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【正文】 Customer related processes 7 Product Realization Quality objectives of Products – Specs Processes, procedures to realize product Verification, validation, monitoring, inspection and testing of product Record to demonstrate conformance Planning of Product realization 7 Product Realization Review of requirements related product prior to acceptance / mitment to customers ability to meet customer requirements Effective munication with customer in relation to ?Product information ?Sales order handling ?Customer feedback ?Customer plaints Identification of Customer / Market requirements ?Specified by customer ?Requirements taken for granted ?Statutory / Regulatory requirements Customer related processes – (Sales) 7 Product Realization Design inputs and outputs Review and verification, validation and control of changes ?Accuracy ?Potential hazards amp。 Product realization Review of Measurement, analysis amp。 measurements Analysis of data Improvement Control of non conforming product Measurement of product Internal audits Customer satisfaction Measurement of processes Corrective action Preventive action Continual improvements General 8 Measurement, analysis and improvement To demonstrate ?Conformity of the product ?Conformity to QMS requirements ?Continually improvements and the effectiveness of the system Monitoring and Measurements ?Customer satisfaction / perception ?Internal audits conformity planned arrangements of QMS and ISO9001 ?Monitoring and measurements of processes – to determine / demonstrate ability of processes to achieve required results ?Monitoring and measurements of product – Conformity to product requirements Control of NCP ?To assure that NCP products are identified and controlled to prevent unintended use / delivery To demonstrate 8 Measurement, analysis and improvement Analysis of data Collection and analysis of data generated through QMS activities to verify suitability, effectiveness and continual improvement of the system Analysis shall provide information related to ?Customer satisfaction / perception ?Conformity to specs, requirements ?Trends of processes and products ? Opportunities for preventive actions ?Suppliers 8 Measurement, analysis and improvement Improvements Continual Improvements ?QMS needed to be continually improved Corrective action ?Actions to prevent recurrence of NCP, NCR etc ?Includes reviews, determination of causes, need of action, implementation of action, review of action and maintenance of relevant records Preventive action ?Actions against potential non conformities to avoid thei
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