From: China Quality Certification Author: Wang Weidong [2003/09/24]
November 13th to 17th, 2000, China Quality System Certification Body State Accreditation (CNACR) invited ISO / TC176 / SC2 / WG18 / TG1.9 "Standard Conversion" Working Group Leader Nigel CROFT to visit, held A series of academic exchange activities. The following is some of our awareness we have formed in this academic activity, for 2,000 version of the ISO 9000 standard user research, to update the concept, pioneering ideas, and effectively do a good job in the new version of the standard conversion. I. Correct understanding of the specific method of meeting the requirements of standard terms and the different types of diversity of diversity organizations, the industry is not the same, and the needs of their customers are characterized, the target market is also very different, this determines the organization The products provided are also rich and colorful. On the other hand, in the process of organizing their own survival and development, it identified its own business purposes, forming their own business management characteristics and organizational culture, and different organizations also have characteristics in technology and resources. These objective conditions determine that the organization is in the process of ensuring that the product meets the requirements and enhances the degree of customer satisfaction, and the specific way to control the process is also characterized. It is based on the above considerations, ISO 9001: 2000 standards only propose requirements for the organization's quality management system, and give organizational's adequate flexibility in how to meet standard requirements, there is no uniform to meet the specific methods and pathways of these requirements. For example, a management consulting company provides training courses for strategic management. The company can train existing consultants to be able to compete for this work needs; you can also recruit the ability to be able to submit this work to external agencies or personnel. The company can integrated customers' requirements, existing human resources, and cost-made factors, choose appropriate ways to provide effective training services for customers. In ISO 9001: 2000, such as "File Requirements" (4.2.1), "Human Resources" (6.2) on how to satisfy people's ability, "Planning of Products" (7 This idea is clearly reflected in the form of operation of the organizational operation in the output form of the required planning. Therefore, in the process of establishing, implementing and improving the quality management system, it should not be in the form, but should use appropriate ways and control methods to ensure effectiveness, according to their actual situation, according to their actual situation, will use appropriate ways and control to organize The daily operation is organically combined to make the quality management system have increased value to the organization. During the review process, auditors should have more open ideas. Under the premise of organizing effectiveness, including achieving predetermined goals and in accordance with the requirements of laws and regulations, we should fully respect the specific choices of the organization, try to avoid your subjective will (including "best methods" in your mind) to the company. . On the other hand, in a few days of review, in-depth understanding of the actual situation behind the organization, it is generally difficult. The auditor determines that specific solutions may have appropriate risks for specific solutions, and in the process of certification is not allowed. Therefore, auditors need to confirm whether the method and extent of the organization can ensure that the process meets the requirements and is effective.
In particular, ISO 9001: 2000 standards mentioned in the case of "necessary" (for example, 4.2.3 b)) or "appropriate" (for example, 7.3.7), organize some activities, Meet the standard requirements, this requires the auditor to judge whether it is necessary and appropriate. Second, the correct understanding and use "process method" With the increasing steps of organizational management and technical progress, the market demand is increasingly changing, the competition between organizations is also increasingly fierce. This requires organizations to meet the changes in the market more accurate and faster than ever, meet customers' needs and expectations. Traditional management (especially large organizations) based on functional (sectors), often due to the barriers between the sectors and too many management levels, it is easy to cause information about customers and products that cannot be delivered quickly and accurately. It is caused to see work performance from the perspective of this department, and ignore the consideration of customers, products, and processes, affecting the overall performance of the organization. Process management method provides a solution to the organization, it helps to eliminate barriers between functions (departments) and management levels, so that organizations can be more close to market and customers, accurately grasp customer demand and expectations, Make the delivery of information more quickly and respond quickly to market changes. For example, a credit card company is divided into three departments such as members raised, member qualification review, payment payment. In order to do a lot of time and fund collection list, the member's raised department spent a lot of time and capital collection, the application will be reviewed by the membership review department. For the member qualification review department, the most concerned is whether the applicant will have problems in the future, so a lot of time and energy is desperately investigated, collect information, brushing any people who may have problems. As a result, from the perspective of the customer, the beginning of the description of the description will be induced, and then "the credit is not enough" is rejected, of course very angry, which directly affects the satisfaction of the customer, I am afraid that he will never be with this later. Corporate deal. From the company, one is to lose the customer. Second, the more "loyal" duty, the greater the company's overall waste, the lower the overall efficiency. If the process method can be used, the membership will be reviewed to the membership, that is, each person will take the entire process of recruitment and even decide whether to accept the work of members. If the merged work still requires a few people to take a team, a team can be established by the team membership, with a job from head to tail, and accompanied by a database, work guidance. In doing so, the time and funds caused by the handover between the department can eliminate the waste of funds and other mistakes, eliminating the disadvantages of the works between the department mutual offset, making the workflow are greatly shortened, the work responsibility is clear, the efficiency is improved, the management cost is lowered and won Customer satisfaction. Therefore, organizational should identify key processes in the quality management system according to the needs of themselves, identify the products provided by the products provided by the customer's needs and expectations. For example, for property management companies, its services include security, cleaning, facility maintenance, green, and residents' living services. The detailed process identification and determination should be considered from the actual situation of the organization, from the perspective of ensuring process and system effectiveness and product compliance. Usually, the process is related to the input and output, and the input of a process may come from several processes, and the output of a process may provide input for several processes. The "Service Features and Specification Design Process" of Property Management "is the information input for its" service providing process ", and the input of" standardized design process "is from" quality objectives "," Measurement of customer satisfaction "," Customer Requirements "," Resource Management "Process Output.
Therefore, the input and output of the relevant process are the key to the order and interaction between the identification process. Based on the process of identifying the process required by the quality management system, the organization may also find some non-value processes, and it is necessary to delete; it may also be found to adjust the relative order and interface relationship between the procedure, and even merge. On the other hand, it may be necessary to adjust the existing organization, such as reducing management level, merging functions, etc. to suit the need for process effectiveness and improve process efficiency. Therefore, when organizing the quality management system, the planning of functional allocation and organizational structure settings is critical in accordance with the process. In addition, organizations should be considered to avoid pastting-related standards and individuals to partition to sectoral and individuals to ignore from the procedure of the relevant standards (elements) as responsives and individuals to ignore the compliance with standards. The responsibility of the department and individual is to correspond to the activities undertaken in the process, and the enterprise should identify the relevant activities of a specific process and the standard requirements for the relevant activities of a specific process, and combine these requirements with specific activities. In implementing the responsibilities of the relevant functions, the implementation of the standard can effectively improve the effectiveness and efficiency of the process. ISO 9001: 2000 4.1 Quality Management System "General Requirements" reflect the quality management principles of "process methods" and PDCA methods for all processes, organizations should plan the quality management system in accordance with this request. It is suggested that this requires this requirement to provide a comprehensive evaluation of organizational quality management system in internal audit management. The auditor should be familiar with the organization's business process (including the input and output of the process). In accordance with the organization's business process, the planning and implementation of the audit should be carried out, confirming the management of activities in the specific process (including the planning, implementation and control of the relevant requirements for the applicable requirements), and according to ISO 9001: 2000 4.1 As a guiding ideology for comprehensive evaluation of the enterprise quality management system. It should be based on the idea of the PDCA cycle, pay attention to the effectiveness of process results and the system. This is very beneficial for ensuring the depth of the audit. For new standards, the method of implementing auditing in accordance with the provisions may not apply, some implementation and results of the functions related to management responsibilities, resources, etc. in ISO 9001: 2000 may include / reflect the business process in the organization ( For example, internal communication). This requires the auditor to make judgments based on the evidence observed throughout the audit process. In this case, the specific review time of these terms may not be appropriate in the audit plan. Third, the role of correct understanding of the document is somewhat, the role of program files is to ensure the repetitability and consistency of the process, and the role of the record is to confirm the product, the process meets the requirements, and the quality management system is effectively operated. Therefore, like other tools (such as a computer) employed, the file is only a tool for ensuring the expected result of the process. The preparation file is not the ultimate purpose of the organization, and the value of the file should be brought to the process of using the process to ensure the effectiveness and efficiency of the process. It is recommended that organizations in establishing, implementing, implementing effective planning, implementation and control, etc. in the process of the process, considering the detailed extent of whether to prepare documents and documents. It should be avoided to prepare only files to cope with certification, or moving other organizations, even for the convenience of file compilation, and human changing process and other errors. Otherwise, the file is not a tool, which has become a "shackle". The number of documents and detailed sorry should be based on the size of the organization and the complexity of the business type, the process and its interaction, and the ability of personnel.
For example, for a noodle museum with only two people, if the two people have consistent concepts for the fabrication process of noodles, they can be consistent, and they can be consistent during the production process, they do not need to prepare related procedures. file. Regarding the quality manual, it is recommended to organize the development of its own business type and characteristics to avoid the "dead control" of the standards, as the coverage standard requires not only the quality manual. For small organizations, the quality management system is described in a quality manual, including the program file required by the ISO 9001: 2000 standard, may be sufficient. For large multinational organizations, there may be multi-quality manuals and more complex file systems in the region, national and global levels. In addition, it should be noted that do not take the standard terms or slightly change the standard terms in the quality manual. If the quality policy of the organization can reflect the adaptation to its purpose, it can provide a framework for quality objectives, and in quality policy, it is not necessary to re-need to meet the requirements and continuous improvement of quality management system validity. The text of the "Supreme Administrator should ensure the quality policy: a), b), c). The auditor should not require the organization's quality manual to correspond to the provisions of the standards; at the same time, it should also be paid to a variety of forms of evidence to meet the requirements, not just records. The evaluation of the number of documents and the degree of intensity of the organization should not be terminated from the perspective of ensuring the effectiveness of the process. In short, regardless of the organization or auditor, the focus should be the validity of customers, products, and processes, not program files and records. Fourth, combined with the "design and development" and outsourced processes, correctly understand the terms of ISO 9001: 2000, we are used to link design and development and tangible products, while design and development also apply to services . When the organization and auditors apply to the design and development, the organization and the development of "design and development" definitions are determined in accordance with the definition of "design and development" in ISO 9000: 2000, and pay special attention to service products, avoid the design and development of misunderstandings that are not applicable to service products. . For example, for a bus company, before operating a new route, you need to consider the needs and expectations of passengers on ride comfort, running line, station setting position and environment, waiting time. Therefore, the organization needs to design new bus lines, and transform the needs of passengers into specific service characteristics and specifications, such as the specific location of the station and environmental requirements, the type of vehicle and the time interval of the departure. In principle, the company should have product design and development process as long as it involves product characteristics or norms to translate customer demand and expectation. The organization should overcome the fear of design and development process. In fact, the intensity of design and development processes depends on factors such as the products and companies that are responsible for design and development. For example, an organization is not responsible for the original product design and development process, but may be responsible for the implementation of product specifications or product characteristics. In this case, although the requirements of 7.3 in ISO 9001: 2000 cannot be cut as a whole, some submarkets may not apply. In the case of the organization's negative responsibility for the product, if you organize a subcontracting or outsourcing, such as the design and development, manufacturing or monitoring of the product, does not become an organization in quality management The full reason for deleting these processes in the system. Because the organization needs to be comprehensive and responsible for these processes, you must confirm that you can press the ISO 9001: 2000 requirements to fully control these processes. Organizations should clarify the quality management system to cover these subcontracting or outsourcing activities in the quality manual and any other public document, and will have a negative responsibility for these activities.
