 9001:2000 is contained in three primary documentsISO 9000:2000 Quality management systems – Fundamentals and vocabularyISO 9001:2000 Quality management systems – RequirementsISO 9004:2000 Quality management systems – Guidelines for performance improvementsA few guidance documents
22 ISO 9001:2000 RequirementsISO 9001:2000 contains five (5) main clauses defining the requirements4 Quality management system5 Management responsibilities6 Resource management7 Product realization8 Measurement, analysis and improvement
23 ISO 9001:2000 Balancing the Equation +=ABC6.2 Human Resources+7 Product Realization8 Measurement, Analysis and Improvement5.4.1 Quality Objectives=6.3 Infrastructure+8.2.1 Customer Satisfaction=+6.4 Work Environment
24 4 Quality Management System The Core Requirement4.1 General requirementsThe organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International StandardThe organization shall;Identify the processes needed for the QMS and their applicationDetermine the sequence and interaction of these processesDetermine criteria and methods needed to ensure both the operation and control of processes are effectiveEnsure the availability of resources and information as necessaryMonitor, measure and analyze these processesImplement actions necessary to achieve planned results and continual improvement of these processes
25 4 Quality Management System 4.2 Documentation requirementsThe quality management system documentation shall include;Documented statements of quality policy and quality objectivesA quality manualDocumented procedures required by this International StandardDocuments needed by the organization to ensure the effective planning, operation and control of its processes, andRecords required by this International Standard (see 4.2.4)
26 4 Quality Management System 4.2.1 General (Cont.)Note 1: The term “documented procedure” means that the procedure is established, documented, implemented and maintained.Note 2: The extent of the quality management system documentation can differ from one organization to another due to;The size of the organization and type of activitiesThe complexity of processes and their interactionsThe competence of personnelNote 3: The documentation can be in any medium
27 4 Quality Management System 4.2.2 Quality ManualThe organization shall establish and maintain a quality manual that includes;The scope of the quality management system, including details of and justification for any exclusions (see 1.2)The documented procedures established for the quality management system, or reference to them, andA description of the interaction between the processes of the quality management system (see handout)
28 4 Quality Management System 4.2.3 Control of documentsDocuments required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4A documented procedure shall be established to define controlsTo approve documents for adequacy prior to issueTo review and update as necessary and re-approve documentsTo ensure that changes and the current revision status of document are identifiedTo ensure that relevant versions of applicable documents are available at points of useTo ensure that documents remain legible and readily identifiableTo ensure that documents of external origin are identified and their distribution controlledTo prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
29 4 Quality Management System 4.2.4 Control of recordsRecords shall be established and maintained to provide evidence ofConformity to requirementsEffective operation of the quality systemRecords shall remainLegibleReady retrievableDocumented procedure must be established to define;Identification, storage, protection, retrieval, retention time and disposition
30 4 Quality Management System Key points;Document control enables creation and revision, must not curtail change.Record control prevents loss of company information
31 4 Quality Management System Documented procedures = 6Quality records categories = 20
32 4 Quality Management System Alternatives to documented proceduresCompetent employees - having defined education, skills and experienceEmployee training - trained for specific tasksProcess controls – calibrated monitoring and measuring equipment, mistake proofingVerification and validation – product evaluations that separate good products from bad
33 4 Quality Management System “Picture if you will….”A process operated by employees meeting defined competence requirements, specifically trained to do tasks as expected, using process controls that allow adjustment and correction to defined parameters, with product verification.…and no document procedures.”
34 5 Management Responsibility 5.1 Management commitmentTop management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by;Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirementsEstablishing the quality policyEnsuring that quality objectives are establishedConducting management reviews andEnsuring the availability of resources
35 5 Management Responsibility 5.2 Customer focusTop management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see and 8.2.1)
36 5 Management Responsibility 5.3 Quality policyTop management shall ensure that the quality policyIs appropriate to the purpose of the organizationIncludes a commitment to comply with requirements and continually improve the effectiveness of the quality management systemProvides a framework for establishing and reviewing quality objectivesIs communicated and understood within the organizationIs reviewed for continuing suitablity
37 5 Management Responsibility 5.4 Planning5.4.1 Quality (business) ObjectivesTop management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1 a) are established at relevant functions and levels within the organization.The quality objectives shall be measurable and consistent with the quality policy.
38 5 Management Responsibility 5.4.2 Organizations must plan on how to meet objectivesPlanQualityImprovementActDoCheckQuality PolicyPlanProductivityImprovementActDoCheck
39 5 Management Responsibility 5.4.1 Quality objectives established at relevant functions and levels with the organization.
40 5 Management Responsibility 5.4 Planning5.4.2 Quality management system planningTop management shall ensure thatThe planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, andThe integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
41 5 Management Responsibility A simplified view of the components of planning;Objectives (results expected)Quality management processes affected or requiredResourcesMeasurementContinual improvement
42 5 Management Responsibility Quality Management Systems ApproachDetermine customer needs and expectationsEstablish quality policies and objectivesDetermine (and implement) required processes and responsibilitiesDetermine and provide necessary resourcesEstablish measurement methods for each processApply measurements to check effectiveness and efficiencyDetermine means of preventing nonconformances and elimination of their causesEstablish and apply a process for continual improvementPlanDoCheckAct
43 5 Management Responsibility Business StrategyPlanning considerations;Objectives for the strategyQMS processes requiredResources requiredMeasurement and analysisImprovement opportunitiesPlanActDoCheckLeadership!
44 5 Management Responsibility The “Shall plan” requirements found in clauses;5.4.2 Quality Management System Planning7.1.1 Planning of Product Realization7.3.1 Design and Development Planning8.1 Plan for Measurement and Monitoring Activities8.5.1 Planning for Continual Improvement
45 5 Management Responsibility Considering the planning requirements, then what are plans?Quality manual, quality objectives, procedures, work instructions, and information documents contain the output of most planning requirements.Project specific examples;Design project plansContinuous improvement projectsCorrective and preventive actionsEmployee work plans (e.g. MBO)
46 5 Management Responsibility 5.5 Responsibility, authority and communication5.5.1 Responsibility and authorityTop management shall ensure that responsibilities and authorities are defined and communicated within the organization.
47 5 Management Responsibility 5.5 Responsibility, authority and communication5.5.2 Management representativeTop management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes;Ensuring that processes needed for the quality management system are established, implemented and maintained;Reporting to top management on the performance of the quality management system and need for improvement, andEnsuring the promotion of awareness of customer requirements throughout the organization
48 5 Management Responsibility 5.5 Responsibility, authority and communication5.5.3 Internal communicationTop management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
49 5 Management Responsibility 5.6 Management review5.6.1 GeneralTop management shall review the organization’s quality management system, at planned intervals to ensure it’s continuing suitability, adequacy and effectiveness.This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.Records from management reviews shall be maintained (see 4.2.4)
50 5 Management Responsibility 5.6 Management review5.6.2 Review inputThe input to management review shall include;Results of auditsCustomer feedbackProcess performance and product conformityStatus of preventive and corrective actionsFollow-up action from previous management reviewsChanges that could affect the quality management systemRecommendations for improvement
51 5 Management Responsibility 5.6 Management review5.6.3 Review outputThe output from management review shall include any decisions and actions related to;Improvement of effectiveness of the QMS and it’s processesImprovement of product related to customer requirementsResource needs
52 6.1 Provision of resources 6 Resource Management6.1 Provision of resourcesThe organization shall determine and provide the resources neededTo implement and maintain the quality management system and continually improve it’s effectivenessTo enhance customer satisfaction by meeting customer requirements
53 6.2 Human Resources 6 Resource Management 6.2.1 General Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.Competence: demonstrated ability to apply knowledge and skills (ISO 9000: )
54 6 Resource Management 6.2 Human resources 6.2.2 Competence, awareness and trainingThe organization shallDetermine the necessary competence for personnel performing work affecting product quality,Provide training or take other actions to satisfy these needsEvaluate the effectiveness of the actions taken,Ensure that its personnel are aware of the relevance and importance of their activities and how they contribution to the achievement of the quality objectives, andMaintain appropriate record of education, training, skills and experience (see 4.2.4)
55 6 Resource Management 6.3 Infrastructure The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable;Buildings, workspace and associated utilitiesProcess equipment (both hardware and software)Supporting services (such as transport or communication)
56 6.4 Work environment 6 Resource Management The organization shall determine and manage the work environment needed to achieve conformity to product requirements.“Set of conditions under which work is performed”“Note: Conditions include physical, social, psychological and environmental factors (such as temperature, recognition schemes, ergonomics and atmospheric composition)Definition from ISO 9000:2000
57 7.1 Planning of product realization The organization shall plan and develop the processes needed for product realization.Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1)
58 7.1 Planning of product realization In planning product realization, the organization shall determine the following, as appropriate:Quality objectives and requirements for the productThe need to establish processes, documents and provide resource specifics to the productRequired verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptanceRecords needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)The output of this planning shall be in a form suitable for the organization’s method of operations.
59 7.2 Customer-related processes 7 Product Realization7.2 Customer-related processes7.2.1 Determination of requirements related to productThe organization shall determineRequirements specified by the customer, including the requirements for delivery and post-delivery activitiesRequirements not stated by the customer but necessary for specified or intended use,where knownStatutory and regulatory requirements related to the product, andAny additional requirements determined by the organization
60 7.2 Customer-related processes 7 Product Realization7.2 Customer-related processes7.2.2 Review of requirements related to productThe organization shall review the requirements related to product. The review shall be conducted prior to the organization’s commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that;Product requirements are definedContract or order requirements differing from those previously expressed are resolved, andThe organization has the ability to meet the defined requirements
61 7.2 Customer-related processes 7 Product Realization7.2 Customer-related processes7.2.2 Review of requirements related to productRecords of the results of the review and actions arising from the review shall be maintained (see 4.2.4)Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
62 7.2.3 Customer communication 7 Product Realization7.2.3 Customer communicationThe organization shall determine and implement effective arrangements for communicating with customers in relation to;Product informationEnquiries, contracts or order handling, including amendments, andCustomer feedback, including customer complaints
63 7 Product Realization 7.3 Design and development 7.3.1 Design and development planningThe organization shall plan and control the design and development of productDuring the design and development planning, the organization shall determineThe design and development stages,The review, verification and validation that are appropriate to each stage, andThe responsibilities and authorities
64 7 Product Realization 7.3.2 Design and development inputs Inputs relating to product requirements shall be determined and records maintained (see 4.24.) This inputs shall include;Functional and performance requirementsApplicable statutory and regulatory requirementsWhere applicable, information derived from previous similar designs, andOther requirements essential for design and development
65 7 Product Realization 7.3.3 Design and development outputs The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.Design and development outputs shallMeet the input requirements for design and developmentProvide appropriate information for purchasing, production and for service provisionContain or reference product acceptance criteria, andSpecify the characteristics of the product that are essential for it’s safe and proper use.
66 7 Product Realization 7.3.4 Design and development review At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see planning)To evaluate the ability of the results of design and development to meet requirements, andTo identify any problems and propose necessary actions.Participate in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed.Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4)
67 7.3.5 Design and development verification 7 Product Realization7.3.5 Design and development verificationVerification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements.Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4)
68 7.3.6 Design and development validation 7 Product Realization7.3.6 Design and development validationDesign and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known.Wherever practicable, validation shall be completed prior to the delivery or implementation of the product.Records of the results of validation and any necessary actions shall be maintained (see 4.2.4)
69 7 Product Realization 7.3.7 Control of design and development changes Design and development changes shall be identified and records maintained.The changes shall be reviewed, verified and validated, as appropriate, and approved before implemented.The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4)
70 7.4.1 Purchasing process 7 Product Realization The organization shall ensure that product conforms to specified purchase requirements.The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or final product.
71 7.4.1 Purchasing process 7 Product Realization The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements.Criteria for selection, evaluation and re-evaluation shall be established.Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4)
72 7.4.2 Purchasing information 7 Product Realization7.4.2 Purchasing informationPurchasing information shall describe the product to be purchased, including where appropriate;Requirements for approval of product, procedures, processes and equipmentRequirements for qualification of personnel, andQuality management system requirements.The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
73 7.4.3 Verification of purchased product 7 Product Realization7.4.3 Verification of purchased productThe organization shall establish and implement the inspection or other activities necessary for ensuring that purchases product meets specified purchase requirements.Where the organization or its customer intend to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
74 7.5.1 Control of production and service provision 7 Product Realization7.5.1 Control of production and service provisionThe organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicableAvailability of information that describes the characteristics of the productAvailability of work instruction, as necessaryUse of suitable equipmentAvailability and use of monitoring and measuring devicesImplementation of monitoring and measurement, andImplementation of release, delivery and post-delivery activities
75 7.5.2 Validation of processes for production and service provision 7 Product Realization7.5.2 Validation of processes for production and service provisionThe organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement.This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.
76 7 Product Realization7.5.2 Validation of processes for production and service provisionValidation shall demonstrate the ability of these processes to achieve planned resultsThe organization shall establish arrangements for these processes includingDefined criteria for review and approval of the processesApproval of equipment and qualification of personnelUse of specific methods and proceduresRequirements for recordsRevalidation
77 7.5.3 Identification and traceability 7 Product Realization7.5.3 Identification and traceabilityWhere applicable, the organization shall identify the product by suitable means throughout product realization.The organization shall identify the product status with respect to monitoring and measurement requirementsWhere traceability is a requirements, the organization shall control and record the unique identification of the product (see 4.2.4)
78 7.5.4 Customer property 7 Product Realization The organization shall exercise care with customer property while it is under the organization’s control or being used by the organization.The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product.If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4)
79 7.5.5. Preservation of product 7 Product RealizationPreservation of productThe organization shall preserve the conformity of product during internal processing and delivery to the intended destination.This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.
80 7.6 Control of monitoring and measuring devices 7 Product Realization7.6 Control of monitoring and measuring devicesThe organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1)The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
81 7 Product Realization 7.6 Control of monitoring and measuring devices Where necessary to ensure valid results, measuring equipment shallBe calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis for calibration or verification shall be recorded;Be adjusted or re-adjusted as necessaryBe identified to enable the calibration status to be determinedBe safeguarded from adjustments that would invalidate the measurement resultBe protected from damage and deterioration during handling, maintenance and storage.
82 7 Product Realization 7.6 Control of monitoring and measuring devices In addition, the organization shall access and record the validity of the previous measuring results when the equipment is found not to conform to requirements.The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4)When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.See ISO and ISO for guidance
83 8 Measurement, analysis, and improvement 8.1 GeneralThe organization shall plan and implement the monitoring, measurement, analysis and improvement processes neededTo demonstrate conformity of the product,To ensure conformity of the quality management system, andTo continually improve the effectiveness of the quality management systemThis shall include determination of applicable statistical methods, including statistical techniques, and the extent of their use.
84 8 Measurement, analysis, and improvement 8.2 Monitoring and measurement8.2.1 Customer satisfactionAs one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements.The methods for obtaining and using this information shall be determined.
85 8 Measurement, analysis, and improvement Add examples of customer satisfaction measurementExpectations for managing the use of the information
86 8 Measurement, analysis, and improvement 8.2.2 Internal auditThe organization shall conduct internal audits at planned intervals to determine whether the quality management systemConforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, andIs effectively implemented and maintained
87 8 Measurement, analysis, and improvement 8.2.2 Internal auditAn audit program shall be planned, taking into account the status and importance of the processes and areas to be audited, as well as the results of previous audits.The audit criteria, scope, frequency and methods shall be defined.Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.
88 8 Measurement, analysis, and improvement 8.2.2 Internal auditThe responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes.Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2)
89 8 Measurement, analysis, and improvement ISO 9004:2000 recommendations for internal auditing(see ISO 9004: )Effective implementation of processesOpportunities for improvementCapability of processesEffective and efficient use of statistical techniquesUse of information technologyRelationships with interested partiesAnalysis of quality cost dataEffective and efficient use of resourcesProcess and product performance results and expectationsKnow eventsAdequacy and accuracy of performance measurementImprovement activities
90 8 Measurement, analysis, and improvement 8.2.3 Monitoring and measurement of processesThe organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality system processes.These processes shall demonstrate the ability of the processes to achieve planned results.When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure the conformity of product.
91 8 Measurement, analysis, and improvement 8.2.4 Monitoring and measurement of productThe organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1)Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product (see 4.2.4)Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable, the customer.
92 8 Measurement, analysis, and improvement 8.3 Control of nonconforming productThe organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
93 8 Measurement, analysis, and improvement 8.3 Control of nonconforming materialThe organization shall deal with nonconforming product by one of the following ways;By taking action to eliminate the detected nonconformityBy authorizing its use, release or acceptance under concession by a relevant authority, and where applicable, by the customerBy taking action to preclude its original intended use or applicationRecords of the nature of nonconformance and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4)
94 8 Measurement, analysis, and improvement 8.3 Control of nonconforming materialWhen nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential affects, of the nonconformity.
95 8 Measurement, analysis, and improvement 8.4 Analysis of dataThe organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made.This shall include data generated as a result of monitoring and measurement and from other relevant sources.
96 8 Measurement, analysis, and improvement 8.4 Analysis of dataThe analysis of data shall provide information relating to;Customer satisfaction (see 8.2.1)Conformity to product requirements (see 7.2.1)Characteristics and trends of processes and products including opportunities for preventive action, andSuppliers
97 8 Measurement, analysis, and improvement Measurement results are analyzed and driven into continuous improvements8.2.1Mgmt Review8.2.2Analyze 8.4Process improvement220.127.116.11.4Improvement!7.4.1
98 8 Measurement, analysis, and improvement 8.5.1 Continual improvementThe organization shall continually improve the effectiveness of the quality management system through the use of the;quality policyquality objectivesaudit resultsanalysis of datacorrective and preventive actionsmanagement review.
99 8 Measurement, analysis, and improvement 8.5.2 Corrective actionThe organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.Corrective actions shall be appropriate to the effects of the nonconformities encountered
100 8 Measurement, analysis, and improvement 8.5.2 Corrective actionA documented procedure shall be established to define requirements forReviewing nonconformities (including customer complaints)Determining the causes of nonconformitiesEvaluating the need for action to ensure that nonconformities do not recurDetermining and implementing action neededRecords of the results of action taken (see 4.2.4) andReviewing corrective action taken
101 8 Measurement, analysis, and improvement 8.5.3 Preventive actionThe organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.Preventive actions shall be appropriate to the affects of the potential problems.
102 8 Measurement, analysis, and improvement 8.5.3 Preventive actionA documented procedure shall be established to define requirements forDetermining potential nonconformities and their causesEvaluating the need for action to prevent occurrence of nonconformitiesDetermining and implementing action needed,Recording the results of action taken (see 4.2.4)Reviewing preventive action take.