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Quality Management System, QMS ISO9001: 2005 standard defines as " command and control an organization with regard to quality management system ", usually including the development of quality policy, objectives and quality planning , quality control, quality assurance and quality improvement activities. Quality management to achieve policy objectives effectively carry out the quality management activities , we must establish the appropriate management system, this system is called quality management system.
Quality management system is established within the organization , as necessary to achieve quality objectives , quality management system , the organization is a strategic decision . It will combine resources and processes , systems management to process management methods , the choice of a number of system elements are combined according to business characteristics , including general management activities , provision of resources , product realization and measurement, analysis and improvement activities related to the composition of the process , you can understood as covering everything from determining customer needs , design and development , production , testing, marketing , planning the whole process before delivery , implementation, monitoring, corrective and improvement requirements activities generally documented way to become the organization 's internal quality management requirements.
For the requirements of quality management system , quality management and quality assurance International Organization for Standardization Technical Committee has developed the ISO9000 series of standards to apply to different types of organizations , products, scale and nature of such standard or supplemented by a number of interrelated single standard components , which is known to everyone ISO9001 " quality Management System requirements" , asking it to make is complementary to requirements for products , after several revision . In this standard , based on different industries and develop the corresponding technical specifications, such as ISO / TS 16949 " automotive production and service part organizations applied ISO9001: 2008 Special requirements ", ISO 13485 " Quality Management System for Medical Devices Regulations request " and the like.