iso9001-2000資料(文件)
【正文】 Improvement cycle General requirements General requirements ISO 9001:20xx – Model CUSTOMERS CUSTOMERS Quality Management System Responsibility 7. Product Realization 6. Resource Management 8. Measurement Analysis and Improvement Requirements Satisfaction Continual Improvement of the Quality Management System Consumption Product Principles of new standard Principles of new standard Customer focus ?Organization depends customers ?Understand current amp。 future customer needs. ?Meet / exceed customer expectations Leadership ?Leaders establish purpose amp。 its suppliers are interdependent ?Mutually beneficial relationship enhances the ability of both to create value Expectations of the new Standard Avoid the application of systems that are separate from the anization’s business process Enable the development of a Quality system that is fully integrated into the normal operations of anization’s business Enable Continual improvements of the system for enhanced customer satisfaction Enable pliance to statutory amp。 outputs Process approach – Continual improvements of Process PDCA Cycle Processes in terms Of Added Value DO Continual improvements of Processes based on objective measurements ACTION Measure results of process Performance and effectiveness Objective Measurements CHECK Understandings amp。 munication Management Reviews 5 Management Responsibility 8 Measurement Analysis amp。 resources for operation amp。 authority 5 Management Responsibility Development, implementation and continually improvement of QMS Communication of importance of ?Regulatory amp。 training Provision of resources 6 Resource Management Resources required to Implementing, monitoring amp。 faults ?Corrections ?Evaluations against lessons learned Planning ?Effective amp。 efficiency of processes ?Opportunities for improvements ?Use of data / information ?Effective amp。 improvements Review of Management responsibility Review of Resource management 1st visit 2nd visit 3rd visit 4th visit Thank You 。 market requirements System performance Criteria for measurements –Inspection and testing of ining, in process and final product –Product verification –Product validation –Process capability / process validation –Reaction time –Cycle time / throughput (Capacity) –Utilization of technology –Waste reduction –Cost reduction Products Processes Pros and Cons More business oriented. Less procedure oriented Company wide involvement Mutual benefit to all interested parties Customer focus than product focus Demanding more resources ?? Continual improvements Less emphasis
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