13) ISO-DGuide-83

DRAFT ISO GUIDE
ISO/DGUIDE 83
ISO/TMBG Secretariat: ISO

Voting begins on: Voting terminates on:
2023-03-24 2023-06-16
Harmonized structure for MSS with guidance for use

Structure-harmonisée pour les NSM avec préconisations relatives à l’utilisation
ICS: ISO ics
iTeh STANDARD PREVIEW

(standards.iteh.ai)
ISO/DGuide 83
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42a6118be9cb/iso-dguide-83
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REVISION OF ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES

PART 1, ANNEX SL, APPENDIX 2 (HARMONIZED STRUCTURE FOR
MSS WITH GUIDANCE FOR USE)
Background
In September 2021, ISO members have signed the London Declaration to combat climate change
through standards. To help deliver on ISO commitments, the TMB has developed an action plan
that will support the ISO technical community. One of the focus of the TMB action plan is for
committees to include climate considerations in their works.
Because ISO Management Systems Standards (MSS) are widespread, well enshrined in
business organizations, and respected, they have the capacity to induce change. For this reason,
the TMB action plan requested the TMB/JTCG (Joint Technical Coordination Group, gathering all
leaders of committees in charge of MSS) to submit change proposal to the Appendix 2 of the
Annex SL of the ISO Supplement to the ISO/IEC Directives Part 1. This Appendix 2 is also known
as "Harmonized Structure" (formerly known as "High Level Structure", or "HLS") and provides
identical clause numbers, clause titles, text and common terms and core definitions for all MSS.
Change in the Harmonized Structure will therefore have repercussions in all ISO MSS, and it is
expected that the proposed changes will support the delivery of the ISO climate commitment.
Change proposal
asked the JTCG to provide(standards.iteh.ai)
The TMB (through a dedicated Task Force in charge of implementing the TMB action plan) has
recommendations for the revision of the Harmonized Structure. Via
dedicated plenary meetings, the JTCG has reached consensus on the changes to the
Harmonized Structure. These proposed changes were reviewed and accepted by TMB and are
outlined below (additions highlighted): ISO/DGuide 83
4.1 Understanding the organization and its context
The organization shall determine external and internal issues that are relevant to
its purpose and that affect its ability to achieve the intended result(s) of its XXX
management system.
The organization shall determine whether climate change is a relevant issue.
4.2 Understanding the needs and expectations of interested parties

The organization shall determine:
— the interested parties that are relevant to the XXX management system;
— the relevant requirements of these interested parties;
— which of these requirements will be addressed through the XXX management
system.
NOTE: Relevant interested parties can have requirements related to climate
change.
The full Appendix 2 is provided as an Annex for your convenience.
DGuide approval process

Because he Harmonized Structure is the part of the Annex SL that is the basis for all MSS and
because it is technical text, the same level of approval as for an International Standard is needed.
The use of the DGuide approval process ensures that the change proposal will be balloted to all
ISO members, in the exact same way as for Draft International Standards (DIS): the vehicle
© ISO 2023 – All rights reserved

Reference
Page 2
(DGuide ballot) is different but the process is the same. This guarantees that all ISO members
are consulted, they are asked to vote and comment, and the resulting Harmonized Structure
benefits from the same member consensus as International Standards do, hence providing the
same legitimacy.

(standards.iteh.ai)
ISO/DGuide 83

Annex SL Appendix 2
(normative)
Harmonized structure for MSS with guidance for use

Harmonized structure (identical clause numbers, clause titles, text and common terms Guidance for MSS writers
(standards.iteh.ai)
and core definitions) for MSS
(informative)
(normative)
In the identical text proposals: Throughout this guidance:
⎯ XXX = a Management System Standard (MSS) discipline ISO/DGuide 83
specific qualifier (e.g. energy, ⎯ MS = Management System
road traffic safety, IT security, food safety, environment, quality) that needs to be inserted ⎯ MSS = Management System Standard
42a6118be9cb/iso-dguide-83 ⎯ MSS writers = ISO TC/SC/PCs that are responsible for writing discipline-specific MSS
Red italicized text is given as advisory notes to MSS writers
based on Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1,
as well as editors of MSS
⎯ HS = Harmonized structure - that part of the Harmonized Approach that defines the
identical clause numbers, clause titles, text and common terms and core definitions
General
a) This guidance is intended for MSS writers. It does not add to or change any requirement of
the ISO/IEC Directives, Part 1 or Part 2 (including the HS). The objectives of the guidance
are to promote a common understanding of the HS, reduce the need for deviations, and
indicate opportunities for further alignment between the various discipline-specific
requirements that an MSS committee may choose to add.
b) MSS writers should be aware that an organization may address the requirements of
several MSS within a single MS. They should therefore aim to ensure that any additional
discipline-specific requirements can be integrated into such a system.
c) If MSS writers are considering additional discipline-specific requirements, they can consult
other MSS to verify if similar additions have been made and, wherever possible, use
identical or similar text and positioning to ensure ongoing alignment of these additional
requirements. A complete list of MSS can be found at https://www.iso.org/management-
system-standards-list.html. MSS writers should liaise with their Committee Manager to
arrange access to relevant documents including an editable template of the Harmonized
Structure available from the JTCG Secretariat. Further advice is also available via
participation in the ISO/TMBG/JTCG (Joint Technical Coordination Group on MSS).
d) Where references are made in this guidance to other documents, or where examples are
provided, these references are offered to provide MSS writers with a better understanding
and context of the use of discipline-specific elements of an MSS. The references and
examples are not intended for inclusion in discipline-specific MSS. MSS writers can
consult these standards and consider them as potential inputs when drafting their own
MSS.
1
(informative)
(normative)
e) MSS writers should be aware of the ISO Policy on references to legal requirements in
standards, and in particular to TMB Resolution 70/2018 and the additional “Guidance on
iTeh STANDARD PREVIEW f)

legal statements in ISO standards” (see https://www.iso.org/drafting-standards.html).
There are many requirements in the HS that use the verb “determine”. MSS writers should
(standards.iteh.ai)
be aware that this does not specifically require documented information to be available as
evidence of conformity.
g) If MSS writers need to include discipline-specific requirements for documented information
(see 3.10) in any clause of their MSS, they should base such requirements on the same
ISO/DGuide 83 phrases that are used in the HS:
⎯ “… shall be available …” = the documented information is available for use
⎯ “… shall be available as evidence of …” = the documented information is to provide
evidence of conformity
h) While this guidance can also be of interest for users of discipline-specific MSS, it is the
responsibility of the relevant MSS writers to decide on the need for any guidance on the
implementation of their standards, and to provide such guidance as appropriate.
i) For clauses where no additional guidance is deemed necessary, this column is marked as
“No additional guidance”.
No additional guidance
Introduction
Drafting instruction: Specific to the discipline.
This text has been prepared using the harmonized structure (i.e. identical clause numbers,
clause titles, text and common terms and core definitions) intended to enhance alignment
among MSS and to facilitate their implementation for organizations that need to meet the
requirements of two or more such standards.
Text taken from the harmonized structure is highlighted in the text of Clauses 1 to 10 by the
use of blue font. Discipline-specific text is given in black. Strikeout is used to show agreed
deletions within the HS text. The use of blue text and strikeout is only to facilitate analysis and
will not be incorporated after the Draft International Standard stage of development for this
document.
The “intended results” refer to the results that are expected to be achieved by implementing the
1. Scope MSS. MSS writers should be aware that throughout the HS, references to the “intended results
Drafting instruction: Specific to the discipline. of the MS" include, but are not limited to, those mentioned by the MSS writers in Clause 1, within
the scope of the MS as defined by the organization (see 4.3).

(informative)
(normative)
Drafting instruction: The scope of the document shall address the intended result(s) of the To facilitate translation and to provide a better link with the definition of “objective” (see 3.6), MSS
management system. writers should avoid introducing new terms such as “outcomes” instead of “results”.
2. Normative references iTeh STANDARD PREVIEW See guidance on Normative references in ISO/IEC Directives, Part 2.
(standards.iteh.ai)
Drafting instruction: Specific to the discipline.
Include generic text specified in ISO/IEC Directives, Part 2.
See guidance on Terms and definitions in ISO/IEC Directives, Part 2, as well as Appendix 3.
3. Terms and definitions ISO/DGuide 83
https://standards.iteh.ai/catalog/standards/sist/c7778f32-bd4a-4d48-ac0d- Drafting Instruction 1
Drafting instruction 1: Common terms and core definitions shall be included in the MSS and they
42a6118be9cb/iso-dguide-83 When the terms and their associated definitions that are located in Clause 3 of the MSS are also
may also be included in a separate vocabulary standard.
included in a separate vocabulary standard, in accordance with ISO/IEC Directives, Part 2, the
In Clause 3, discipline specific terms and definitions may also be included. vocabulary standard is required to be listed as a Normative reference in Clause 2 of the MSS.
Include generic text specified in ISO/IEC Directives, Part 2. Depending on the way in which terms and definitions are given for the standard, MSS writers
should choose the appropriate introductory wording specified in ISO/IEC Directives, Part 2.
ISO/IEC Directives, Part 2 recommends that terms and definitions are organized according to
the hierarchy of concepts (i.e. systematic order). Term entries in an MSS may be numbered
The arrangement of terms and definitions should preferably be in systematic order, but may differently from those in the HS because of the addition of discipline-specific concepts.
differ from the order given below in Clause 3. Alphabetical order is the least preferred order.
Drafting Instruction 2
General
Drafting instruction 2: The following terms and definitions constitute an integral part of the The term entries (i.e. terms, definitions and all associated notes) stated in Clause 3 of the HS
harmonized structure for management systems standards. Additional terms and definitions are mandatory in all MSS.
may be added as needed. Notes to entry may be added to serve the purpose of each standard.
MSS writers should be aware that any changes made to these term entries in discipline-specific
When drafting terms and definitions, MSS writers are advised to make use of the flowcharts MSS can change requirements in the remainder of the MSS. If a modification of a definition or
given in Annex SL Appendix 3. note to entry is made, this is regarded as a deviation for which a justification is required (see
Annex SL 8.3.4).
Additional notes to entry
Notes to entry may be added to serve the purpose of a discipline-specific MSS provided they do
not contradict, or deviate from, the defined concept.
Additional terms and definitions
When drafting a new definition corresponding to a discipline-specific term, the guidelines of ISO
10241-1 should be followed.

(informative)
(normative)
When a new definition corresponding to a subordinate (i.e. XXX MSS) concept is drafted, the
definition should begin with the term of the concept defined in Clause 3 of the HS, followed by
iTeh STANDARD PREVIEW the specific characteristics of the subject field in question (see Annex SL Appendix 3).
Example from ISO 45001:2018:
(standards.iteh.ai) 3.14
policy
intentions and direction of an organization as formally expressed by its top
management
ISO/DGuide 83
https://standards.iteh.ai/catalog/standards/sist/c7778f32-bd4a-4d48-ac0d-3.15
occupational health and safety policy
42a6118be9cb/iso-dguide-83 OH&S policy
policy (3.14) to prevent work-related injury and ill health to workers and to provide safe
and healthy workplaces
Example:
Drafting instruction 3: Italic type in a definition indicates a cross-reference to another term 3.20
defined in this clause, and the number reference for the term is given in parentheses. monitoring
determining the status of a system, a process (3.8) or an activity
“XXX” in the Notes to entry should be substituted with the appropriate reference. These additional
terms (subordinate concepts) may be included as new term entries.
Example from ISO 14001:2015:
Drafting instruction 4: Where the text “XXX” appears throughout this clause, the appropriate
reference should be inserted depending on the context in which these terms and definitions are 3.2.5
being applied. For example: “an XXX objective” could be substituted as “an information security objective
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 or
process.

(informative)
(normative)
Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended result, a
purpose, an operational criterion, as an environmental objective (3.2.6) or by the use of other words

with similar meaning (e.g. aim, goal, or target).
Note 4 to entry: In the context of environmental management systems objectives are set by the
organization, consistent with the environmental policy, to achieve specific results.
(standards.iteh.ai) 3.2.6
environmental objective
objective (3.2.5) set by the organization consistent with its environmental policy
3.1
ISO/DGuide 83 MSS writers should ensure that any use of the term “organization” with a different intent from that
organization https://standards.iteh.ai/catalog/standards/sist/c7778f32-bd4a-4d48-ac0d- described in Note 2 to entry is clearly distinguished.
person or group of people that has its own42a6118be9cb/iso-dguide-83
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 XXX management system (3.4).
3.2 MSS writers should use the term “interested party”, in which case “stakeholder” may be deleted
interested party (preferred term) from the term entry.
stakeholder (admitted term) The use of the term “stakeholder” is not considered a deviation, but if MSS writers choose to
use that term (e.g. for reasons of tradition in their specific discipline), they should be aware of
person or organization (3.1) that can affect, be affected by, or perceive itself to be affected by a
potential translation problems to find an equivalent in other languages. If MSS writers choose
decision or activity
to use the term “stakeholder”, the term “interested party” may be deleted from the term entry.
MSS writers should not use the terms “interested party” and “stakeholder” as synonyms or
representing different concepts in the same MSS.
3.3 No additional guidance

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.

(informative)
(normative)
3.4 The scope of an MS may include the whole of the organization, specific and identified functions
management system or activities of the organization, specific and identified sections of the organization, or one or

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
more functions across a group of organizations.
MSS writers should take care not to confuse the scope of the MSS, the scope of the MS, and
(standards.iteh.ai)
Note 1 to entry: A management system can address a single discipline or several disciplines. the scope of any eventual certification of the MS.
Note 2 to entry: The management system elements include the organization’s structure, roles and
responsibilities, planning and operation.
3.5 ISO/DGuide 83 No additional guidance

policy https://standards.iteh.ai/catalog/standards/sist/c7778f32-bd4a-4d48-ac0d-
intentions and direction of an organization (3.1)42a6118be9cb/iso-dguide-83
as formally expressed by its top management
(3.3)

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 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 an XXX objective or by the use of other words with similar meaning (e.g. aim,
goal, or target).
Note 4 to entry: In the context of XXX management systems (3.4), XXX objectives are set by the
organization (3.1), consistent with the XXX policy (3.5), to achieve specific results.
3.7 It is recognized that some MSS disciplines have their own understanding of risk, which is not
risk exactly aligned with that of others, but which has been adopted over many years.
effect of uncertainty MSS writers need to be aware that the main advantage of the HS is to make it easier for an
Note 1 to entry: An effect is a deviation from the expected — positive or negative. organization to incorporate the requirements of multiple MSS into its management system.
They should therefore be aware of the need to maintain alignment wherever possible when
Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding introducing discipline-specific term entries or requirements related to risk.
or knowledge of, an event, its consequence, or likelihood.
If MSS writers (due to discipline-specific or sector-specific requirements) need to address a
Note 3 to entry: Risk is often characterized by reference to potential events (as defined in ISO Guide 73) and
consequences (as defined in ISO Guide 73), or a combination of these. particular risk group, category or type for their users, in addition to the general concept
specified here, they should consult Annex SL 8.3.8.
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) of For further information, MSS writers can refer to ISO 31000 (Risk management – Guidelines).
occurrence.

(informative)
(normative)

process
set of interrelated or interacting activities that uses or transforms inputs to deliver a result
(standards.iteh.ai)
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.

competence ISO/DGuide 83
ability to apply knowledge and skills to achieve intended results
3.10 MSS writers need to be aware that “documented information” is a term to represent any
documented information information that needs to be documented for the effective implementation of the MS, and to
information required to be controlled and maintained by an organization (3.1) and the medium demonstrate conformity to the MS requirements. This includes requirements specified by the
relevant MSS as well as requirements that the organization has to, or chooses to, comply with.
on which it is contained
Note 1 to entry: Documented information can be in any format and media and from any source. The term “documented information” is used to convey the fact that the focus should be primarily
on the delivery of information rather than the medium used to convey it.
Note 2 to entry: Documented information can refer to:
– the management system (3.4), including related processes (3.8); “Documented information” replaces the nouns “documentation”, “documents” “records” and
– information created in order for the organization to operate (documentation); “documented procedures” used in previous editions of some MSS.
– evidence of results achieved (records).
MSS writers need to be aware that whenever reference is made to “documented information”
throughout the HS, the requirements specified in 7.5 apply.

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).

continual improvement
recurring activity to enhance performance (3.11)
3.13 MSS writers should only use the terms "effectiveness" and "effective" when referring to the
effectiveness ability to deliver intended results. It is important not to confuse the concept of "effectiveness"
extent to which planned activities are realized and planned results are achieved with that of "efficiency", which relates the result achieved compared to the resources used.

(informative)
(normative)
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.
(standards.iteh.ai)
Note 2 to entry: A specified requirement is one that is stated, e.g. in documented information (3.10).
3.15 The term “conformity” applies to all requirements, including those specified in the relevant
MSS.
conformity ISO/DGuide 83
fulfilment of a requirement (3.14) The term “compliance” can have a different meaning from the term “conformity” and is not used
in the HS.
MSS writers who want to introduce the term “compliance” should provide appropriate guidance
on how to interpret it with respect to “conformity” in their specific discipline.
MSS writers should consult ISO 37301 (Compliance management systems – Requirements
with guidance for use) for more information if they need to include discipline-specific
requirements relating to compliance.
3.16 Nonconformity relates to the non-fulfilment of requirements (see 3.14) including those specified
nonconformity by the MSS or adopted by the organization as an integral part of its MS (e.g. for products,
non-fulfilment of a requirement (3.14) processes, agreements with interested parties).

corrective action
action to eliminate the cause(s) of a nonconformity (3.16) and to prevent recurrence
3.18 This definition of “audit” differs slightly from the definition given in ISO 19011:2018 (Guidelines
audit for auditing management systems), in that the definition in 3.18 does not specifically state that
systematic and independent process (3.8) for obtaining evidence and evaluating it objectively to the audit process is to be “documented”.
determine the extent to which the audit criteria are fulfilled If MSS writers need to include additional discipline-specific definitions related to audit, they
Note 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party), should consult ISO 19011.
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.
3.19 Measurement consists of determining a value (e.g. physical quantity, property) using
measurement measurement resources such as a measuring instrument, equipment, system or surveys.
process (3.8) to determine a value

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DRAFT ISO GUIDE

ISO/TMBG Secretariat: ISO

Harmonized structure for MSS with guidance for use

ICS: ISO ics

iTeh STANDARD PREVIEW

THIS DOCUMENT IS A DRAFT CIRCULATED

iTeh STANDARD PREVIEW

COPYRIGHT PROTECTED DOCUMENT

ii ﻿ © ISO 2023 – All rights reserved

REVISION OF ISO SUPPLEMENT TO THE ISO/IEC DIRECTIVES

The organization shall determine whether climate change is a relevant issue.

4.2 Understanding the needs and expectations of interested parties

The full Appendix 2 is provided as an Annex for your convenience.

DGuide approval process

© ISO 2023 – All rights reserved

iTeh STANDARD PREVIEW

© ISO 2023 – All rights reserved

Harmonized structure for MSS with guidance for use

iTeh STANDARD PREVIEW

iTeh STANDARD PREVIEW f)

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© ISO 2023 – All rights reserved

© ISO 2023 – All rights reserved

iTeh STANDARD PREVIEW

3.3 No additional guidance

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iTeh STANDARD PREVIEW

3.5 ISO/DGuide 83 No additional guidance

3.6 No additional guidance

© ISO 2023 – All rights reserved

3.8 No additional guidance

iTeh STANDARD PREVIEW

3.9 No additional guidance

3.11 No additional guidance

3.12 No additional guidance

3.14 No additional guidance

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3.17 No additional guidance

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