Article 2.4 of ISO 9000:2000 describes the treatment method as follows:
"Any activity or group of activities that use resources to turn input into output can be regarded as a process.
In order to make the organization run effectively, many interrelated and interactive processes must be identified and managed. Usually the output of one process will directly become the input of the next process. Systematically identifying and managing the processes applied in an organization, especially the interaction between these processes, is called' process method' ".
The process method replaces the "20 elements" of ISO 9001:KLOC-0/994, which is embodied in the new structures of ISO 9004:2000 ("Quality Management System-Performance Improvement Guide") and ISO 900 1: 2000 ("Quality Management System-Requirements").
As the basis of the new standard, two of the eight quality management principles are "process method" and "system management method":
Process method: managing activities and related resources as a process can achieve the expected results more efficiently.
Systematic management method: identifying, understanding and managing interrelated processes as a system will help organizations improve the effectiveness and efficiency of achieving their goals.
This guide aims to help users of the new standard ISO 9000:2000 understand the concept and purpose of "process method" related to management. 2. Process methods Process methods strive to achieve a dynamic cycle of continuous improvement, which enables organizations to gain considerable benefits, typically in terms of products, performance, effectiveness, efficiency and cost.
The process method also promotes the organization to pay attention to customers and improve customer satisfaction by identifying the key processes in the organization and the subsequent development and continuous improvement of the processes. The self-assessment method expressed in Appendix A of ISO 9004:2000 can be used to assess the maturity of the process.
The process approach encourages organizations to clearly understand all processes, rather than being limited to those required by the quality management system. A process contains one or more activities that transform input into output. Inputs and outputs are usually tangible and/or intangible products. Input and output can include equipment, material parts, energy, information and financial resources, etc. Appropriate resources should be allocated in order to implement the activities in the process. Measurement systems can be used to collect information and data to analyze process performance and/or input and output characteristics.
Ji O 900 1:2000 requires the organization to identify, implement, manage and continuously improve the effectiveness of the processes required by the quality management system, and manage the interaction of these processes to achieve the organization's goals. These processes include top management, product realization and related support processes, as well as monitoring and measurement processes.
Figure 1 system embodies the implementation of QMS process method. Figure 1- The process method can be evaluated by internal or external review process, and the effectiveness and efficiency of the process can be evaluated according to the maturity ratio. The typical division of maturity ratio is from "no formal system" to "optimal operation level" The advantage of this method is that the results can be continuously recorded and monitored to achieve the improvement goal. Many mature tables have been made for different applications. Appendix A-ISO 9004:2000 self-evaluation guide has such a model. 3. Circulation and treatment methods
PDCA ("plan-do-check-act") is a dynamic cycle, which can be applied in the process of organization (sending a letter to a page on the Internet continuously). It is closely related to the planning, implementation, control and continuous improvement of product realization and other quality management system processes.
By applying PDCA concept at all levels of the organization, process capability can be maintained and continuously improved. PDCA is also applied to high-level strategic processes, such as quality management system planning or management review, and simple operation activities as a product realization process.
The annotation of Article 0.2 of ISO 900 1: 2000 describes the application of PDCA mode in the process as follows:
"P- planning: according to the customer's requirements and the organization's policy, establish the necessary goals and processes for providing results;
D-do: implementation process;
C- inspection: monitoring and measuring the process and products according to the policies, objectives and product requirements, and reporting the results;
Disposal: Take measures to continuously improve process performance. "
The following system reflects the relationship between PDCA and Article 4. 1: 2000 "General Requirements". Fig. Application of PDCA cycle in ISO 90065438 +0: 2000 clause 4. 1. The management of interactive process sometimes the interdependence of organizational activities may be complex, and the links between different processes and sub-processes are networked. The input and output of these processes are related to both external customers and internal customers. Fig. 3 is an example of a network connection of an interactive process. The "systematic management method" takes into account the coordination and compatibility of the processes planned by the organization and the clear definition of process interfaces.
These requirements are applicable to organizations of all types and sizes, and can be met by limiting the processes required for quality management, organically linking them and merging them into a system.
Figure 3 shows that by adding PDCA cycle, management and control can be applied to both a single process and the whole network.
The process network model reflects that customers play an important role in specifying input requirements. Customer satisfaction feedback on process output is the key input in the process of continuous improvement of quality management system. 5. Implement the process method according to the requirements of ISO 900 1: 2000. Article 0.2 in the introduction of ISO 900 1: 2000 reads:
"The application of process method in quality management system emphasizes the importance of the following aspects:
A) Understand and meet the requirements;
B) The process needs to be considered from the perspective of value-added;
C) Obtaining the results of process performance and effectiveness;
D) Continuously improve the process on the basis of objective measurement. "
In ISO 900 1: 2000, the process method includes the process needed for product realization and the process needed for effective implementation of quality management system. The requirements of these processes are described in the following international standard clauses:
◆ 4 Quality management system
◆ 5 Management responsibilities
◆ 6 Resource management
◆ 7 Product realization
◆ 8 Measurement, analysis and improvement
Article 4 of ISO 900 1:2000 stipulates the general requirements of quality management system. In order to solve these needs, here are some organizations that can choose to ask their own guidelines. It should be emphasized that these are just examples and should not be regarded as the only way to meet the requirements.
A) Identify the processes required by the quality management system and its application in the whole organization.
◆ What processes does our QMS need?
◆ Are these processes outsourced?
◆ What are the inputs and outputs of each process?
◆ Who is the customer of the process?
◆ What are the requirements of these customers?
Who is the "owner" of the process?
B) Determine the sequence and interaction of these processes.
◆ What is the general process of our process?
◆ How do we describe this process? (Flowchart or Flowchart? )
◆ What is the interface between processes?
◆ What documents do we need?
C) Determine the criteria and methods needed to ensure the effective operation and control of these processes.
◆ What are the characteristics of the expected and unexpected results of the process?
◆ What are the criteria for monitoring, measurement and analysis?
◆ How do we integrate standards into QMS planning and product realization?
◆ What are the economic problems (cost, time, waste, etc.)? )?
◆ What method is suitable for collecting data?
D) Ensure that necessary resources and information are obtained to support the operation and monitoring of these processes.
◆ What resources are needed for each process?
◆ What is the communication channel?
◆ How can we provide external and internal information about the process?
◆ How do we get feedback?
◆ What information do we need to collect?
◆ What records do we need to keep?
E) Measure, monitor and analyze these processes.
◆ How do we monitor process performance (process capability, customer satisfaction)?
◆ What are the necessary measurements?
◆ How can we analyze the collected information (statistical technology)?
◆ What does analysis tell us?
F) Implement necessary measures to realize the planned results of these processes and the continuous improvement of these processes.
◆ How to improve the process?
◆ What corrective/preventive measures are needed?
◆ Have these corrective/preventive measures been implemented?
◆ Are these measures effective?
6. There are documented processes in the organization, and the initial method should be limited to identifying and managing these processes in the most appropriate way. т 900120000 All procedures required by the quality control system shall be managed according to Article 4. 1 "General Requirements". There is no Table of Contents or process list that must be recorded. Each organization should determine the process that needs to be documented according to its customers, the requirements of applicable laws and regulations, the nature of its activities and the overall business strategy.
When determining the process that should be documented, the organization may be willing to consider some factors, such as:
◆ Influence on quality;
◆ Risk of customer dissatisfaction;
◆ Legal requirements;
◆ Economic risks;
◆ Effectiveness and efficiency.
If it is found that the process needs to be documented, many different methods can be used, such as charts, written instructions, checklists, flowcharts, visual media or spreadsheets.
See ISO/TC 176/SC2/N525R for a guide to the requirements of ISO 900 1: 2000 documents.