【正文】 ultidisciplinary approach Design and Development Inputs Product design input Manufacturing process design input Special characteristics Design and Development Outputs Product design outputs Manufacturing process design output Design and Development Review Monitoring Design and Development Verification Design and Development Validation. Design and development validation Prototype programme Product approval process Control of Design and Development Changes Purchasing Purchasing Control Regulatory pliance Supplier quality management system development Customerapproved sources Purchasing Information Purchasing Process Verification of Purchased Service Ining product quality Supplier monitoring. Production Provision Control of Production Provision Control plan Work instructions Verification of job setups Preventive and predictive maintenance Management of production tooling Production scheduling Feedback of information from service Servicing agreement with customer Validation of Processes for Production and Service Provision Validation of processes for production and service provision Identification and Traceability Customer Property Customerowned production tooling Preservation of Service Storage and inventory Control of Monitoring and Measuring Devices . Measurement system analysis. Calibration records Laboratory requirements Internal laboratory External laboratory8. MEASUREMENT, ANALYSIS AND IMPROVEMENT General Monitoring and Measurement Customer Satisfaction Customer satisfaction and Internal Quality Audit and Quality management system audit Manufacturing process audit Product audit Internal audit plans Internal auditor qualification Monitoring and Measuring of Processes Monitoring and measurement of manufacturing processes Monitoring and Measurement of Product Layout inspection and functional testing Appearance items Control of Nonconformity Control of nonconforming product Control of rework product Customer information Customer waiver Analysis of Data Analysis and use of data Improvement Continual Improvement Continual improvement of the organization Manufacturing process improvement Corrective Action Problem solving Errorproofing Corrective action impact Rejected product test/analysis Preventive Action Listing of Quality Management System ProceduresClauseClause DescriptionQM ClauseQuality ProcedureStandard Operating Procedure (SOP)4Quality Management SystemGeneral RequirementsDocumentation Requirements5Management ResponsibilityManagement CommitmentCustomer FocusQuality PolicyPlanningResponsibility, Authority and CommunicationManagement Review6Resource ManagementProvision of ResourcesHuman Resources InfrastructureWork Environment7Service RealisationPlanning of Service RealisationCustomerRelated ProcessesDesign and DevelopmentPurchasingService ProvisionControl of Monitoring and Measuring Devices8Measurement, Analysis and ImprovementGeneralMonitoring and MeasurementControl of NonConforming ServiceAnalysis of DataImprovement