ISO 13940:2015 健康情報学—ケアの継続性をサポートする概念のシステム | ページ 2

3.2.3

deprecated term

term rejected by an authoritative body

[SOURCE:ISO 1087‑1:2000, 3.4.17]

3.3.1

organization

unique framework of authority within which a person (3.3.4) or persons act, or are designated to act towards some purpose

[SOURCE:ISO/IEC 6523‑1:1998, 3.1]

Note 1 to entry: Groupings or subdivisions of organizations may also be considered as organizations where there is need to identify them in this way for purposes of information interchange.

Note 2 to entry: In this International Standard, this definition applies to any kind of organizations, whatever their legal status.

3.3.2

organizational pattern

relationships between the various parts of an organization (3.3.1)

3.3.3

party

person or group performing a role (3.3.5) in relation to the business of a specific community or domain

[SOURCE:ISO 8459:2009, 2.33]

3.3.4

person

human being regarded as an individual

3.3.5

role

function or position

[SOURCE:ISO/HL7 21731:2006]

3.3.6

person role

role (3.3.5) of a person (3.3.4)

3.3.7

organization role

role (3.3.5) of an organization (3.3.1)

3.4.1

resource

asset that is utilized or consumed during the execution of a process (3.6.1)

Note 1 to entry: Includes diverse entities such as funding, personnel, facilities, capital equipment, tools, and utilities such as power, water, fuel and communication infrastructures.

Note 2 to entry: Resources include those that are reusable, renewable or consumable.

[SOURCE:ISO/IEC/IEEE 15288:2015, 4.1.38, modified]

3.4.2

medical device

Note 1 to entry: This definition has been developed by the Global Harmonization Task Force (GHTF)

Note 3 to entry: Accessories intended specifically by manufacturers to be used together with a “parent” medical device to enable that medical device to achieve its intended purpose, should be subject to this International Standard.

[SOURCE:ISO 14971:2007, 2.9]

3.4.3

medicinal product

any substance or combination of substances that can be administered to human beings for treating or preventing disease, with the view to making a medical diagnosis or to restore, correct, or modify physiological functions

Note 1 to entry: A medicinal product may contain one or more manufactured items and one or more pharmaceutical products.

Note 2 to entry: In certain jurisdictions a Medicinal Product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis.

Note 3 to entry: The provisions in this International Standard apply to proprietary medicinal products for human use intended to be placed on the market and to industrially manufactured medicinal products, the marketing of which has been authorized by a Medicines Regulatory Agency. However, the provisions do not apply to medicinal products prepared according to prescription, for instance, prepared in a pharmacy from a prescription intended for a specific patient; medicinal products prepared in accordance with an official formula, for instance, prepared in a pharmacy in accordance with the instructions in a pharmacopoeia and intended to be given direct to the patient by the pharmacy; medicinal products intended for research and development trials; intermediate products intended for subsequent processing by an authorized manufacturer.

[SOURCE:ISO 11615:2012, 3.1.49]

3.5.1

quality in healthcare

degree to which healthcare (3.1.1) fulfils requirements related to defined quality characteristics

Note 1 to entry: Quality is defined in ISO 9000:2015, 3.6.2, as the 'degree to which a set of inherent characteristics of an object fulfils requirements'.

3.5.2

quality management

management with regard to quality

Note 1 to entry: Quality management can include establishing quality policies and quality objectives, and processes to achieve these quality objectives through quality planning, quality assurance, quality control, and quality improvement.

[SOURCE:ISO 9000:2015, 3.3.4]

3.5.3

quality assurance

part of quality management (3.5.2) focused on providing confidence that quality requirements will be fulfilled

[SOURCE:ISO 9000:2015, 3.3.6]

3.5.4

quality control

part of quality management (3.5.2) focused on fulfilling quality requirements

[SOURCE:ISO 9000:2015, 3.3.7]

3.5.5

risk

combination of the probability of an event and its consequences

[SOURCE:ISO Guide 73:2009, 1.1]

3.5.6

unintended event

phenomenon that is not part of the normal course of a process (3.6.1) but might influence it

Note 1 to entry: An unintended event can be either expected or unexpected.

Note 2 to entry: Activities in a process are deliberate and have a purpose. In an ideal situation purposes are always fulfilled. If an activity in whatever other process has an impact on the process currently analysed, the effect of this activity is perceived by the current process as an unintended event. Then the course of the process may deviate from the expected one. Such an exception from the desired course might prove negative or positive in comparison to the desired process outcome.

3.6.1

process

set of interrelated or interacting activities that use inputs to deliver an intended result

Note 1 to entry: Whether the “intended result” of a process is called output, product or 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 are generally planned and carried out under controlled conditions to add value.

Note 5 to entry: A process where the conformity 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.

[SOURCE:ISO 9000:2015, 3.4.1]

3.6.2

process model

representation of a process (3.6.1)

3.6.3

product

output of an organization that can be produced without any transaction taking place between the organization and the customer

Note 1 to entry: Production of a product is achieved without any transaction necessarily taking place between provider and customer, but can often involve this service 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 (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 regardless of delivery medium (e.g. computer programme, mobile phone app, instruction manual, dictionary content, musical composition copyright, driver's license).

[SOURCE:ISO 9000:2015, 3.7.6]

3.6.4

service

output of an organization (3.3.1) with at least one activity necessarily performed between the organization and the customer

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 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 (3.6.3) (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 (3.9.5) 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.

[SOURCE:ISO 9000:2015, 3.7.7]

3.6.5

output

result of a process

Note 1 to entry: Whether an output of the organization (3.3.1) is a product (3.6.3) or a service (3.6.4) depends on the preponderance of the characteristics 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.

[SOURCE:ISO 9000:2015, 3.7.5]

3.7.1

appointment

arrangement to meet someone at a particular time and place

3.8.1

commitment

action resulting in an obligation by one or more of the participants in the act to comply with a rule or perform a contract

Note 1 to entry: The enterprise object(s) participating in an action of commitment may be parties or agents acting on behalf of a party or parties. In the case of an action of commitment by an agent, the principal becomes obligated.

[SOURCE:ISO 12967‑1:2009, 3.6.2]

3.9.1

data

reinterpretable representation of information in a formalized manner suitable for communication, interpretation or processing

Note 1 to entry: Data can be processed by humans or by automatic means.

[SOURCE:ISO/IEC 2382:2015, 2121272, modified]

3.9.2

data repository

an identifiable data (3.9.1) storage facility

Note 1 to entry: In ISO 10303-22:1998 this is the definition of repository.

3.9.3

healthcare data

data (3.9.1) produced during healthcare activities

Note 1 to entry: Healthcare activity is defined in 7.2.

3.9.4

healthcare information

information (3.9.5) about a person (3.3.4) , relevant to his or her healthcare (3.1.1)

3.9.5

information

knowledge concerning objects that within a certain context has a particular meaning

Note 1 to entry: Facts, events, things, processes, and ideas, including concepts, are examples of objects.

Note 2 to entry: Information is something that is meaningful. Data might be regarded as information once its meaning is revealed.

[SOURCE:ISO/IEC 2382:2015, 2123204, modified]

3.9.6

information model

formal model of a bounded set of facts, concepts or instructions to meet a specified requirement

[SOURCE:ISO 10303‑1:1994, 3.2.21]

3.9.7

electronic health record

repository of information (3.9.5) regarding the health of a subject of care in computer processable format

Note 1 to entry: Subject of care is defined in 5.2.1.

[SOURCE:ISO 13606‑2:2008, 4.7, modified]

3.9.8

medium

material on which data is stored (e.g. a magnetic disk)

[SOURCE:ISO/IEC 14776‑151:2010, 3.1.117, modified]