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Basic requirements of ISO9000 standard
Time:2022-03-24 Clicks:

Product quality is the key to the survival of an enterprise. There are many factors that affect the quality of products. Simply relying on inspection is just to pick out qualified products from the products produced. This makes it impossible to consistently produce quality products at optimum cost.


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


1. Control the quality of all processes.


The ISO9000 family of standards is based on the understanding that "all work is done through a process". The quality management of an organization is achieved through the management of various processes within the organization, which is the theoretical basis of the ISO9000 family on quality management. When an organization conducts quality system planning in order to implement the quality system, the first thing is to determine which processes should be based on the specific situation of the organization, and then analyze the quality activities that need to be carried out in each process, and determine the effective control measures and methods that should be taken. .


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


At all stages of the product life cycle, the control of all processes from the initial identification of market needs to the final fulfillment of requirements embodies the idea of prevention. E.g:


---Control the quality of market research and marketing, develop new products on the basis of accurately determining the market demand, prevent blind development and cause unsuitable sales and waste manpower and material resources. --- Control the quality of the design process. By carrying out activities such as design review, design verification, and design confirmation, it is ensured that the design output meets the input requirements and that the product meets the needs of users. Prevent congenital failure and defects in product quality due to design quality problems, or cause losses to subsequent processes.


---Control the quality of procurement. Select qualified supply units and control their supply quality to ensure that the raw materials, purchased parts, and cooperative parts required for the production of products meet the specified quality requirements, and prevent the use of unqualified purchased products from affecting the quality of finished products.


---Control the quality of the production process. Determine and implement suitable production methods, use suitable equipment, maintain the normal working capacity of the equipment and the required working environment, 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 substandard products.


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


--- Control handling, storage, packaging, protection and delivery. Effective measures are taken at all these steps to protect the product from damage and deterioration.


---Control the quality of inspection, measurement and experimental equipment, ensure that qualified inspection methods are used for inspection and testing, ensure the validity of inspection and test results, and prevent incorrect determination of product quality due to unqualified inspection methods.


---Control documents and materials to ensure that all the documents and materials used by the site are current and effective, and prevent the use of outdated or obsolete documents, resulting in unqualified products or quality system elements.


  ---Corrective and preventive actions. When nonconformity (including product or quality system) or customer complaints occurs, the cause should be identified, and corrective measures should be taken to prevent the recurrence of the problem. Through the analysis of various quality information, potential problems should be proactively found and the occurrence of problems should be prevented, thereby improving the quality of products.


---Full staff training, train all staff who are engaged in the impact on quality to ensure that they are competent for their jobs, and prevent the failure of products or quality systems due to lack of knowledge or skills.


3. The central task of quality management is to establish and implement a documented quality system.


Quality management operates in the entire 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. It is required that the quality system established by an organization shall be documented and maintained. The composition of a typical quality system document is divided into three levels, namely the quality manual, the quality system procedure and other quality documents. A quality manual is a document describing the quality system in accordance with the quality policy specified by the organization and the applicable ISO 9000 family of standards. The quality manual may include the quality system procedures and may also indicate where the quality system procedures are specified. The quality system procedure is to control the quality of each process, to specify effective measures and methods for how to carry out various quality activities, and is a document used by relevant functional departments. Other quality documents, including work instructions, reports, forms, etc., are more detailed work documents used by workers. The basic requirements for the content of the quality system documents are: what should be done, what should be done, and the results must be recorded, that is, write what you need, do what you write, and remember what you do.


4. Continuous quality improvement:


Quality improvement is an important quality system element, and the GB/T 19004.1 standard specifies that when implementing a quality system, an organization's managers should ensure that its quality system can drive and facilitate continuous quality improvement. Quality improvement includes product quality improvement and work quality improvement. Striving for customer satisfaction and achieving continuous quality improvement should be the eternal goals pursued by managers at all levels of the organization. A quality system without quality improvement can only maintain quality. Quality improvement aims to improve quality. Quality improvement is achieved by improving the process, which is a goal of pursuing higher process benefits and efficiency.


5. An effective quality system should meet the needs and interests of both the customer and the organization.


That is, for customers, it is necessary for the organization to have the ability to deliver the desired quality and to maintain the quality continuously; for the organization, to achieve and maintain the desired quality at an appropriate cost in operation. That is, to meet the needs and expectations of customers, and to protect the interests of the organization.


6. 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, three basic questions must be asked about each process being evaluated:


A. Has the process been identified? Are process procedures properly documented?


B. Has the process been fully developed and implemented according to the document requirements?


C. Is the process effective in delivering the expected results?


7. The key to good quality management lies in leadership. ——The top management of the organization should do the following five things in terms of quality management:


A. Determine the quality policy. The quality policy, including quality objectives and commitment to quality, is defined by managers with executive responsibility.


B. Determine the responsibilities and authorities of each position.


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


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


E. Responsible for management review. To ensure the continued suitability and effectiveness of the quality system.


Looking back on history, the ISO9000 family of standards originated from the progress of science and the development of technology. Looking forward to the future, the development of high-tech is more subject to the guidance of the ISO9000 family of standards. The application of mature ISO9000 series standards in the field of science and technology provides endless power for the progress of science and technology.