What are the steps to establish an ISO quality management system?

According to PDCA process method, the establishment of quality management system should focus on solving the following main problems:

1. Designate the management representative to be responsible for the establishment, operation, maintenance and continuous improvement of the ISO900 1 management system, and contact with consulting institutions/certification bodies. The management organization should be held by people with certain management responsibilities in the organization in order to coordinate the work of various departments.

2, determine the organizational structure, clear responsibilities and authority of various functional departments and positions, especially in quality management.

3. Receive training related to ISO900 1 (such as basic knowledge training, explanation of standard terms, document writing method training, internal auditor training, statistical technology training, on-site 5S management training, etc.). ), so as to deepen the knowledge and understanding of standards, and facilitate the application of standards for management in the future.

4. Prepare ISO900 1 quality management system documents: system documents are generally divided into four levels, from top to bottom:

1) quality manual: generally describe the composition and basic requirements of the management system, and define the quality policy and quality objectives of the enterprise.

2) Procedure document: specifies 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 control process, supplier evaluation control process, etc.

3) Work instruction/operation instruction: it is an important guiding document that describes the specific activities involved in the above key processes in detail, such as the operation instruction and inspection instruction of a certain equipment.

4) Various quality record forms: evidence of the implementation of the above management system documents.

——ISO900 1 standard does not specify the number of documents, but the prepared system documents should at least include 1 manual, 6 program documents (which can be quoted completely in the manual, not necessarily independently compiled) and 17 quality records (which are expressly stipulated in the standard provisions).

5. After the document review and release, all departments shall operate according to the signed system documents, and keep necessary quality records, which shall be the records of continuous and effective operation of the system for more than 3 months according to 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 are within the validity period of calibration.

7. Confirm whether the enterprise has special types of work (welder, electrician, tower crane worker, elevator worker, boiler worker, motor vehicle driver in the factory, painter, chef, etc.). ), if any, special types of work must hold relevant certificates.

8. Internal audit and management review must be completed before certification audit, and records shall be kept separately.

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

It must be remembered that the spirit of ISO900 1 lies in: meeting the requirements of laws and regulations, meeting the requirements of customers and continuous improvement; The way to implement ISO900 1 standard is 16: write what I should do, do what I write, remember what I do and keep improving.