procedure (3.2.6)

HSMs

< IMMd&d >

& ISO.org documents

ISO 45004:2024

Управління охороною праці — Методичні рекомендації з оцінки ефективності

ISO 45001:2018(en)

Occupational health and safety management systems — Requirements with guidance for use

3.1

organization

person or group of people that has its own functions with responsibilities, authorities and relationships to achieve its objectives (3.16)

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.

3.2

interested party (preferred term)

stakeholder (admitted term)

person or organization (3.1) that can affect, be affected by, or perceive itself to be affected by a decision or activity

3.3

worker

person performing work or work-related activities that are under the control of the organization (3.1)

Note 1 to entry: Persons perform work or work-related activities under various arrangements, paid or unpaid, such as regularly or temporarily, intermittently or seasonally, casually or on a part-time basis.

Note 2 to entry: Workers include top management (3.12), managerial and non-managerial persons.

Note 3 to entry: The work or work-related activities performed under the control of the organization may be performed by workers employed by the organization, workers of external providers, contractors, individuals, agency workers, and by other persons to the extent the organization shares control over their work or work-related activities, according to the context of the organization.

3.4

participation

involvement in decision-making

Note 1 to entry: Participation includes engaging health and safety committees and workers’ representatives, where they exist.

3.5

consultation

seeking views before making a decision

Note 1 to entry: Consultation includes engaging health and safety committees and workers’ representatives, where they exist.

3.6

workplace

place under the control of the organization (3.1) where a person needs to be or to go for work purposes

Note 1 to entry: The organization’s responsibilities under the OH&S management system (3.11) for the workplace depend on the degree of control over the workplace.

3.7

contractor

external organization (3.1) providing services to the organization in accordance with agreed specifications, terms and conditions

Note 1 to entry: Services may include construction activities, among others.

3.8

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 parties (3.2) that the need or expectation under consideration is implied.

Note 2 to entry: A specified requirement is one that is stated, for example in documented information (3.24).

3.9

legal requirements and other requirements

legal requirements that an organization (3.1) has to comply with and other requirements (3.8) that an organization has to or chooses to comply with

Note 1 to entry: For the purposes of this document, legal requirements and other requirements are those relevant to the OH&S management system (3.11).

Note 2 to entry: “Legal requirements and other requirements” include the provisions in collective agreements.

Note 3 to entry: Legal requirements and other requirements include those that determine the persons who are workers’ (3.3) representatives in accordance with laws, regulations, collective agreements and practices.

3.10

management system

set of interrelated or interacting elements of an organization (3.1) to establish policies (3.14) and objectives (3.16) and processes (3.25) to achieve those objectives

Note 1 to entry: A management system can address a single discipline or several disciplines.

Note 2 to entry: The system elements include the organization’s structure, roles and responsibilities, planning, operation, performance evaluation and improvement.

Note 3 to entry: The scope of a management system may 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. Note 2 to entry has been modified to clarify some of the wider elements of a management system.

3.11

occupational health and safety management system

OH&S management system

management system (3.10) or part of a management system used to achieve the OH&S policy (3.15)

Note 1 to entry: The intended outcomes of the OH&S management system are to prevent injury and ill health (3.18) to workers (3.3) and to provide safe and healthy workplaces (3.6).

Note 2 to entry: The terms “occupational health and safety” (OH&S) and “occupational safety and health” (OSH) have the same meaning.

3.12

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, provided ultimate responsibility for the OH&S management system (3.11) is retained.

Note 2 to entry: If the scope of the management system (3.10) covers only part of an organization, then top management refers to those who direct and control that part of the organization.

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. Note 1 to entry has been modified to clarify the responsibility of top management in relation to an OH&S management system.

3.13

effectiveness

extent to which planned activities are realized and planned results achieved

3.14

policy

intentions and direction of an organization (3.1), as formally expressed by its top management (3.12)

3.15

occupational health and safety policy

OH&S policy

policy (3.14) to prevent work-related injury and ill health (3.18) to workers (3.3) and to provide safe and healthy workplaces (3.6)

3.16

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 financial, health and safety, and environmental goals) and can apply at different levels (such as strategic, organization-wide, project, product and process (3.25)).

Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended outcome, a purpose, an operational criterion, as an OH&S objective (3.17), or by the use of other words with similar meaning (e.g. aim, goal, or target).

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 Note 4 to entry has been deleted as the term “OH&S objective” has been defined separately in 3.17.

ISO - Occupational safety

3.17

occupational health and safety objective

OH&S objective

objective (3.16) set by the organization (3.1) to achieve specific results consistent with the OH&S policy (3.15)

3.18

injury and ill health

adverse effect on the physical, mental or cognitive condition of a person

Note 1 to entry: These adverse effects include occupational disease, illness and death.

Note 2 to entry: The term “injury and ill health” implies the presence of injury or ill health, either on their own or in combination.

3.19

hazard

source with a potential to cause injury and ill health (3.18)

Note 1 to entry: Hazards can include sources with the potential to cause harm or hazardous situations, or circumstances with the potential for exposure leading to injury and ill health.

3.20

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 is often characterized by reference to potential “events” (as defined in ISO Guide 73:2009, 3.5.1.3) and “consequences” (as defined in ISO Guide 73:2009, 3.6.1.3), 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” (as defined in ISO Guide 73:2009, 3.6.1.1) of occurrence.

Note 5 to entry: In this document, where the term “risks and opportunities” is used this means OH&S risks (3.21), OH&S opportunities (3.22) and other risks and other opportunities for the management system.

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. Note 5 to entry has been added to clarify the term “risks and opportunities” for its use within this document.

3.21

occupational health and safety risk

OH&S risk

combination of the likelihood of occurrence of a work-related hazardous event(s) or exposure(s) and the severity of injury and ill health (3.18) that can be caused by the event(s) or exposure(s)

3.22

occupational health and safety opportunity

OH&S opportunity

circumstance or set of circumstances that can lead to improvement of OH&S performance (3.28)

3.23

competence

ability to apply knowledge and skills to achieve intended results

3.24

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:

a) the management system (3.10), including related processes (3.25);
b) information created in order for the organization to operate (documentation);
c) evidence of results achieved (records).

3.25

process

set of interrelated or interacting activities which transforms inputs into outputs

3.26

procedure

specified way to carry out an activity or a process (3.25)

Note 1 to entry: Procedures may be documented or not.

[SOURCE:ISO 9000:2015, 3.4.5, modified — Note 1 to entry has been modified.]

3.27

performance

measurable result

Note 1 to entry: Performance can relate either to quantitative or qualitative findings. Results can be determined and evaluated by qualitative or quantitative methods.

Note 2 to entry: Performance can relate to the management of activities, processes (3.25), products (including services), systems or organizations (3.1).

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. Note 1 to entry has been modified to clarify the types of methods that may be used for determining and evaluating results.

3.28

occupational health and safety performance

OH&S performance

performance (3.27) related to the effectiveness (3.13) of the prevention of injury and ill health (3.18) to workers (3.3) and the provision of safe and healthy workplaces (3.6)

3.29

outsource,verb

make an arrangement where an external organization (3.1) performs part of an organization’s function or process (3.25)

Note 1 to entry: An external organization is outside the scope of the management system (3.10), although the outsourced function or process is within the scope.

3.30

monitoring

determining the status of a system, a process (3.25) or an activity

Note 1 to entry: To determine the status, there may be a need to check, supervise or critically observe.

3.31

measurement

process (3.25) to determine a value

3.32

audit

systematic, independent and documented process (3.25) for obtaining audit 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.

3.33

conformity

fulfilment of a requirement (3.8)

3.34

nonconformity

non-fulfilment of a requirement (3.8)

Note 1 to entry: Nonconformity relates to requirements in this document and additional OH&S management system (3.11) requirements that an organization (3.1) establishes for itself.

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. Note 1 to entry has been added to clarify the relationship of nonconformities to the requirements of this document and to the organization’s own requirements for its OH&S management system.

3.35

incident

occurrence arising out of, or in the course of, work that could or does result in injury and ill health (3.18)

Note 1 to entry: An incident where injury and ill health occurs is sometimes referred to as an “accident”.

Note 2 to entry: An incident where no injury and ill health occurs, but has the potential to do so, may be referred to as a “near-miss”, “near-hit” or “close call”.

Note 3 to entry: Although there can be one or more nonconformities (3.34) related to an incident, an incident can also occur where there is no nonconformity.

3.36

corrective action

action to eliminate the cause(s) of a nonconformity (3.34) or an incident (3.35) and to prevent recurrence

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 definition has been modified to include reference to “incident”, as incidents are a key factor in occupational health and safety, yet the activities needed for resolving them are the same as for nonconformities, through corrective action.

3.37

continual improvement

recurring activity to enhance performance (3.27)

Note 1 to entry: Enhancing performance relates to the use of the OH&S management system (3.11) in order to achieve improvement in overall OH&S performance (3.28) consistent with the OH&S policy (3.15) and OH&S objectives (3.17).

Note 2 to entry: Continual does not mean continuous, so the activity does not need to take place in all areas simultaneously.

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. Note 1 to entry has been added to clarify the meaning of “performance” in the context of an OH&S management system; Note 2 to entry has been added to clarify the meaning of “continual”.

Only informative sections of standards are publicly available. To view the full content, you will need to purchase the standard by clicking on the "Buy" button.

Bibliography

[1]

ISO 9000:2015, Quality management systems — Fundamentals and vocabulary

[2]

ISO 9001, Quality management systems — Requirements

[3]

ISO 14001, Environmental management systems — Requirements with guidance for use

[4]

ISO 19011, Guidelines for auditing management systems

[5]

ISO 20400, Sustainable procurement — Guidance

[6]

ISO 26000, Guidance on social responsibility

[7]

ISO 31000, Risk management — Guidelines

[8]

ISO 37500, Guidance on outsourcing

[9]

ISO 39001, Road traffic safety (RTS) management systems — Requirements with guidance for use

[10]

ISO Guide 73:2009, Risk management — Vocabulary

[11]

IEC 31010, Risk management — Risk assessment techniques

[12]

ILO. Guidelines on occupational safety and health management systems, ILO-OSH 2001. 2nd ed. International Labour Office, Geneva, 2009. Available at: http://www.ilo.org/safework/info/standards-and-instruments/WCMS_107727/lang--en/index.htm

[13]

ILO. International Labour Standards (including those on occupational safety and health). International Labour Office, Geneva. Available at: http://www.ilo.org/normlex (click on “instruments”, then “Conventions and Recommendations by subject”)

[14]

OHSAS 18001. Occupational health and safety management systems — Requirements. 2nd ed. OHSAS Project Group, London, July 2007, ISBN 978 0 580 50802 8

[15]

OHSAS 18002. Occupational health and safety management systems — Guidelines for the implementation of OHSAS 18001:2007. 2nd ed. OHSAS Project Group, London, Nov 2008, ISBN 978 0 580 61674 7

Alphabetical index of terms

audit 3.32

organization 3.1

competence 3.23

outsource, verb 3.29

conformity 3.33

participation 3.4

consultation 3.5

performance 3.27

continual improvement 3.37

policy 3.14

contractor 3.7

procedure 3.26

corrective action 3.36

process 3.25

documented information 3.24

requirement 3.8

effectiveness 3.13

risk 3.20

hazard 3.19

top management 3.12

incident 3.35

worker 3.3

injury and ill health 3.18

workplace 3.6

interested party 3.2

legal requirements and other requirements 3.9

management system 3.10

measurement 3.31

monitoring 3.30

nonconformity 3.34

objective 3.16

occupational health and safety management system 3.11

OH&S management system

occupational health and safety objective 3.17

OH&S objective

occupational health and safety opportunity 3.22

OH&S opportunity

occupational health and safety performance 3.28

OH&S performance

occupational health and safety policy 3.15

OH&S policy

occupational health and safety risk 3.21

OH&S risk

actions to regenerate ecosystems

ISO 6385:2016(en)

Ergonomics principles in the design of work systems

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.

The committee responsible for this document is ISO/TC 159, Ergonomics, Subcommittee SC 1, General ergonomic principles.

This third edition cancels and replaces the second edition (ISO 6385:2004), which has been technically revised with the following changes:

— terms were aligned with the terms given in ISO 26000;
— 3.2, 3.7 and Clause 4 have been technically revised;
— life cycle of a work system was introduced in 3.2;
— principle of adjustment was added to 3.7 and validation replaced by verification;
— new subclause on conformity was added to Clause 4;
— examples were added in several clauses.

Introduction

Technological, economic, organizational and human factors affect the work behaviour and well-being of people as part of a work system. Applying ergonomic knowledge in the light of practical experience in the design of a work system is intended to satisfy human requirements.

This International Standard provides a basic ergonomic framework for professionals and other people who deal with the issues of ergonomics, work systems and working situations. The provisions of this International Standard will also apply to the design of products for use in work systems.

Following the principles and requirements described in this International Standard will support management in making better decisions, for instance related to the sustainability of investments in work system innovation.

In the design of work systems in accordance with this International Standard, the body of knowledge in the field of ergonomics is taken into account. Ergonomic evaluations of existing or new work systems will show the need for, and encourage attention to, the role of the worker within those systems.

ISO 26800 provides a general starting point for thought on ergonomics and determines the essential general principles and concepts. This International Standard presents these in the context of the design and evaluation of work systems.

This International Standard is also valuable in the application of management systems such as OHSAS 18001. Besides guidelines for processes, it also offers guidance for achieving good human performance.

1 Scope

This International Standard establishes the fundamental principles of ergonomics as basic guidelines for the design of work systems and defines relevant basic terms. It describes an integrated approach to the design of work systems, where ergonomists will cooperate with others involved in the design, with attention to the human, the social and the technical requirements in a balanced manner during the design process.

Users of this International Standard will include executives, managers, workers (and their representatives, when appropriate) and professionals, such as ergonomists, project managers and designers who are involved in the design or redesign of work systems. Those who use this International Standard can find a general knowledge of ergonomics (human factors), engineering, design, quality and project management helpful.

The term “work system” in this International Standard is used to indicate a large variety of working situations, including permanent and flexible work places. The intention of this International Standard is to assist in the improvement, (re)design or change of work systems. Work systems involve combinations of workers and equipment, within a given space and environment, and the interactions between these components within a work organization. Work systems vary in complexity and characteristics, for example, the use of temporary work systems. Some examples of work systems in different areas are the following:

— production, e.g. machine operator and machine, worker and assembly line;
— transportation, e.g. driver and car or lorry, personnel in an airport;
— support, e.g. maintenance technician with work equipment;
— commercial, e.g. office worker with workstation, mobile worker with a tablet computer, cook in a restaurant kitchen;
— other areas like health care, teaching and training.

The observance of ergonomic principles applies to all phases throughout the life cycle of the work system from conception through development, realization and implementation, utilization, maintenance and support to decommissioning.

The systems approach in this International Standard gives guidance to the users of this International Standard in existing and new situations.

The definitions and ergonomic principles specified in this International Standard apply to the design of optimal working conditions with regard to human well-being, safety and health, including the development of existing skills and the acquisition of new ones, while taking into account technological and economic effectiveness and efficiency.

The principles in this International Standard are applicable to many other human activities, e.g. in the design of products for domestic and leisure activities. A more general description of the principles in this International Standard can be found in ISO 26800.

NOTE 1 This International Standard is considered to be the core ergonomic standard for work systems from which many others on specific issues are derived.

Note 2 Although elements of the system can be the same, this International Standard is not intended to be applied to systems used in a non-work context (e.g. the use of a vehicle for private purposes).

actions to regenerate ecosystems

2 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

2.1

well-being

<work system> sustainable internal state resulting from satisfaction of the physical and cognitive needs of the worker (2.4) during his/her activity

Note 1 to entry: Well-being can contribute to the quality of working life.

2.2

work system

system comprising one or more workers (2.4) and work equipment (2.6) acting together to perform the system function (2.21), in the workspace (2.9), in the work environment (2.8), under the conditions imposed by the work tasks (2.17)

2.3

ergonomics

human factors

scientific discipline concerned with the understanding of interactions among human and other elements of a system, and the profession that applies theory, principles, data and methods to design in order to optimize human well-being (2.1) and overall system performance

[SOURCE:ISO 26800:2011, 2.2]

2.4

worker

person performing one or more activities to achieve a goal within a work system (2.2)

[SOURCE:ISO 26800:2011, 2.11, modified — synonym “operator” omitted]

2.5

work organization

interacting work systems (2.2) acting to produce a specific overall outcome

Note 1 to entry: The process of work organization includes coherent actions in relation to establishing the form and mode of organization to be adopted (e.g. individual or collective work, teams working separately or interdependently, etc.). It is also necessary to define and allocate resources and determine the means and channels of communication. All these actions lead to the definition and assignment of prescribed tasks to the operators involved.

2.6

work equipment

tools, including hardware and software, machines, vehicles, devices, furniture, installations and other components used in the work system (2.2)

2.7

work process

sequence in time and space of the interaction of workers (2.4), work equipment (2.6), materials, energy and information within a work system (2.2)

2.8

work environment

physical, chemical, biological, organizational, social and cultural factors surrounding a worker (2.4)

2.9

workspace

volume allocated to one or more persons in the work system (2.2) to complete the work task (2.17)

2.10

external work load

work stress

external conditions and demands in a work system (2.2) which influence a person's physical and/or mental internal load

Note 1 to entry: In some countries, “external work load” is referred to as “work stress”.

Note 2 to entry: Compare ISO 26800:2011, 2.4.

2.11

work strain

internal response of a worker (2.4) to being exposed to external work load (2.10) depending on his/her individual characteristics (e.g. body size, age, capacities, abilities, skills, etc.)

Note 1 to entry: In ISO 26800, “work strain” is called “internal load”.

Note 2 to entry: Compare ISO 26800:2011, 2.6.

2.12

usability

extent to which a system, product or service can be used by specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a specified context of use

Note 1 to entry: Systems, products or services are part of work systems (2.2) and used by workers (2.4) within those systems.

Note 2 to entry: In this International Standard, the context of use is within a work system.

[SOURCE:ISO 9241‑210:2010, 2.13]

2.13

human-centred design

approach to systems design and development that aims to make interactive systems more usable by focusing on the use of the system and applying human factors/ergonomics (2.3) and usability (2.12) knowledge and techniques

[SOURCE:ISO 9241‑210:2010, 2.7, modified — Notes 1 and 2 to entry omitted]

2.14

accessibility

extent to which products, systems, services, environments and facilities can be used by people from a population with the widest range of characteristics and capabilities to achieve a specified goal in a specified context of use

[SOURCE:ISO 26800:2011, 2.1, modified — Notes 1 and 2 to entry omitted]

Note 1 to entry: Products, systems, services and facilities are part of work systems (2.2) and used by workers (2.4) within those systems.

Note 2 to entry: In this International Standard, the context of use is within a work system.

2.15

allocation of functions

process of deciding whether system functions (2.21) will be implemented by humans, by equipment and/or hardware and/or software

2.16

job

organization and sequence in time and space of an individual's work tasks (2.17) or the combination of all human performance by one worker (2.4) within a work system (2.2)

2.17

work task

activity or set of activities required of the worker (2.4) to achieve an intended outcome

2.18

workstation

combination and spatial arrangement of work equipment (2.6), surrounded by the work environment (2.8) under the conditions imposed by the work tasks (2.17)

2.19

work fatigue

impairing non-pathological manifestation of work strain (2.11), completely reversible with rest

Note 1 to entry: Work fatigue can be mental, physical, local and/or general.

Note 2 to entry: Compare ISO 26800:2011, 2.5.

2.20

target population

people for whom the design is intended, specified according to the relevant characteristics

Note 1 to entry: Relevant characteristics include, for example, the skill level, intelligence or physical characteristics, such as anthropometric dimensions, of these people. Gender and age can be related to variations in these characteristics. In addition to these intrinsic characteristics, extrinsic factors (e.g. cultural differences) could also be relevant.

[SOURCE:ISO 26800:2011, 2.8]

2.21

system function

broad category of activity performed by a system

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