Software engineering - Guidelines for the application of ISO 9001:2000 to computer software
Some standard content:
ICS03.120.10
National Standard of the People's Republic of China
GB/T19000—2008/IS09000.2005 replaces GB/T19000-2000
Quality management systems---Fundamentals and terminology vocabulary(ISO9000:2005,IDT)
2008-10-29Release
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaStandardization Administration of the People's Republic of China
2009-05-01Implementation
Basics of quality management system
Theoretical description of quality management system
Quality management system requirements and product requirements
Quality management system approach
Process approach
Quality policy and quality objectives
The role of top management in the quality management systemDocument
Quality management system evaluation
Continuous improvement
The role of statistical techniques·
The focus of the quality management system and other management systems…The relationship between the quality management system and the excellence model·3 Terms and definitions||t t||Terms related to quality
Terms related to management
Terms related to organization
Terms related to process and product
Terms related to characteristics
Terms related to conformity
Terms related to documents
3.8 Terms related to inspection
3.9 Terms related to audit
Terms related to quality management of measurement processes
Appendix A (informative) Definitions of terms in the standard Methods used References
Chinese index
English index
GB/T19000—2008/ISO9000:200513
GB/T19000--2008/ISO9000:2005This standard is equivalent to ISO9000:2005 "Quality management system fundamentals and vocabulary". This standard is one of the core standards of GB/T19000 family. This standard replaces GB/T19000-2000 "Fundamentals and Vocabulary of Quality Management System". Compared with GB/T19000-2000, the main changes of this standard are as follows: In terms of basic knowledge, the text has been carefully considered to express the intention of this standard more accurately; a)
Three new terms have been added. They are: contract (3.3.8), audit plan (3.9.12), audit scope (3.9.13); b)
Some original terms have been adjusted in terms of text or arrangement position; c)
d) In order to distinguish different capabilities, Note 2 is added after term 3.1.6. Appendix A of this standard is an informative appendix.
This standard is proposed and managed by the National Technical Committee for Standardization of Quality Management and Quality Assurance (SAC/TC151). The drafting units of this standard are: China National Institute of Standardization, China National Accreditation Service for Conformity Assessment, China Quality Certification Center, China Building Materials Inspection and Certification Center, Fangyuan Mark Certification Group Co., Ltd., Beijing Solvis Enterprise Management Consulting Center, Shenzhen Huantong Certification Center. The main drafters of this standard are: Li Jing, Gu Yanjun, Shi Xinbo, Li Jie, Shi Xinyong, Liang Ping, Wang Haidong, Qu Xintian. The previous versions of the standards replaced by this standard are: GB6583.1-1986, GB/T6583-1992, GB/T6583-1994, GB/T19000-2000 (the content of GB/T19000.11994 is merged. At the same time, this standard is cancelled). GB/T19000-2008/ISO9000:20050.1 General Principles
The GB/T19000 family of standards can help organizations of all types and sizes to establish and operate effective quality management systems. These standards include:
-GB/T19000, which describes the basic knowledge of quality management system and specifies the terminology of quality management system; -GB/T19001, which specifies the requirements of quality management system, which is used to prove that the organization has the ability to provide products that meet customer requirements and applicable regulatory requirements, and is specifically aimed at improving customer satisfaction; -GB/T19004, which provides guidelines for considering the effectiveness and efficiency of quality management system. The purpose of this standard is to improve the performance of the organization and achieve customer and other interested parties' satisfaction; -GB/T19011, which 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 Quality Management Principles
Successfully leading and operating an organization requires management in a systematic and transparent manner. An organization can be successful by implementing and maintaining a management system that continuously improves its performance in response to the needs of all interested parties. Quality management is one of the management contents of an organization. The eight quality management principles proposed in this standard are identified as guiding principles for top management to lead the organization to improve performance. a) Customer Focus
Organizations depend on customers. Therefore, organizations should understand the current and future needs of customers, meet customer requirements and strive to exceed customer expectations.
Leadership
Leaders should ensure that the organization's day and direction are consistent. They should create and maintain a good internal environment so that employees can fully participate in the activities to achieve organizational goals.
c) Full Employee Participation
People at all levels are the foundation of the organization. Only with their full participation can they use their talents for the benefit of the organization. d)
Process Approach
Managing activities and related resources as processes can achieve the desired results more efficiently. System Approach to Management
Viewing, understanding and managing interrelated processes as a system helps organizations improve the effectiveness and efficiency of achieving their goals. f)
Continuous Improvement
Continuous improvement of overall performance should be the eternal goal of the organization. Fact-based Decision-making Approach
Effective decision-making is based on data and information analysis. Mutually beneficial relationship with suppliers
Organizations and suppliers are interdependent, and mutually beneficial relationships can enhance the ability of both parties to create value. The above eight quality management principles form the basis of the GB/T19000 family of quality management system standards. 1 Scope
Quality management system
GB/T19000—2008/IS09000:2005 Foundations and terms
This standard describes the foundation of the quality management system that constitutes the main content of the GB/T19000 family of standards and defines related terms. This standard applies to:
Organizations seeking advantages through the implementation of a quality management system; a)
Organizations seeking confidence that suppliers can meet their product requirements b)
Users of products;
People and organizations that need to reach a consensus on the terms used in quality management (e.g. suppliers, customers, regulatory agencies); internal or external people and organizations that evaluate the quality management system of an organization or audit its compliance with the requirements of GB/T19001 (e.g. auditors, regulatory agencies, certification bodies); f
Internal or external people and organizations that make recommendations or provide training on the quality management system of an organization; g) People who develop relevant standards.
2 Foundations of quality management system
2.1 Theoretical description of quality management system
Quality management system can help organizations improve customer satisfaction. Customers require products to have characteristics that meet their needs and expectations, which are expressed in product specifications and are collectively referred to as customer requirements. Customer requirements can be specified by the customer in a contract or determined by the organization itself. In either case, the customer ultimately determines whether a product is acceptable. Because customer needs and expectations are constantly changing, as well as competitive pressures and technological developments, organizations are driven to continually improve their products and processes.
The quality management system approach encourages organizations to analyze customer requirements, define related processes, and continually control them to achieve products that are acceptable to the customer. The quality management system can provide a framework for continual improvement to increase the organization's chances of achieving customer and other interested party satisfaction. The quality management system can also provide confidence in the organization and its customers that products will continue to meet requirements. 2.2 Quality Management System Requirements and Product Requirements GB/T19000 family of standards distinguishes between quality management system requirements and product requirements. GB/T19001 specifies quality management system requirements, which are universal and applicable 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. Product requirements are sometimes included in technical specifications, product standards, process standards, contractual agreements and regulatory requirements together with related process 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; determine the processes and responsibilities necessary to achieve quality objectives; determine and provide the resources necessary to achieve quality objectives; specify methods for measuring the effectiveness and efficiency of each process: apply these measurement methods to determine the effectiveness and efficiency of each process: determine measures to prevent nonconformities and eliminate their causes; establish and apply processes for continuous improvement of the quality management system. GB/T19000—2008/ISO9000:2005The above methods are also applicable to maintaining and improving the existing quality management system. Organizations that adopt the above methods can build confidence in their process capabilities and product quality, provide a basis for continuous improvement, thereby enhancing customer and other interested parties' satisfaction and making 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 used by an organization, especially the interactions between these processes, is called a "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 interested parties play an important role in providing inputs to the organization. Monitoring the satisfaction of interested parties requires evaluating information about the feelings of interested parties, 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 interested parties)
Legend:
Value-added activities
Information flow
Note: Statements in brackets do not apply to GB/T 19001. Product
Measurement, analysis
and improvement
Figure 1 Process-based quality management system model 2.5 Quality policy and quality objectives
Customers (and
other interested parties)
The establishment of a quality policy and quality objectives provides the organization with a focus. Both define the desired results and help the organization use its resources to achieve those results. The quality policy provides a framework for establishing and reviewing quality objectives. Quality objectives need to be consistent with the quality policy and the commitment to continual improvement, and their achievement needs to 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 system Top management, through its leadership and practical actions, can create an environment in which employees are fully involved and the quality management system can operate effectively. Top management can use the principles of quality management (see 0.2) as the basis for performing the following roles: a) formulate and maintain the organization's quality policy and quality objectives; b) enhance employee awareness, motivation and involvement by promoting the quality policy and quality objectives throughout the organization;
ensure that the entire organization focuses on customer requirements;
GB/T19000-2008/ISO9000:2005
ensure the implementation of appropriate processes to meet customer and other interested party requirements and achieve quality objectives; ensure the establishment, implementation and maintenance of an effective and efficient quality management system to achieve these quality objectives; e)
ensure the availability of necessary resources;
g) review the quality management system regularly;
decide on measures related to the quality policy and quality objectives; decide on measures to improve the quality management system. i)
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;
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: Documents that provide information about the conformity of the quality management system to the organization and to external parties. Such documents are called quality manuals: a) Documents that describe how the quality management system applies to a specific product, project or contract. Such documents are called quality plans; b) Documents that state requirements. Such documents are called specifications; c) Documents that state recommended practices or suggestions. Such documents are called guidelines; d) Documents that provide information to enable processes to be performed consistently. Such documents include documented procedures, work instructions and drawings; f) Documents that provide objective evidence of activities performed or results obtained. 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, four basic questions should be asked of each process being evaluated: a) Are the processes identified and appropriately defined? b) Are responsibilities assigned?
c) Are the procedures implemented and maintained?
d) Are the processes effective in achieving the required results? The answers to the above questions will determine the evaluation results. Quality management system evaluation can be carried out at different scales through a range of activities, such as auditing and reviewing the quality management system and self-assessment. 2.8.2 Quality Management System Audits
Audits are used to determine the extent of conformity to the requirements of the quality management system. Audit findings are used to assess the effectiveness of the quality management system and to identify opportunities for improvement.
First-party audits are conducted by the organization itself or on its behalf for internal purposes and may 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 its behalf. 3
GB/T19000—2008/ISO9000:2005 Third-party audits are conducted by external independent organizations. Such organizations are usually accredited and provide certification that meets requirements (such as GB/T19001).
GB/T19011 provides audit guidelines.
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 against the quality policy and quality objectives. Such reviews may include considering whether the quality policy and quality objectives need to be modified in response to changes in the needs and expectations of stakeholders. The review includes determining whether measures need to be taken. The audit report is used together with other information sources for the review of the quality management system. 2.8.4 Self-assessment
The self-assessment of an organization is a comprehensive and systematic review of the organization's activities and results with reference to a quality management system or excellence model.
Self-assessment can provide a comprehensive picture of the organization's performance and the maturity of the quality management system. It also helps in identifying areas for improvement in the organization and setting priorities for work to be done.2.9 Continuous Improvement
The purpose of continuous improvement of the quality management system is to increase the organization's chances of achieving improved customer and other interested party satisfaction. Improvement includes the following activities:
a) Analyze and evaluate the current situation to identify areas for improvement;
determine improvement objectives;
find possible solutions to achieve these objectives; evaluate these solutions and make a selection;
implement the selected solution;
f) measure, verify, analyze and evaluate the results of implementation to determine that these objectives have been achieved;
formally adopt 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 helps to understand variation, which can help 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 operation and results of many processes, even under apparently stable conditions. This variation can be observed through measurable characteristics of products and processes, and can also be seen at different 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 this variation, even when data is relatively limited. Statistical analysis of this data can help to better understand the nature, extent and causes of variation, thereby helping to solve or even prevent problems caused by variation and promote continuous improvement. GB/Z19027 gives 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 achieving results related to quality objectives. When appropriate, meet the needs, expectations and requirements of interested parties. The organization's quality objectives complement other objectives, such as growth, financing, profitability, environment and occupational health and safety. Several management systems of an organization can be integrated with the quality management system into an integrated management system using common elements. This will facilitate planning, resource allocation, determination of complementary objectives and evaluation of the overall effectiveness of the organization. The organization's management system can be evaluated against its requirements or audited against the requirements of national standards such as GB/T19001 and GB/T24001. These audits can be conducted separately or in combination.
2.12 Relationship between quality management system and excellence model GB/T19000-2008/ISO9000:2005
The quality management system approaches proposed by the GB/T19000 family of standards and the organizational excellence model are based on common principles. They both: enable an organization to identify its strengths and weaknesses; a)
contain provisions for evaluation against a common model; provide a basis for continuous improvement;
d) contain provisions for external recognition.
The difference between the GB/T19000 family of quality management system approaches and the excellence model is their different scope of application. The GB/T19000 family of standards proposes quality management system requirements and performance improvement guidelines. The quality management system evaluation can determine whether these requirements are met. The Excellence Model contains criteria that enable comparative evaluation of organizational performance and can be applied to all activities and all stakeholders of the organization. The Excellence Model 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 expressed in bold and the original term number will be indicated in brackets after them. Such terms expressed in bold can be replaced by their complete definitions. For example: Product (3.4.2) is defined as "the result of 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, the product becomes "the result of a set of interrelated or interacting activities that transform inputs into outputs". For concepts that are limited to specific meanings in specific situations, the applicable scope is indicated in angle brackets before the definition. Example: In the terminology related to auditing, the entry for technical experts is: 3.9.11
Technical expertstechnical expert
(audit> a person who provides specific knowledge or skills to the audit team (3.9.10) Note: The terms in this clause are grouped according to different topics. The relationship between different terms in the same group can be found in the concept map in Appendix A. 3.1 Terms related to quality
Quality
The degree to which a set of inherent characteristics (3.5.1) meets requirements (3.1.2) Note 1 to entry: The term "quality" can be modified by adjectives such as; poor, good or excellent. Note 2 to entry: "Inherent" (the antonym of "endowed") means a characteristic that is already present, especially one that is permanent. 3.1.2
Requirement
A need or expectation that is stated, generally implied or must be fulfilled Note 1 to entry: "Generally implied\ refers to the custom or general practice of the organization (3.3.1), customers (3.3.5) and other interested parties (3.3.7), and the need or expectation under consideration is self-evident.||tt| |NOTE 2: Specific requirements may be indicated by qualifiers, such as product requirements, quality management requirements, customer requirements. NOTE 3: Specified requirements are requirements that are stated, such as those stated in a document (3.7.2). NOTE 4: Requirements may be raised by different interested parties (3.3.7). NOTE 5: This definition differs from the definition given in 3.12.1 of ISO/IEC Directives, Part 2:2004, which states that 3.12.1
requirement
a clause expressing criteria to be followed
grade
a classification or grading of different quality requirements for a product (3.4.2), process (3.4.1) or system (3.2.1) with the same functional purpose. Example: aircraft cabin classes and hotel grade classification. 5
GB/T19000—2008/ISO9000:2005 NOTE: In defining quality requirements, grades are usually specified. 3.1.4
customer satisfaction
customer satisfaction
customer’s perception of the degree to which their requirements (3.1.2) have been met Note 1 to entry: Customer disappointment is the most common way of expressing a low level of satisfaction, but the absence of disappointment 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
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: The term process capability in the statistical context is defined in ISO 3358. 3.1.6
competence
the demonstrated ability to apply knowledge and skills Note 1 to entry: In this International Standard, the concept of competence is defined in a general sense. In other ISO documents, the term may be used more specifically. Note 2 to entry: In the GB/T 19000 family of standards, the term capability (3.1.5) refers specifically to the "capability" of an organization, system or process, while competence (3.1.6) refers specifically to the "capability" of personnel. 3.2 Terms related to management
System
system
A group of interrelated or interacting elements 3.2.2
managementsystem
Management system
A system for establishing policies and objectives and achieving those objectives (3.2.1) Note 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.
Quality management systemqualitymanagementsystemthe management system (3.2.2) that directs and controls the organization (3.3.1) with respect to quality (3.1.1)3.2.4
Quality policyqualitypolicy
The overall intention and direction regarding quality (3.1.1) formally issued by the top management (3.2.7) of the organization (3.3.1)Note 1: The quality policy is usually consistent with the overall policy of the organization and provides a framework for setting quality objectives (3.2.5).Note 2: The quality management principles presented in this International Standard can be used as the basis for the development of a quality policy (see 0.2). 3.2.5
quality objective qualityobjective
the purpose pursued in terms of quality (3.1.1) Note 1 to entry: Quality objectives are normally set in relation to the organization's quality policy (3.2.4). Note 2 to entry: Quality objectives are normally set for the 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 1 to entry: In English, the term "management" sometimes refers to people, i.e. a person or group of people with the responsibility and authority to direct and control an organization. Whenever "management" is used in this sense, some qualifier should be attached to avoid confusion with the concept identified in the definition of "management" above. For example, the use of "managementshall...." is not recommended and "topmanagement (3.2.7)shall...." should be used instead. 6
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
GB/T19000—2008/IS09000:2005 The coordinated activities of an organization (3.3.1) in terms of quality (3.1.1) Note: Directing and controlling activities in terms of quality typically include establishing quality policies (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 qualityplanning
Part of quality management (3.2.8) dedicated 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: Preparation of quality plans (3.7.5) can be part of quality planning 3.2.10
qualitycontrol
quality control
part of quality management (3.2.8) focused on meeting quality requirements 3.2.11
quality assurance
quality assurance
part of quality management (3.2.8) focused on providing confidence that quality requirements will be met 3.2.12
qualityimprovement
part of quality management (3.2.8) focused on enhancing the ability to meet quality requirements NOTE 1 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
Continuous improvement
a cyclic activity that enhances the ability to meet requirements (3.1.2) NOTE The process (3.4.1) of establishing objectives and identifying 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 typically results in 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
The relationship between the results achieved and the resources used 3.3 Terms relating to organization
Organization
A group of people and facilities with arranged responsibilities, authorities and relationships Examples: company, group, firm, enterprise, research institute, charity, agency, society or parts or combinations of these. Note 1 to entry: An arrangement is usually ordered.
Note 2: An organization may be public or private. Note 3 to entry: This definition applies to quality management systems (3.2.3) standards. The term “organization” is defined differently in ISO/IEC Guide 2. 3.3.2
organizational structure
Organizational structure
The arrangement of responsibilities, authorities and relationships of personnel7
GB/T19000—2008/IS09000:2005Note 1, The arrangement is usually ordered.
Note 2: A formal statement of the organizational structure is usually provided in the quality manual (3.7.4) or the quality plan (3.7.5) of the project (3.4.3). Note 3: The scope of the organizational structure may include relevant interfaces with external organizations (3.3.1). 3.3.3
Infrastructureinfrastructure
《Organization》Facilities, equipment and services necessary for the operation of the organization (3.3.1) system (3.2.1)3.3.4
work environment
workenvironment
the set of conditions in which work is performed
Note: Conditions include physical, social, psychological and environmental factors (such as temperature, mode of reception, ergonomics and atmospheric composition). 3.3.5
customercustomer
the organization (3.3.1) or individual who receives the product (3.4.2). Examples: consumer, client, end-user, retailer, beneficiary and purchaser. Note: Customers can be internal or external to the organization. 3.3.6
suppliersupplier organization (3.3.1) or person that supplies products (3.4.2) Examples: manufacturer, wholesaler, retailer or dealer 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 called a "contractor". 3.3.7
interestedparty
A person or group that has an interest in the performance or achievements of an organization (3.3.1). Examples: customer (3.3.5), owner, employee, supplier (3.3.6), bank, union, partner or society. Note 3 to entry: A group can consist of an organization or part of it or of more than one organization. 3.3.8
Contract ontract
binding agreement
Note: The concept of contract defined in this International Standard is general. In other ISO documents, the use of this vocabulary may be more specific. 3.4 Terms relating to process and product
process
a set of interrelated or interacting activities that transform inputs into outputs Note 1 to entry: The inputs to a process are often the outputs of other processes. Note 2 to entry: An organization (3.3.1) normally plans and operates processes under controlled conditions in order to add value. Note 3 to entry: Processes for which conformity (3.6.1) of the resulting product (3.4.2) cannot be easily or economically verified are often referred to as “special processes”. 3.4.2
productproduct
result of a process (3.4.1)
Note 1 to entry: 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).8
Quality managementqualitymanagement
GB/T19000—2008/IS09000:2005Directing and controlling the coordinated activities of an organization (3.3.1) with respect to quality (3.1.1)Note: Directing and controlling activities with respect to quality typically include the development of 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 planningqualityplanning
Part of quality management (3.2.8), dedicated 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: Preparation of quality plans (3.7.5) can be part of quality planning. 3.2.10
qualitycontrol
quality control
part of quality management (3.2.8) focused on meeting quality requirements 3.2.11
quality assurance
quality assurance
part of quality management (3.2.8) focused on providing confidence that quality requirements will be met 3.2.12
qualityimprovement
part of quality management (3.2.8) focused on enhancing the ability to meet quality requirements NOTE 1 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
Continuous improvement
a cyclic activity that enhances the ability to meet requirements (3.1.2) NOTE The process (3.4.1) of establishing objectives and identifying 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 typically results in 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
The relationship between the results achieved and the resources used 3.3 Terms relating to organization
Organization
A group of people and facilities with arranged responsibilities, authorities and relationships Examples: company, group, firm, enterprise, research institute, charity, agency, society or parts or combinations of these. Note 1 to entry: An arrangement is usually ordered.
Note 2: An organization may be public or private. Note 3 to entry: This definition applies to quality management systems (3.2.3) standards. The term “organization” is defined differently in ISO/IEC Guide 2. 3.3.2
organizational structure
Organizational structure
The arrangement of responsibilities, authorities and relationships of personnel7
GB/T19000—2008/IS09000:2005Note 1, The arrangement is usually ordered.
Note 2: A formal statement of the organizational structure is usually provided in the quality manual (3.7.4) or the quality plan (3.7.5) of the project (3.4.3). Note 3: The scope of the organizational structure may include relevant interfaces with external organizations (3.3.1). 3.3.3
Infrastructureinfrastructure
《Organization》Facilities, equipment and services necessary for the operation of the organization (3.3.1) system (3.2.1)3.3.4
work environment
workenvironment
the set of conditions in which work is performedbzxz.net
Note: Conditions include physical, social, psychological and environmental factors (such as temperature, mode of reception, ergonomics and atmospheric composition). 3.3.5
customercustomer
the organization (3.3.1) or individual who receives the product (3.4.2). Examples: consumer, client, end-user, retailer, beneficiary and purchaser. Note: Customers can be internal or external to the organization. 3.3.6
suppliersupplier organization (3.3.1) or person that supplies products (3.4.2) Examples: manufacturer, wholesaler, retailer or dealer 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 called a "contractor". 3.3.7
interestedparty
A person or group that has an interest in the performance or achievements of an organization (3.3.1). Examples: customer (3.3.5), owner, employee, supplier (3.3.6), bank, union, partner or society. Note 3 to entry: A group can consist of an organization or part of it or of more than one organization. 3.3.8
Contract ontract
binding agreement
Note: The concept of contract defined in this International Standard is general. In other ISO documents, the use of this vocabulary may be more specific. 3.4 Terms relating to process and product
process
a set of interrelated or interacting activities that transform inputs into outputs Note 1 to entry: The inputs to a process are often the outputs of other processes. Note 2 to entry: An organization (3.3.1) normally plans and operates processes under controlled conditions in order to add value. Note 3 to entry: Processes for which conformity (3.6.1) of the resulting product (3.4.2) cannot be easily or economically verified are often referred to as “special processes”. 3.4.2
productproduct
result of a process (3.4.1)
Note 1 to entry: 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).8
Quality managementqualitymanagement
GB/T19000—2008/IS09000:2005Directing and controlling the coordinated activities of an organization (3.3.1) with respect to quality (3.1.1)Note: Directing and controlling activities with respect to quality typically include the development of 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 planningqualityplanning
Part of quality management (3.2.8), dedicated 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: Preparation of quality plans (3.7.5) can be part of quality planning. 3.2.10
qualitycontrol
quality control
part of quality management (3.2.8) focused on meeting quality requirements 3.2.11
quality assurance
quality assurance
part of quality management (3.2.8) focused on providing confidence that quality requirements will be met 3.2.12
qualityimprovement
part of quality management (3.2.8) focused on enhancing the ability to meet quality requirements NOTE 1 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
Continuous improvement
a cyclic activity that enhances the ability to meet requirements (3.1.2) NOTE The process (3.4.1) of establishing objectives and identifying 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 typically results in 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
The relationship between the results achieved and the resources used 3.3 Terms relating to organization
Organization
A group of people and facilities with arranged responsibilities, authorities and relationships Examples: company, group, firm, enterprise, research institute, charity, agency, society or parts or combinations of these. Note 1 to entry: An arrangement is usually ordered.
Note 2: An organization may be public or private. Note 3 to entry: This definition applies to quality management systems (3.2.3) standards. The term “organization” is defined differently in ISO/IEC Guide 2. 3.3.2
organizational structure
Organizational structure
The arrangement of responsibilities, authorities and relationships of personnel7
GB/T19000—2008/IS09000:2005Note 1, The arrangement is usually ordered.
Note 2: A formal statement of the organizational structure is usually provided in the quality manual (3.7.4) or the quality plan (3.7.5) of the project (3.4.3). Note 3: The scope of the organizational structure may include relevant interfaces with external organizations (3.3.1). 3.3.3
Infrastructureinfrastructure
《Organization》Facilities, equipment and services necessary for the operation of the organization (3.3.1) system (3.2.1)3.3.4
work environment
workenvironment
the set of conditions in which work is performed
Note: Conditions include physical, social, psychological and environmental factors (such as temperature, mode of reception, ergonomics and atmospheric composition). 3.3.5
customercustomer
the organization (3.3.1) or individual who receives the product (3.4.2). Examples: consumer, client, end-user, retailer, beneficiary and purchaser. Note: Customers can be internal or external to the organization. 3.3.6
suppliersupplier organization (3.3.1) or person that supplies products (3.4.2) Examples: manufacturer, wholesaler, retailer or dealer 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 called a "contractor". 3.3.7
interestedparty
A person or group that has an interest in the performance or achievements of an organization (3.3.1). Examples: customer (3.3.5), owner, employee, supplier (3.3.6), bank, union, partner or society. Note 3 to entry: A group can consist of an organization or part of it or of more than one organization. 3.3.8
Contract ontract
binding agreement
Note: The concept of contract defined in this International Standard is general. In other ISO documents, the use of this vocabulary may be more specific. 3.4 Terms relating to process and product
process
a set of interrelated or interacting activities that transform inputs into outputs Note 1 to entry: The inputs to a process are often the outputs of other processes. Note 2 to entry: An organization (3.3.1) normally plans and operates processes under controlled conditions in order to add value. Note 3 to entry: Processes for which conformity (3.6.1) of the resulting product (3.4.2) cannot be easily or economically verified are often referred to as “special processes”. 3.4.2
productproduct
result of a process (3.4.1)
Note 1 to entry: 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).15
Efficiency
The relationship between the results obtained and the resources used 3.3 Terms related to organization
Organization
A group of people and facilities with arranged responsibilities, authorities and relationships. Examples: company, group, firm, enterprise, institution, research institute, charity, agency, society or part or combination of these. Note 1 to entry: The arrangement is usually ordered.
Note 2: An organization can be public or private. Note 3 to entry: This definition applies to quality management systems (3.2.3) standards. The term "organization" has a different definition in ISO/IEC Guide 2. 3.3.2
organizational structure
Organizational structure
The arrangement of responsibilities, authorities and relationships of personnel7
GB/T19000—2008/IS09000:2005Note 1, The arrangement is usually ordered.
Note 2: A formal statement of the organizational structure is usually provided in the quality manual (3.7.4) or the quality plan (3.7.5) of the project (3.4.3). Note 3: The scope of the organizational structure may include relevant interfaces with external organizations (3.3.1). 3.3.3
Infrastructureinfrastructure
《Organization》Facilities, equipment and services necessary for the operation of the organization (3.3.1) system (3.2.1)3.3.4
work environment
workenvironment
the set of conditions in which work is performed
Note: Conditions include physical, social, psychological and environmental factors (such as temperature, mode of reception, ergonomics and atmospheric composition). 3.3.5
customercustomer
the organization (3.3.1) or individual who receives the product (3.4.2). Examples: consumer, client, end-user, retailer, beneficiary and purchaser. Note: Customers can be internal or external to the organization. 3.3.6
suppliersupplier organization (3.3.1) or person that supplies products (3.4.2) Examples: manufacturer, wholesaler, retailer or dealer 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 called a "contractor". 3.3.7
interestedparty
A person or group that has an interest in the performance or achievements of an organization (3.3.1). Examples: customer (3.3.5), owner, employee, supplier (3.3.6), bank, union, partner or society. Note 3 to entry: A group can consist of an organization or part of it or of more than one organization. 3.3.8
Contract ontract
binding agreement
Note: The concept of contract defined in this International Standard is general. In other ISO documents, the use of this vocabulary may be more specific. 3.4 Terms relating to process and product
process
a set of interrelated or interacting activities that transform inputs into outputs Note 1 to entry: The inputs to a process are often the outputs of other processes. Note 2 to entry: An organization (3.3.1) normally plans and operates processes under controlled conditions in order to add value. Note 3 to entry: Processes for which conformity (3.6.1) of the resulting product (3.4.2) cannot be easily or economically verified are often referred to as “special processes”. 3.4.2
productproduct
result of a process (3.4.1)
Note 1 to entry: 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).15
Efficiency
The relationship between the results obtained and the resources used 3.3 Terms related to organization
Organization
A group of people and facilities with arranged responsibilities, authorities and relationships. Examples: company, group, firm, enterprise, institution, research institute, charity, agency, society or part or combination of these. Note 1 to entry: The arrangement is usually ordered.
Note 2: An organization can be public or private. Note 3 to entry: This definition applies to quality management systems (3.2.3) standards. The term "organization" has a different definition in ISO/IEC Guide 2. 3.3.2
organizational structure
Organizational structure
The arrangement of responsibilities, authorities and relationships of personnel7
GB/T19000—2008/IS09000:2005Note 1, The arrangement is usually ordered.
Note 2: A formal statement of the organizational structure is usually provided in the quality manual (3.7.4) or the quality plan (3.7.5) of the project (3.4.3). Note 3: The scope of the organizational structure may include relevant interfaces with external organizations (3.3.1). 3.3.3
Infrastructureinfrastructure
《Organization》Facilities, equipment and services necessary for the operation of the organization (3.3.1) system (3.2.1)3.3.4
work environment
workenvironment
the set of conditions in which work is performed
Note: Conditions include physical, social, psychological and environmental factors (such as temperature, mode of reception, ergonomics and atmospheric composition). 3.3.5
customercustomer
the organization (3.3.1) or individual who receives the product (3.4.2). Examples: consumer, client, end-user, retailer, beneficiary and purchaser. Note: Customers can be internal or external to the organization. 3.3.6
suppliersupplier organization (3.3.1) or person that supplies products (3.4.2) Examples: manufacturer, wholesaler, retailer or dealer 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 called a "contractor". 3.3.7
interestedparty
A person or group that has an interest in the performance or achievements of an organization (3.3.1). Examples: customer (3.3.5), owner, employee, supplier (3.3.6), bank, union, partner or society. Note 3 to entry: A group can consist of an organization or part of it or of more than one organization. 3.3.8
Contract ontract
binding agreement
Note: The concept of contract defined in this International Standard is general. In other ISO documents, the use of this vocabulary may be more specific. 3.4 Terms relating to process and product
process
a set of interrelated or interacting activities that transform inputs into outputs Note 1 to entry: The inputs to a process are often the outputs of other processes. Note 2 to entry: An organization (3.3.1) normally plans and operates processes under controlled conditions in order to add value. Note 3 to entry: Processes for which conformity (3.6.1) of the resulting product (3.4.2) cannot be easily or economically verified are often referred to as “special processes”. 3.4.2
productproduct
result of a process (3.4.1)
Note 1 to entry: 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).
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