3 術語和定義
For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.
Daniel Yang 2021/3/21 引用 ISO 22000:2018
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/CD 9000 including the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses: • ISO Online browsing platform: available at https:// www .iso .org/ obp •
IEC Electropedia: available at https:// www .electropedia .org
3.1 organization
person or group of people that has its own functions with responsibilities, authorities and relationships to achieve its objectives (3.6)
Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation, firm, enterprise, authority, partnership, charity or institution, or part or combination thereof, whether incorporated or not, public or private.
Note 2 to entry: If the organization is part of a larger entity, the term “organization” refers only to the part of the larger entity that is within the scope of the quality management system (3.4.1).
3.2 interested party stakeholder person or organization (3.1) that can affect, be affected by, or perceive itself to be affected by a decision or activity
EXAMPLE Customers, owners, people in an organization, providers, bankers, regulators, unions, partners or society that can include competitors or opposing pressure groups.
3.3 top
management
person or group of people who directs and controls an organization (3.1) at the highest level
Note 1 to entry: Top management has the power to delegate authority and provide resources within the organization.
Note 2 to entry: If the scope of the management system (3.4) covers only part of an organization, then top management refers to those who direct and control that part of the organization.
3.4 management system
set of interrelated or interacting elements of an organization (3.1) to establish policies (3.5) and objectives (3.6), as well as processes (3.8) to achieve those objectives
Note 1 to entry: A management system can address a single discipline or several disciplines.
Note 2 to entry: The management system elements include the organization’s structure, roles and responsibilities, planning and operation.
Note 3 to entry: The management system elements can include the organization’s policies, practices, rules, and beliefs.
Note 4 to entry: An organization manages its interrelated elements in an orderly manner to achieve its objectives.
Note 5 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.
3.4.1 quality management
system
part of a management system (3.4)related to quality
3.5 policy
intentions and direction of an organization (3.1) as formally expressed by its top management (3.3)
3.5.1 quality policy policy (3.5) related to quality
Note 1 to entry: The quality policy is generally consistent with the overall policy of the organization (3.1), can be aligned with the organization's vision and mission and provides a framework for the setting of quality objectives (3.6.1).
Note 2 to entry: Quality management principles presented in ISO/CD 9000 can form a basis for the establishment of a quality policy.
3.6 objective result to be achieved
Note 1 to entry: An objective can be strategic, tactical, or operational.
Note 2 to entry: Objectives can relate to different disciplines (such as finance, health and safety, and environment). They can be, for example, organization-wide or specific to a project, product, service, or process (3.8).
Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended result, as a purpose, as an operational criterion, as a quality objective (3.6.1)or by the use of other words with similar meaning (e.g. aim, goal, or target).
Note 4 to entry: In the context of quality management system (3.4.1), quality objectives (3.6.1) are set by the organization (3.1), consistent with the quality policy (3.5.1), to achieve specific results.
3.6.1 quality objective
objective (3.6) related to quality
Note 1 to entry: Quality objectives are generally based on the organization's (3.1) quality policy (3.5.1).
Note 2 to entry: Quality objectives are generally specified for relevant functions, levels and processes (3.8) in the organization.
3.7 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 related to, understanding or knowledge of an event, its consequence, or likelihood.
Note 3 to entry: risk (3.7) is often characterized by reference to potential events and consequences or a combination of these.
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 of occurrence.
Note 5 to entry: The word “risk” is sometimes used when there is the possibility of only negative consequences.
3.8
process
set of interrelated or interacting activities that uses or transforms inputs to deliver a result
Note 1 to entry: Whether the result of a process is called an output, a product or a service depends on the context of the reference.
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 (3.1) are generally planned and carried out under controlled conditions to ensure that intended results can be achieved.
Note 5 to entry: A process where the conformity (3.15) of the resulting output cannot be readily or economically validated is frequently referred to as a “special process”.
3.9 competence
ability to apply knowledge and skills to achieve intended results
Note 1 to entry: Demonstrated competence is sometimes referred to as qualification.
3.10 documented information information required to be controlled and maintained by an organization (3.1) and the medium on which it is contained
Note 1 to entry: Documented information can be in any format and media and from any source.
Note 2 to entry: Documented information can refer to:
— the management system (3.4), including related processes (3.8);
— information created in order for the organization to operate (documentation);
— evidence of results achieved (records).
3.11
performance
measurable result
Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
Note 2 to entry: Performance can relate to managing activities, processes (3.8), products, services, systems or organizations (3.1).
3.12
continual improvement
recurring activity to enhance performance (3.11)
3.13
effectiveness
extent to which planned activities are realized and planned results are achieved
3.14
requirement
need or expectation that is stated, generally implied or obligatory
Note 1 to entry: “Generally implied” means that it is custom or common practice for the organization (3.1) and interested party (3.2) that the need or expectation under consideration is implied.
Note 2 to entry: A specified requirement is one that is stated, e.g. in documented information (3.10).
Note 3 to entry: A qualifier can be used to denote a specific type of requirement, e.g. product requirement, service requirement, quality management requirement, customer requirement, quality requirement.
Note 4 to entry: Requirements can be generated by different interested parties or by the organization itself.
3.15
conformity
fulfilment of a requirement (3.14)
Note 1 to entry: In English the word “conformance” is synonymous but deprecated. In French the word “compliance” is synonymous but deprecated.
3.16 nonconformity non-fulfilment of a requirement (3.14)
3.17
corrective action
action to eliminate the cause(s) of a nonconformity (3.16) and to prevent recurrence
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 is taken to prevent occurrence.
3.18
audit
systematic and independent process (3.8) for obtaining evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled
Note 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party), and it can be a combined audit (combining two or more disciplines).
Note 2 to entry: An internal audit is conducted by the organization (3.1) itself, or by an external party on its behalf.
Note 3 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011.
Note 4 to entry: The fundamental elements of an audit include the determination of the conformity (3.15) of an object according to a procedure carried out by people selected to ensure impartiality and objectivity of the audit process.
Note 5 to entry: Internal audits are conducted for management review 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 6 to entry: Second party audits are conducted by parties having an interest in the organization, such as customers, 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 7 to entry: An audit can also be a joint audit carried out by two or more auditing organizations.
3.19
measurement
process (3.8) to determine a value
Note 1 to entry: According to ISO 3534-2:2006 , 3.2.1, the value determined is generally the value of a quantity.
3.20
monitoring
determining the status of a system, a process (3.8) or an activity
Note 1 to entry: To determine the status, there can be a need to check, supervise or critically observe.
Note 2 to entry: Monitoring can also determine the status of a product or a service.
Note 3 to entry: Monitoring is generally a determination of the status of an object carried out at different stages or at different times.
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