41. What is the scope of use of the ISO 9001:2000 standard?
The ISO 9001:2000 standard states: “This standard specifies quality management system requirements for organizations with the following requirements:â€
(1) It is necessary to demonstrate that it has the ability to stably provide products that meet customer and applicable legal and regulatory requirements;
(2) To enhance customer satisfaction through the effective application of the system, including the process of continuous improvement of the system and ensuring compliance with customers and applicable laws and regulations.
The standard also states: “All requirements specified in this standard are generic and are intended to apply to organizations of all types, sizes and offering different products.â€
It can be seen that the “Quality Management System Requirements†defined by the standard are “universalâ€, which is applicable to various organizations and is applicable to all industries or economic fields, as well as to any category of products.
42. Under what circumstances can the “requirements†of the ISO 9001:2000 standard be deleted?
The deletion is limited to those requirements in Chapter 7 of the ISO 9001:2000 standard that do not affect the ability or responsibility of the organization to provide products that meet customer and applicable legal and regulatory requirements. Possible reasons for the deletion:
(1) The nature of the products provided by the organization
If the nature of the product provided by the organization does not require the execution of an activity or the absence of a process, a process can be deleted.
Conversely, if there is a quality activity or process in the nature of the product provided by the organization, then a process cannot be deleted.
(2) Customer requirements and applicable legal and regulatory requirements
The deletion is allowed only if it does not affect the organization's ability to provide product services, and does not exempt from meeting customer requirements or legal and regulatory requirements.
On the contrary, if the customer has corresponding legal and regulatory requirements for the service function of the product and its products, the corresponding quality management system requirements shall not be deleted.
43. What are the general requirements for establishing a quality management system in the ISO 9001:2000 standard?
The establishment of a quality management system requires the formation of documents that must be controlled and implemented and maintained as documented. Continuous improvement refers to “recycling activities that enhance the ability to meet requirementsâ€, that is, continuous improvement and improvement at the original level.
44. How do the organization implement the general requirements of the quality management system?
In order to implement the general requirements of the quality management system, the organization must do the following:
(1) First identify all the processes and applications that the organization needs to establish a quality management system. These processes are closely related to the type and size of the organization and the products produced or the services provided. The organization can use a process-based quality management system model that combines the realities of the organization to identify these processes.
(2) In the process of identifying all processes, the input of a certain process is usually the output of the previous process, and the output of a process is usually the input of the subsequent process. Therefore, it is necessary to reasonably determine the interface and sequence between these processes. And their interactions.
(3) In order to ensure the effective operation and control of these processes and achieve the desired goals and requirements, it is necessary to plan the input, output, resources and activities of the process, make clear provisions, and propose guidelines and methods for process control. Such as XX process control plan, control program, operation method, etc.
(4) In order to support the operation and monitoring of these processes, it is important to ensure that each process has access to the necessary resources (such as human resources, infrastructure and work environment, etc.) and the necessary information (including plans, standards, specifications, drawings, processes, Work instructions, etc.).
(5) Information on the operation of these processes, including the status and results of input activities and outputs, for monitoring, measurement (checking) and analysis.
(6) Implement the necessary corrective, preventive or improvement measures for these processes based on the results of monitoring, measurement and analysis to achieve the results and continuous improvement planned for these processes.
45. What steps should be taken to maintain the implementation of the general requirements of the quality management system?
These steps include:
(1) The top management (general manager) unifies the leadership thinking and determines the progress target of establishing a quality management system;
(2) Establishing the organization's leading leadership team and work team;
(3) Formulate specific work plans for the establishment and implementation of the quality management system according to the time schedule objectives;
(4) Organize all employees to conduct ISO 9000 family standard training in different levels;
(5) Focus on the customer, develop the quality policy of the organization and establish quality objectives at relevant functional departments and levels;
(6) planning the process required for product realization;
(7) Conduct a status survey based on the requirements of the ISO 9001:2000 standard to identify weak links;
(8) Identify the quality activities that should be carried out in each process and sub-process;
(9) Perform quality function allocation;
(10) System (repair) the quality management responsibilities, authorities and mutual relations of each department;
(11) Conducting assessments of quality management responsibilities and responsibilities;
(12) Prepare a quality management system document;
(13) After the quality management system document is reviewed, it shall be approved by the top management (general manager);
(14) Conducting publicity and education on quality management system documents;
(15) Providing and managing human resources, infrastructure, and working environment;
(16) Trial operation according to the established quality management system (more than three months);
(17) Train internal quality management system auditors and be appointed by the factory manager (general manager);
(18) Conduct internal quality management system audits and follow-up of corrective actions (more than one time);
(19) The top management (general manager) personally presides over the management review.
46. ​​What documents are included in the ISO 9001:2000 standard for establishing a quality management system?
There are five types of quality management system documents required by the ISO 9001:2000 standard, namely:
(1) Quality policy and quality objectives for document formation;
(2) Quality Manual;
(3) procedures for documenting;
(4) Organizing the documents required to ensure effective planning, operation and control of their processes;
(5) Records required by the standard.
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