Introduction to the functions of the QMS system of the QMS system

Product quality has a profound impact on the image and future development of an enterprise. At present, the implementation of ISO9000 family standards has been valued by many enterprises, and has become a kind of "passport" for enterprises to prove their product quality and work quality.

ISO9000 family of standards is a quality management and quality assurance standard formulated by the International Organization for Standardization to meet the needs of international economic and technological exchanges and international development, and has been adopted by more than 100 countries. In particular, the latest version of the ISO9001:2008 quality standard in 2008 has the advantages of wide applicability, strong versatility, and systematic control of quality-related activities, and its core content is "customer satisfaction".

With the deepening of the process of intelligent manufacturing, intelligent manufacturing software has also been used as a tool for improving quality and efficiency by more and more enterprises, and QMS for product quality has also become an important part of quality management.

QMS is the abbreviation of Quality Management System, which means quality management system in Chinese, that is, the management system that commands and controls the organization in terms of quality. QMS includes four elements: management responsibility, resource management, value creation process, measurement and analysis, and improvement, which form a closed loop.

1. Massive data analysis

The system supports the superposition of massive curves and analyzes the trend of process curve data.

2. Real-time monitoring of key parameters

The system provides real-time monitoring of key parameters to achieve accurate push of abnormal information.

3. Customization of discriminant criteria

Process analysis 8 major discriminant standards custom configuration.

4. Quality process capability analysis

Implement process SPC analysis, support metering and counting control chart analysis. Includes 10 commonly used control charts.

5. Electronic file of workpiece information

Establish an electronic file for the workpiece to realize the traceability of the whole life cycle of data.

6. Monitoring of key measurement areas

The system provides the function of monitoring the key areas of the process data curve. Alarm prompts are provided for curves that do not pass through critical areas.

7. IoT technology

The system supports a variety of protocols and production equipment for data acquisition. Collect massive amounts of structured and unstructured data.

Through data collection, quality analysis, quality early warning, cause and countermeasure analysis, countermeasure implementation, and continuous improvement, the quality management informatization level of manufacturing enterprises is improved.

Help enterprises to carry out quality control, track and trace quality problems, improve the first-time pass rate of products, reduce the defect rate and scrap rate, invisibly reduce the production and operating costs of enterprises, and promote their efficient and rapid development in market competition.

It can help enterprises accumulate professional process knowledge and form a proprietary knowledge base.

On this basis, the system learns the knowledge accumulated by the enterprise for many years through deep learning algorithms, forms an expert analysis model, helps the enterprise quickly realize the migration of core processes, avoids the occurrence of process defects, and provides auxiliary decision-making for process personnel.

The full name of QMS system is Quality Management System, which is a quality management system designed and developed based on the management requirements of ISO TS system. Its core value is to solidify the continuous improvement mechanism of enterprise quality management. Realize the leapfrog development of quality management mode in the context of the rapid development of existing science and technology.

A set of management systems designed to improve the quality assurance capabilities of enterprises.

Summary. 1. Planning and management: determine the positioning and objectives of QMS, formulate quality policies and quality objectives, design organizational structures to achieve quality policies and objectives, and prepare QMS documents.

2. Implementation management: establish and implement various management activities, including management responsibilities, resources, implementation plans, daily management, process control, record management, internal audit, etc. 3. Inspection management

Formulate inspection plans, carry out inspections, collect inspection data, analyze inspection results, and determine improvement measures. 4. Analysis and management: analyze and evaluate the implementation effect of QMS and determine improvement measures.

5. Improvement management: Implement quality improvement activities, such as design changes, process and system improvement, organizational culture improvement, etc. 6. Maintenance management

Regularly evaluate the implementation effect of QMS, determine maintenance measures, and reduce quality risks.

1. Planning and management: determine the positioning and objectives of QMS, formulate quality policies and quality objectives, design organizational structures to achieve quality policies and objectives, and prepare QMS documents. 2. Implementation management:

Establish and implement various management activities, including management responsibilities, resources, implementation plans, daily management, process control, records management, internal audit, etc. 3. Inspection management: formulate the inspection plan, implement the inspection based on the department, collect the inspection data, analyze the inspection results, and determine the improvement measures.

4. Analysis and management: analyze and evaluate the implementation effect of QMS, and determine the improvement measures. 5. Improve management

Implement quality improvement activities such as design changes, process and system improvements, organizational culture improvements, etc. 6. Maintenance management: regularly evaluate the implementation effect of QMS, determine maintenance measures, and reduce quality risks.

There is another question, briefly describe the link and key points of QMS, and after talking about it before, there is another key point.

The key points of QMS are:1Establish an effective quality management system to ensure safety and reliability; 2.

Strengthen the quality control system to ensure that the product quality meets the requirements of customers; 3.Strengthen quality inspection to ensure the quality of products; 4.Strengthen quality assurance to ensure stable quality; 5.

Strengthen quality management to ensure the effectiveness of quality control; 6.Strengthen quality improvement and continuously improve product quality.

Please share your thoughts on the development of regulations related to the management of in vitro diagnostics and provide valuable suggestions.

My feeling about the development of regulations related to the management of in vitro diagnostic reagents is that this development is extremely necessary to provide patients with safer and more effective **, improve the level of diagnosis, and improve the efficiency of patient care. My valuable suggestion is that we should strengthen the management of diagnostic reagents outside the physical slag, strengthen the control of their quality, establish a sound management system, establish a standardized and perfect management system, strictly implement quality standards, strengthen technical training, improve the technical level of medical personnel, and ensure the safety and effectiveness of diagnostic reagents.

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QMS is the abbreviation of Quality Management System, which means quality management system in Chinese. Command and control the organization's management system in terms of quality. QMS includes four elements: management responsibility, resource management, value creation process, measurement and analysis, and improvement, which form a closed loop.

A quality management system (QMS) usually includes the formulation of quality policies, objectives, and activities such as quality planning, quality control, quality assurance, and quality improvement. To achieve the policy and objectives of quality management and effectively carry out various quality management activities, it is necessary to establish a corresponding management system, which is called the quality management system. It refers to the systematic quality activities established within the enterprise that are necessary to ensure product quality or quality objectives.

It selects a number of system elements according to the characteristics of the enterprise and combines them, strengthens the quality management activities from the whole process of design and development, production, inspection, sales and use, and institutionalizes and standardizes them, and becomes the requirements and activity procedures of the internal quality work of the enterprise.

QMS, Chinese meaning quality management system, command and control the management system of the organization in terms of quality, QMS includes management responsibilities, resource management, value creation process, measurement and analysis improvement and other four elements, these four elements form a closed loop.

The quality management system usually includes the formulation of quality policies, objectives and quality planning, quality control, quality assurance and quality improvement activities, to achieve the policy and objectives of quality management, and to effectively carry out various quality management activities, the corresponding management system must be established, which is called the quality management system. It is a systematic quality activity established within the enterprise to ensure product quality or quality loss goals, and a number of system elements are selected according to the characteristics of the enterprise to be combined, and the design and development, production and inspection are strengthened.

QMS system design concept:

1. Based on ISO9001 TS16949 PDCA continuous improvement mechanism.

The model of the PDCA continuous improvement mechanism of the IS09001 system can be briefly described as follows:

P--Planning: Establish the necessary goals and processes for delivering results according to the customer's requirements and the organization's policy;

d--Implementation: the implementation process;

C--Inspection: According to the policy, objectives and product requirements, monitor and measure the process and products, and report the results;

A - Disposition: Take measures to continuously improve process performance.

The QIS system is designed based on the business process and terms requirements of the ISO9001 system, the business process functions are sorted out and productized, and the PDCA model continuous improvement mechanism of the ISO system is integrated into the system business logic to realize the systematic solidification of the continuous improvement mechanism of the ISO system.

2. Based on GE's Industrial Digital Nervous System Theory The core idea of GE's industrial digital nervous system theory is to realize the "knowledge", "control", "management" and "planning" of the industrial production process. Based on GE's industrial digital neural theory, the QIS system realizes the "knowable" quality working status through the collection of key business data information and management target data. Through the standardization and solidification of the core business process of quality management, the optimization of the quality management workflow is realized, and the "controllable" quality process management is realized. Through the layer-by-layer decomposition of quality management plans and quality objectives, the statistics and monitoring of achievement rates, and the monitoring and management of rectification of major quality problems, the comprehensive "manageability" of quality management work is realized; Through the comprehensive quantification of the performance indicators of the enterprise's quality objectives, it provides quantitative data support for the decision-making of the management and realizes the "seeking" of quality management.

3. Based on Peter Drucker's Cognitive Problem Peter Drucker clearly put forward in "Effective Managers" that in order to improve the efficiency of managers, the first problem of understanding must be solved. In the process of QIS system design, it fully integrates advanced management models and standard analysis methods to realize the explicit and visualization of hidden quality problems, help enterprise managers to achieve a rapid understanding of enterprise operation status, and provide support for efficient decision-making of enterprise managers.