h) Mutually beneficial relationships with suppliers
Interstate standard GOST ISO 9000-2011
"Quality management systems. Fundamentals and vocabulary"
(put into effect by order of the Federal Agency for Technical Regulation and Metrology dated December 22, 2011 N 1574-st)
Quality management systems. Fundamentals and vocabulary
Introduced for the first time
Preface
The goals, basic principles and basic procedure for carrying out work on interstate standardization are established by GOST 1.0-92 "Interstate standardization system. Basic provisions" and GOST 1.2-2009 "Interstate standardization system. Interstate standards, rules and recommendations for interstate standardization. Rules for development, adoption, application, renewal and cancellation"
Introduction
General provisions
The ISO 9000 family of standards listed below have been developed to assist organizations of all types and sizes in implementing and maintaining effective quality management systems:
ISO 9000 describes the fundamentals of quality management systems and establishes terminology for quality management systems;
ISO 9001 establishes requirements for quality management systems where an organization must demonstrate the ability to produce products that meet customer and regulatory requirements and aims to improve customer satisfaction;
ISO 9004 provides guidelines for improving the effectiveness and efficiency of a quality management system and is intended to improve the performance of an organization and increase the satisfaction of customers and other interested parties;
ISO19011 contains guidelines for conducting audits (inspections) of quality and environmental management systems.
This set of quality management system standards is intended to improve mutual understanding in national and international trade.
Quality management principles
The successful management and functioning of an organization is ensured through its systematic and transparent management. Success can be achieved by implementing and maintaining a quality management system designed to continuously improve operations while taking into account the needs of all stakeholders. Managing an organization, in addition to quality management, also includes other aspects of management.
The following eight principles of quality management have been defined so that senior management can apply them to improve the performance of the organization.
a) Customer focus
Organizations depend on their customers and therefore must understand their current and future needs, meet their requirements and strive to exceed their expectations.
b) Manager's leadership
Leaders ensure unity of purpose and direction for the organization. They should create and maintain an internal environment in which employees can be fully involved in solving the organization's problems.
c) Employee involvement
Employees at all levels form the backbone of the organization, so their full involvement in solving problems allows the organization to profitably use their abilities.
d) Process approach
The desired result is achieved more effectively when activities and associated resources are managed as a process.
e) Systematic approach to management
Identifying, understanding and managing interconnected processes as a system contributes to increasing the effectiveness and efficiency of the organization in achieving its goals.
f) Continuous improvement
Continuous improvement of the organization as a whole should be considered as its constant goal.
g) Fact-based decision making
Effective decisions must be based on the analysis of data and information.
h) Mutually beneficial relationships with suppliers
The organization and its suppliers are interdependent, so relationships of mutual benefit enhance the ability of both parties to create value.
These eight principles of quality management were taken as the basis for the development of quality management system standards that are part of the ISO 9000 family of standards.
1 area of use
This International Standard establishes the fundamental principles of quality management systems that are the subject of the ISO 9000 family of standards and defines relevant terms.
This standard may be used:
a) organizations seeking to achieve advantage through the implementation of a quality management system;
b) organizations that want to be confident that their specified product requirements will be met by suppliers;
c) users of the products;
d) those interested in a common understanding of the terminology used in quality management (eg suppliers, customers, regulatory authorities);
e) those parties, internal or external to the organization, who evaluate the quality management system or verify its conformity with the requirements of ISO 9001 (for example, auditors, regulators, certification/registration bodies);
f) those parties, internal or external to the organization, who provide advice or training on the quality management system to the organization;
g) developers of relevant standards.
2 Basic provisions of quality management systems
2.1 Rationale for the need for quality management systems
Quality management systems can assist organizations in improving customer satisfaction.
Consumers need products that meet their needs and expectations. These needs and expectations are typically reflected in product specifications and are generally considered customer requirements. Requirements may be specified by the customer in a contract or defined by the organization itself. In any case, it is the consumer who ultimately determines product acceptability. As consumer needs and expectations change, and as organizations face competitive and technological pressures, they must continually improve their products and processes.
The implementation of quality management systems encourages organizations to analyze customer requirements, identify processes that contribute to the creation of products acceptable to customers, and maintain these processes in a controlled state. A quality management system can be the basis for continuous improvement, contributing to increased satisfaction of both customers and other interested parties. The implementation of this system provides the organization and customers with confidence in its ability to deliver products that fully comply with requirements.
2.2 Requirements for quality management systems and product requirements
The ISO 9000 family of standards distinguishes between requirements for quality management systems and requirements for products.
The requirements for quality management systems are set out in ISO 9001 and are general and applicable to organizations in any industrial or economic sector, regardless of product category. ISO 9001 does not specify product requirements.
Requirements for products can be established by consumers or an organization based on expected consumer requests or the requirements of technical regulations. Requirements for products and, in some cases, also for associated processes can be established in technical specifications, product standards, process standards, contractual agreements and regulations.
2.3 Approach to the development and implementation of a quality management system
The approach to the development and implementation of a quality management system consists of several steps, including:
a) identifying the needs and expectations of customers and other interested parties;
b) developing the organization's quality policy and objectives;
c) defining the processes and responsibilities needed to achieve quality objectives;
d) identifying and providing the necessary resources to achieve quality objectives;
e) developing methods to measure the effectiveness and efficiency of each process;
f) applying the results of these measurements to determine the effectiveness and efficiency of each process;
g) determining the means necessary to prevent nonconformities and eliminate their causes;
h) developing and implementing a process for continuous improvement of the quality management system.
This approach is also used to maintain and improve the implemented quality management system.
An organization that takes the above approach creates confidence in the capabilities of its processes and the quality of its products, and provides a basis for continuous improvement. This can lead to increased customer and other stakeholder satisfaction and organizational success.
2.4 Process approach
Any activity that uses resources to transform inputs into outputs can be considered a process.
In order to function effectively, an organization must define and manage numerous interrelated and interacting processes. Often the output of one process is the immediate input of the next. The systematic definition and management of the processes used by an organization, and especially the interaction of these processes, can be considered a "process approach".
The purpose of this standard is to encourage the adoption of a process approach to the management of an organization.
Notes
1 The term "quality" can be used with adjectives such as bad, good or excellent.
2 The term "inherent", which is the opposite of the term "assigned", means existing in something, especially if it relates to permanent characteristics.
3.1.2 requirement: A need or expectation that is established, usually assumed, or obligatory.
Notes
NOTE 1 The words “usually expected” mean that it is the generally accepted practice of the organization (3.3.1), its customers (3.3.5) and other interested parties (3.3.7) when the needs or expectations in question are expected.
2 To designate a specific type of requirement, qualifying words can be used, for example, product requirement, quality system requirement, consumer requirement.
3 An established requirement is one that is defined, for example in document (3.7.2).
4 Requirements may be made by various stakeholders.
5 This definition differs from that specified in clause 3.12.1 of the ISO/IEC Directive, Part 2.
3.1.2.1 requirement: A documented criterion that must be met if compliance with a document is required, and against which deviations are not permitted.
3.1.3 grade class, grade, category or grade corresponding to different quality requirements for products (3.4.2), processes (3.4.1) or systems (3.2.1) having the same functional application
Example - Air ticket class or hotel category in a hotel directory.
NOTE When defining a quality requirement, a gradation is usually established.
3.1.4 customer satisfaction: Customers' perception of the extent to which their requirements have been met (3.1.2).
Notes
1 Customer complaints are a general indicator of low customer satisfaction, but their absence does not necessarily imply high customer satisfaction.
2 Even if customer requirements have been agreed upon and met, this does not necessarily ensure high customer satisfaction.
3.1.5 capabilities: The ability of an organization (3.3.1), system (3.2.1) or process (3.4.1) to produce a product (3.4.2) that will meet the requirements (3.1.2) for that product.
NOTE Terms related to statistical process capabilities are defined in ISO 3534-2.
3.1.6 competence: Demonstrated ability to apply knowledge and skills in practice.
NOTE Competence is defined in this standard in a general sense. The use of this term may have additional features and be clarified in other documents.
3.2 Terms related to management
3.2.1 system: A set of interconnected and interacting elements.
3.2.2 management system: A system (3.2.1) for developing policies and goals and achieving those goals.
NOTE An organization's management system (3.3.1) may include various management systems, such as a quality management system (3.2.3), a financial management system or an environmental management system.
3.2.4 quality policy: The overall intentions and direction of an organization (3.3.1) in the area of quality (3.1.1), as formally expressed by top management (3.2.7).
Notes
Note 1 to entry: Generally, a quality policy is consistent with the overall policy of the organization and provides the basis for setting quality objectives (3.2.5).
NOTE 2 The principles of quality management set out in this standard can serve as a basis for the development of a quality policy.
3.2.5 quality objectives: What is achieved or strived for in the area of quality (3.1.1).
Notes
NOTE 1 Quality objectives are usually based on the organization's quality policy (3.2.4).
NOTE 2 Quality objectives are usually established for relevant departments and levels of the organization (3.3.1).
3.2.6 management: 3.3.1).
Note - In Russian, the term "management" sometimes refers to people, i.e. a person or group of employees with authority and responsibility for the direction and management of an organization. When the term "management" is used in this sense, it should always be used with qualifying words to avoid confusion with the concept of "management" used above. For example, the expression “management shall.” should not be used, while “top management (3.2.7) shall...” is acceptable.
3.2.7 top management: The person or group of people who directs and controls an organization (3.3.1) at the highest level.
3.2.8 quality management: Coordinated activities to direct and control an organization (3.3.1) with respect to quality (3.1.1).
NOTE Direction and control for quality typically includes the development of a quality policy (3.2.4) and quality objectives (3.2.5), quality planning (3.2.9), quality management (3.2.10), quality assurance quality (3.2.11) and quality improvement (3.2.12).
3.2.9 quality planning: The part of quality management (3.2.8) aimed at establishing quality objectives (3.2.5) and identifying the necessary operational processes (3.4.1) and associated resources to achieve quality objectives.
NOTE The development of quality plans (3.7.5) may be part of quality planning.
3.2.10 quality control: Part of quality management (3.2.8) aimed at meeting quality requirements.
3.2.11 quality assurance: Part of quality management (3.2.8) aimed at providing confidence that quality requirements will be met.
3.2.12 quality improvement: Part of quality management (3.2.8) aimed at increasing the ability to meet quality requirements.
NOTE Requirements can relate to any aspect such as effectiveness (3.2.14), efficiency (3.2.15) or traceability (3.5.4).
3.2.13 continuous improvement: Repeated activities to increase the ability to meet requirements (3.1.2).
NOTE The process (3.4.1) of establishing objectives and identifying opportunities for improvement is an ongoing process using audit observations (3.9.5) and audit conclusions (3.9.6), data analysis, management review (3.8.7) or other means and usually leading to corrective action (3.6.5) or preventive action (3.6.4).
3.2.14 effectiveness: The degree to which planned activities are implemented and planned results are achieved.
3.2.15 efficiency: The connection between the achieved result and the resources used.
3.3 Terms related to the organization
3.3.1 organization: A group of workers and the necessary funds with the distribution of responsibilities, powers and relationships.
EXAMPLE A company, corporation, firm, enterprise, institution, charity, retailer, association, or any subdivision or combination thereof.
Notes
2 An organization can be public or private.
NOTE 3 This definition is valid for quality management system standards (3.2.3). ISO/IEC Guide 2 provides a different definition of the term "organization".
3.3.2 organizational structure: Distribution of responsibilities, powers and relationships between employees.
Notes
1 The distribution is usually ordered.
NOTE 2 A formal organizational structure is often contained in the quality manual (3.7.4) or quality plan (3.7.5) of the project (3.4.3).
3 The organizational structure may include appropriate interactions with external organizations (3.3.1).
3.3.3 infrastructure: <Организация>The set of buildings, equipment and support services necessary for the functioning of an organization (3.3.1).
3.3.4 work environment: The set of conditions under which work is performed.
NOTE Conditions include physical, social, psychological and environmental factors (such as temperature, recognition and reward systems, ergonomics and atmospheric composition).
3.3.5 consumer: Organization (3.3.1) or person receiving product (3.4.2).
Example - Client, customer, end user, retailer, beneficiary and purchaser.
NOTE The customer may be internal or external to the organization.
3.3.6 supplier: Organization (3.3.1) or person providing the product (3.4.2).
Example - Manufacturer, wholesaler, retailer or product seller, service provider, information provider.
Notes
NOTE 1 The supplier may be internal or external to the organization.
2 In a contractual situation, the supplier is sometimes called the "contractor".
3.3.7 interested party person or group of persons with an interest in the activities or success of an organization (3.3.1)
EXAMPLE Customers (3.3.5), owners, employees of an organization, suppliers (3.3.6), bankers, associations, partners or the public.
Note: A group may consist of an organization, part of an organization, or several organizations.
3.3.8 contract: A binding agreement.
3.4 Process and product terms
3.4.1 process: A set of interrelated or interacting activities that transforms inputs into outputs.
Notes
1 Inputs to a process are usually the outputs of other processes.
Notes
1 There are four general product categories:
Services (for example, transportation);
Software (for example, computer program, dictionary);
Technical means (for example, engine assembly);
Recyclable materials (eg lubricant).
Many products contain elements belonging to different general product categories. The classification of products as services, software, hardware or processed materials depends on the predominant element.
For example, the supplied product “car” consists of hardware (for example, tires), processed materials (fuel, coolant), software (engine control software, driver’s manual) and services (operating instructions provided by the seller).
2 A service is the result of at least one action necessarily performed during the interaction between the supplier (3.3.6) and the consumer (3.3.5), and, as a rule, is intangible. The provision of a service may include, for example, the following:
Activities carried out on material products supplied by the consumer (for example, repairing a faulty car);
Activities carried out on intangible products supplied by the consumer (for example, drawing up an income statement necessary to determine the amount of tax);
Providing intangible products (for example, information in the sense of knowledge transfer);
Creating favorable conditions for consumers (for example, in hotels and restaurants).
Software contains information and is usually intangible, but may also be in the form of approaches, operations or procedures (3.4.5).
A technical means, as a rule, is material, and its quantity is expressed by a countable characteristic (3.5.1). The materials processed are usually tangible and their quantity is expressed as a continuous characteristic. Technical equipment and recyclable materials are often called goods.
4 Adapted from ISO 10006:2003.
3.4.4 design and development: Set of processes (3.4.1) that translate requirements (3.1.2) into specified characteristics (3.5.1) or specifications (3.7.3) for a product (3.4.2), process (3.4.1) or system (3.2.1) ).
Notes
1 Terms "design" and "development" are sometimes used interchangeably and sometimes to refer to various stages of the design and development process as a whole.
NOTE 2 Qualifying words may be used to identify the subject of design and development (for example, 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).
Notes
NOTE 1 Procedures may be documented or undocumented.
2 If the procedure is documented, the term is often used "written procedure" or "documented procedure". A document (3.7.2) containing a procedure may be called "procedural document".
3.5 Terms related to characteristics
3.5.1 characteristic: Distinctive property.
Notes
1 A characteristic may be inherent or assigned.
2 Characteristics can be qualitative or quantitative.
3 There are different classes of characteristics, such as:
Physical (for example, mechanical, electrical, chemical or biological characteristics);
Organoleptic (for example, those related to smell, touch, taste, vision, hearing);
Ethical (eg, courtesy, honesty, truthfulness);
Temporary (for example, punctuality, reliability, availability);
Ergonomic (for example, physiological characteristics or related to human safety);
Functional (for example, the maximum speed of the aircraft).
3.5.2 quality characteristic: An inherent characteristic (3.5.1) of a product (3.4.2), process (3.4.1) or system (3.2.1) that is relevant to a requirement (3.1.2).
Notes
1 The word “inherent” means inherent in something, especially if it refers to a permanent characteristic.
NOTE 2 Assigned characteristics of a product, process or system (eg product price, product owner) are not characteristics of the quality of that product, process or system.
3.5.4 traceability: The ability to trace the history, application, or location of what is being considered.
Notes
1 Product traceability (3.4.2) may refer to:
Origin of materials and components;
Processing history;
Distribution and location of products after delivery.
2 In the field of metrology, the definition given in VIM-1993, subsection 6.10 is accepted.
3.6 Terms related to compliance
3.6.3 defect failure to comply with a requirement (3.1.2) associated with an intended or specified use
Notes
NOTE 1 The distinction between the concepts of defect and nonconformity (3.6.2) is important because it has legal implications, especially related to issues of product liability. Therefore, the term "defect" should be used with extreme caution.
NOTE 2 The intended use by the customer (3.3.5) may depend on the nature of the information, such as instructions for use and maintenance, provided by the supplier (3.3.6).
3.6.4 preventive action: An action taken to eliminate the cause of a potential nonconformity (3.6.2) or other potentially undesirable situation.
Notes
1 Potential nonconformity may have several causes.
NOTE 2 Preventive action is taken to prevent the event from occurring, and corrective action (3.6.5) is taken to prevent the event from reoccurring.
3.6.5 corrective action: An action taken to eliminate the cause of a detected nonconformity (3.6.2) or other undesirable situation.
Notes
1 Nonconformity may have several causes.
NOTE 2 Corrective action is taken to prevent the recurrence of an event, and preventive action (3.6.4) is taken to prevent the occurrence of an event.
NOTE 3 A distinction should be made between the terms correction (3.6.6) and corrective action.
3.6.6 correction: Action taken to correct a detected nonconformity (3.6.2).
Notes
NOTE 1 Correction may be carried out in combination with corrective action (3.6.5).
NOTE 2 Correction may include, for example, rework (3.6.7) or reduction in gradation (3.6.8).
3.6.7 rework action taken on nonconforming product (3.4.2) to make it conform to requirements (3.1.2)
NOTE Unlike rework, repair (3.6.9) may affect or change parts of the nonconforming product.
3.6.9 repair action taken on nonconforming product (3.4.2) to make it acceptable for its intended use
Notes
NOTE 1 Repair includes remedial action taken on previously conforming products to restore them for use, for example as part of maintenance.
NOTE Permission to deviate generally applies to the supply of products that do not conform to the specifications (3.5.1) for the specified agreed time or quantity limits for that product.
3.6.12 deviation permit: Permission to deviate from the original specified requirements (3.1.2) for a product (3.4.2), issued before its production.
NOTE A derogation is usually granted for a limited quantity of product or period of time, or for a specific use.
3.6.13 release: Permission to move to the next stage of a process (3.4.1).
Note - In English, in the context of software, the term "release" often refers to the version of the software itself.
3.7 Terms related to documentation
3.7.1 information: Meaningful data.
3.7.2 document: Information (3.7.1) presented on an appropriate medium.
Example - Records (3.7.6), specification (3.7.3), procedural document, drawing, report, standard.
Notes
1 The medium may be paper, magnetic, electronic or optical, computer disk, photograph or master sample, or a combination thereof.
2 A set of documents, such as specifications and records, is often called "documentation".
NOTE Specifications may relate to an activity (for example, a procedure document, a process specification or a test specification) or a product (3.4.2) (for example, product specifications, operational documents and drawings).
3.7.4 quality manual: Document (3.7.2) defining the quality management system (3.2.3) of the organization (3.3.1).
NOTE Quality manuals may vary in detail and form depending on the size and complexity of the particular organization.
3.7.5 quality plan: Document (3.7.2) specifying which procedures (3.4.5) and associated resources are to be applied, by whom, and when for a particular project (3.4.3), product (3.4.2), process (3.4.1), or contract (3.3.8).
Notes
NOTE 1 These procedures typically include those associated with quality management processes and product life cycle processes.
NOTE 3 A quality plan is usually one of the outputs of quality planning (3.2.9).
3.7.6 record: Document (3.7.2) containing results achieved or evidence of activities performed.
Notes
NOTE 1 Records can be used, for example, to document traceability (3.5.4) and evidence of verification (3.8.4), preventive actions (3.6.4) and corrective actions (3.6.5).
2 Revisions of records generally do not need to be managed.
3.8 Terms related to assessment
3.8.1 objective evidence: Data confirming the presence or truth of something.
NOTE Objective evidence may be obtained by observation, measurement, test (3.8.3) or other means.
3.8.4 verification: Confirmation, by the provision of objective evidence (3.8.1), that specified requirements (3.1.2) have been met.
Notes
1 The term “verified” is used to indicate the corresponding status.
2 Requirement validation activities may include:
Implementation of alternative calculations;
Notes
1 Term "qualified" used to indicate the corresponding status.
NOTE 2 Qualifications may apply to workers, products (3.4.2), processes or systems (3.2.1).
Example - Auditor qualification process, material qualification process.
3.8.7 review activity undertaken to determine the suitability, adequacy and effectiveness (3.2.14) of a subject item to achieve specified objectives
NOTE The analysis may also include a determination of effectiveness (3.2.15).
Example - Management review, design and development review, customer requirements review, nonconformity review.
3.9 Terms related to audit (verification)
3.9.1 audit (check): A systematic, independent and documented process (3.4.1) of obtaining audit evidence (3.9.4) and evaluating it objectively to determine the extent to which agreed audit criteria (3.9.3) have been met.
Notes
NOTE 1 Internal audits, sometimes called first-party audits, are usually conducted by or on behalf of the organization itself (3.3.1) for internal purposes and may form the basis of a declaration of conformity (3.6.1). In many cases, especially in smaller organizations, independence can be demonstrated by a lack of responsibility for the work being audited.
NOTE 2 External audits include audits commonly referred to as second party audits or third party audits. Second-party audits are conducted by parties with an interest in the organization's activities, such as customers (3.3.5) or others on their behalf. Third party audits are conducted by external independent organizations. These organizations provide certification or registration for compliance with requirements such as ISO 9001 and ISO 14001.
NOTE 3 When two or more management systems (3.2.2) are audited together, this is called a comprehensive audit.
NOTE 4 When two or more organizations jointly conduct an audit of an auditee (3.9.8), this is called a joint audit.
3.9.2 audit program: A set of one or more audits (3.9.1) planned for a specific period of time and aimed at achieving a specific objective.
NOTE An audit program includes all activities necessary to plan, organize and conduct audits.
3.9.3 audit criteria: A set of policies, procedures (3.4.5) or requirements (3.1.2) that are used by reference.
NOTE Audit criteria are used to compare audit evidence (3.9.4) with them.
3.9.4 audit evidence: Records (3.7.6), statements of fact or other information (3.7.1) that are related to audit criteria (3.9.3) and can be verified.
NOTE Audit evidence may be qualitative or quantitative.
3.9.5 audit findings: The results of evaluating the collected audit evidence (3.9.4) in relation to the audit criteria (3.9.3).
NOTE Audit observations may indicate compliance (3.6.1) or non-compliance (3.6.2) with audit criteria or opportunities for improvement.
3.9.7 audit client: The organization (3.3.1) or person commissioning the audit (3.9.1).
NOTE The audit client can be the auditee (3.9.8) or any other organization (3.3.1) that has the legal or contractual right to request an audit.
3.9.9 auditor person who has demonstrated the personal qualities and competence (3.1.6 and 3.9.14) to conduct an audit (3.9.1)
NOTE A description of the important personal qualities of an auditor is given in ISO 19011.
3.9.10 audit team: One or more auditors (3.9.9) conducting an audit (3.9.1), supported as necessary by technical experts (3.9.11).
Notes
1 One of the auditors in the audit team is usually designated as the team leader.
2 The audit team may also include trainee auditors.
3.9.11 technical expert: <Аудит>A person who has the specialized knowledge or experience required by the audit team (3.9.10).
Notes
NOTE 1 Specific knowledge or experience includes knowledge or experience specific to the organization (3.3.1), process (3.4.1) or activity being audited, as well as knowledge of the language and culture of the country in which the audit is being conducted.
2 The technical expert does not have auditor credentials (3.9.9) on the audit team.
3.9.13 audit scope: Contents and boundaries of the audit (3.9.1).
NOTE The scope of the audit typically includes location, organizational structure, activities and processes (3.4.1), and the time period covered.
3.9.14 competence: <Аудит>Demonstrated personal qualities and ability to apply knowledge and skills.
3.10 Terms related to quality management of measurement processes
3.10.1 measurement management system: A set of interrelated or interacting elements necessary to achieve metrological confirmation of suitability (3.10.3) and ongoing control of measurement processes (3.10.2).
3.10.2 measurement process: A set of operations carried out to determine the value of a quantity.
3.10.3 metrological confirmation: A set of operations carried out to ensure that measuring equipment (3.10.4) meets the requirements (3.1.2) for its intended purpose.
Notes
NOTE 1 Metrological confirmation of suitability usually includes calibration or verification (3.8.4), any necessary adjustment or repair (3.6.9) and subsequent recalibration, comparison with metrological requirements for the intended use of the equipment, and any required sealing and marking.
2 Metrological confirmation of suitability is not considered complete until the suitability of the measuring equipment for its intended use has been demonstrated and documented.
3 Intended use requirements include such characteristics as range, resolution, maximum permissible error, etc.
4 Requirements for metrological confirmation of suitability usually differ from the requirements for products and are not regulated by them.
3.10.4 measuring equipment: Measuring instruments, software, standards, reference materials, auxiliary equipment, or a combination thereof, necessary to perform the measurement process (3.10.2).
3.10.5 metrological characteristic: A distinctive feature that may affect the measurement results.
Notes
NOTE 1 Measuring equipment (3.10.4) usually has several metrological characteristics.
2 Metrological characteristics may be subject to calibration.
3.10.6 metrological function: The organizational structure with administrative and technical responsibility for defining and implementing a measurement management system (3.10.1).
Note - The word "definition" has the meaning of "establishing standards". It is not used in the terminological sense of "defining a concept" (in some languages this distinction is unclear without context).
Alphabetical index of terms in Russian
Analysis................................................. .......... 3.8.7 audit.................................... ........................... 3.9.1 auditor................... ......................................... 3.9.9 validation..... ........................................................ ... 3.8.5 verification................................................. ............. 3.8.4 capabilities................................. ....................... 3.1.5 release................................. .................................... 3.6.13 gradation........ ........................................................ 3.1.3 audit team.................................................... ....... 3.9.10 corrective action.................................... ....... 3.6.5 warning action................................................. ..... 3.6.4 defect............................................ .................... 3.6.3 document................................. ...................................
GOST ISO 9000-2011 Group T59
INTERSTATE STANDARD
QUALITY MANAGEMENT SYSTEMS
Fundamentals and Vocabulary
Quality management systems. Fundamentals and vocabulary
OKS 03.120.10; 01.040.03 OKSTU 0025 IDT
Date of introduction 2013-01-01
Preface
The goals, basic principles and basic procedure for carrying out work on interstate standardization have been established GOST 1.0-92 "Interstate standardization system. Basic provisions" And GOST 1.2-2009 "Interstate standardization system. Interstate standards, rules and recommendations for interstate standardization. Rules for development, adoption, application, updating and cancellation" Standard information
1 PREPARED by the Open Joint Stock Company "All-Russian Scientific Research Institute of Certification" (JSC "VNIIS") on the basis of the Russian version of the standard specified in paragraph 4
2 INTRODUCED by the Federal Agency for Technical Regulation and Metrology of the Russian Federation
3 ADOPTED by the Interstate Council for Standardization, Metrology and Certification (Protocol No. 48 of the adoption of interstate regulatory documents by correspondence dated December 22, 2011) Voted for adoption:
4 By order of the Federal Agency for Technical Regulation and Metrology of December 22, 2011 N 1574-st interstate standard GOST ISO 9000-2011 entered into force as a national standard of the Russian Federation on January 1, 2013
5 This standard is identical to the international standard ISO 9000:2005* Quality management systems - Fundamentals and vocabulary ________________ * Access to international and foreign documents mentioned hereinafter can be obtained by following the link to website http://shop.cntd.ru. - Database manufacturer's note. This standard has been prepared based on the application
GOST R ISO 9000-2008 6 INTRODUCED FOR THE FIRST TIME
Introduction
Information on the entry into force (termination) of this standard is published in the “National Standards” index. Information about changes to this standard is published in the “National Standards” index, and the text of the changes is published in the “National Standards” information indexes. In case of revision or cancellation of this standard, the relevant information will be published in the information index "National Standards". Relevant information, notifications and texts are also posted in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet
Quality management principles The successful management and functioning of an organization is ensured through its systematic and transparent management. Success can be achieved by implementing and maintaining a quality management system designed to continuously improve operations while taking into account the needs of all stakeholders. Managing an organization, in addition to quality management, also includes other aspects of management.
The following eight principles of quality management have been defined so that senior management can apply them to improve the performance of the organization. a) Customer focus
Organizations depend on their customers and therefore must understand their current and future needs, meet their requirements and strive to exceed their expectations. b) Manager's leadership
Leaders ensure unity of purpose and direction for the organization. They should create and maintain an internal environment in which employees can be fully involved in solving the organization's problems. c) Employee involvement
Employees at all levels form the backbone of the organization, so their full involvement in solving problems allows the organization to profitably use their abilities. d) Process approach
The desired result is achieved more effectively when activities and associated resources are managed as a process. e) Systematic approach to management
Identifying, understanding and managing interconnected processes as a system contributes to increasing the effectiveness and efficiency of the organization in achieving its goals. f) Continuous improvement
Continuous improvement of the organization as a whole should be considered as its constant goal. g) Fact-based decision making
Effective decisions must be based on the analysis of data and information. h) Mutually beneficial relationships with suppliers
The organization and its suppliers are interdependent, so relationships of mutual benefit enhance the ability of both parties to create value.
These eight principles of quality management were taken as the basis for the development of quality management system standards that are part of the ISO 9000 family of standards.
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INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION
Preface
The goals, basic principles and basic procedure for carrying out work on interstate standardization have been established GOST 1.0-92“Interstate standardization system. Basic provisions" and GOST 1.2-2009“Interstate standardization system. Interstate standards, rules and recommendations for interstate standardization. Rules for development, adoption, application, updating and cancellation"
Standard information
1 PREPARED by the Open Joint Stock Company “All-Russian Scientific Research Institute of Certification” (JSC “VNIIS”) based on the Russian version of the standard specified in paragraph 4
2 INTRODUCED by the Federal Agency for Technical Regulation and Metrology of the Russian Federation
3 ADOPTED by the Interstate Council for Standardization, Metrology and Certification (Protocol No. 48 of the adoption of interstate regulatory documents by correspondence dated December 22, 2011)
4 By Order of the Federal Agency for Technical Regulation and Metrology dated December 22, 2011 No. 1574-st, the interstate standard GOST ISO 9000-2011 was put into effect as a national standard of the Russian Federation on January 1, 2013
5 This standard is identical to the international standard ISO 9000:2005 Quality management systems - Fundamentals and vocabulary.
This standard has been prepared based on the application GOST R ISO 9000-2008
6 INTRODUCED FOR THE FIRST TIME
7 REPUBLICATION. February 2013
Information on the entry into force (termination) of this standard is published in the “National Standards” index.
Information about changes to this standard is published in the “National Standards” index, and the text of the changes- V information signs “National Standards”. In case of revision or cancellation of this standard, the relevant information will be published in the information index “National Standards”. Relevant information, notices and texts are also posted in the public information system- on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet
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1 area of use. 4 2 Basic provisions of quality management systems. 4 2.1 Justification of the need for quality management systems. 4 2.2 Requirements for quality management systems and product requirements. 5 2.3 Approach to the development and implementation of a quality management system. 5 2.4 Process approach. 5 2.5 Quality policy and goals. 6 2.6 The role of top management in the quality management system. 6 2.7 Documentation. 7 2.8 Evaluation of quality management systems. 7 2.9 Continuous improvement. 8 2.10 The role of statistical methods. 9 2.12 Relationship between quality management systems and excellence models. 9 3 Terms and definitions. 10 3.1 Terms related to quality. 10 3.2 Terms related to management. eleven 3.3 Terms related to the organization. 12 3.4 Process and product terms. 13 3.5 Terms related to characteristics... 14 3.6 Terms related to compliance... 15 3.7 Terms related to documentation. 16 3.8 Terms related to assessment. 17 3.9 Terms related to audit (verification) 18 3.10 Terms related to quality management of measurement processes. 19 Appendix A (informative) Methodology used in developing the dictionary. 20 Alphabetical index of terms in Russian. 28 Alphabetical index of terms in English. thirty Bibliography. 31 |
Introduction
Information on the entry into force (termination) of this standard is published in the “National Standards” index.
The ISO 9000 family of standards listed below have been developed to assist organizations of all types and sizes in implementing and maintaining effective quality management systems:
ISO 9000 describes the fundamentals of quality management systems and establishes terminology for quality management systems;
ISO 9001 establishes requirements for quality management systems where an organization must demonstrate the ability to produce products that meet customer and regulatory requirements and aims to improve customer satisfaction;
ISO 9004 provides guidelines for improving the effectiveness and efficiency of a quality management system and is intended to improve the performance of an organization and increase the satisfaction of customers and other interested parties;
ISO 19011 contains guidelines for conducting audits of quality and environmental management systems.
This set of quality management system standards is intended to improve mutual understanding in national and international trade.
Quality management principles
The successful management and functioning of an organization is ensured through its systematic and transparent management. Success can be achieved by implementing and maintaining a quality management system designed to continuously improve operations while taking into account the needs of all stakeholders. Managing an organization, in addition to quality management, also includes other aspects of management.
The following eight principles of quality management have been defined so that senior management can apply them to improve the performance of the organization.
The following eight principles of quality management have been defined so that senior management can apply them to improve the performance of the organization.
Organizations depend on their customers and therefore must understand their current and future needs, meet their requirements and strive to exceed their expectations.
Organizations depend on their customers and therefore must understand their current and future needs, meet their requirements and strive to exceed their expectations.
Leaders ensure unity of purpose and direction for the organization. They should create and maintain an internal environment in which employees can be fully involved in solving the organization's problems.
c) Employee involvement
Employees at all levels form the backbone of the organization, so their full involvement in solving problems allows the organization to profitably use their abilities.
d) Process approach
The desired result is achieved more effectively when activities and associated resources are managed as a process.
The desired result is achieved more effectively when activities and associated resources are managed as a process.
Identifying, understanding and managing interconnected processes as a system contributes to increasing the effectiveness and efficiency of the organization in achieving its goals.
f) Continuous improvement
Continuous improvement of the organization as a whole should be considered as its constant goal.
g) Fact-based decision making
Effective decisions must be based on the analysis of data and information.
h) Mutually beneficial relationships with suppliers
The organization and its suppliers are interdependent, so relationships of mutual benefit enhance the ability of both parties to create value.
These eight principles of quality management were taken as the basis for the development of quality management system standards that are part of the ISO 9000 family of standards.
INTERSTATE STANDARD
QUALITY MANAGEMENT SYSTEMS
Fundamentals and Vocabulary
Quality management systems.
Fundamentals and vocabulary
Date of introduction - 2013-01-01
1 area of use
This International Standard establishes the fundamental principles of quality management systems that are the subject of the ISO 9000 family of standards and defines relevant terms. This standard may be used:
a) organizations seeking to achieve advantage through the implementation of a quality management system;
b) organizations that want to be confident that their specified product requirements will be met by suppliers;
c) users of the products;
d) those interested in a common understanding of the terminology used in quality management (eg suppliers, customers, regulatory authorities);
e) those parties, internal or external to the organization, who evaluate the quality management system or verify its conformity with the requirements of ISO 9001 (for example, auditors, regulators, certification/registration bodies);
f) those parties, internal or external to the organization, who provide advice or training on the quality management system to the organization;
g) developers of relevant standards.
2 Basic provisions of quality management systems
2.1 Rationale for the need for quality management systems
Quality management systems can assist organizations in improving customer satisfaction.
Consumers need products that meet their needs and expectations. These needs and expectations are typically reflected in product specifications and are generally considered customer requirements. Requirements may be specified by the customer in a contract or defined by the organization itself. In any case, it is the consumer who ultimately determines product acceptability. As consumer needs and expectations change, and as organizations face competitive and technological pressures, they must continually improve their products and processes.
The implementation of quality management systems encourages organizations to analyze customer requirements, identify processes that contribute to the creation of products acceptable to customers, and maintain these processes in a controlled state. A quality management system can be the basis for continuous improvement, contributing to increased satisfaction of both customers and other interested parties. The implementation of this system provides the organization and customers with confidence in its ability to deliver products that fully comply with requirements.
2.2 Requirements for quality management systems and product requirements
The ISO 9000 family of standards distinguishes between requirements for quality management systems and requirements for products.
The requirements for quality management systems are set out in ISO 9001 and are general and applicable to organizations in any industrial or economic sector, regardless of product category. ISO 9001 does not specify product requirements.
Requirements for products can be established by consumers or an organization based on expected consumer requests or the requirements of technical regulations. Requirements for products and, in some cases, also for associated processes can be established in technical specifications, product standards, process standards, contractual agreements and regulations.
2.3 Approach to the development and implementation of a quality management system
The approach to the development and implementation of a quality management system consists of several steps, including:
a) identifying the needs and expectations of customers and other interested parties;
b) developing the organization's quality policy and objectives;
c) defining the processes and responsibilities needed to achieve quality objectives;
d) identifying and providing the necessary resources to achieve quality objectives;
e) developing methods to measure the effectiveness and efficiency of each process;
f) applying the results of these measurements to determine the effectiveness and efficiency of each process;
g) determining the means necessary to prevent nonconformities and eliminate their causes;
h) developing and implementing a process for continuous improvement of the quality management system.
This approach is also used to maintain and improve the implemented quality management system.
An organization that takes the above approach creates confidence in the capabilities of its processes and the quality of its products, and provides a basis for continuous improvement. This can lead to increased customer and other stakeholder satisfaction and organizational success.
2.4 Process approach
Any activity that uses resources to transform inputs into outputs can be considered a process.
In order to function effectively, an organization must define and manage numerous interrelated and interacting processes. Often the output of one process is the immediate input of the next. The systematic definition and management of the processes used by an organization, and especially the interaction of these processes, can be considered a "process approach".
The purpose of this standard is to encourage the adoption of a process approach to the management of an organization.
Figure 1 illustrates the process-based quality management system described in the ISO 9000 family of standards. It shows that stakeholders play an essential role in providing input to the organization. Monitoring stakeholder satisfaction requires assessing information regarding stakeholder perceptions of the extent to which their needs and expectations are being met. The model shown in Figure 1 does not show processes at a detailed level.
Figure 1 - Model of a quality management system based on
process approach
NOTE Statements given in parentheses are not applicable to ISO 9001.
2.5 Quality Policy and Objectives
Quality policies and objectives are set to guide the organization. They define the desired results and facilitate the organization's use of the necessary resources to achieve those results. The quality policy provides the basis for developing and reviewing quality objectives. Quality objectives must be consistent with the quality policy and commitment to continuous improvement, and results must be measurable. Achieving quality objectives can have a positive impact on product quality, operational performance and financial performance and, as a result, on stakeholder satisfaction and confidence.
2.6 Role of top management in the quality management system
Through leadership and action, senior management can create an environment that promotes full employee involvement and the effective operation of the quality management system. The principles of quality management can be used by senior management as a basis for fulfilling their role in:
a) developing and maintaining the organization’s quality policies and objectives;
b) promoting the quality policy and objectives throughout the organization to increase staff awareness, motivation and involvement;
c) orientation of all personnel of the organization to customer requirements;
d) implementing appropriate processes to meet the requirements of customers and other interested parties and achieve quality objectives;
e) developing, implementing and maintaining an effective and efficient quality management system to achieve established quality objectives;
f) provision of necessary resources;
g) conducting periodic reviews of the quality management system;
h) making decisions regarding quality policies and objectives;
i) deciding on measures to improve the quality management system.
2.7 Documentation
2.7.1 Importance of documentation
Documentation makes it possible to convey the meaning and sequence of actions and contributes to:
a) achieving compliance with customer requirements and improving quality;
b) providing appropriate training;
c) repeatability and traceability;
d) providing objective evidence;
e) assessing the effectiveness and continuing suitability of the quality management system. Documentation development should not be an end in itself, but should add value to its users.
2.7.2 Types of documents used in quality management systems
The following types of documents are used in quality management systems:
a) documents providing consistent information about the organization’s quality management system, intended for both internal and external use (such documents include quality manuals);
b) documents describing how the quality management system applies to a specific product, project or contract (such documents include quality plans);
c) documents establishing requirements (such documents include specifications);
e) documents containing information on how to carry out activities and processes in sequence (such documents may include documented procedures, work instructions and drawings);
f) documents containing objective evidence of actions performed or results achieved (such documents include records).
Each organization determines the scope of required documentation and its media. This depends on factors such as the type and size of the organization, the complexity and interactions of processes, product complexity, customer and related regulatory requirements, the demonstrated capabilities of personnel, and the extent to which compliance with the quality management system requirements needs to be demonstrated.
2.8 Evaluation of quality management systems
2.8.1 Evaluation of quality management system processes
During the assessment of quality management systems, the following four basic questions must be answered in relation to each process being assessed:
a) has the process been identified and defined appropriately?
b) is responsibility shared?
c) are procedures implemented and maintained?
d) does the process achieve the required results?
The combined answers to the above questions can determine the results of the assessment. Assessment of a quality management system may vary in scope and include activities such as audit and review of the quality management system, as well as self-assessment.
2.8.2 Audit (verification) of the quality management system
Audits (inspections) (hereinafter referred to as audits) are used to determine the degree of fulfillment of the requirements for the quality management system. Audit observations are used to evaluate the effectiveness of the quality management system and identify opportunities for improvement.
Audits conducted by a first party (the organization itself) or on its behalf for internal purposes can form the basis for the organization's declaration of compliance.
Second-party audits may be conducted by the organization's customers or by others on behalf of customers.
Third party audits are performed by external independent organizations. These organizations, usually accredited, provide certification or registration for compliance with requirements such as ISO 9001.
ISO 19011 provides guidelines for auditing.
2.8.3 Analysis of the quality management system
One of the tasks of top management is to carry out regular, systematic assessment of the suitability, adequacy, effectiveness and efficiency of the quality management system, taking into account the quality policy and objectives. This analysis may include consideration of the need to adapt the quality policy and objectives in response to changing needs and expectations of interested parties, and the identification of necessary actions.
When analyzing the quality management system, along with other sources of information, audit reports should be used.
2.8.4 Self-esteem
An organization's self-assessment is a comprehensive and systematic analysis of an organization's performance and results against a quality management system or excellence model.
Self-assessment can provide an overview of the organization's performance and the level of development of the quality management system, and also helps to identify areas for improvement and priorities.
2.9 Continuous improvement
The goal of continuous improvement of the quality management system is to increase the possibility of increasing the satisfaction of consumers and other interested parties. Improvement actions include:
a) analysis and assessment of the current situation to identify areas for improvement;
b) setting improvement goals;
c) searching for possible solutions to achieve goals;
d) evaluation and selection of solutions;
e) implementation of selected solutions;
f) measuring, verifying, analyzing and evaluating performance results to determine whether objectives have been achieved;
g) registration of changes.
The results are analyzed to identify further opportunities for improvement. Thus, improvement is a continuous action. Feedback from customers and other interested parties, audits and reviews of the quality management system can also be used to identify opportunities for improvement.
2.10 The role of statistical methods
The use of statistical methods can help in understanding variability and can therefore help an organization in solving problems and improving efficiency and effectiveness. These methods also promote better use of available data in the decision-making process.
Variability can be observed in the course and results of many activities, even in conditions of apparent stability. Such variability can be observed in the measured characteristics of products and processes. Its presence can be seen at various stages of the product life cycle, from market research to customer service and product disposal.
The application of statistical methods helps to measure, describe, analyze, interpret and model such variability, even with relatively limited data. Statistical analysis of such data can help to better understand the nature, extent and causes of variability, facilitating the resolution and even prevention of problems that may result from such variability, as well as continuous improvement.
Guidelines for the application of statistical methods in a quality management system are given in ISO/TR 10017.
2.11 Focus of quality management systems and other management systems
A quality management system is part of an organization's management system that aims to achieve results in accordance with quality objectives to meet the needs, expectations and requirements of interested parties. Quality goals complement other organizational goals related to development, financing, profitability, environmental protection, and working conditions and personnel safety. The various parts of an organization's management system can be integrated together with the quality management system into a single management system using common elements. This can facilitate planning, allocating resources, setting additional goals, and assessing the overall performance of the organization.
An organization's management system can be assessed against the organization's own requirements. It can also be audited for compliance with ISO 9001 and ISO 14001. These audits can be carried out separately or jointly.
2.12 Relationship between quality management systems and excellence models
The approaches to implementing and maintaining quality management systems outlined in the ISO 9000 family of standards and excellence models are based on general principles. Both of these approaches:
a) enable the organization to identify its strengths and weaknesses;
c) provide a basis for continuous improvement;
d) include methods of external recognition.
The difference between the approaches to implementing and maintaining quality management systems in the ISO 9000 family of standards and the excellence models lies in their scope. The standards of the ISO 9000 family establish requirements for quality management systems and recommendations for improving activities; The assessment of quality management systems determines the fulfillment of these requirements. Excellence models contain criteria that allow for comparative assessment of an organization's performance and are applied to all activities and to all stakeholders. The evaluation criteria used in excellence models provide an organization with a basis for comparing its performance with that of other organizations.
3 Terms and definitions
A term defined elsewhere in this section appears in bold type. It is followed by its serial number in parentheses. Such a term in bold may be replaced in the definition by its own definition. For example:
- products(3.4.2) is defined as “the result process(3.4.1)";
- process defined as “a set of interrelated or interacting activities that transform inputs into outputs.”
If the term "process" replace it with your own definition, then:
- products can be defined as “the result of a set of interrelated or interacting activities that transform inputs into outputs.”
If a concept has a special meaning in a particular context, then the scope of use is indicated by angle brackets (< >) before definition.
Example - In the context of the term audit, the introduced term technical expert means:
3.9.11 technical expert:<Аудит>A person having the special knowledge or experience necessary audit team(3.9.10).
3.1 Terms related to quality
3.1.1 quality(quality): The degree of conformity to the totality of inherent characteristics(3.5. requirements(3.1.2).
Notes
1 The term “quality” can be used with adjectives such as bad, good or excellent.
2 The term "inherent", which is the opposite of "attributed", means having something, especially if it relates to permanent characteristics.
3.1.2 requirement requirement: A need or expectation that is stated, usually assumed, or required.
Notes
1 The words “usually expected” mean that it is a common practice organizations(3.3.1),ee consumers(3.3.5) and others interested parties(3.3.7) when the needs or expectations in question are assumed.
2 To designate a specific type of requirement, qualifying words can be used, for example, product requirement, quality system requirement, consumer requirement.
3 A specified requirement is one that is specified, for example, in document(3.7.2).
4 Requirements may be made by various stakeholders.
5 This definition differs from that specified in clause 3.12.1 of the ISO/IEC Directive, Part 2.
3.12.1 requirement requirement: A documented criterion that must be met if conformance to a document is required, and from which deviations are not permitted.
3.1.3 gradation(grade): Class, grade, category or rank corresponding to various quality requirements products(3.4.2),processes(3.4.1)or systems(3.2.1), having the same functional application.
Example - Air ticket class or hotel category in the hotel directory.
NOTE When defining a quality requirement, a gradation is usually established.
3.1.4 customer satisfaction(customer satisfaction): Consumers' perception of the degree to which their requirements(3.1.2).
Notes
1 Customer complaints are a general indicator of low customer satisfaction, but their absence does not necessarily imply high customer satisfaction.
2 Even if customer requirements have been agreed upon and met, this does not necessarily ensure high customer satisfaction.
3.1.5 possibilities(capability): Ability organizations(3.3.1),systems(3.2.1)or process(3.4.1) produce products(3.4.2), which will correspond requirements(3.1.2) to this product.
NOTE Terms related to statistical process capabilities are defined in ISO 3534-2.
3.1.6 competence(competence): Demonstrated ability to apply knowledge and skills in practice.
NOTE Competence is defined in this standard in a general sense. The use of this term may have additional features and be clarified in other documents.
3.2 Terms related to management
3.2.1system(system): A set of interconnected and interacting elements.
3.2.2 management system(management system): System(3.2.1) to develop policies and goals and achieve those goals.
Note - Management system organizations(3.3.1) may include various management systems such as Quality Management System(3.2.3), financial management system or environmental management system.
3.2.3 Quality Management System(quality management system): Management system(3.2.2) for guidance and control organization(3.3.1) applied to quality (3.1.1 ).
3.2.4quality policy(quality policy): General intentions and direction of activity organizations(3.3.1) in the area quality(3.1.1), formally formulated senior management(3.2.7).
Notes
NOTE 1 Typically, a quality policy is consistent with the overall policy of the organization and provides the basis for establishing quality goals(3.2.5).
NOTE 2 The principles of quality management set out in this standard can serve as a basis for the development of a quality policy.
3.2.5 quality goals(quality objective): What is being achieved or strived for in an area quality(3.1.1).
Notes
1 Quality objectives are usually based on politics organizations in quality areas(3.2.4).
2 Quality objectives are usually set for relevant departments and levels organizations(3.3.1).
3.2.6 management(management): Coordinated activities of direction and management organization(3.3.1).
Note - In Russian, the term "management" sometimes refers to people, i.e. a person or group of employees with authority and responsibility for the direction and management of an organization. When the term "management" is used in this sense, it should always be used with qualifying words to avoid confusion with the concept of "management" used above. For example, you should not use the expression “management should...” when "top management(3.2.7) must...” is allowed for use.
3.2.7 top management(top management): The person or group of employees who exercise leadership and control organization(3.3.1) at the highest level.
3.2.8 quality management(quality management): Coordinated leadership and management activities organization(3.3.1) applied to quality(3.1.1).
NOTE Governance and management for quality usually includes the development quality policies(3.2.4)and quality goals(3.2.5),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(quality planning): Part quality management(3.2.8), aimed at establishing quality goals(3.2.5) and determining the necessary operational processes(3.4.1) and associated resources to achieve quality objectives.
Note - Development quality plans(3.7.5) may be part of quality planning.
3.2.10 quality control(quality control): Part quality management(3.2.8) aimed at meeting quality requirements.
3.2.11 quality assurance(quality assurance): Part quality management(3.2.8) aimed at providing confidence that quality requirements will be met.
3.2.12 quality improvement(quality improvement): Part quality management(3.2.8) aimed at increasing the ability to meet quality requirements.
NOTE Requirements may relate to any aspect, such as effectiveness(3.2.14),efficiency(3.2.15) or traceability(3.5.4).
3.2.13 continuous improvement(continuous improvement): Repeated activity to increase the ability to perform requirements (3.1.2).
Note - Process(3.4.1) setting goals and seeking opportunities for improvement is an ongoing process using audit observations(3.9.5) and conclusions based on audit results(3.9.6), data analysis, analysis(3.8.7) by management or other means and usually leading to corrective actions(3.6.5)or preventive actions(3.6.4).
3.2.14 effectiveness effectiveness: The extent to which planned activities are implemented and planned results are achieved.
3.2.15 efficiency(efficiency): The relationship between the result achieved and the resources used.
3.3 Terms related to the organization
3.3.1organization(organization): A group of workers and necessary funds with a distribution of responsibilities, powers and relationships.
Example - A company, corporation, firm, enterprise, institution, charity, retailer, association, or any subdivision or combination thereof.
Notes
2 An organization can be public or private.
3 This definition applies to standards for quality management systems(3.2.3). ISO/IEC Guide 2 provides a different definition of the term "organization".
3.3.2organizational structure(organizational structure): Distribution of responsibilities, powers and relationships between employees.
Notes
1 The distribution is usually ordered.
2 A formal organizational structure is often contained in quality manual(3.7.4)or in in terms of quality(3.7.5)project(3.4.3).
3 The organizational structure may include appropriate interactions with external organizations(3.3.1).
3.3.3 infrastructure(infrastructure):<Организация>The totality of buildings, equipment and support services necessary for the operation of organizations(3.3.1).
3.3.4 work environment work environment: The set of conditions in which work is performed.
NOTE Conditions include physical, social, psychological and environmental factors (such as temperature, recognition and reward systems, ergonomics and atmospheric composition).
3.3.5 consumer(customer): Organization(3.3.1) or the person receiving products(3.4.2).
Example - Client, customer, end user, retailer, beneficiary and purchaser.
NOTE The customer may be internal or external to the organization.
3.3.6 provider(supplier): Organization(3.3.1) or the person providing products(3.4.2).
Example - Manufacturer, wholesaler, retailer or product seller, service provider, information provider.
Notes
NOTE 1 The supplier may be internal or external to the organization.
2 In a contractual situation, the supplier is sometimes called the "contractor".
3.3.7 interested party interested party: A person or group of people interested in an activity or success organizations(3.3.1).
Example - Consumers(3.3.5), owners, employees of the organization, suppliers (3.3.6), bankers, associations, partners or the public.
Note: A group may consist of an organization, part of an organization, or several organizations.
3.3.8 Contract(contract): A binding agreement.
3.4 Process and product terms
3.4.1process(process): A set of interrelated or interacting activities that transforms inputs into outputs.
Notes
1 Inputs to a process are usually the outputs of other processes.
2 Processes, in organizations(3.3.1) are typically planned and implemented under controlled conditions to add value.
3 The process in which confirmation compliance(3.6.1) finite products(3.4.2) is difficult or economically impractical, often referred to as a “special process”.
3.4.2 products(product): Result process(3.4.1).
Notes
1 There are four general product categories:
Services (for example, transportation);
Software (for example, computer program, dictionary);
Technical means (for example, engine assembly);
Recyclable materials (eg lubricant).
Many products contain elements belonging to different general product categories. The classification of products as services, software, hardware or processed materials depends on the predominant element.
For example, the supplied product “car” consists of hardware (for example, tires), processed materials (fuel, coolant), software (engine control software, driver’s manual) and services (operating instructions provided by the seller).
2 The service is the result of at least one action necessarily performed during interaction supplier(3.3.6) and consumer(3.3.5), and, as a rule, intangible. The provision of a service may include, for example, the following:
Activities carried out on material products supplied by the consumer (for example, repairing a faulty car);
Activities carried out on intangible products supplied by the consumer (for example, drawing up an income statement necessary to determine the amount of tax);
Providing intangible products (for example, information in the sense of knowledge transfer);
Creating favorable conditions for consumers (for example, in hotels and restaurants).
Software contains information and is usually intangible, may also be in the form of approaches, operations or procedures(3.4.5).
A technical means, as a rule, is material, and its quantity is expressed in a countable quantity. characteristic(3.5.1). The materials processed are usually tangible and their quantity is expressed as a continuous characteristic. Technical equipment and recyclable materials are often called goods.
3 Quality assurance(3.2.11) is aimed primarily at the intended product.
3.4.3 project(project): Unique process(3.4.1) consisting of a set of coordinated and controlled activities with start and end dates, undertaken to achieve a goal corresponding to a specific requirements(3.1.2), including restrictions on timing, cost and resources.
Notes
1 A single project may be part of a larger project structure.
2 In some projects, goals are improved, and characteristics(3.5.1) products are determined accordingly as the project progresses.
3 The output of a project can be one product or several units products(3.4.2).
4 Adapted from ISO 10006:2003.
3.4.4 design and development(design and development): Totality processes(3.4.1), translating requirements(3.1.2) to the established characteristics(3.5.1)or specifications(3.7.3)on products(3.4.2),process(3.4.1)or system(3.2.1).
Notes
NOTE 1 The terms “design” and “development” are sometimes used interchangeably and sometimes to define different stages of the design and development process as a whole.
NOTE 2 Qualifying words may be used to identify the subject of design and development (for example, product design and development or process design and development).
3.4.5 procedure(procedure): A specified way of carrying out an activity or process(3.4.1).
Notes
NOTE 1 Procedures may be documented or undocumented.
NOTE 2 When a procedure is documented, the term “written procedure” or “documented procedure” is often used. Document(3.7.2) containing a procedure may be called a "procedural document".
3.5 Terms related to characteristics
3.5.1 characteristic(characteristic): Distinctive property.
Notes
1 A characteristic may be inherent or assigned.
2 Characteristics can be qualitative or quantitative.
3 There are different classes of characteristics, such as:
Physical (for example, mechanical, electrical, chemical or biological characteristics);
Organoleptic (for example, those related to smell, touch, taste, vision, hearing);
Ethical (eg, courtesy, honesty, truthfulness);
Temporary (for example, punctuality, reliability, availability);
Ergonomic (for example, physiological characteristics or related to human safety);
Functional (for example, the maximum speed of the aircraft).
3.5.2 quality characteristic(quality characteristic): Inherent products(3.4.2),process(3.4.1)or system(3.2.1)characteristic(3.5.1) related to requirement(3.1.2).
Notes
1 The word “inherent” means inherent in something, especially if it refers to a permanent characteristic.
NOTE 2 Assigned characteristics of a product, process or system (eg product price, product owner) are not characteristics of the quality of that product, process or system.
3.5.4 traceability traceability: The ability to trace the history, application, or location of something being considered.
Notes
1 Traceability in relation to products(3.4.2) may refer to:
Origin of materials and components;
Processing history;
Distribution and location of products after delivery.
2 In the field of metrology, the definition given in VIM-1993, subsection 6.10 is accepted.
3.6 Terms related to compliance
3.6.1correspondence(conformity): Execution requirements(3.1.2).
3.6.2 inconsistency(nonconformity): Failure to comply requirements(3.1.2).
3.6.3 defect(defect): Failure to execute requirements(3.1.2) associated with the intended or specified use.
Notes
1 The difference between the concepts of defect and inconsistency(3.6.2) is important because it has legal implications, especially related to product liability issues. Therefore, the term "defect" should be used with extreme caution.
2 Intended use consumer(3.3.5), may depend on the nature of the information, such as instructions for use and maintenance, provided supplier(3.3.6).
3.6.4preventive action(preventive): Action taken to eliminate the cause of a potential inconsistencies(3.6.2) or other potentially undesirable situation.
Notes
1 Potential nonconformity may have several causes.
2 Preventive action is taken to prevent an event from occurring and corrective action(3.6.5) - to prevent reoccurrence of the event.
3.6.5 corrective action(corrective action): Action taken to eliminate the cause of a detected inconsistencies(3.6.2) or other undesirable situation.
Notes
1 Nonconformity may have several causes.
2 Corrective action is taken to prevent recurrence of the event, and preventive action(3.6.4) - to prevent the occurrence of an event.
3 Terms should be distinguished correction(3.6.6) and corrective action.
3.6.6 correction(correction): Action taken to correct a detected inconsistencies(3.6.2).
Notes
1 Correction can be carried out in combination with corrective action (3.6.5).
2 Correction may include, for example, rework(3.6.7)or reduction in gradation (3.6.8).
3.6.7 alteration(rework): Action taken regarding non-conforming products(3.4.2) in order for it to correspond requirements (3.1.2).
Note - Unlike rework repair(3.6.9) may affect or change parts of the nonconforming product.
3.6.8 reduction in gradation(regrade): Change gradations(3.1.3) non-conforming products(3.4.2) in order for it to correspond requirements(3.1.2), different from the original ones.
3.6.9 repair(repair): Action taken regarding non-conforming products(3.4.2) in order to make it acceptable for its intended use.
Notes
NOTE 1 Repair includes remedial action taken on previously conforming products to restore them for use, for example as part of maintenance.
2 Unlike alterations(3.6.7) Repairs may affect or change parts of the nonconforming product.
3.6.10disposal(scrap): Action regarding non-conforming products(3.4.2) taken to prevent its originally intended use.
Example - Recycling or destruction.
Note - In a non-conforming service situation, use is prevented by termination of the service.
3.6.11 permission to deviate(concession): Permission to use or release (3.6.13)products(3.4.2), which does not comply with the established requirements (3.1.2).
NOTE Authorization for deviation usually applies to the supply of products with non-conforming characteristics(3.5.1) for established agreed upon time or quantity limits for a given product.
3.6.12 permission to retreat(deviation permit): Permission to deviate from the original established requirements(3.1.2)k products(3.4.2) issued before its production.
NOTE A derogation is usually granted for a limited quantity of product or period of time, or for a specific use.
3.6.13 release(release): Permission to proceed to the next stage process (3.4.1).
Note - In English, in the context of software, the term “release” often refers to the version of the software itself.
3.7 Terms related to documentation
3.7.1 information(information): Meaningful data.
3.7.2 document(document): Information(3.7.1), presented on an appropriate medium.
Example - Posts(3.7.6), specification(3.7.3), procedural document, drawing, report, standard.
Notes
1 The medium may be paper, magnetic, electronic or optical, computer disk, photograph or master sample, or a combination thereof.
2 A set of documents, such as specifications and records, is often called “documentation”.
3 Some requirements(3.1.2) (e.g. legibility requirements) apply to all types of documents, but there may be specific requirements for specifications (e.g. revision control requirements) and records (e.g. recovery requirements).
3.7.3 specification(specification): Document(3.7.2), establishing requirements(3.1.2).
NOTE Specifications may relate to an activity (for example, a procedural document, a process specification or a test specification) or products(3.4.2) (for example, product specifications, operational documentation and drawings).
3.7.4 quality quide(quality manual): Document(3.7.2), defining quality management system(3.2.3)organizations(3.3.1).
NOTE Quality manuals may vary in detail and form depending on the size and complexity of the particular organization.
3.7.5 quality plan(quality plan): Document(3.7.2), which determines which procedures(3.4.5) and related resources, by whom and when, should be applied in relation to a particular project(3.4.3),products(3.4.2),process(3.4.1)or contract(3.3.8).
Notes
NOTE 1 These procedures typically include those associated with quality management processes and product life cycle processes.
3 A quality plan is usually one of the deliverables quality planning (3.2.9).
3.7.6 record(record): Document(3.7.2) containing results achieved or evidence of activities performed.
Notes
1 Records can be used, for example, to document traceability(3.5.4) and evidence of performance verification(3.8.4),preventive actions(3.6.4) and corrective actions(3.6.5).
2 Revisions of records generally do not need to be managed.
3.8 Terms related to assessment
3.8.1 objective evidence(objective evidence): Data confirming the presence or truth of something.
NOTE Objective evidence may be obtained by observation, measurement, test (3.8.3) or other means.
3.8.3 trial(test): Determination of one or more characteristics(3.5.1) according to the established procedure(3.4.5).
3.8.4 verification(verification): Confirmation by representation objective evidence(3.8.1) that the established requirements(3.1.2) were fulfilled.
Notes
1 The term “verified” is used to indicate the corresponding status.
2 Requirement validation activities may include:
Implementation of alternative calculations;
Comparison specifications(3.7.3) for a new project with similar documentation for the approved project;
Carrying out tests(3.8.3) and demonstrations;
Analysis of documents before their release.
3.8.5 validation(validation): Confirmation by presentation objective evidence(3.8.1) that requirements(3.1.2) intended for a specific use or application are met.
Notes
1 The term “validated” is used to indicate the corresponding status.
2 Application conditions may be real or simulated.
3.8.6 qualification process(qualification process): Process(3.4.1) demonstrating the ability to meet specified requirements(3.1.2).
Notes
1 The term “qualified” is used to indicate the appropriate status.
2 Qualifications may apply to employees products(3.4.2), processes or systems (3.2.1).
Example - The process of qualifying auditors, the process of qualifying material.
3.8.7 analysis(review): Activities undertaken to determine the suitability, adequacy and effectiveness(3.2.14) of the object under consideration to achieve the established goals.
NOTE The analysis may also include determining efficiency (3.2.15).
Example - Management analysis, design and development analysis, customer requirements analysis, non-conformance analysis.
3.9 Terms related to audit (verification)
3.9.1 audit (verification)(audit): Systematic, independent and documented process(3.4.1)receipt audit evidence(3.9.4) and their objective assessment in order to establish the degree of fulfillment of the agreed audit criteria(3.9.3).
Notes
1 Internal audits, sometimes called first-party audits, are usually conducted by the organization(3.3.1) or on its behalf for internal purposes and may form the basis for a declaration of compliance(3.6.1). In many cases, especially in smaller organizations, independence can be demonstrated by a lack of responsibility for the work being audited.
NOTE 2 External audits include audits commonly referred to as second party audits or third party audits. Second party audits are conducted by parties with an interest in the organization's activities, e.g. consumers(3.3.5) or other persons on their behalf. Third party audits are conducted by external independent organizations. These organizations provide certification or registration for compliance with requirements such as ISO 9001 and ISO 14001.
3 If two or more management systems(3.2.2) are audited together, this is called a comprehensive audit.
4 If two or more organizations jointly conduct an audit audited organization(3.9.8), this is called joint audit.
3.9.2 audit program(audit program): A collection of one or more audits(3.9.1) planned for a specific period of time and aimed at achieving a specific goal.
NOTE An audit program includes all activities necessary to plan, organize and conduct audits.
3.9.3 audit criteria(audit criteria): The set of policies procedures(3.4.5)or requirements(3.1.2), which are used by reference.
NOTE Audit criteria are used for comparison audit evidence (3.9.4).
3.9.4 audit certificate(audit evidence): Posts(3.7.6), statement of facts or other information(3.7.1), which are related to audit criteria(3.9.3) and can be verified.
NOTE Audit evidence may be qualitative or quantitative.
3.9.5 audit observations(audit findings): Results of evaluation of collected audit evidence(3.9.4) with respect to audit criteria(3.9.3).
NOTE Audit observations may indicate correspondence(3.6.1)or inconsistency(3.6.2) audit criteria or opportunities for improvement.
3.9.6 conclusions based on audit results(audit conclusion): Output audit(3.9.1) provided audit team(3.9.10) after considering the audit objectives and all audit observations(3.9.5).
3.9.7 audit client(audit client): Organization(3.3.1) or the person who ordered audit(3.9.1).
Note - The audit client can be audited organization(3.9.8) or any other organization(3.3.1) that has the legal or contractual right to request an audit.
3.9.8 audited organization(auditee): Organization(3.3.1), subject to audit(3.9.1).
3.9.9 auditor(auditor): A person who has demonstrated his personal qualities and has competence(3.1.6 and 3.9.14) to carry out audit(3.9.1).
NOTE A description of the important personal qualities of an auditor is given in ISO 19011.
3.9.10 audit team(audit team): One or more auditors(3.9.9), conducting audit(3.9.1), supported if necessary technical experts(3.9.11).
Notes
1 One of the auditors in the audit team is usually designated as the team leader.
2 The audit team may also include trainee auditors.
3.9.11 technical expert(technical expert):<Аудит>A person having the special knowledge or experience necessary audit team(3.9.10).
Notes
1 Specialized knowledge or experience includes knowledge or experience related to organizations(3.3.1),process(3.4.1) or the activity being audited, as well as knowledge of the language and culture of the country in which the audit is being conducted.
2 The technical expert has no authority auditor(3.9.9) in the audit team.
3.9.12 audit plan(audit plan): Description of activities and measures to carry out audit(3.9.1).
3.9.13 audit area(audit scope): Content and boundaries audit(3.9.1).
NOTE The scope of an audit typically includes location, organizational structure, activities and processes(3.4.1), as well as the time period covered.
3.9.14 competence(competence):<Аудит>Demonstrated personal qualities and ability to apply knowledge and skills.
3.10 Terms related to quality management of measurement processes
3.10.1 measurement management system measurement management system: A set of interrelated or interacting elements necessary to achieve metrological confirmation of suitability(3.10.3) and constant control measurement processes(3.10.2).
3.10.2 measurement process measurement process: A set of operations carried out to determine the value of a quantity.
3.10.3 metrological confirmation of suitability(metrological confirmation): The set of operations carried out to ensure compliance measuring equipment(3.10.4)requirements(3.1.2) suitable for its purpose.
Notes
1 Metrological confirmation of suitability usually includes calibration or verification(3.8.4), any necessary adjustment or repair(3.6.9) and subsequent recalibration, comparison with metrological requirements for the intended use of the equipment, and any required sealing and marking.
2 Metrological confirmation of suitability is not considered complete until the suitability of the measuring equipment for its intended use has been demonstrated and documented.
3 Requirements for intended use include characteristics such as range, resolution, maximum permissible error, etc.
4 Requirements for metrological confirmation of suitability usually differ from the requirements for products and are not regulated by them.
3.10.4 measuring equipment(measuring equipment): Measuring instruments, software, standards, reference materials, auxiliary equipment, or a combination thereof, necessary to perform measurement process(3.10.2).
3.10.5 metrological characteristic(metrological characteristic): A distinctive feature that can affect the results of a measurement.
Notes
1 Measuring equipment(3.10.4) usually has several metrological characteristics.
2 Metrological characteristics may be subject to calibration.
3.10.6 metrological service(metrological function): Organizational structure with administrative and technical responsibility for defining and implementing measurement management systems(3.10.1).
Note - The word “definition” has the meaning of “establishing standards”. It is not used in the terminological sense of "defining a concept" (in some languages this distinction is unclear without context).
Appendix A
(informative)
Methodology used to develop the dictionary
A.1 Introduction
The universality of application of the ISO 9000 family of standards requires the use of:
Technical description, but not in highly specialized technical language;
A coherent and harmonized vocabulary that is understandable to all potential users of quality management system standards.
Concepts are interdependent, and analyzing the relationships between quality management system concepts and organizing them into concept systems is a prerequisite for developing a consistent vocabulary. Such analysis was carried out in developing the vocabulary specified in this standard. Since the graphical constructions of concepts used in the development may be useful from the point of view of information content, they are presented in A.4.
A concept forms a unit of transition from one language to another (including variants of one language, such as American English and British English). From each language, the most suitable term is selected for complete clarity of the concept in that language, i.e. a non-literal translation approach is used.
The definition is constructed by describing only those features that are essential for identifying the concept. Important information that is relevant to a concept but not essential to its description is given in one or more notes to the definition.
When replacing a term in a text with its definition with minimal syntactic changes, the meaning of the text should not change. This replacement allows us to obtain a simple method for checking the correctness of the definition. However, if the definition is complex and contains several terms, it is better to replace it using at most two definitions at the same time. Complete replacement of all terms will create syntactic difficulties and will be useless in conveying meaning.
A.3 Relationships between concepts and their graphical representation
A.3.1 General
In terminological work, connections between concepts are based on hierarchical relationships between the characteristics of types in such a way that the most economical description of a concept is formed by naming its types and describing the characteristics that distinguish it from superior or subordinate concepts.
There are three main types of connections between concepts, indicated in this appendix: generic (A.3.2), partitive (A.3.3) and associative (A.3.4).
A.3.2 Generic relationship
Subordinate concepts within the hierarchy inherit the features of the superordinate concept and contain descriptions of those features that distinguish them from superordinate (superior) and coordinate (subordinate) concepts, for example, the connection between spring, summer, autumn and winter with the seasons.
Generic connections are depicted graphically in the form of a “fan” or “tree” without arrows (Figure A.1).
Figure A.1 - Graphic representation of the genus-species relationship
A.3.3 Partitive communication
Subordinate concepts within one hierarchical system are part of a superordinate concept, for example, spring, summer, autumn and winter can be defined as parts of the year, and it is unacceptable to define good weather (one of the possible characteristics of summer) as part of the year.
Partitive relations are depicted in the form of a “rake” (Figure A.2), with single parts depicted by one line, and multiple parts by several.
Figure A.2 - Graphical representation of participatory communication
A.3.4 Associative connection
Associative connections are not as economical as generic and partitive ones, but they help determine the nature of the relationship between two concepts within a system of concepts, for example, cause and effect, action and place, action and result, tool and function, material and product.
Associative connections are depicted as a single line with an arrow at each end (Figure A.3).
Figure A.3 - Graphical representation of an associative relationship
A.4 Graphical representation of concepts
Figures A.4 - A.13 present graphical representations of the concepts on which the subject groups of Section 3 of this standard are based.
Definitions of terms are repeated, but they are not illustrated with notes, so it is recommended that you refer to Section 3 for notes.
Figure A.4 - Concepts related to quality (3.1)
Figure A.5 - Concepts related to management (3.2)
Figure A.6 - Concepts related to organization (3.3)
Figure A.7 - Concepts related to processes and products (3.4)
Figure A.8 - Concepts related to characteristics (3.5)
Figure A.9 - Concepts related to conformance (3.6)
Figure A.10 - Concepts related to documentation (3.7)
Figure A.11 - Concepts related to assessment (3.8)
Figure A.12 - Concepts related to audit (verification) (3.9)
Figure A.13 - Concepts related to quality management of measurement processes (3.10)
Alphabetical index of terms in Russian
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analysis................................................. ........................................................ ......................... |
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audit........................................................ ........................................................ ........................... |
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auditor................................................. ........................................................ ...................... |
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validation........................................................ ........................................................ ............... |
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verification......................................................... ........................................................ ............. |
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possibilities................................................. ........................................................ ............. |
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release................................................. ........................................................ ....................... |
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gradation........................................................ ........................................................ .................... |
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audit team........................................................ ........................................................ ........ |
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corrective action................................................... ......................................... |
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preventive action................................................... ....................................... |
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defect................................................. ........................................................ ........................ |
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document................................................. ........................................................ .................... |
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audit client........................................................ ........................................................ .......... |
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conclusions based on the audit results......................................................... ............................... |
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recording........................................................ ........................................................ ......................... |
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information................................................. ........................................................ ............... |
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infrastructure................................................. ........................................................ ........ |
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trial................................................. ........................................................ ............. |
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quality................................................. ........................................................ .................... |
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competence................................................. ........................................................ ......... |
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competence<аудит>............................................................................................ |
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Contract................................................. ........................................................ .................... |
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control................................................. ........................................................ .................... |
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correction................................................. ........................................................ ............... |
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audit criteria................................................................ ........................................................ ........ |
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management................................................. ........................................................ ............... |
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quality management................................................ ........................................................ |
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audit observations................................................................ ........................................................ .... |
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reliability................................................. ........................................................ ................ |
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inconsistency......................................................... ........................................................ .......... |
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quality assurance................................................ ........................................................ |
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audit scope......................................................... ........................................................ ............ |
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measuring equipment................................................... .................................... |
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organization................................................. ........................................................ ............... |
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organization being inspected......................................................... ........................................... |
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rework......................................................... ........................................................ ................... |
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audit plan................................................... ........................................................ ................ |
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quality plan................................................... ........................................................ ............. |
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quality planning........................................................ ............................................... |
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metrological confirmation of suitability................................................... ........ |
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quality policy......................................................... ........................................ |
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provider................................................. ........................................................ ............. |
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consumer................................................. ........................................................ ............... |
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audit program........................................................ ........................................................ ...... |
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products........................................................ ........................................................ ............... |
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project................................................. ........................................................ ........................ |
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design and development........................................................ .................................... |
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traceability................................................. ........................................................ .... |
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procedure................................................. ........................................................ ............... |
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process................................................. ........................................................ ...................... |
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measurement process................................................... ........................................................ .... |
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qualification process................................................... ............................................... |
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permission to deviate................................................... ........................................... |
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permission to retreat......................................................... ......................................... |
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effectiveness........................................................ ........................................................ ...... |
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repair................................................. ........................................................ ........................ |
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senior management................................................... ........................................................ .. |
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quality quide............................................... ............................................... |
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audit certificate................................................................ ........................................................ |
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objective evidence......................................................... ........................................ |
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system................................................. ........................................................ ....................... |
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management system........................................................ ........................................................ |
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measurement management system................................................................... ............................... |
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Quality Management System............................................... ................................... |
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metrological service................................................... ............................................... |
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reduction in gradation................................................... ........................................................ ... |
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correspondence................................................. ........................................................ .............. |
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specification................................................. ........................................................ .......... |
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production environment........................................................ ........................................................ |
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interested party........................................................ ........................................... |
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organizational structure........................................................ ....................................... |
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technical expert<аудит>.................................................................................... |
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requirement................................................. ........................................................ ............. |
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customer satisfaction................................................................ ............................... |
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quality improvement................................................................ ........................................................ .. |
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constant improvement................................................... ............................................... |
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quality control................................................ ................................................... |
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disposal................................................. ........................................................ ................ |
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characteristic................................................. ........................................................ ......... |
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quality characteristics........................................................ ............................................... |
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quality goals......................................................... ................................................... |
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metrological characteristics................................................... ............................... |
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efficiency................................................. ........................................................ .......... |
Alphabetical index of terms in English
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audit........................................................ ........................................................ ........................... |
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audit client........................................................ ........................................................ ............... |
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audit conclusion................................................ ........................................................ .......... |
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audit criteria................................................... ........................................................ ................ |
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audit evidence................................................... ........................................................ ............ |
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audit findings................................................ ........................................................ ............. |
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audit plan........................................................ ........................................................ .................... |
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audit program........................................................ ........................................................ ......... |
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audit scope................................................ ........................................................ ............... |
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team audit................................................... ........................................................ ................... |
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auditee........................................................ ........................................................ ....................... |
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auditor........................................................ ........................................................ ....................... |
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capability........................................................ ........................................................ ................... |
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characteristic................................................... ........................................................ .............. |
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competence........................................................ ........................................................ ................ |
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competence |
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concession........................................................ ........................................................ ............... |
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conformity........................................................ ........................................................ ............. |
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continual improvement................................................... ................................................... |
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contract........................................................ ........................................................ ...................... |
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correction........................................................ ........................................................ ................... |
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corrective action................................................ ........................................................ ......... |
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customer................................................... ........................................................ .................... |
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customer satisfaction................................................... ........................................................ .. |
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defect................................................ ........................................................ ......................... |
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dependability........................................................ ........................................................ ............. |
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design and development........................................................ ................................................... |
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deviation permit................................................ ........................................................ .......... |
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document........................................................ ........................................................ ................... |
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effectiveness........................................................ ........................................................ .............. |
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efficiency........................................................ ........................................................ ................... |
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grade........................................................ ........................................................ ........................... |
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information................................................ ........................................................ ................ |
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infrastructure........................................................ ........................................................ ............. |
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inspection........................................................ ........................................................ ................... |
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interested party................................................ ........................................................ .......... |
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management........................................................ ........................................................ ............... |
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management system................................................ ........................................................ .... |
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measurement management system........................................................ ................................... |
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measurement process................................................... ........................................................ .. |
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measuring equipment................................................... ........................................................ .. |
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metrological characteristic................................................... ............................................ |
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metrological confirmation................................................... ............................................... |
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metrological function................................................... ........................................................ .. |
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nonconformity......................................................... ........................................................ .......... |
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objective evidence................................................... ........................................................ ...... |
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organization........................................................ ........................................................ ............... |
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organizational structure................................................ ................................................... |
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preventive........................................................ ........................................................ ............... |
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procedure................................................... ........................................................ ................... |
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process........................................................ ........................................................ ....................... |
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product........................................................ ........................................................ ...................... |
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project................................................ ........................................................ ........................ |
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qualification process................................................... ........................................................ ... |
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quality........................................................ ........................................................ ........................ |
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quality assurance................................................... ........................................................ ......... |
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quality characteristic................................................... ........................................................ ... |
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quality control................................................ ........................................................ ............. |
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quality improvement................................................ ........................................................ ... |
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quality management................................................ ........................................................ .... |
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quality management system........................................................ ........................................... |
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quality manual................................................ ........................................................ ............ |
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quality objective................................................ ........................................................ ......... |
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quality plan........................................................ ........................................................ ............. |
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quality planning........................................................ ........................................................ .......... |
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quality policy................................................ ........................................................ .............. |
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record........................................................ ........................................................ ......................... |
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upgrade........................................................ ........................................................ ....................... |
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release................................................ ........................................................ ........................ |
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repair........................................................ ........................................................ ........................... |
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requirement........................................................ ........................................................ ................ |
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review................................................ ........................................................ ........................ |
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rework........................................................ ........................................................ ........................ |
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scrap................................................ ........................................................ ........................... |
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specification........................................................ ........................................................ ............... |
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supplier........................................................ ........................................................ ...................... |
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system........................................................ ........................................................ ........................ |
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technical expert |
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test................................................... ........................................................ ............................ |
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top management................................................ ........................................................ ......... |
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traceability........................................................ ........................................................ ............. |
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validation........................................................ ........................................................ ................... |
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verification........................................................ ........................................................ ............. |
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work environment........................................................ ........................................................ ....... |
Bibliography
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Terminology work - Principles and methods |
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Terminology work - Vocabulary - Part 1: Theory and application |
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Statistics - Vocabulary and symbols - Part 2: Applied statistics 1) |
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Quality management systems - Requirements 2) |
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Quality management systems - Guidelines for performance improvements 3) |
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Measurement management systems - Requirements for measurement processes and measuring equipment |
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Guidelines for quality management system documentation |
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Guidance on statistical techniques for ISO 9001:2000 |
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Guidelines for the selection of quality management system consultants and use of their services |
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International terminology standards - Preparation and layout |
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Guidelines for the selection of statistical methods in standardization and specification |
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|
Conformity assessment - Vocabulary and general principles |
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|
Guidelines for quality and/or environmental management systems auditing |
|
|
ISO/IEC Guide 2 |
Standardization and related activities - General vocabulary |
|
International Electrotechnical Vocabulary - Chapter 191: Dependability and quality of service |
|
|
IEC 60050-191/A2:2002 |
International Electrotechnical Vocabulary - Chapter 191: Dependability and quality of service: Amendment 2 |
|
International vocabulary of basic and general terms in metrology, BIPM/IEC/ /IFCC/ISO/OIML/IUPAC/IUPAP |
|
|
Quality Management Principles Brochure 4) |
|
|
ISO9000 + ISO 14000 |
News (a bimonthly publication which provides comprehensive coverage of international developments relating to ISO's management system standards, including news of their implementation by diverse organizations around the world) 5) |
|
Directives, Part 1, Part 2:2004 and Supplement |
2) Since November 15, 2008, ISO 9001:2008 has been in force instead of ISO 9001:2000.
3) From 01.11.2009, instead of ISO 9004:2000, ISO 9004:2009 is in force.
4) The brochure is available on the Internet: http://www.iso.ch.
5) Distributed by the ISO Central Secretariat ( [email protected]).
Keywords: quality management system, quality management principles, process approach, continuous improvement, terms and definitions
This International Standard establishes the fundamental principles of quality management systems that are the subject of the ISO 9000 family of standards and defines relevant terms.
This standard may be used:
a) organizations seeking to achieve advantage through the implementation of a quality management system;
b) organizations that want to be confident that their specified product requirements will be met by suppliers;
c) users of the products;
d) those interested in a common understanding of the terminology used in quality management (eg suppliers, customers, regulatory authorities);
e) those parties, internal or external to the organization, who evaluate the quality management system or verify its conformity with the requirements of ISO 9001 (for example auditors, regulatory bodies, certification/registration bodies);
f) those parties, internal or external to the organization, who provide advice or training on the quality management system to the organization;
g) developers of relevant standards
| Title of the document: | GOST ISO 9000-2011 |
| Document type: | standard |
| Document status: | current |
| Russian name: | Quality management systems. Fundamentals and Vocabulary |
| English name: | Quality management systems. Fundamentals and vocabulary |
| Date of text update: | 01.08.2013 |
| Date of introduction: | 01.01.2013 |
| Description update date: | 01.08.2013 |
| Number of pages in the main text of the document: | 32 pcs. |
| Publication date: | 07.11.2012 |
| Reissue: | |
| Last modified date: | 22.05.2013 |
| Is located in: | OKS All-Russian classifier of standards 01 GENERAL PROVISIONS. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION 01.040 Dictionaries 01.040.03 Services. Organization of companies, management and quality. Administration. Transport. Sociology (Dictionaries) (Standards included in this group should also be included in other groups and/or subgroups according to their topics) 03 SERVICES. COMPANY ORGANIZATION, MANAGEMENT AND QUALITY. ADMINISTRATION. TRANSPORT. SOCIOLOGY. 03.120 Quality 03.120.10 Quality management and quality assurance |
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