Brainstorming: A group activity that involves generating as many ideas as possible without judging or evaluating them
Breakdown maintenance: The process of repairing a machine or equipment only after it has failed or stopped working
Business process reengineering (BPR): The process of redesigning an organization's processes to improve efficiency, effectiveness, and competitiveness
Business Value-added Activities: These activities are required to stay in business but do not add value from the customer's perspective.
C
Capacity: The maximum amount of work that a process or system can handle within a specific period
Capability: The ability of a process or system to produce conforming products or services within specified limits
Cause and effect diagram: A tool used to identify and organize the causes of a problem or issue. This is also called the Fishbone diagram or Ishikawa Diagram.
Certification: The process of verifying that an individual or organization meets a specific set of standards or requirements
Change management: The process of planning, implementing and controlling changes to an organization's processes, products, or services.
Charter: A document that outlines the purpose, goals, and objectives of a project or initiative, as well as the roles, responsibilities, and expectations of the team members involved.
Control phase: The final step in the DMAIC process (define, measure, analyze, improve, control), where the solutions implemented in the improve phase are put into place on a long-term basis and monitored to ensure that the problem does not reoccur
Control chart: A graphical representation of process data over time that is used to identify patterns, trends, and special causes of variation
Control plan: A document that outlines the measures and methods that will be used to ensure that a product or process remains within specified limits
Corrective action: A specific course of action taken to correct a problem or deviation from established standards or requirements to avoid the recurrence of the problem.
Cost of quality (COQ): The total cost of all activities that are associated with ensuring that a product or service meets the required quality standards
Customer satisfaction: The degree to which a product or service meets or exceeds a customer's expectations
D
Data: The facts, figures, or information that are collected and analyzed to support decision making
Data collection: The process of gathering, organizing, and recording data for a specific purpose
Data mining: The process of extracting useful or meaningful information from a large dataset
Data visualization: The process of using graphical techniques, such as charts, graphs, and maps, to represent and communicate data in a clear and concise manner
Design for six sigma (DFSS): A methodology used to design and develop new products, processes, or services that meet or exceed customer requirements and expectations, focusing on reducing defects and variability.
Design of experiments (DOE): A statistical method used to test and evaluate multiple variables simultaneously to determine the effect of each variable on the outcome of a process or experiment
DMAIC: Define, measure, analyze, improve, control, a problem-solving approach used in Six Sigma methodology
Documentation: The process of creating, organizing, and maintaining records or documents that provide evidence of an organization's processes, products, or services
E
Effective: The degree to which a product or service meets or exceeds the intended purpose or objective
Efficiency: The relationship between the output of a process or system and the input of resources, such as time, money, or materials
Employee engagement: The degree to which employees are committed to the success of an organization and are motivated to contribute to its goals and objectives
Error proofing: The process of designing or implementing controls or systems to prevent errors or defects from occurring in a process or product. This is called Poka-yoke in Japanese.
F
Failure mode and effects analysis (FMEA): A systematic method used to identify and evaluate a product's or process's potential failure modes and the effects of those failures on the overall system. Related term: Risk Priority Number (RPN)
Flowchart: A diagram that represents the steps or tasks in a process, as well as the relationships between those steps or tasks
Focus group: A group of individuals who are selected and brought together to discuss a specific topic or issue
Force field analysis: A tool used to identify the forces that are driving or resisting change in a system or process
G
Gantt chart: A graphical representation of the planned and actual progress of a project, typically showing the tasks, resources, and dependencies involved in the project.
Gemba: A Japanese term that means "the real place" or "the place where the work is done," often used in lean manufacturing to refer to the factory floor or the place where value is created
Genchi genbutsu: Literally translated as "go see for yourself." In quality management, this refers to visiting a company's production facilities to observe how it actually makes things happen
Goal: A specific, measurable, achievable, relevant, and time-bound (SMART) objective or target that an organization or individual strives to achieve
Governance: The policies, processes, and practices that are used to manage and control an organization or system
Green belt: A lean manufacturing term for a Six Sigma practitioner who has been trained in the basics of the methodology and is capable of leading and facilitating small improvement projects
H
Hoshin planning: A strategic planning and deployment method that aligns an organization's goals and objectives with its business plans and operational activities
House of quality: A tool used in new product development to identify the relationships between customer requirements, product characteristics, and technical requirements
Hypothesis: A testable statement or prediction that is made based on limited evidence or data and that can be confirmed or rejected through further testing or observation
I
Implementation: The process of putting a plan, solution, or strategy into action
Improvement: The process of making changes to a product, process, or system to increase its effectiveness, efficiency, or quality
Inspection: The process of evaluating a product or service to determine whether it meets the specified standards or requirements
J
Just in Time (JIT): An approach to production scheduling that emphasizes delivering products at just the right time to meet demand
Jidoka: Automation with a human touch. See also Autonomation.
K
Kaikaku: radical change or innovation.
Kaizen: A Japanese term that means "continuous improvement," often used in lean manufacturing to refer to the process of making small, incremental improvements to processes, products, or services on an ongoing basis.
Kanban: A Japanese term that refers to a visual signal or symbol used to indicate what needs to be worked on next. Kanban boards are used to track the flow of materials throughout a manufacturing facility.
Key performance indicator (KPI): A metric that is used to measure the performance of an organization, process, or individual against specific goals or objectives
L
Lean manufacturing: A methodology that focuses on reducing waste and increasing value by eliminating or minimizing activities that do not add value to the end product or service
Learning organization: An organization that fosters continuous learning and development and can adapt and change in response to new information or challenges.
Level loading: The process of balancing the workload of a process or system over time to ensure that it operates at a consistent and optimal level
Limit: A maximum or minimum value that is used to define the acceptable range of a process or product characteristic
Lower specification limit (LSL): the minimum value or threshold that a product or process characteristic can have without being considered defective or out of specification.
M
Maintenance: The process of preserving, repairing, or replacing equipment, machinery, or facilities to ensure that they continue to operate at their intended level of performance
Management review: A systematic evaluation of an organization's processes, products, or services to determine whether they are meeting the intended goals and objectives and to identify opportunities for improvement
Matrix organization: An organizational structure that combines functional and project-based structures and that allows for cross-functional collaboration and coordination
Metric: A measure or indicator that is used to evaluate the performance of a process, product, or system against specific goals or standards
Mission: A statement that defines the purpose or reason for the existence of an organization and that guides its decision-making and actions
Mistake-proofing: See error proofing
Muda: In Japanese, Muda means "waste" or "loss." Muda occurs when resources are wasted because they were not put to use efficiently.
Mura: Mura is the waste of unevenness or inconsistency.
Muri: Muri means overburdening, beyond one's power, excessive, or unreasonable.
N
Nemawashi: A Japanese word for informal consultation or consensus-building.
Non-value-added Activities: Activities that do not contribute directly to the creation of value for customers, such as administrative tasks, training, and meetings
O
Objective: A specific, measurable, achievable, relevant, and time-bound (SMART) goal or target that an organization or individual strives to achieve
OEE (overall equipment effectiveness): A metric that is used to measure the efficiency and effectiveness of a manufacturing process, typically by calculating the percentage of planned production time that is productive
Operational definition: A clear and specific description of a term, concept, or measurement that is used in a study or experiment
Opportunity cost: The value of the next best alternative that is foregone as a result of choosing a particular course of action
Organizational culture: The shared values, beliefs, attitudes, and behaviours that define an organization and shape its interactions with its employees, customers, and other stakeholders
Outcome: The result or impact of a particular course of action or decision
Outlier: A data point that is significantly different from the other points in a dataset
P
Pareto analysis: A tool used to prioritize a set of issues or problems by identifying the most significant ones that contribute to the majority of the overall impact or effect
Performance measurement: The process of collecting, analyzing, and reporting data on the performance of an organization, process, or individual against specific goals or standards
Poka-yoke: A method of preventing errors through the use of simple checks and procedures that have been designed to eliminate human error
Preventive Action: An action taken before a problem occurs to prevent the problem from happening
Process: A series of steps or activities that are carried out to achieve a specific result or outcome
Process capability: The ability of a process to produce conforming products or services within specified limits.
Process flowchart: A diagram that represents the steps or tasks in a process, as well as the relationships between those steps or tasks
Process mapping: The process of documenting, analyzing, and improving the flow of information, materials, or people within a process or system
Process improvement: The process of making changes to a process or system to increase its effectiveness, efficiency, or quality
Process performance: The degree to which a process meets or exceeds the intended goals or objectives
Productivity: The relationship between the output of a process or system and the input of resources, such as time, money, or materials
Project charter: A document that outlines the scope, objectives, and stakeholders of a project, as well as the roles and responsibilities of the project team
Project management: The process of planning, organizing, and controlling the resources and activities of a project to achieve its specific goals and objectives
Q
Quality: The degree to which a product or service meets or exceeds the intended purpose or objective
Quality assurance (QA): The process of ensuring that a product or service meets the specified standards or requirements
Quality control (QC): The process of inspecting, testing, or evaluating a product or service to ensure that it meets the specified standards or requirements
Quality management: The process of planning, organizing, and controlling the activities and resources of an organization to ensure that its products or services meet or exceed the required quality standards.
Quality policy: A written statement describing how a company intends to implement and manage quality
Quality plan: A detailed description of how a company plans to improve its processes and procedures to ensure that they consistently produce high-quality products or services
Quality system: The policies, processes, and procedures used to manage and control the quality of an organization's products or services. This is also called Quality Management System (QMS)
R
RACI matrix: A tool used to clarify and communicate the roles and responsibilities of individuals or teams within a project or process
Reducing setup time: The process of reducing the time required to change over or set up a machine, process, or system from one product or operation to another. Also, see Single Minute Exchange of Die (SMED)
Reliability: The ability of a product or system to function consistently and dependably over time
Requirements: The specific needs, specifications, or constraints that must be satisfied by a product, process, or system
Risk Priority Number (RPN): An estimate of the relative risk associated with each potential problem or failure. It is calculated by multiplying severity, likelihood and detection numbers.
Robust: The ability of a product or system to perform consistently and effectively under varying conditions or circumstances
Root cause analysis: The process of identifying the underlying or fundamental cause of a problem or issue, as opposed to the symptoms or surface-level causes
S
Single Minute Exchange of Die (SMED): The process of exchanging dies in less than 10 minutes (single digit) to reduce downtime and improve productivity
SIPOC diagram: A tool used to map and document the suppliers, inputs, process, outputs, and customers of a process or system
Six Sigma: A methodology that uses data and statistical analysis to identify and eliminate defects or variations in a process or product. A Six Sigma process produces less than 3.4 defects per million opportunities (DPMO).
Standard: A specific requirement, guideline, or criterion that is used to evaluate the performance of a product, process, or system
Statistical process control (SPC): The use of statistical tools and techniques to monitor and control the performance of a process or system to improve its quality and consistency.
Strategic planning: The process of defining an organization's goals, objectives, and strategies and of allocating the resources and activities needed to achieve those goals
Sustainability: The ability of a system or process to meet the needs of the present without compromising the ability of future generations to meet their own needs
Systems engineering: A discipline that focuses on the design and management of complex systems, processes, or products
T
Takt time: The rate of customer demand.
Target: A specific objective or goal that an organization, process or individual strives to achieve
Theory of constraints (TOC): A management philosophy that focuses on identifying and removing the constraints or bottlenecks that limit the performance of a process or system
Total productive maintenance (TPM): A maintenance strategy that involves all employees in the maintenance and improvement of equipment, machinery, or facilities
Total quality management (TQM): A management philosophy that focuses on achieving continuous improvement in the quality of products, services, or processes through the involvement and participation of all employees
U
Upper specification limit (USL): the maximum value or threshold that a product or process characteristic can have without being considered defective or out of specification.
V
Value: The benefit or utility that is derived from a product, service, or process
Value-added activities: Activities that add value to a product or service
Value stream mapping: A tool used to visualize and analyze the flow of materials, information, and activities in a process or system, from the beginning to the end, to identify opportunities for improvement.
Variation: The difference or deviation from the expected or average value of a process or product characteristic
W
Waste: Any activity, process, or resource that does not add value to the end product or service or that creates excess or unnecessary costs
Work breakdown structure (WBS): A tool used to decompose a project or process into smaller, more manageable units or tasks
World Class Manufacturing (WCM): A set of principles and practices that are used to improve the performance, efficiency, and quality of manufacturing processes and systems.
X
X-bar chart: a statistical control chart used to monitor the process mean or average over time.
Y
Yield: the percentage or proportion of units or items that meet the required quality standards and specifications.
Z
Zero defects: the goal of achieving perfect quality, with no defects or errors in products or processes.
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Terms & Definitions (ISO 9000:2015)
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3.3.5
quality planning
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3.3.6
quality assurance
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3.3.7
quality control
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3.3.8
quality improvement
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3.3.9
configuration management
[SOURCE:ISO 10007:2003, 3.6, modified — Note 1 to entry has been modified]
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3.3.10
change control
[SOURCE:ISO 10007:2003, 3.1, modified]
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3.3.11
activity
<project management> smallest identified object of work in a
project (3.4.2)[SOURCE:ISO 10006:2003, 3.1, modified]
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3.3.12
project management
planning, organizing,
monitoring (3.11.3), controlling and reporting of all aspects of a
project (3.4.2), and the motivation of all those involved in it to achieve the project objectives
[SOURCE:ISO 10006:2003, 3.6]
*****************************************************************************************
3.3.13
configuration object
[SOURCE:ISO 10007:2003, 3.5, modified]
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3.4 Terms related to process
*****************************************************************************************
3.4.1
process
set of interrelated or interacting activities that use inputs to deliver an intended result
Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are generally the inputs to other processes.
Note 3 to entry: Two or more interrelated and interacting processes in series can also be referred to as a process.
Note 4 to entry: Processes in an
organization (3.2.1) are generally planned and carried out under controlled conditions to add value.
Note 5 to entry: A process where the
conformity (3.6.11) of the resulting output cannot be readily or economically validated is frequently referred to as a “special process”.
Note 6 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified to prevent circularity between process and output, and Notes 1 to 5 to entry have been added.
*****************************************************************************************
3.4.2
project
Note 1 to entry: An individual project can form part of a larger project structure and generally has a defined start and finish date.
Note 3 to entry: The
output (3.7.5) of a project can be one or several units of product or service.
Note 4 to entry: The project’s
organization (3.2.1) is normally temporary and established for the lifetime of the project.
Note 5 to entry: The complexity of the interactions among project activities is not necessarily related to the project size.
[SOURCE:ISO 10006:2003, 3.5, modified — Notes 1 to 3 have been modified]
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3.4.3
quality management system realization
[SOURCE:ISO 10019:2005, 3.1, modified — Notes have been deleted]
*****************************************************************************************
3.4.4
competence acquisition
[SOURCE:ISO 10018:2012, 3.2, modified]
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3.4.5
procedure
Note 1 to entry: Procedures can be documented or not.
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3.4.6
outsource (verb)
Note 1 to entry: An external organization is outside the scope of the
management system (3.5.3), although the outsourced function or process is within the scope.
Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1.
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3.4.7
contract
binding agreement
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3.4.8
design and development
Note 1 to entry: The requirements forming input to design and development are often the result of research and can be expressed in a broader, more general sense than the requirements forming the
output (3.7.5) of design and development. The requirements are generally defined in terms of
characteristics (3.10.1). In a
project (3.4.2) there can be several design and development stages.
Note 2 to entry: In English the words “design” and “development” and the term “design and development” are sometimes used synonymously and sometimes used to define different stages of the overall design and development. In French the words “conception” and “développement” and the term “conception et développement” are sometimes used synonymously and sometimes used to define different stages of the overall design and development.
Note 3 to entry: A qualifier can be applied to indicate the nature of what is being designed and developed (e.g.
product (3.7.6) design and development,
service (3.7.7) design and development or process design and development).
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3.5 Terms related to system
*****************************************************************************************
3.5.1
system
set of interrelated or interacting elements
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3.5.2
infrastructure
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3.5.3
management system
Note 1 to entry: A management system can address a single discipline or several disciplines, e.g.
quality management (3.3.4), financial management or environmental management.
Note 2 to entry: The management system elements establish the organization’s structure, roles and responsibilities, planning, operation, policies, practices, rules, beliefs, objectives and processes to achieve those objectives.
Note 3 to entry: The scope of a management system can include the whole of the organization, specific and identified functions of the organization, specific and identified sections of the organization, or one or more functions across a group of organizations.
Note 4 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by modifying Notes 1 to 3 to entry.
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3.5.4
quality management system
*****************************************************************************************
3.5.5
work environment
set of conditions under which work is performed
Note 1 to entry: Conditions can include physical, social, psychological and environmental factors (such as temperature, lighting, recognition schemes, occupational stress, ergonomics and atmospheric composition).
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3.5.6
metrological confirmation
Note 1 to entry: Metrological confirmation generally includes calibration or
verification (3.8.12), any necessary adjustment or
repair (3.12.9), and subsequent recalibration, comparison with the metrological requirements for the intended use of the equipment, as well as any required sealing and labelling.
Note 2 to entry: Metrological confirmation is not achieved until and unless the fitness of the measuring equipment for the intended use has been demonstrated and documented.
Note 3 to entry: The requirements for intended use include such considerations as range, resolution and maximum permissible errors.
Note 4 to entry: Metrological requirements are usually distinct from, and are not specified in,
product (3.7.6) requirements.
[SOURCE:ISO 10012:2003, 3.5, modified — Note 1 to entry has been modified]
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3.5.7
measurement management system
[SOURCE:ISO 10012:2003, 3.1, modified]
*****************************************************************************************
3.5.8
policy
Note 1 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1.
*****************************************************************************************
3.5.9
quality policy
Note 2 to entry: Quality management principles presented in this International Standard can form a basis for the establishment of a quality policy.
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3.5.10
vision
*****************************************************************************************
3.5.11
mission
3.5.12
strategy
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3.6 Terms related to requirement
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3.6.1
object
entity
item
anything perceivable or conceivable
EXAMPLE:
Note 1 to entry: Objects can be material (e.g. an engine, a sheet of paper, a diamond), non-material (e.g. conversion ratio, a project plan) or imagined (e.g. the future state of the organization).
[SOURCE:ISO 1087‑1:2000, 3.1.1, modified]
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3.6.2
quality
Note 1 to entry: The term “quality” can be used with adjectives such as poor, good or excellent.
Note 2 to entry: “Inherent”, as opposed to “assigned”, means existing in the
object (3.6.1).
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3.6.3
grade
EXAMPLE:
Class of airline ticket and category of hotel in a hotel brochure.
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3.6.4
requirement
need or expectation that is stated, generally implied or obligatory
Note 4 to entry: Requirements can be generated by different interested parties or by the organization itself.
Note 5 to entry: It can be necessary for achieving high
customer satisfaction (3.9.2) to fulfil an expectation of a customer even if it is neither stated nor generally implied or obligatory.
Note 6 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by adding Notes 3 to 5 to entry.
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3.6.5
quality requirement
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3.6.6
statutory requirement
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3.6.7
regulatory requirement
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3.6.8
product configuration information
[SOURCE:ISO 10007:2003, 3.9, modified]
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3.6.9
nonconformity
Note 1 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1.
*****************************************************************************************
3.6.10
defect
Note 1 to entry: The distinction between the concepts defect and nonconformity is important as it has legal connotations, particularly those associated with
product (3.7.6) and
service (3.7.7) liability issues.
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3.6.11
conformity
Note 1 to entry: In English the word “conformance” is synonymous but deprecated. In French the word “compliance” is synonymous but deprecated.
Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by adding Note 1 to entry.
*****************************************************************************************
3.6.12
capability
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3.6.13
traceability
ability to trace the history, application or location of an
object (3.6.1)Note 1 to entry: When considering a
product (3.7.6) or a
service (3.7.7), traceability can relate to: — the origin of materials and parts; — the processing history; — the distribution and location of the product or service after delivery.
Note 2 to entry: In the field of metrology, the definition in
ISO/IEC Guide 99 is the accepted definition.
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3.6.14
dependability
ability to perform as and when required
[SOURCE:IEC 60050‑192, modified — Notes have been deleted]
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3.6.15
innovation
Note 1 to entry: Activities resulting in innovation are generally managed.
Note 2 to entry: Innovation is generally significant in its effect.
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3.7 Terms related to result
*****************************************************************************************
3.7.1
objective
result to be achieved
Note 1 to entry: An objective can be strategic, tactical, or operational.
Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended outcome, a purpose, an operational criterion, as a
quality objective (3.7.2) or by the use of other words with similar meaning (e.g. aim, goal, or target).
Note 5 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by modifying Note 2 to entry.
*****************************************************************************************
3.7.2
quality objective
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3.7.3
success
*****************************************************************************************
3.7.4
sustained success
Note 1 to entry: Sustained success emphasizes the need for a balance between economic-financial interests of an
organization (3.2.1) and those of the social and ecological environment.
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3.7.5
output
Note 1 to entry: Whether an output of the
organization (3.2.1) is a
product (3.7.6) or a
service (3.7.7) depends on the preponderance of the
characteristics (3.10.1) involved, e.g. a painting for sale in a gallery is a product whereas supply of a commissioned painting is a service, a hamburger bought in a retail store is a product whereas receiving an order and serving a hamburger ordered in a restaurant is part of a service.
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3.7.6
product
Note 1 to entry: Production of a product is achieved without any transaction necessarily taking place between
provider (3.2.5) and customer, but can often involve this
service (3.7.7) element upon its delivery to the customer.
Note 2 to entry: The dominant element of a product is that it is generally tangible.
Note 3 to entry: Hardware is tangible and its amount is a countable
characteristic (3.10.1) (e.g. tyres). Processed materials are tangible and their amount is a continuous characteristic (e.g. fuel and soft drinks). Hardware and processed materials are often referred to as goods. Software consists of
information (3.8.2) regardless of delivery medium (e.g. computer programme, mobile phone app, instruction manual, dictionary content, musical composition copyright, driver's license).
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3.7.7
service
Note 1 to entry: The dominant elements of a service are generally intangible.
Note 2 to entry: Service often involves activities at the interface with the customer to establish customer
requirements (3.6.4) as well as upon delivery of the service and can involve a continuing relationship such as banks, accountancies or public organizations, e.g. schools or hospitals.
Note 3 to entry: Provision of a service can involve, for example, the following: — an activity performed on a customer-supplied tangible
product (3.7.6) (e.g. a car to be repaired); — an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return); — the delivery of an intangible product (e.g. the delivery of
information (3.8.2) in the context of knowledge transmission); — the creation of ambience for the customer (e.g. in hotels and restaurants);
Note 4 to entry: A service is generally experienced by the customer.
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3.7.8
performance
measurable result
Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by modifying Note 2 to entry.
*****************************************************************************************
3.7.9
risk
effect of uncertainty
Note 1 to entry: An effect is a deviation from the expected — positive or negative.
Note 2 to entry: Uncertainty is the state, even partial, of deficiency of
information (3.8.2) related to, understanding or knowledge of, an event, its consequence, or likelihood.
Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including changes in circumstances) and the associated likelihood (as defined in
ISO Guide 73:2009, 3.6.1.1) of occurrence.
Note 5 to entry: The word “risk” is sometimes used when there is the possibility of only negative consequences.
Note 6 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by adding Note 5 to entry.
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3.7.10
efficiency
relationship between the result achieved and the resources used
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3.7.11
effectiveness
extent to which planned activities are realized and planned results are achieved
Note 1 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by adding “are” before “achieved”.
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3.8 Terms related to data, information and document
*****************************************************************************************
3.8.1
data
*****************************************************************************************
3.8.2
information
*****************************************************************************************
3.8.3
objective evidence
data (3.8.1) supporting the existence or verity of something
*****************************************************************************************
3.8.4
information system
*****************************************************************************************
3.8.5
document
EXAMPLE:
Note 1 to entry: The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or combination thereof.
Note 2 to entry: A set of documents, for example specifications and records, is frequently called “documentation”.
Note 3 to entry: Some
requirements (3.6.4) (e.g. the requirement to be readable) relate to all types of documents. However there can be different requirements for specifications (e.g. the requirement to be revision controlled) and for records (e.g. the requirement to be retrievable).
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3.8.6
documented information
Note 1 to entry: Documented information can be in any format and media and from any source.
Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1.
*****************************************************************************************
3.8.7
specification
EXAMPLE:
*****************************************************************************************
3.8.8
quality manual
Note 1 to entry: Quality manuals can vary in detail and format to suit the size and complexity of an individual
organization (3.2.1).
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3.8.9
quality plan
*****************************************************************************************
3.8.10
record
document (3.8.5) stating results achieved or providing evidence of activities performed
Note 2 to entry: Generally records need not be under revision control.
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3.8.11
project management plan
Note 1 to entry: A project management plan should include or refer to the project’s
quality plan (3.8.9).
Note 2 to entry: The project management plan also includes or references such other plans as those relating to organizational structures, resources, schedule, budget,
risk (3.7.9)management (3.3.3), environmental management, health and safety management, and security management, as appropriate.
[SOURCE:ISO 10006:2003, 3.7]
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3.8.12
verification
Note 2 to entry: The activities carried out for verification are sometimes called a qualification
process (3.4.1).
Note 3 to entry: The word “verified” is used to designate the corresponding status.
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3.8.13
validation
Note 2 to entry: The word “validated” is used to designate the corresponding status.
Note 3 to entry: The use conditions for validation can be real or simulated.
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3.8.14
configuration status accounting
[SOURCE:ISO 10007:2003, 3.7]
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3.8.15
specific case
[SOURCE:ISO 10005:2005, 3.10, modified — Note 1 to entry has been modified]
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3.9 Terms related to customer
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3.9.1
feedback
[SOURCE:ISO 10002:2014, 3.6, modified — The term “service” has been included in the definition]
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3.9.2
customer satisfaction
customer’s (3.2.4) perception of the degree to which the customer’s expectations have been fulfilled
Note 1 to entry: It can be that the customer’s expectation is not known to the
organization (3.2.1), or even to the customer in question, until the
product (3.7.6) or
service (3.7.7) is delivered. It can be necessary for achieving high customer satisfaction to fulfil an expectation of a customer even if it is neither stated nor generally implied or obligatory.
Note 2 to entry: Complaints (3.9.3) are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction.
Note 3 to entry: Even when customer
requirements (3.6.4) have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.
[SOURCE:ISO 10004:2012, 3.3, modified — Notes have been modified]
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3.9.3
complaint
[SOURCE:ISO 10002:2014, 3.2, modified — The term “service” has been included in the definition]
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3.9.4
customer service
[SOURCE:ISO 10002:2014, 3.5, modified — The term “service” has been included in the definition]
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3.9.5
customer satisfaction code of conduct
Note 2 to entry: In
ISO 10001:2007, the term “code” is used instead of “customer satisfaction code of conduct”.
[SOURCE:ISO 10001:2007, 3.1, modified — The term “code” has been removed as an admitted term, and Note 2 to entry has been modified]
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3.9.6
dispute
Note 1 to entry: Some
organizations (3.2.1) allow their
customers (3.2.4) to express their dissatisfaction to a DRP-provider in the first instance. In this situation, the expression of dissatisfaction becomes a complaint when sent to the organization for a response, and becomes a dispute if not resolved by the organization without DRP-provider intervention. Many organizations prefer their customers to first express any dissatisfaction to the organization before utilizing dispute resolution external to the organization.
[SOURCE:ISO 10003:2007, 3.6, modified]
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3.10 Terms related to characteristic
*****************************************************************************************
3.10.1
characteristic
distinguishing feature
Note 1 to entry: A characteristic can be inherent or assigned.
Note 2 to entry: A characteristic can be qualitative or quantitative.
Note 3 to entry: There are various classes of characteristic, such as the following: a) physical (e.g. mechanical, electrical, chemical or biological characteristics); b) sensory (e.g. related to smell, touch, taste, sight, hearing); c) behavioural (e.g. courtesy, honesty, veracity); d) temporal (e.g. punctuality, reliability, availability, continuity); e) ergonomic (e.g. physiological characteristic, or related to human safety); f) functional (e.g. maximum speed of an aircraft).
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3.10.2
quality characteristic
Note 1 to entry: Inherent means existing in something, especially as a permanent characteristic.
Note 2 to entry: A characteristic assigned to an object (e.g. the price of an object) is not a quality characteristic of that object.
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3.10.3
human factor
Note 1 to entry: Characteristics can be physical, cognitive or social.
*****************************************************************************************
3.10.4
competence
ability to apply knowledge and skills to achieve intended results
Note 1 to entry: Demonstrated competence is sometimes referred to as qualification.
Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by adding Note 1 to entry.
*****************************************************************************************
3.10.5
metrological characteristic
Note 2 to entry: Metrological characteristics can be the subject of calibration.
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3.10.6
configuration
[SOURCE:ISO 10007:2003, 3.3, modified — The term “service” has been included in the definition]
*****************************************************************************************
3.10.7
configuration baseline
[SOURCE:ISO 10007:2003, 3.4, modified — The term “service” has been included in the definition]
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3.11 Terms related to determination
*****************************************************************************************
3.11.1
determination
*****************************************************************************************
3.11.2
review
EXAMPLE:
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3.11.3
monitoring
Note 1 to entry: For the determination of the status there can be a need to check, supervise or critically observe.
Note 2 to entry: Monitoring is generally a determination of the status of an
object (3.6.1), carried out at different stages or at different times.
Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition and Note 1 to entry have been modified, and Note 2 to entry has been added.
*****************************************************************************************
3.11.4
measurement
Note 1 to entry: According to
ISO 3534-2, the value determined is generally the value of a quantity.
Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by adding Note 1 to entry.
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3.11.5
measurement process
set of operations to determine the value of a quantity
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3.11.6
measuring equipment
measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a
measurement process (3.11.5)*****************************************************************************************
3.11.7
inspection
Note 1 to entry: If the result of an inspection shows conformity, it can be used for purposes of
verification (3.8.12).
Note 2 to entry: The result of an inspection can show conformity or
nonconformity (3.6.9) or a degree of conformity.
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3.11.8
test
*****************************************************************************************
3.11.9
progress evaluation
[SOURCE:ISO 10006:2003, 3.4, modified — Notes to entry have been modified]
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3.12 Terms related to action
*****************************************************************************************
3.12.1
preventive action
action to eliminate the cause of a potential
nonconformity (3.6.9) or other potential undesirable situation
Note 1 to entry: There can be more than one cause for a potential nonconformity.
Note 2 to entry: Preventive action is taken to prevent occurrence whereas
corrective action (3.12.2) is taken to prevent recurrence.
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3.12.2
corrective action
Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action is taken to prevent recurrence whereas
preventive action (3.12.1) is taken to prevent occurrence.
Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by adding Notes 1 and 2 to entry.
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3.12.3
correction
*****************************************************************************************
3.12.4
regrade
*****************************************************************************************
3.12.5
concession
Note 1 to entry: A concession is generally limited to the delivery of products and services that have
nonconforming (3.6.9)characteristics (3.10.1) within specified limits and is generally given for a limited quantity of products and services or period of time, and for a specific use.
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3.12.6
deviation permit
Note 1 to entry: A deviation permit is generally given for a limited quantity of products and services or period of time, and for a specific use.
*****************************************************************************************
3.12.7
release
permission to proceed to the next stage of a
process (3.4.1) or the next process
Note 1 to entry: In English, in the context of software and
documents (3.8.5), the word “release” is frequently used to refer to a version of the software or the document itself.
*****************************************************************************************
3.12.8
rework
Note 1 to entry: Rework can affect or change parts of the nonconforming product or service.
*****************************************************************************************
3.12.9
repair
Note 1 to entry: A successful repair of a nonconforming product or service does not necessarily make the product or service conform to the
requirements (3.6.4). It can be that in conjunction with a repair a
concession (3.12.5) is required.
Note 2 to entry: Repair includes remedial action taken on a previously conforming product or service to restore it for use, for example as part of maintenance.
Note 3 to entry: Repair can affect or change parts of the nonconforming product or service.
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3.12.10
scrap
EXAMPLE:
Recycling, destruction.
Note 1 to entry: In a nonconforming service situation, use is precluded by discontinuing the service.
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3.13 Terms related to audit
*****************************************************************************************
3.13.1
audit
Note 3 to entry: Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the
organization (3.2.1) itself for
management (3.3.3)review (3.11.2) and other internal purposes, and can form the basis for an organization’s declaration of conformity. Independence can be demonstrated by the freedom from responsibility for the activity being audited.
Note 4 to entry: External audits include those generally called second and third-party audits. Second party audits are conducted by parties having an interest in the organization, such as
customers (3.2.4), or by other persons on their behalf. Third-party audits are conducted by external, independent auditing organizations such as those providing certification/registration of conformity or governmental agencies.
Note 5 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition and Notes to entry have been modified to remove effect of circularity between audit criteria and audit evidence term entries, and Notes 3 and 4 to entry have been added.
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3.13.2
combined audit
Note 1 to entry: The parts of a management system that can be involved in a combined audit can be identified by the relevant management system standards, product standards, service standards or process standards being applied by the
organization (3.2.1).
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3.13.3
joint audit
*****************************************************************************************
3.13.4
audit programme
set of one or more
audits (3.13.1) planned for a specific time frame and directed towards a specific purpose
[SOURCE:ISO 19011:2011, 3.13, modified]
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3.13.5
audit scope
Note 1 to entry: The audit scope generally includes a description of the physical locations, organizational units, activities and
processes (3.4.1).
[SOURCE:ISO 19011:2011, 3.14, modified — Note to entry has been modified]
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3.13.6
audit plan
[SOURCE:ISO 19011:2011, 3.15]
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3.13.7
audit criteria
[SOURCE:ISO 19011:2011, 3.2, modified — The term “audit evidence” has been replaced by “objective evidence”]
*****************************************************************************************
3.13.8
audit evidence
[SOURCE:ISO 19011:2011, 3.3, modified — Note to entry has been deleted]
*****************************************************************************************
3.13.9
audit findings
Note 2 to entry: Audit findings can lead to the identification of opportunities for
improvement (3.3.1) or recording good practices.
[SOURCE:ISO 19011:2011, 3.4, modified — Note 3 to entry has been modified]
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3.13.10
audit conclusion
[SOURCE:ISO 19011:2011, 3.5]
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3.13.11
audit client
[SOURCE:ISO 19011:2011, 3.6, modified — Note to entry has been deleted]
*****************************************************************************************
3.13.12
auditee
[SOURCE:ISO 19011:2011, 3.7]
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3.13.13
guide
[SOURCE:ISO 19011:2011, 3.12]
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3.13.14
audit team
Note 1 to entry: One
auditor (3.13.15) of the audit team is appointed as the audit team leader.
Note 2 to entry: The audit team can include auditors-in-training.
[SOURCE:ISO 19011:2011, 3.9, modified]
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3.13.15
auditor
[SOURCE:ISO 19011:2011, 3.8]
*****************************************************************************************
3.13.16
technical expert
[SOURCE:ISO 19011:2011, 3.10, modified — Note 1 to entry has been modified]
*****************************************************************************************
3.13.17
observer
[SOURCE:ISO 19011:2011, 3.11, modified — The verb “audit” has been removed from the definition; Note to entry has been modified]
***********************************************************
Table of common words used in ISO 9000:2015 and in ISO 9001:2015 |
| Word (and clauses where it is used, if used in different dictionary meanings) | Meaning |
1 | ability | noun | being able |
2 | ( in accordance with) | noun | in a manner conforming with |
3 | action (see ISO 9000: A.5 fig. A.15) | noun | activity to achieve something |
4 | activity (see ISO 9000: A.5 fig. A.6) | noun | doing something |
5 | Adequacy | noun | sufficiency |
6 | adjustment | noun | act of making something different |
7 | analysis | noun | detailed determination |
8 | appropriate | adjective | suitable (for, to) |
9 | applicable (requirement) ISO 9001: 0.1, 1 para 1 1a), 1 para 1 1b), 4.2, 5.1.2, 5.2.1, 6.2.1, 8.2.2, 8.2.3.1, 8.3.2, 8.4.2, A3 para 1 line 6 | adjective | necessary to apply |
10 | applicable (as applicable) ISO 9000: Introduction, 1, 3.2.2; ISO 9001: 0.3.2, 1 para 2, 4.3, 7.2, 7.5.3.2, 8.2.3.2, 8.5.1, 10.2.1, A.3 para 1 line 5, A.5, Annex B | adjective | possible to apply |
11 | applicable (as applicable) ISO 9001: 8.6 | adjective | when required |
12 | authority ISO 9000: 2.3.2.4, 2.3.4.4, 3.1.1, 3.1.5 (def), 3.3.3; ISO 9001: 4.4.1 e), 5.3, 8.3.2, A.1 | noun | power to command or give a decision |
13 | authority ISO 9000:3.1.5 (term), 3.2.1, 3.6.7; ISO 9001: 8.6, 8.7.2 | noun | person or body that has powers and rights |
14 | authority ISO 9001: 7.5.3.2 | noun | permission to do something |
15 | available | adjective | able to be used or obtained |
16 | aware (to be aware, to make aware) | adverb/ verb | to have or to create knowledge or perception of a situation or fact |
17 | awareness | noun | knowledge or perception of a situation or fact |
18 | boundary | noun | limit |
19 | calibration | noun | See VIM: 2007, Clause 2.39 |
20 | can | verb | ISO/IEC Directives Part 2, 2016, Clause 7.5, Table 6 – be able to – there is a possibility of – it is possible to |
21 | cannot | verb | ISO/IEC Directives Part 2, 2016, Clause 7.5, Table 6 – be unable to – there is no possibility of – it is not possible to |
22 | commitment | noun | obligation and promise to do something |
23 | communication | noun | sharing or exchanging information |
24 | confirm | verb | establish as true |
25 | conform (to/with) | verb | fulfill |
26 | consistent (with) | adjective | conforming to or in agreement with |
27 | consistently | adverb | changing over time |
28 | control | noun | part of management focused on fulfilling requirements |
29 | control | verb | manage focusing on fulfilling requirements |
30 | define | verb | state or describe exactly |
31 | demonstrate | verb | show clearly |
32 | determine | verb | find out (one or more characteristics and their characteristic values) |
33 | distribution | noun | bringing objects to their destination |
34 | disposition | noun | define what to do with an object |
35 | documentation | noun | set of documents |
36 | enhance | verb/noun | improve/improvement |
37 | ensure | verb | make sure |
38 | essential ISO 9001: 0.3.1, 0.4, 7.1.5.2, 8.3.3, 8.3.5, Annex B | adjective | necessary |
39 | essential ISO 9000: 2.2.5.2, 2.3.3.1,2.3.5.2; ISO 9001: 0.3.3 | adjective | important |
40 | essential characteristics ISO 9001: A.8 | noun | character |
41 | establish ISO 9000: 2.3.3.1, 2.3.4.4, 2.3.5.4, 3.3.3, 3.3.4, 3.5.9, 3.6.3, 3.7.7, 3.10.7, 3.11.2 | verb | define |
42 | establish ISO 9000: 2.3.2.4, 2.3.7.4, 3.2.7, 3.3.2, 3.3.5, 3.3.9, 3.4.2, 3.4.3, 3.5.3; ISO 9001: 0.3.2, 0.3.3, 4.3, 4.4.1, 5.1.1, 5.2.1, 6.2.1, 7.1.1, 8.1, 8.2.1, 8.3.1, 9.2.2, Annex B | verb | make |
43 | evaluate | verb | judge |
44 | expectation | noun | wish to be fulfilled |
45 | experience | verb | perceive |
46 | experience | noun | practice |
47 | facilitate | verb | make easier |
48 | focus | noun | center of interest |
49 | ISO 9001 framework : 0.4 | noun | high level structure, identical core text, common terms and core definitions (ISO/IEC Directives, Part 1, Consolidated ISO supplement 2014, Annex SL, Appendix 2) |
50 | framework ISO 9000 intro, 2.4.2, 3.5.9; ISO 9001: 5.2.1 | noun | set of principles |
51 | function ISO 9000: 2.2.1, 3.3.13, A.4 | noun | purpose |
52 | function ISO 9000: 3.2.7 | noun | resources |
53 | function ISO 9000: 2.3.2.3, 3.2.1, 3.2.9, 3.4.6, 3.5.3, 3.7.2; ISO 9001: 6.2.1 | noun | organizational unit |
54 | functional | adjective | practical and for use |
55 | hardware | noun | See ISO 9000:2015 Clause 3.7.6 “product” especially Note 3 |
56 | identify ISO 9000: 2.2.2, 2.2.4, 2.4.1.2, 2.4.2, 2.4.3, 3.13.2; ISO 9001: 0.3.2, 7.5.3.2, 8.3.6, 8.5.2 (para 2) | verb | find out |
57 | identify/identification ISO 9000: 3.3.11, 3.5.3; ISO 9001: 7.1.5.2, 7.5.2, 8.5.2 (title, para 1 & 3), 8.5.3, 8.5.4, 8.7.1, Annex B | verb/noun | mark or label |
58 | identify/identification ISO 9000: intro, 3.13.9, A.4; ISO 9001: 8.7.2 | verb/noun | show |
59 | Impartiality | noun | evenhandedness |
60 | implement | verb | put into effect or practice |
61 | integrity ISO 9000: 2.3.2.4 | noun | moral soundness |
62 | integrity ISO 9001: 5.3, 6.3, 7.5.3.1 | noun | wholeness |
63 | justification | noun | reason |
64 | knowledge | noun | available collection of information being a justified belief and having a high certainty to be true |
65 | maintain | verb | enable to continue |
66 | maintenance | noun | enabling to continue |
67 | May | verb | ISO/IEC Directives Part 2, 2016, Clause 7.4, Table 5 – is permitted – is allowed – is permissible |
68 | measurable | adjective | able to be measured |
69 | measure | verb | determine a value |
70 | monitor | verb | determine a status |
71 | necessary | adjective | needed |
72 | need | noun | necessity |
73 | opportunity | noun | chance |
74 | origin | noun | provenance |
75 | perception | noun | cognition |
76 | periodic | adjective | regular |
77 | person (see ISO 9000: A.5 fig. A.4) | noun | individual human |
78 | plan | verb | prearrange |
79 | preservation | noun | maintaining something in its original or existing state |
80 | property | noun | object owned by a person or organization |
81 | provide | verb | supply |
82 | relevant | adjective | related to and important to that which is being considered |
83 | responsibility/responsible | noun/ adjective | accountable |
84 | result | noun | output |
85 | retain | verb | keep |
86 | safeguard | verb | protect |
87 | scope | noun | area of application |
88 | sequence | noun | order |
89 | shall Note: “shall” is used 136 times in ISO 9001:2015 | verb | ISO/IEC Directives Part 2, 2016, Clause 7.2, Table 3 – is to – is required to – it is required that – has to – only … is permitted – it is necessary |
90 | shall not | verb | ISO/IEC Directives Part 2, 2016, Clause 7.2, Table 3 – is not allowed [permitted] [acceptable] [permissible] – is required to be not – is required that … be not – is not to be |
91 | should | verb | ISO/IEC Directives Part 2, 2016, Clause 7.3, Table 4 – it is recommended that – ought to |
92 | software | noun | See ISO 9000:2015 Clause 3.7.6 “product” especially Note 3 |
93 | specific | adjective | particular |
94 | specify | verb | define |
95 | suitable | adjective | appropriate |
96 | supply | verb | provide |
97 | systematic | adjective | orderly |
98 | unambiguous | adjective | clear |
99 | validity | noun | state of being valid |
100 | verify | verb | carry out verification (see ISO 9000:2015 Clause 3.8.12) |
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