1. Quality Management Quality management refers to the overall management functions of an organization in formulating and implementing a quality policy. Quality management includes strategic planning, resource allocation and other systematic activities such as quality planning, operation and organizational implementation.
This definition shows that the connotation of quality management can be observed from different angles. Vertically, quality management includes quality policy, quality objectives, and the quality system to achieve the quality policy objectives; horizontally, quality management includes quality planning, quality control, and quality improvement. No matter from which perspective, a series of systematic activities from strategic planning, resource allocation to full-process control and improvement should be carried out.
2. Quality Assurance
Quality assurance refers to all planned and systematic activities necessary to provide appropriate confidence that a product or service can meet specified quality requirements.
Quality assurance is an organic combination of activities that have specific quality requirements. It is a purposeful, planned and systematic activity. Quality assurance is not only a means of implementing quality management, but also a specific measure to implement quality policies and quality objectives. Through the development of quality assurance activities, it is conducive to the orderly operation of an organization's quality management work in accordance with specified requirements.
Quality assurance is divided into two parts: internal quality assurance and external quality assurance. Internal quality assurance is an important component of the overall quality management function. External quality assurance mainly means that in a contract environment, the organization, as a supplier, provides full trust to the buyers of the organization's products through quality assurance, provides product quality guarantees, and makes the buyers believe in the organization's products or services. Meet specified quality requirements.
3. Quality system
Quality system refers to the organizational structure, responsibilities, procedures, processes and resources for implementing quality management. The quality system contains only what is required to achieve the quality objectives. This is an organic whole, a synthesis established to achieve quality goals. The quality management of any enterprise is to establish and improve a sound quality system so that it can operate effectively and achieve quality objectives.
In addition, the quality system is the entity of quality management, which not only includes organizational structure, responsibilities, procedures and other software, but also includes resources such as human resources, professional skills, design technology, manufacturing equipment, inspection and test equipment and Instruments, instruments and computer systems, etc. In summary, the core of the quality system refers to the entities of people and things.
Quality systems have two forms: one is a quality management system for internal management, and the other is a quality assurance model for external certification. However, the quality management system and the quality assurance model are not parallel, independent, or parallel. They are closely related and intrinsically connected.
What type of quality system an enterprise should establish should be determined based on the actual situation of the enterprise and the requirements of the internal and external environment. Currently, there are three modes to choose from, one is the design and development mode; the second is the production and installation mode; the third is the final inspection and test mode.
4. Quality system certification
Quality system certification is based on the internationally accepted series of "quality management and quality assurance" standards. The certification body audits the company's quality system and issues a certification certificate to prove the company's quality. The quality system and quality assurance capabilities meet the corresponding requirements. Quality system certification is also known as enterprise certification, quality system registration, quality system review, quality system audit, etc. According to the above determination, quality system certification has the following characteristics:
(1) The object of certification is the quality system. To be more precise, it is "the impact of the enterprise's quality system on continuing to provide products or services as required by the demander." Certain elements of service capabilities,” that is, quality assurance system or quality assurance capabilities.
(2) The basis for implementing quality system certification is that there must be national standards for quality systems. Enterprises applying for certification should use the series of standards as a guide to establish an applicable quality system, and the certification agency will conduct inspections and assessments according to the quality assurance standards in the series of standards corresponding to the assurance model selected by the enterprise.
(3) The method to identify whether the quality system meets the standard requirements is the quality system audit. The certification body sends registered inspectors (auditors) to inspect and evaluate the company's quality system, submit audit reports, and propose audit conclusions.
(4) The way to prove the qualification for quality system certification is the quality system certification certificate and the system certification mark.
(5) Quality system certification is an activity performed by a third party. The third party refers to a party other than the independent first party (supplier) and the second party (demander). It has neither administrative affiliation nor economic interest with the first party and the second party. Emphasizing that system certification must be implemented by a third party is to ensure the fairness of certification activities.