GB/T 19000--2000
This standard is equivalent to ISO9000:2000 "Fundamentals and Vocabulary of Quality Management Systems". This standard is one of the GB/T19000 family of standards. "Shall" in the standard indicates requirements, and "should" only serves as a guide.
Due to the difference between the two languages, the terms 3.1.5 capability and 3.9.12 competence are both translated as "capability", but their definitions are different. In the GB/T19000 family of standards, the term 3.1.5 capability refers specifically to the "capability" of an organization, system or process, while 3.9.12 competence refers specifically to the "capability" of a person. The "Notes" added below some definitions are additional information provided to users of the English version of the international standard (such as the "Note" in 3.2.6, the "Note 2" in 3.6.1, the "Note" in 3.6.13 and the "Note 2" in 3.7.2). In order to adopt the international standards equivalently, this standard still retains these contents.
This standard has made technical revisions to GB/T6583-1994, so when this standard is released, it replaces GB/T6583-1994. Appendix A of this standard is a prompt appendix.
This standard is proposed and managed by the National Technical Committee for Standardization of Quality Management and Quality Assurance (CSBTS/T C151). This standard was drafted by the China Standards Research Center. The drafting units of this standard are: China Standards Research Center, China National Accreditation Service for Conformity Assessment, Shanghai Standardization Research Institute, 708th Institute of China Aerospace Science and Technology Group, China Classification Society, Shenzhen ZTE Corporation, China Tianchen Chemical Engineering Corporation, and China New Era Quality System Certification Center.
The main drafters of this standard are: Li Jing, Xu Yougang, Lu Guanxin, Guo Ruixia, Gu Zuofu, Li Su, Qiao Yuesheng, Zheng Yan. 3
GB/T19000—2000
ISOForeword
The International Organization for Standardization (ISO) is a worldwide federation composed of national standardization bodies (ISO member bodies). The work of formulating international standards is usually completed by ISO's technical committees. If each member body is interested in a project established by a technical committee, it has the right to participate in the work of the committee. International organizations (official or unofficial) that maintain contact with ISO may also participate in the relevant work. In the field of electrotechnical standardization, ISO maintains a close cooperative relationship with the International Electrotechnical Commission (IEC). International standards are drafted in accordance with the rules of Part 3 of the ISO/IEC Directives. The draft international standards adopted by the technical committee are submitted to the member bodies for voting. They must obtain the consent of at least 75% of the member bodies participating in the voting before they can be officially published as international standards. Some of the contents of this standard may involve some patent rights issues, which should be noted. ISO is not responsible for identifying any such patent issues.
ISO 9000 was prepared by Technical Committee ISO/TC 176/SC 1, Quality Management and Quality Assurance, Subcommittee on Concepts and Terminology. This standard replaces ISO 8402:1994.
Annex A of this standard is an informative appendix only, which provides a diagram of the relationships between terms in a specific conceptual area related to quality management systems.
GB/T 19000—2000
0.1 General
The following standards in the GB/T 19000 family can help organizations of all types and sizes to implement and operate an effective quality management system. These standards include:
GB/T 19000 describes the basics of quality management systems and defines the terminology of quality management systems; - GB/T 19001 defines the requirements of quality management systems to demonstrate the ability of an organization to provide products that meet customer requirements and applicable regulatory requirements, with the goal of improving customer satisfaction; GB/T 19004 provides guidance on both the effectiveness and efficiency of quality management systems. The purpose of this standard is to improve organizational performance and satisfy customers and other stakeholders; -GB/T19011 provides guidelines for auditing quality and environmental management systems. The above standards together constitute a group of closely related quality management system standards to promote mutual understanding in domestic and international trade. 0.2 Principles of quality management
In order to successfully lead and operate an organization, it is necessary to adopt a systematic and transparent approach to management. The implementation and maintenance of a management system that continuously improves its performance in response to the needs of all stakeholders can make the organization successful. Quality management is one of the management contents of the organization. Eight quality management principles have been confirmed, and the top management can use these principles to lead the organization to improve performance: a) Customer focus
The organization depends on customers. Therefore, the organization should understand the current and future needs of customers, meet customer requirements and strive to exceed customer expectations. b) Leadership
Leaders establish the unified purpose and direction of the organization. They should create and maintain an internal environment that enables employees to fully participate in achieving organizational goals.
c) Full participation
People at all levels are the foundation of the organization. Only with their full participation can their talents bring benefits to the organization. d) Process approach
Managing activities and related resources as processes can achieve the desired results more efficiently. e) System approach to management
Identifying, understanding and managing interrelated processes as a system can help organizations improve the effectiveness and efficiency of achieving their goals. f) Continuous improvement
Continuous improvement of overall performance should be an eternal goal of the organization. g) Fact-based decision-making method
Effective decision-making is based on data and information analysis. h) Mutually beneficial relationship with suppliers
Organizations and suppliers are interdependent, and mutually beneficial relationships can enhance the ability of both parties to create value. These eight quality management principles form the basis of the GB/T19000 family of quality management system standards. 5
1 Scope
National Standard of the People's Republic of China
Quality management system
Fundamentals and vocabulary
Quality management systems -
Fundamentals and vocabulary
GB/T 19000--2000
idt ISO 9000:2000
Replaces GB/T6583--1994
This standard describes the foundations of quality management systems in the GB/T19000 family of standards and defines the relevant terminology. This standard applies to: a) organizations seeking advantages through the implementation of a quality management system; b) organizations seeking confidence in suppliers who can meet their product requirements; c) users of products
d) people who need to reach a consensus on the terms used in quality management (e.g. suppliers, customers, administrative enforcement agencies); e) internal or external personnel and organizations who evaluate the quality management system of an organization or audit its compliance with the requirements of GB/T19001 (e.g. auditors, administrative enforcement agencies, certification (registration) bodies); f) internal or external personnel who make recommendations or provide training on the quality management system of an organization; g) personnel who develop relevant standards.
2 Basics of quality management system
2.1 Theoretical description of quality management system
Quality management system can help organizations enhance customer satisfaction. Customers require products to have characteristics that meet their needs and expectations, which are expressed in product specifications and are collectively summarized as customer requirements. Customer requirements can be stipulated by customers in a contract or determined by the organization itself. In either case, the customer ultimately determines whether the product is acceptable. Because customer needs and expectations are constantly changing, as well as competitive pressures and technological developments, these all drive organizations to continuously improve products and processes.
The quality management system approach encourages organizations to analyze customer requirements, specify related processes, and keep them under continuous control to achieve products that customers can accept. The quality management system can provide a framework for continuous improvement to increase the chances of customer and other interested parties being satisfied. The quality management system also provides confidence to the organization and its customers that the organization can provide products that continue to meet requirements. 2.2 Quality Management System Requirements and Product Requirements The GB/T19000 family of standards distinguishes between quality management system requirements and product requirements. GB/T19001 specifies quality management system requirements. Quality management system requirements are universal and apply to all industries or economic sectors, regardless of the type of products they provide. GB/T19001 itself does not specify product requirements. Product requirements may be specified by customers, or by organizations through anticipating customer requirements, or by regulations. In some cases, product requirements and related process requirements may be included in requirements such as technical specifications, product standards, process standards, contractual agreements and regulatory requirements. 2.3 Quality Management System Methods
The methods for establishing and implementing a quality management system include the following steps: a) Determine the needs and expectations of customers and other interested parties; b) Establish the organization's quality policy and quality objectives; c) Determine the processes and responsibilities necessary to achieve quality objectives; State Administration of Quality and Technical Supervision Approved on December 28, 2000 6
2001-06-01 Implementation
GB/T19000--2000
d) Determine and provide the resources necessary to achieve quality objectives; e) Specify methods for measuring the effectiveness and efficiency of each process; f) Apply these measurement methods to determine the effectiveness and efficiency of each process: g) Determine measures to prevent nonconformities and eliminate their causes; h) Establish and apply processes for continuous improvement of the quality management system. The above methods are also applicable to maintaining and improving existing quality management systems. Organizations that adopt the above methods can build confidence in their process capabilities and product quality, provide a basis for continuous improvement, and thus enhance customer and other interested party satisfaction and make the organization successful. 2.4 Process approach
Any activity or group of activities that uses resources to transform inputs into outputs can be considered a process. In order for an organization to operate effectively, many interrelated and interacting processes must be identified and managed. Usually, the output of a process will directly become the input of the next process. Systematically identifying and managing the processes applied by an organization, especially the interactions between these processes, is called the "process approach".
This standard encourages the use of a process approach to manage organizations. The process-based quality management system model described by the GB/T19000 family of standards is shown in Figure 1. The figure shows that stakeholders play an important role in providing inputs to the organization. Monitoring the satisfaction of stakeholders requires evaluating information about the feelings of stakeholders, which can indicate the extent to which their needs and expectations have been met. The model in Figure 1 does not show more detailed processes. Continuous improvement of the quality management system
Management responsibilities
Customers and
Other relevant
Resource management
Value-added activities
Information flow
Note: The statements in brackets are not applicable to GB/T19001. Product
Measurement,
Analysis and improvement
Figure 1 Process-based quality management system model 2.5 Quality policy and quality objectives
Customers (and
other relevant
Establishing quality policy and quality objectives provides a focus for the organization. Both determine the expected results and help the organization use its resources to achieve these results. The quality policy provides a framework for establishing and reviewing quality objectives. Quality objectives need to be consistent with the quality policy and commitment to continual improvement, and their achievement must be measurable. The achievement of quality objectives has a positive impact on product quality, operational effectiveness and financial performance, and therefore has a positive impact on the satisfaction and trust of stakeholders. 2.6 The role of top management in the quality management system7
GB/T 19000—2000
Top management, through its leadership and through various actions, can create an environment in which employees are fully involved and in which the quality management system can operate effectively. Top management can use the principles of quality management (see 0.2) as the basis for the following roles: a) Establish and maintain the organization's quality policy and quality objectives; b) Promote the achievement of the quality policy and quality objectives throughout the organization by enhancing employee awareness, motivation and involvement; c) Ensure that the entire organization is focused on customer requirements; d) Ensure that appropriate processes are implemented to meet customer and other interested party requirements and achieve quality objectives; e) Ensure that an effective quality management system is established, implemented and maintained to achieve these quality objectives; f) Ensure that necessary resources are available; g) Review the quality management system regularly; h) Decide on actions related to the quality policy and quality objectives; i) Decide on actions to improve the quality management system. 2.7 Documents
2.7.1 The value of documents
Documents can communicate intentions and unify actions. Their use helps: a) meet customer requirements and improve quality;
b) provide appropriate training;
c) repeatability and traceability;
d) provide objective evidence:
e) evaluate the effectiveness and continued suitability of the quality management system. The formation of documents is not an end in itself, it should be a value-added activity. 2.7.2 Types of documents used in the quality management system The following types of documents are used in the quality management system: a) Documents that provide consistent information about the quality management system to the organization and to the outside world. Such documents are called quality manuals. b) Documents that describe how the quality management system applies to a specific product, project or contract. Such documents are called quality plans. c) Documents that state requirements. Such documents are called specifications. d) Documents that state recommended methods or suggestions. Such documents are called guidelines. e) Documents that provide information on how activities and processes are to be performed consistently. Such documents include documented procedures, work instructions and drawings. f) Documents that provide objective evidence of activities performed or results achieved. Such documents are called records. Each organization determines the amount and level of detail of the documents it needs and the media to be used. This depends on factors such as the type and size of the organization, the complexity and interaction of processes, the complexity of the product, customer requirements, applicable regulatory requirements, demonstrated competence of personnel and the degree of demonstration required to meet the requirements of the quality management system. 2.8 Quality Management System Evaluation
2.8.1 Evaluation of Quality Management System Processes
When evaluating a quality management system, the following four basic questions should be asked for each process being evaluated: a) Is the process identified and appropriately defined? b) Are responsibilities assigned?
c) Are procedures implemented and maintained?
d) Are processes effective in achieving the required results? The answers to the above questions can determine the evaluation results. Quality management system evaluations, such as quality management system audits and quality management system reviews and self-assessments, can vary in scope and can include many activities. 2.8.2 Quality Management System Audits
Audits are used to determine the extent of conformity to quality management system requirements. Audit findings are used to assess the effectiveness of the quality management system and identify opportunities for improvement.
GB/T 19000--2000
First-party audits are conducted for internal purposes by the organization itself or on its behalf and can serve as the basis for the organization's self-declaration of conformity. Second-party audits are conducted by the organization's customers or by others on their behalf. Third-party audits are conducted by external independent organizations. Such organizations are usually accredited and provide certification or registration that meets the requirements of (e.g., GB/T19001).
ISO19011 provides audit guidance.
2.8.3 Quality Management System Review
One of the tasks of top management is to regularly and systematically evaluate the suitability, adequacy, effectiveness and efficiency of the quality management system in relation to the quality policy and quality objectives. Such reviews may include consideration of the need to revise the quality policy and quality objectives in response to changes in the needs and expectations of interested parties. The review includes determining the need for action. Audit reports are used together with other sources of information in the review of the quality management system. 2.8.4 Self-assessment
Self-assessment of an organization is a comprehensive and systematic review of its activities and results with reference to a quality management system or model of excellence.
Self-assessment provides an overall measure of the organization's performance and the maturity of its quality management system. It also helps to identify areas for improvement in the organization and to prioritize actions. 2.9 Continuous Improvement
The purpose of continuous improvement of the quality management system is to increase the chances of customer and other interested parties being satisfied. Improvement includes the following activities: a) Analyze and evaluate the current situation to identify areas for improvement; b) Determine improvement objectives,
c) Find possible solutions to achieve these objectives; d) Evaluate these solutions and make a selection; e) Implement the selected solution;
f) Test, verify, analyze and evaluate the results of implementation to determine that these objectives have been achieved, g) Formalize the changes.
When necessary, the results are reviewed to identify opportunities for further improvement. In this sense, improvement is a continuous activity. Feedback from customers and other interested parties as well as audits and reviews of the quality management system can be used to identify opportunities for improvement. 2.10 The role of statistical techniques
The application of statistical techniques can help organizations understand variation, thereby helping organizations solve problems and improve effectiveness and efficiency. These techniques also help to make better use of available data for decision-making. Variation can be observed in the states and results of many activities, even under apparently stable conditions. This variation can be observed through measurable characteristics of products and processes, and can be seen at all stages of the product's life cycle (from market research to customer service and final disposal).
Statistical techniques can help measure, describe, analyze, explain and build models for such variations, even when data is relatively limited. Statistical analysis of this data can help to better understand the nature, extent and causes of variation. This helps to solve or even prevent problems caused by variation and promote continuous improvement. GB/Z19027 provides guidance on statistical techniques in quality management systems. 2.11 Focus of quality management system and other management systems The quality management system is part of the organization's management system, which is committed to making the results related to quality objectives appropriately meet the needs, expectations and requirements of stakeholders. The quality objectives of an organization complement other objectives, such as growth, capital, profit, environment, and occupational health and safety. The various parts of an organization's management system, together with the quality management system, can be integrated into a whole, thus forming a single management system that uses common elements. This will facilitate planning, resource allocation, determining complementary objectives and evaluating the overall effectiveness of the organization. The management system of an organization can be evaluated against its requirements, or audited against national standards such as GB/T19001 and GB/T24001-1996. These audits can be conducted separately or in combination. 2.12 Relationship between quality management system and excellent model The quality management system methods proposed by the GB/T19000 family of standards and the organizational excellent model are based on common principles. They both: a) enable the organization to identify its strengths and weaknesses, b) contain provisions for evaluation against common models; c) provide a basis for continuous improvement; d) contain provisions for external recognition.
The difference between the GB/T19000 family of quality management systems and the best practices is their scope of application. The GB/T19000 family of standards sets out the requirements for a quality management system and performance improvement guidelines, and the quality management system evaluation can determine whether these requirements are met. The best practices contain criteria that can be used to compare the performance of an organization and can be applied to all activities and all stakeholders of the organization. The best practices evaluation criteria provide a basis for comparing the performance of an organization with that of other organizations. 3 Terms and definitions
Terms defined in this chapter, if they appear in other definitions or notes, will be indicated in boldface and followed by the original term number in brackets. Such terms in boldface can be replaced by their full definitions. For example: product (3.4.2) is defined as "the result of a process (3.4.1)". Process is defined as "a set of interrelated or interacting activities that transform inputs into outputs". If the term "process" is replaced by its definition: product becomes "the result of a set of interrelated or interacting activities that transform inputs into outputs". For concepts that are limited to a specific meaning in a specific context, the scope of application is indicated in angle brackets <) before the definition. For example: technical expert <audit> (3.9.11).
3.1 Terms related to quality
3.1.1 Quality
The degree to which a group of inherent characteristics (3.5.1) meets a requirement (3.1.2) Note 1 to entry: The term “quality” may be qualified by adjectives such as poor, good or excellent. Note 2 to entry: “Inherent” (the antonym of “ascribed”) means a characteristic that is inherent in something or something, especially one that is permanent. 3.1.2 Requirement
A need or expectation that is stated, generally implied or obligatory Note 1 to entry: “Generally implied” means that the need or expectation in question is implicit in the usual practice or general conduct of the organization (3.3.1), customers (3.3.5) and other interested parties (3.3.7).
Note 2: Specific requirements may be indicated by the use of qualifiers, such as product requirements, quality management requirements, customer requirements. Note 3: A stated requirement is an explicit requirement, for example, one that is stated in a document (3.7.2). Note 4: Requirements may be stated by different interested parties. 3.1.3 Grade
Classification or classification of products (3.4.2), processes (3.4.1) or systems (3.2.1) that have the same functional purpose but different quality requirements (3.1.2)
Example: Classification of cabins in aircraft and classes of hotels. Note 1: Grades are usually specified when quality requirements are specified. 3.1.4 Customer satisfaction customer's perception of the extent to which their requirements (3.1.2) have been met Note 1: Customer satisfaction is the most common way of expressing low satisfaction, but the absence of satisfaction does not necessarily mean that the customer is satisfied. Note 2: Even if stated customer requirements meet customer wishes and are met, this does not necessarily ensure customer satisfaction. 3.1.5 capability capability
GB/T 19000—2000
The ability of an organization (3.3.1), system (3.2.1) or process (3.4.1) to achieve a product (3.4.2) that meets requirements (3.1.2) Note 1 to entry: IS3534-2 defines the term process capability in the statistical context. 3.2 Terms related to management
3.2.1 system
group of interrelated or interacting elements
3.2.2 management system management system a system (3.2.1) for establishing policies and objectives and for achieving those objectives Note 1 to entry: The management system of an organization (3.3.1) may include several different management systems, such as a quality management system (3.2.3), a financial management system or an environmental management system.
www.bzxz.net3.2.3 quality management system quality management system management system (3.2.2) that directs and controls an organization (3.3.1) with respect to quality (3.1.1) 3.2.4 quality policy quality policy overall purpose and direction for quality (3.1.1) of an organization (3.3.1) formally issued by its top management (3.2.7) Note 1 to entry: The quality policy is usually consistent with the overall policy of the organization and provides a framework for the development of quality objectives (3.2.5). Note 2 to entry: The quality management principles set out in this International Standard can be used as a basis for the development of a quality policy (see 0.2). 3.2.5 quality objective: purpose pursued with respect to quality (3.1.1) Note 1 to entry: Quality objectives are usually set in accordance with the organization's quality policy (3.2.4). Note 2 to entry: Quality objectives are usually set for relevant functions and levels of the organization (3.3.1). 3.2.6 management management
the coordinated activities of directing and controlling an organization (3.3.1) NOTE In English, the term "management" sometimes refers to people, that is, a person or group of people with the capacity and authority to direct and control an organization. When "management" is used in this sense, it should be accompanied by some qualifier to avoid confusion with the concept defined in the above definition of "management". For example, it is not recommended to use "management shall." Instead, "top management (3.2.7) shall." 3.2.7 top management - a person or group of people who directs and controls an organization (3.3.1) at the highest level 3.2.8 quality management quality management directing and controlling the coordinated activities of an organization (3.3.1) with respect to quality (3.1.1) Note to entry: Directing and controlling activities with respect to quality typically include the establishment of the quality policy (3.2.4) and quality objectives (3.2.5) as well as quality planning (3.2.9), quality control (3.2.10), quality assurance (3.2.11) and quality improvement (3.2.12). 3.2.9 quality planning part of quality management (3.2.8) devoted to establishing quality objectives (3.2.5) and specifying the necessary operating processes (3.4.1) and related resources to achieve the quality objectives Note to entry: Preparation of quality plans (3.7.5) can be part of quality planning. 3.2.10 quality control quality control quality management (3.2.9).part of quality management (3.2.8) focused on meeting quality requirements (3.1.2) 3.2.11 quality assurance quality assurance part of quality management (3.2.8) focused on providing confidence that quality requirements (3.1.2) will be met 3.2.12 quality improvement quality improvement part of quality management (3.2.8) focused on enhancing the ability to meet quality requirements (3.1.2) Note 1 to entry: Requirements can relate to any aspect, such as effectiveness (3.2.14), efficiency (3.2.15) or traceability (3.5.4). 3.2.13 continual improvement a cyclic activity that enhances the ability to meet requirements (3.1.2) Note 1 to entry: The process (3.4.1) of establishing objectives for improvement and seeking opportunities for improvement is a continual process that uses audit findings (3.9.5) and audit conclusions (3.9.6), analysis of data, management review (3.8.7), or other methods, and its results typically lead to corrective action (3.6.5) or preventive action (3.6.4). 3.2.14 effectiveness effectiveness the extent to which planned activities are performed and planned results are achieved 3.2.15 efficiency efficiency
the relationship between the results achieved and the resources used 3.3 Terms relating to organization
3.3.1 organization organization
a group of people and facilities in which responsibilities, authorities and relationships are arranged Example: company, group, firm, enterprise, research institute, charity, agency, association or part or combination of these. Note 1 to entry: The arrangement is usually ordered.
Note 2: An organization may be public or private. Note 3: This definition applies to the quality management system (3.2.3) standard. The term "organization" is defined differently in ISO/IEC Guide 2. 3.3.2 organizational structure organizational structure an arrangement of responsibilities, authorities and relationships of people Note 1 to entry: The arrangement is usually ordered.
Note 2 to entry: A formal statement of the organizational structure is normally provided in the quality manual (3.7.4) or in the quality plan (3.7.5) for an item (3.4.3). Note 3 to entry: The scope of the organizational structure may include interfaces with external organizations (3.3.1). 3.3.3 infrastructure
the system of facilities, equipment and services necessary for the operation of the organization (3.3.1) 3.3.4 work environment work environment set of conditions in which work takes place
Note 2 to entry: A formal statement of the organizational structure is normally provided in the quality manual (3.7.4) or in the quality plan (3.7.5) for an item (3.4.3). Note 3 to entry: The scope of the organizational structure may include interfaces with external organizations (3.3.1). 3.3.3 infrastructure
the system of facilities, equipment and services necessary for the operation of the organization (3.3.1) 3.3.4 work environment work environment set of conditions in which work takes place
Note 3 to entry: Conditions include physical, social, psychological and environmental factors (such as temperature, accommodation, ergonomics and atmospheric composition). 3.3.5 customer
the organization (3.3.1) or individual who receives the product (3.4.2). Examples include consumers, clients, end users, retailers, beneficiaries and purchasers. Note 3 to entry: A customer can be internal or external to the organization. 3.3.6 supplier supplier an organization (3.3.1) or individual that provides products (3.4.2) examples include a manufacturer, wholesaler, retailer or vendor of products, provider of services or information. Note 1 to entry: A supplier can be internal or external to the organization. Note 2 to entry: In a contractual situation a supplier is sometimes referred to as a “contractor”. 3.3.7 interested party an individual or group that has an interest in the performance or success of an organization (3.3.1). Examples include a customer (3.3.5), owner, employees, suppliers (3.3.6), bank, union, partners or society. Note 2 to entry: A group can consist of an organization or part of it or of several organizations. 3.4 Terms relating to process and product 3.4.1 process a set of interrelated or interacting activities that transform inputs into outputs Note 1 to entry: The inputs to a process are typically the outputs of other processes. Note 2 to entry: An organization (3.3.1) typically plans and operates processes under controlled conditions to add value. Note 3 to entry: Processes for which it is not easy or economical to verify whether the resulting product (3.4.2) is qualified (3.6.1) are usually referred to as "special processes". 3.4.2 Product product
Result of a process (3.4.1)
Note 1: There are four general categories of products: services (e.g. transport),
software (e.g. computer programs, dictionaries); hardware (e.g. engine mechanical parts);
process materials (e.g. lubricants).
GB/T 19000--2000
Many products are made up of products of different categories, and the distinction between services, software, hardware or process materials depends on the dominant component. For example, the externally supplied product "car" is made up of hardware (e.g. tires), process materials (e.g. fuel, coolant), software (e.g. engine control software, driver's manual) and services (e.g. operating instructions given by the salesperson). Note 2 to entry: A service is generally intangible and is the result of at least one activity performed at the interface between the supplier (3.3.6) and the customer (3.3.5). The provision of a service may involve, for example:
activities performed on a tangible product provided by the customer (e.g. a car being repaired);
activities performed on an intangible product provided by the customer (e.g. an income statement required to prepare a tax return); the delivery of an intangible product (e.g. the provision of information for knowledge transfer); the creation of an atmosphere for the customer (e.g. in hotels and restaurants). Software consists of information, is generally an intangible product and may take the form of a method, paper or procedure (3.4.5). Hardware is generally a tangible product whose quantity is of a countable nature (3.5.1). Process materials are generally tangible products whose quantity is of a continuous nature. Hardware and process materials are often referred to as goods. Note 3 to entry: Quality assurance (3.2.11) is primarily concerned with the intended product. 3.4.3 Project
A unique process (3.4.1) consisting of a set of coordinated, controlled activities with start and end dates that achieves objectives that meet specified requirements (3.1.2) including time, cost and resource constraints. Note 1: A single project can be a component of a larger project structure. Note 2: In some projects, as the project progresses, its objectives need to be revised or redefined, and product characteristics (3.5.1) need to be gradually determined. Note 3: The result of a project can be a single or multiple products (3.4.2). Note 4: Adapted from GB/T19016-2000. 3.4.4 design and development design and development set of processes (3.4.1) that transforms requirements (3.1.2) into specified characteristics (3.5.1) or specifications (3.7.3) of a product (3.4.2), process (3.4.1) or system (3.2.1)
Note 1 to entry: The terms “design” and “development” are sometimes used synonymously and are sometimes used to specify different stages of an overall design and development process. Note 2 to entry: The nature of design and development may be indicated by a qualifier (e.g. product design and development or process design and development). 3.4.5 procedure
a specified way of carrying out an activity or process (3.4.1) Note 1 to entry: A procedure may or may not be documented. Note 2 to entry: When a procedure is documented, it is often referred to as a “written procedure” or “documented procedure”. The document (3.7.2) containing the procedure may be referred to as a “procedure document”. 3.5 Terms related to characteristics 3.5.1 characteristic characteristic distinguishing feature NOTE 1 A characteristic can be inherent or imparted. NOTE 2 A characteristic can be qualitative or quantitative. NOTE 3 There are various categories of characteristics, such as physical (e.g. mechanical, electrical, chemical or biological); sensory (e.g. membrane, touch, taste, vision, hearing), behavioural (e.g. politeness, honesty, truthfulness); temporal (e.g. punctuality, reliability, availability); ergonomic (e.g. physiological properties or those related to personal safety), functional (e.g. maximum speed of an aircraft). 3.5.2 quality characteristic quality characteristic an inherent characteristic (3.5.2) of a product (3.4.2), process (3.4.1) or system (3.2.1) that is related to a requirement (3.1.2).1) 13
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Note 1: "Inherent" means something that is inherent in something, especially a permanent characteristic. Note 2: The attributes given to a product, process or system (e.g. the price of a product, the owner of a product) are not their quality characteristics. 3.5.3 Dependability
Collective term used to describe availability and its influencing factors (reliability, maintainability and supportability) Note: Dependability is only used for non-quantitative overall statements. [IEC 60050-191:1990].
3.5.4 Traceability
The ability to trace the history, application or location of an object Note 1: When considering products (3.4.2), traceability may relate to: the origin of raw materials and components; the history of the processing process, the distribution and location of the product after delivery.
Note 2: In the field of metrology, the definition in VIM: 1993, 6.10 is used. 3.6 Terms related to conformity
3.6.1 Conformity
Meeting requirements (3.1.2)
Note 1 This definition is consistent with ISO/IEC Guide 2, but there are differences in the wording. Its purpose is to comply with the concepts of GB/T 19000. NOTE 2 The term "conformance" is synonymous but is not used. 3.6.2 Nonconformity Failure to meet a requirement (3.1.2)
3.6.3 Defect
Failure to meet a requirement related to the intended or specified use (3.1.2) NOTE 1 It is important to distinguish between the concepts of defect and nonconformity (3.6.2) because they have legal connotations, particularly in relation to product liability issues. Therefore, the term "defect" should be used with caution.
NOTE 2 The intended use desired by the customer (3.3.5) may be influenced by the content of information provided by the supplier (3.3.6), such as operating or maintenance instructions provided. 3.6.4 Preventive action action action taken to eliminate the cause of a potential nonconformity (3.6.2) or other potential undesirable situation Note 1 to entry: A potential nonconformity can have several causes. Note 2 to entry: Preventive action is taken to prevent occurrence, while corrective action (3.6.5) is taken to prevent recurrence. 3.6.5 Corrective action corrective action action taken to eliminate the cause of a detected nonconformity (3.6.2) or other undesirable situation Note 1 to entry: A nonconformity can have several causes. Note 2 to entry: Corrective action is taken to prevent recurrence, while preventive action (3.6.4) is taken to prevent occurrence. Note 3 to entry: A correction (3.6.6) is distinguished from corrective action. 3.6.6 correction correction action taken to eliminate a detected nonconformity (3.6.2) Note 1 to entry: A correction can be taken in conjunction with corrective action (3.6.5) Note 2 to entry: Rework (3.6.7) or downgrading (3.6.8) are examples of a correction. 3.6.7 rework
action taken on a nonconforming product (3.4.2) to make it conform to requirements (3.1.2) Note: Rework is different from repair. Repair (3.6.9) may affect or change certain parts of the nonconforming product. 3.6.8 regrade
change the grade (3.1.3) of a nonconforming product (3.4.2) to make it conform to requirements (3.1.2) different from the original ones 3.6.9 repair
action taken on a nonconforming product (3.4.2) to make it fit for its intended use 14
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