How to establish an organization level quality management system

The establishment of an organization-level quality management system generally includes the following steps: (1) Determine the needs and expectations of customers and other interested parties; (2) Establish the organization's quality policy and quality objectives; (3) Determine the necessary processes and responsibilities to achieve quality objectives; (4) Identify and provide the resources necessary to achieve quality objectives; (5) prescribe methods for measuring the effectiveness and efficiency of each process; (6) apply these measurement methods to determine the effectiveness and efficiency of each process; (7) Determine measures to prevent non-conformity and eliminate the causes; (8) Establish and apply the process of continuous improvement of the quality management system. The above approach also applies to maintaining and improving the existing quality management system.

Organizations that adopt this approach build confidence in their process capabilities and product quality, providing the basis for continuous improvement, which in turn increases customer and other stakeholder satisfaction and organizational success.

The establishment of a quality management system in a software enterprise requires the mobilization of the top leaders of the enterprise and the intervention of consulting institutions. The training and examination of the basic knowledge of the quality system for all employees is an important measure to enhance the quality awareness of employees, and the adjustment of the organizational structure of the enterprise is the basis for establishing the system. The consulting organization and the IT company jointly participate in the steps of proposing quality policies and objectives, compiling quality manuals and process documents, and the trial operation of the quality system, which is essentially the process of internal communication, consensus, and maturity.

Quality certification consulting work generally goes through four stages. The first stage is the investigation and diagnosis of the current situation of the enterprise and the ISO9000 standard cluster and software engineering training stage. The second stage is the preparation of quality system documents.

The third stage is the trial operation stage of the quality management system. The fourth stage is continuous improvement and optimization of the process. Enterprises should solve the following problems in establishing a quality management system:

1) Distinguish the difference between manufacturing enterprises and IT enterprises, and clarify the business processes of IT enterprises; (2) Clarify management responsibilities and adjust organizational structure; (3) the process of identifying and establishing a software enterprise; (4) Establish a documented program; (5) Solve the software configuration management and software design change control; (6) Adopt quantitative and statistical techniques to continuously improve the R&D process management of information systems and establish a quality system.

It is good that the quality management system is not only used in manufacturing enterprises, but also in IT service enterprises.

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In accordance with the PDCA process approach, the establishment of a quality management system should focus on addressing the following main issues:

1. Appoint a management representative, responsible for the establishment, operation, maintenance and continuous improvement of the ISO9001 management system, as well as liaison with the consulting body certification body. The management agent should be held by a person with certain management responsibilities within the organization in order to coordinate the work of various departments.

2. Determine the organizational structure, clarify the responsibilities and authority of each functional department and position, especially the responsibility and authority of quality management.

3. Accept training related to ISO9001 (such as basic knowledge training, standard provisions explanation, document preparation method training, internal auditor training, statistical technology training, on-site 5S management training, etc.), so as to deepen the understanding of the standard and facilitate the application of the standard for management in the future.

4. Preparation of ISO9001 quality management system documents: system documents are generally divided into 4 levels, from top to bottom

1) Quality manual: a general description of the composition and basic requirements of the management system, and clarification of the company's quality policy and quality objectives.

2) Procedure documents: the key processes of enterprise management, such as procurement process, production or service process, quality management process, document control process, internal audit process, corrective and preventive measures to implement the control process, business evaluation control process, etc., are stipulated.

3) Work instructions and operating procedures: detailed step descriptions for the specific activities involved in the above key processes, such as equipment operation procedures, inspection procedures, etc., which are important guiding documents for job work.

4) Various quality records**: evidence of the implementation of the above management system documents.

The ISO9001 standard does not stipulate the number of documents, but the system documents prepared should contain at least 1 manual, 6 program documents (which can be fully cited in the manual, not necessarily independently written) and 17 types of quality records (specified in the standard provisions).

5. After the documents are reviewed and released, each department shall operate according to the system documents received and maintain the necessary quality records, which shall be records of continuous and effective operation of the system for more than 3 months according to the regulations.

6. During the operation of the system, before the certification audit, it should be confirmed that all kinds of testing equipment, measuring instruments and pressure vessels have been calibrated and within the effective period of calibration.

7. Confirm whether there are special types of work in the enterprise (welders, electricians, tower cranes, elevator workers, boiler workers, motor vehicle drivers, painters, cooks, etc.), if so, special types of work must be certified to work.

8. Before the certification audit, an internal audit and a management review must be completed, and records must be kept separately.

9. After the preparation is done, you can contact the certification body, submit the system documents for document review, and make an appointment for on-site audit.

It is important to remember that the spirit of ISO9001 is: to meet the requirements of laws and regulations, to meet customer requirements, and to continuously improve; The method of implementing the ISO9001 standard is a 16-word policy: write what I should do, do what I write, remember what I do, and continuous improvement.