【正文】
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 on documentation Challenges in implementing new standard Communication Management Support Other employee Support New ISO Encouragement ISO 9001:20xx Transition Process 2 years Review of QMS amp。 efficiency of processes ?Opportunities for improvements ?Use of data / information ?Effective amp。 testing Product release, delivery and post delivery Process validation Identification and traceability Customers property Material supplied by customers – .. 3rd party blending Production and service provision Manufacturing / service provision under controlled condition to ensure conformity of product 7 Product Realization Control of monitoring and measuring devices Control and Calibration of equipments used for monitoring, inspection and testing 8 Measurement, analysis and improvement Monitoring amp。 faults ?Corrections ?Evaluations against lessons learned Planning ?Effective amp。 traceability Customer property Production amp。 training Provision of resources 6 Resource Management Resources required to Implementing, monitoring amp。 Quality objectives ?Responsibilities amp。 authority 5 Management Responsibility Development, implementation and continually improvement of QMS Communication of importance of ?Regulatory amp。 control of Organization activities Records Document requirements Responsibility authority amp。 resources for operation amp。 measurement Control of NCP Analysis of data Improvements 4 Quality management system General requirements Identification of processes required Criteria and methods to ensure Operation amp。 munication Management Reviews 5 Management Responsibility 8 Measurement Analysis amp。 development Purchasing Production 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