How to Implement ISO9001 quality management system certification

How to Implement ISO9001 quality management system certification
Quality management system certification is a strategic decision of the Organization based on ISO9000 standards. The ISO9000 standard is an international quality management standard that summarizes the quality management experience of all countries in the world, especially developed countries. It reflects the world's advanced quality management ideas, for example, with the customer as the focus, the application of PDCA cycle to continuously improve the product quality characteristics and effectiveness of the system, emphasizing people-oriented, emphasize that the role of leadership is to determine the purpose and direction of the organization and create an internal environment that enables employees to fully participate in the implementation of the quality policy and purpose of the organization. Although the ISO9000 family standard is a basic management standard, it is still a revolution for Chinese organizations and requires the leaders of the organization to make up their minds and participate in it in person, the organization establishes a quality management system in accordance with the ISO9001 standard for quality certification. Generally, the work can be carried out in the following stages:
1. Quality Management System Planning Stage
(1) Training first
Establishing a sound system is a process that begins with education and finally education. All personnel related to the formation of Product Quality Should Have customer awareness education, continuous improvement awareness education, and carry out relevant duty training. The training can be distributed to the following layers:
Leadership: (including middle-level leaders) The leadership personnel should have a certain understanding of the standard and need to understand the development of management ideas, especially the understanding of the role of leadership. They must know what work they should participate in, how to plan the system;
Backbone of the system: including document writing personnel and internal auditors, should accurately master the standards and requirements, have certain management experience and level of text, and master the review skills and methods;
Operator: Combine the publicity and implementation of system documents to clarify the responsibilities of the post (how to do it, how to compile documents, records, etc.) and the relevant work and importance of the post.
(2) establish an organization for implementing certification
All aspects of the standard design organization should be designated. For example, if a lead group headed by the top management personnel is set up, the management representative should be entrusted with the establishment and implementation of the specific responsible system, and offices should also be set up when necessary.
(3) develop a work plan for standardized certification
2. System Design Stage
(1) First, the Organization should determine the positioning in the market, that is, to determine the product and customer, to determine the business purposes that are compatible with the product, and to reflect the commitment to the customer, commitment to continuous improvement and appropriate quality policies and objectives;
(2) determine the processes required to achieve the quality policy and objectives, including the process's responsibilities, required resources, and control methods;
(3) determine the scope of the system (reasonable deletion may be made based on the standards );
(4) Clarify the quality responsibilities, permissions and relationships of all departments and personnel at all levels.
3. Preparation of system documents
(1) Guiding Ideology: organizations need to establish a documented system, rather than just a systematic document. Compiling System documents is not an aim, but a means. Through the document, develop the method, and then run the test according to the document, which is conducive to the implementation, maintenance and improvement of the system. Therefore, the methods and details of system documents must be combined with the Organization Scale, product complexity, and personnel quality.
(2) sort out and analyze existing management files, and keep them as effective as possible.
(3) formulate the planning and preparation plans for preparing system documents.
(4) Review, sign-up, and approve documents in accordance with regulations, especially those prior to approval, and organize relevant departments to seriously discuss the inconsistency. An agreement should be reached through negotiation.
4. system operation and evaluation
(1) A system document Implementation mobilization meeting can be held to attract the attention of all employees, followed by extensive and in-depth Hierarchical Training;
(2) after three months of operation, an Internal Audit and Management Review should be conducted, and the system should be self-diagnosed and self-evaluated. When the system operation enters normal and effective, the certification center can send an audit team for on-site review (the certification contract can be signed after the system design stage and product scope are determined ).
Organizations can hire consultants from consulting institutions for guidance. Consultation should begin with the Organization's training and system planning, and end with the on-site review by the certification authority.
5. Continuous Improvement of the System
Once the organization is successfully certified, it indicates that the Organization's operation of the system basically meets the requirements of ISO9000 Quality Management. There are no major unqualified items, but there are also some general unqualified items. While continuing to implement system regulations, we must constantly discover and improve problems. In the daily operation of the system, the Organization's standards must be continuously reviewed and improved in strict accordance with the standard requirements, in order to continuously improve the organization's operating system and improve the effectiveness of the Organization's operation.