What management system is iso9000 quality system certification?

? Quality Management System is one of the international standards established by the International Organization for Standardization (ISO). The concept put forward in 1987 refers to "all international standards formulated by ISO/TC 176(ISO Technical Committee for Quality Management and Quality Assurance)". This standard is helpful to organize the implementation and effective operation of quality management system, and it is the general requirement and guide of quality management system. In the 1990s, China transformed ISO9000 series standards into national standards, and subsequently, various industries also transformed ISO9000 series standards into industry standards.

Basic requirements of ISO9000 quality management system certification standard

Product quality is the key to the survival of enterprises. There are many factors that affect the quality of products. Simply relying on inspection only selects qualified products from the products produced. It is impossible to continuously and stably produce qualified products at the best cost.

The quality system established and implemented by the organization should be able to meet the quality objectives set by the organization. Ensure that the technical, management and human factors affecting product quality are under control. Whether it is hardware, software, process materials or services, all controls should aim at reducing and eliminating nonconformities, especially preventing nonconformities. This is the basic guiding ideology of the ISO9000 family, which is embodied in the following aspects:

First, control the quality of all processes.

The O9000 family standard is based on the understanding that "all work is done through processes". The quality management of an organization is realized by managing various processes within the organization, which is the theoretical basis of ISO9000 family on quality management. When an organization carries out quality system planning in order to implement the quality system, it should first determine which processes should be carried out according to the specific situation of the organization, and then analyze the quality activities needed in each process to determine the effective control measures and methods that should be taken.

Second, the starting point of the control process is to prevent nonconformity.

At all stages of the product life cycle, the control of all processes from the initial identification of market demand to the final satisfaction of demand embodies the idea of prevention first. For example:

-control the quality of market research and marketing, develop new products on the basis of accurately determining market demand, and prevent blind development from causing unsalable sales that do not meet market demand and wasting manpower and material resources. -Control the quality of the design process. Through design review, design verification, design confirmation and other activities, ensure that the design output meets the input requirements and the products meet the needs of users. Prevent product quality from being unqualified and defective due to design quality problems, or cause losses to subsequent processes.

-Control the purchasing quality. Select qualified suppliers and control their supply quality, so as to ensure that the raw materials, purchased parts and cooperative parts needed to produce products meet the specified quality requirements and prevent the use of unqualified purchased parts from affecting the quality of finished products.

-Control the quality of the production process. Determine and implement appropriate production methods, use appropriate equipment, maintain the normal working capacity and required working environment of the equipment, control the parameters and personnel skills that affect the quality, ensure that the manufacturing meets the quality requirements specified in the design, and prevent the production of unqualified products.

-Control inspection and testing. Carry out incoming inspection, process inspection and finished product inspection according to the quality plan and documented procedures to ensure that the product quality meets the requirements, prevent unqualified purchased products from being put into production, prevent unqualified process products from being transferred to the next process, and prevent unqualified finished products from being delivered to customers.

-Control handling, storage, packaging, protection and delivery. Take effective measures to prevent product damage and deterioration in all these links.

-Control the quality of inspection, measuring and experimental equipment, ensure that qualified testing means are used for inspection and test, ensure the effectiveness of inspection and test results, and prevent misjudgment of product quality due to unqualified testing means.

-Control documents and materials, ensure that all documents and materials used in the site are up-to-date and effective, and prevent the use of expired or invalid documents, resulting in unqualified products or quality system elements.

-Corrective and preventive measures. When nonconformities (including products or quality systems) or customer complaints occur, the reasons should be found out and corrective measures should be taken to prevent the recurrence of the problems. Through the analysis of various quality information, potential problems are actively found and prevented, so as to improve product quality.

-All-staff training, that is, training all personnel engaged in work that has an impact on quality, so as to ensure that they are competent for their jobs and prevent products or quality systems from being unqualified due to lack of knowledge or skills.

Three, the central task of quality management is to establish and implement a documented quality system.

Quality management runs in the whole quality system, so the implementation of quality management must establish a quality system. The ISO9000 family believes that the quality system is an influential system with strong operability and inspection. The quality system required to be established by the organization shall be documented and maintained. Typical quality system documents are divided into three levels, namely, quality manual, quality system procedures and other quality documents. The quality manual is a document describing the quality system according to the quality policy stipulated by the organization and the applicable ISO9000 series standards. The quality manual can include the quality system procedures or indicate the specific location of the quality system procedures. Quality system procedure is a document used by relevant functional departments to control the quality of each process and stipulate effective measures and methods for how to carry out various quality activities. Other quality documents, including work instructions, reports and forms, are more detailed working documents used by workers. The basic requirements of the contents of quality system documents are: what should be written, what should be done, and the results should be recorded, that is, what needs to be written, what should be done, and the nine-character mantra should be remembered.

Fourth, continuous quality improvement:

Quality improvement is an important part of quality system. GB/T 19004. 1 Standard stipulates that the managers of an organization should ensure that their quality system can promote and promote continuous quality improvement when implementing the quality system. Quality improvement includes product quality improvement and work quality improvement. Striving for customer satisfaction and realizing continuous quality improvement should be the eternal goal pursued by managers at all levels of the organization. A quality system without quality improvement can only maintain quality. Quality improvement aims at improving quality. Quality improvement is achieved by improving the process, with the aim of pursuing higher process efficiency and effectiveness.

5. An effective quality system should meet the needs and interests of customers and organizations.

In other words, for customers, the organization needs to have the ability to deliver the expected quality and maintain it continuously; For an organization, the expected quality can be achieved and maintained at an appropriate cost. That is to meet the needs and expectations of customers and protect the interests of the organization.

Six, regularly evaluate the quality system.

Its purpose is to ensure that the implementation of various quality activities and their results conform to the planned arrangements, and to ensure the continued suitability and effectiveness of the quality system. When evaluating, we must ask the following three basic questions for each evaluated process:

A. has the process been determined? Is the process procedure properly documented?

Is the process formulated and implemented in full accordance with the document requirements?

C. is the process effective in providing the expected results?

Seven, the key to do a good job in quality management is leadership. —— The top management of the organization should do the following five things in quality management:

First, determine the quality policy. The quality policy, including quality objectives and commitment to quality, shall be stipulated by the manager responsible for implementation.

B, determine the responsibilities and authority of each position.

C. allocating resources. Including financial and material resources (including manpower).

Designate a management representative to be responsible for the quality system.

E, responsible for management review. Ensure the continuous suitability and effectiveness of the quality system.