ISO/DGuide 83

Harmonized structure for MSS with guidance for use

Structure-harmonisée pour les NSM avec préconisations relatives à l’utilisation

General Information

• Status: Not Published
• Technical Committee: ISO/TMBG - Technical Management Board - groups
• Drafting Committee: ISO/TMBG - Technical Management Board - groups

Standards Content (Sample)

DRAFT ISO GUIDE
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
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
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STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

DRAFT ISO GUIDE
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
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
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WHICH REFERENCE MAY BE MADE IN
Reference number
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DGUIDE 83:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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
The TMB (through a dedicated Task Force in charge of implementing the TMB action plan) has
asked the JTCG to provide 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):
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
/
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.
/
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
and core definitions) for MSS
(informative)
(normative)
In the identical text proposals: Throughout this guidance:
⎯ XXX = a Management System Standard (MSS) discipline 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
⎯ 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.
Harmonized structure (identical clause numbers, clause titles, text and common terms Guidance for MSS writers
and core definitions) for MSS
(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
legal statements in ISO standards” (see https://www.iso.org/drafting-standards.html).
f) There are many requirements in the HS that use the verb “determine”. MSS writers should
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
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
of the MS" include, but are not limited to, those mentioned by the MSS writers in Clause 1, within
Drafting instruction: Specific to the discipline.
the scope of the MS as defined by the organization (see 4.3).
Harmonized structure (identical clause numbers, clause titles, text and common terms Guidance for MSS writers
and core definitions) for MSS
(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”.
See guidance on Normative references in ISO/IEC Directives, Part 2.
2. Normative references
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
Drafting Instruction 1
Drafting instruction 1: Common terms and core definitions shall be included in the MSS and they
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
vocabulary standard is required to be listed as a Normative reference in Clause 2 of the MSS.
In Clause 3, discipline specific terms and definitions may also be included.
Depending on the way in which terms and definitions are given for the standard, MSS writers
Include generic text specified in ISO/IEC Directives, Part 2.
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
differently from those in the HS because of the addition of discipline-specific concepts.
The arrangement of terms and definitions should preferably be in systematic order, but may
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
Anne
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