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Chapter j 38 Self Assessment729QUALITY MANAGEMENT SYSTEM REQUIREMENTSGeneral tablishing and implementing a documented quality management systemImplementing a documented quality management systemMaintaining a documented quality management systemContinually improving the effectiveness of the QMSDetermining processesDetermining process sequence and interactionDetermining criteria and methods for operation and control of processesAvailability of resources necessary to support the operation and control of processesAvailability of information necessary to support the operation and control of processesMonitoring, measurement and analysis of processesRestoring the status quoContinual process improvementProcess managementOutsourcing processesResponsibility for outsourced processesDocumentation RequirementsGeneral16.17.18.19.Documenting the quality policy and objectivesDocumenting the quality manualDocumenting the quality management system proceduresDocumenting the information needed for the effective operation and control ofprocesses20. Documenting recordsQuality Manual21. Establishing and maintaining a quality manualControl of ing documents required by the QMSEstablishing document control proceduresApproval of documentsReview and revision of documentsRe-approval of documents after revisionIdentifying revision statusAvailability of documentsIdentification and legibility of documentsControl of documents of external originControl of obsolete documentsIdentifying obsolete documents retained for use

730PART j 8 System Assessment Certification and Continuing DevelopmentControl of Records33. and maintaining records of conformityEstablishing and maintaining records of effectivenessEnsuring legibility of recordsEnsuring identification of recordsRetrieval of recordsEstablishing a records control procedureMANAGEMENT RESPONSIBILITY REQUIREMENTManagement Commitment39. Evidence of management commitment to developing a QMS40. Evidence of management commitment to continually improving the effectivenessof the QMS41. Evidence of communicating the importance of meeting customer and regulatoryrequirements42. Evidence of management establishing the quality policy43. Evidence of management establishing quality objectives44. Evidence of management commitment by conducting management reviews.45. Evidence of management commitment by ensuring the availability of necessaryresources.Customer Focus46. Determining customer requirements47. Meeting customer requirementsQuality Policy48. of organizationCommitment to comply with requirementsCommitment to continual improvementFramework for quality objectivesCommunication of quality policyReview of quality policyPlanningQuality Objectives54. quality objectivesMeasurement of quality objectivesConsistency of quality objectivesObjectives for meeting product requirementsInclusion of quality objectives in business plan

Chapter j 38 Self AssessmentQuality Management System Planning59. Planning of quality management system in line with process managementprinciples60. Planning of quality management system to meet quality objectives61. Maintaining integrity of quality management systemResponsibility, Authority and CommunicationResponsibility and Authority62. Defining and communicating responsibility and authorityManagement Representative63. Appointment of management representative64. Responsibility and authority of management representativeCustomer Representative65. Designation of customer representativesInternal Communication66. Establishing communication processes67. Communicating the effectiveness of the QMSManagement ReviewGeneral68. Top management review of quality management system69. Assessing opportunities for improvement70. Records of management reviewReview Input71. Performance information for input to management review72. Changes affecting the QMS73. Analysis of field failuresReview Output74. Decisions and action arising from management review731

732PART j 8 System Assessment Certification and Continuing DevelopmentRESOURCE MANAGEMENT REQUIREMENTSProvision of Resources75. Determination and provision of resources to implement the QMS76. Determination and provision of resources to enhance customer satisfactionHuman ResourcesGeneral77. Competence of personnelCompetence, Awareness and Training78. of competenceProvision of trainingEvaluating the effectiveness of trainingAwareness of impact on the achievement of quality objectivesRecords of education, training, skills and experienceTraining83. Establishing procedures for identifying training needs84. Qualification of personnel85. Training in specific customer requirementsInfrastructure86. Provision and maintenance of infrastructureWork Environment87. Determination and management of work environmentPRODUCT REALIZATION REQUIREMENTSPlanning of Product ng product realization processesConsistency of process planningDetermining product quality objectives and requirementsEstablishing product specific processesProviding product specific documentsProviding product specific resourcesDetermining product specific verification and validation activities and methodsDetermining product specific acceptance criteriaDetermining product specific recordsDetermining process specific recordsEnsuring suitability of planning output

Chapter j 38 Self AssessmentCustomer-Related ProcessesDetermination of Requirements Related to the Product99.100.101.102.Determining customer specified requirementsDetermining requirements for intended useDetermining statutory and regulatory requirementsDetermining organizational requirementsReview of Requirements Related to the ng product requirementsTiming of product requirements reviewEnsuring product requirements are definedResolving differing requirementsEnsuring the organization has the ability to meet requirementsMaintaining records of the results of product reviewsConfirming undocumented requirementsAmending documents affected by changed product requirementsInforming personnel of changed requirementsCustomer orforforcommunicating product information to customersdealing with customer enquiriesdealing with contracts and ordersdealing with amendments to contracts and ordersdealing with customer feedbackDesign and DevelopmentDesign and Development Planning117. product design and developmentControlling product design and developmentDetermining design and development stagesDetermining review, verification and validation for each stageDetermining design and development responsibilities and authorityManaging design and development interfacesUpdating design and development planningDesign and Development Inputs124. design and development inputsDetermining functional and performance requirementsDetermining statutory and regulatory requirementsDetermining information from previous designDetermining other design and development requirementsReviewing design and development inputsQuality of design and development inputs733

734PART j 8 System Assessment Certification and Continuing DevelopmentProduct Design Input131. Identification of customer requirements132. Product design information deployment process133. Product quality targetsDesign and Development Outputs134. of design and development outputsApproval of design and development outputsEnsuring design output meets requirementsProvision of purchasing, production and service informationReferencing product acceptance criteriaSpecifying product operation and safety characteristicsDesign and Development Review140. design reviewsEvaluation of designIdentifying problems and correcting errorsParticipants at design reviewsRecords of design reviewsDesign and Development Verification145. Conducting design and development verification146. Records of design and development verificationDesign and Development Validation147. Conducting design and development validation148. Completing validation prior to the delivery or implementation of product149. Records of design and development validationControl of Design and Development Changes150. of design and development changesRecording of design and development changesReview, verification and validation of design changesEvaluating the effects of changeRecording the results of design change reviewsPurchasingPurchasing Process155. Ensuring purchased product conforms to requirements156. Determining supplier controls

Chapter j 38 Self Assessment157. Supplier evaluation158. Establishing selection and evaluation criteria159. Results of supplier evaluationsPurchasing Information160. of productProduct approval requirementsQualification of personnelQuality management system requirementsAdequacy of purchasing requirementsVerification of Purchased Product165. Ensuring purchased product meets requirements166. Verification at supplier’s premisesProduction and Service ProvisionControl of Production and Service lanning production and service provisionControlling production and service provisionEnsuring the availability of information describing the productEnsuring the availability of work instructionsUsing suitable equipmentAvailability and use of monitoring and measuring devicesImplementing monitoring and measurement activitiesImplementing of release activitiesImplementing of delivery activitiesImplementing of post-delivery activitiesValidation of Processes for Production and Service g special processesDefining criteria for review and approvalApproving process equipmentQualifying process personnelEstablishing process methods and proceduresDefining recording requirementsDefining revalidation requirementsScope of process validationIdentification and Traceability185. Identifying product186. Identifying product status187. Controlling unique identification of product735

736PART j 8 System Assessment Certification and Continuing DevelopmentCustomer Property188. care of customer propertyIdentifying customer propertyVerifying customer propertyProtecting customer propertyReporting lost or damaged customer propertyPreservation of Product193. Preserving conformity of product194. Identifying, handling, packing storage and protection of product195. Scope of product preservationControl of Monitoring and Measuring 06.207.208.Determining monitoring and measurements to be undertakenDetermining the monitoring and measurement equipment requiredEstablishing monitoring and measurement processesCalibrating and verifying measuring equipmentRecording the basis for calibration and verificationAdjusting measuring equipmentDetermining calibration statusSafeguarding adjustmentsProtecting measuring equipmentAssessing nonconforming equipmentAction on equipment found out of calibrationMaintaining records of calibration and verificationConfirming integrity of computer software used for measurementMEASUREMENT, ANALYSIS AND IMPROVEMENT REQUIREMENTSGeneral209.210.211.212.Establishing processes necessary to demonstrate product conformityEstablishing processes necessary to ensure system conformityEstablishing processes necessary to improve system effectivenessDetermining monitoring, measurement and analysis methodsMonitoring and MeasurementCustomer Satisfaction213. Monitoring customer perceptions214. Determining customer satisfaction monitoring methodsInternal Audit215. Conducting internal audits for conformity with planned arrangements216. Conducting internal audits for conformity with ISO 9001:2000

Chapter j 38 Self ng internal audits for conformity with the organization requirementsDetermining effective implementation and maintenance of QMSPlanning the internal audit programDefining audit criteria, scope, frequency and methodsSelecting auditorsDocumenting audit proceduresEnsuring prompt action on audit findingsFollowing up audit actionsMonitoring and Measurement of Processes225. Monitoring QMS processes226. Demonstrating processes achieve planned results227. Taking action on process measurementsMonitoring and Measurement of Product228. and measurement of product characteristicsDetermination of product monitoring and measurement stagesMaintaining evidence of conformityIndicating product release authorityHolding product releaseControl of Nonconforming Product233. unintended use of delivery of nonconforming productDocumenting nonconforming product controlsMaintaining records of the nature of nonconformities and actions takenRe-verification of nonconforming productDetecting product nonconformity subsequent to deliveryAnalysis of Data238. and analysing data on the effectiveness of the QMSCollecting data to identify improvements in system effectivenessProviding information on customer satisfactionProviding information on product conformityProviding information on trends and characteristicsProviding information on suppliersSupporting decision making and long-term planningImprovementContinual Improvement245. Improving the effectiveness of the QMS

738PART j 8 System Assessment Certification and Continuing DevelopmentCorrective Action246. action to eliminate the cause of nonconformityAppropriateness of corrective actionsDocumenting corrective action proceduresReviewing nonconformities including customer complaintsDetermining the causes of nonconformitiesEvaluating the needs for actionDetermining and implementing action neededRecording the results of corrective actionsReviewing corrective actions takenPreventive Action255. action to eliminate potential nonconformitiesAppropriateness of preventive actionsDocumenting preventive action proceduresDetermining the cause of potential nonconformitiesEvaluating the needs for actionDetermining and implementing actionRecording the results of preventive actionsReviewing preventive actions taken

QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements 1. Establishing and implementing a documented quality management system 2. Implementing a documented quality management system 3. Maintaining a documented quality management system 4. Continually improving the effectiveness of the QMS 5. Determining processes 6.