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GUIDELINES FOR THE JUSTIFICATION AND DEVELOPMENT OF SYSTEM STANDARDS

OF MANAGEMENT

1. OBJECT

This guide provides:

Guidance for justifying and evaluating a proposed management system standard project, with
you look to evaluate its relevance in the market.

Guidance on the methodology (process) of development and maintenance (that is, the review
to evaluate and modify) the management system standards with a view to ensuring
compatibility and improve alignment, and

Guidance on terminology, structure, and common elements of the system standards

management, with a view to ensuring compatibility, as well as increasing alignment and ease
for use.

This guide is supplemental to the procedures for technical work and the methodology for the
development of international standards established by the ISO/IEC Directives. It also establishes
a distinction between three different types of management system standards (MSS), as follows:

Type A: Requirements standards for the management system, both generic and sector-specific
specific.
Type B: Guidelines on the management system, both generic and specific for
sectors.
Type C: Standards related to the management system.

Although this guide is primarily aimed at Type A NSG, it is equally applicable to Type B.

This guide applies to Type C, with the exception of numeral 7.3, which relates to the
structure of the NSG and the common elements.

This guide is intended for use by all ISO bodies involved in development.
requirements and guidelines of the management system and guidelines, and standards of the system of
management related. They can also be used by standardizing organizations different from ISO.
international, regional or national level that they are considering developing or are developing
standards of the management system and/or comparable documents.

It is important to emphasize that this guide is not useful as a standard of the system of
integrated management. It is intended for use by standardizers, not by organizations that
they are implementing management system standards, nor for certification purposes.

Note 1 Whenever the term 'norm' is used in this guide, it refers to the entire range of products.
available from the ISO [that is, international standards, ISO (IEC) guidelines, technical specifications, technical reports,
publicly available specifications and International Workshop Agreements] unless reference is made to a
specific type of document.

Note 2 In this entire guide, the abbreviation NSG is used to refer to standards type A, B, and C.

Note 3 Whenever the term technical committee (TC) is used in this guide, it includes all ISO bodies that
they develop NSG.

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2. NORMATIVE REFERENCES

The following rules contain provisions that, by reference to this text, constitute
provisions of this standard. At the time of its publication, the editions were in force
indicated. All the rules are subject to review, therefore, the parties are invited to
Make agreements based on this standard, to investigate the possibility of applying the latest editions.
recently from the following list. The members of IEC and ISO maintain updated records of the
international standards.

ISO/IEC Directives Part 1, 2001, Procedures for technical work

ISO/IEC Directives Part 2, 2001, Rules for the structure and drafting of international standards

Guide 2 ISO/IEC:1996, Standardization and related activities – General vocabulary

ISO 9000:2000, Quality Management Systems – Fundamentals and Vocabulary

ISO 14050:1998, Environmental management - Vocabulary

3. TERMS AND DEFINITIONS

For the purposes of this guide, the terms and definitions established in Guide 2 apply.
ISO/IEC, in ISO 9000, ISO 14050, and the following:

3.1
Management system:
System to establish the policy and objectives and to achieve those objectives.

ISO 9000:2000, definition 3.2.2

Note 1 Organizations use management systems to develop their policies and implement them through
objectives and goals, using:

An organizational structure in which the functions, responsibilities, authority, etc., of individuals are defined.

Systematic processes and associated resources to achieve these objectives and goals.

Measurement and evaluation methodologies to assess performance against objectives and goals, with feedback.
from the results to plan improvements to the system, and

A review process to ensure that issues are corrected and recognized and implemented
opportunities for improvement, when justified.

Note 2 All organizations have (whether consciously or not, documented or not) a system
general management through which the organization's objectives are established, executed, and controlled.

3.2 MANAGEMENT SYSTEM STANDARDS

3.2.1
Management system requirements standard, Type A
Standard established to provide the market with the relevant specifications for the system of
management of an organization demonstrates its ability to meet internal requirements and
externals (for example: through the evaluation of that capacity by internal or external parties).

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EXAMPLES

System management requirements standards (specifications).

Specific management system requirements standards for a sector.

3.2.2
Directives standard of the management system, Type B
Standard established to help an organization implement and/or improve its management system
through the provision of additional guidance to the elements of a requirements standard
management system or independent guide not equivalent to a system requirements standard
management.

EXAMPLES

Guide on the use of the requirements of the management system standards.

Guide on establishing a management system.

Guide to improving a management system.

Guidelines of the management system specific to a sector.

3.2.3
Standard related to the management system, Type C
Standard established to provide additional information on specific parts of the management system,
and guidance on related support techniques, in addition to the standards of the systems of
management.

EXAMPLES

Management system terminology documents.

Audit standards, documentation, training, monitoring, measurement, and performance evaluation.

Standards on labeling and life cycle assessment.

3.3
Family of standards of the management system
NSG family
Set of guidelines and requirements of the management system (3.2.1 and 3.2.2) and standards
related (3.2.3) developed by the same technical committee.

3.4
Draft standard of the management system
NSG Project
Project to initially develop, review or add new parts to the guidelines and
system management requirements (3.2.1 and 3.2.2) and related standards (3.2.3).

3.5
Compatibility
Convenience of similar standards for joint use under conditions
specific, to meet the relevant requirements without causing unacceptable interactions.

Note 1 Based on Guide 2 ISO/IEC.

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Note 2 In the case of an NSG, 'compatibility' means that organizations can implement elements
common to the standard, in a shared manner, in whole or in part, without unnecessary duplication or the imposition of
conflicting requirements. 'Compatibility' does not mean that the text of the common elements of the standards must be
identical, although it should be in practice, when possible. See ISO/TAG 12, Report to the ISO/TMB on ISO
9000 and ISO 14000 compatibility.

3.6
Process of the justification study
Process of EJ
Process for justifying and evaluating the relevance of NSG projects in the market (3.4).

Note The initial justification study is carried out by the proponent of the NSG project. After the evaluation,
and if any correction is necessary, the entry is made for subsequent evaluation and the recommendation report
(see numeral 6.2).

4. ABBREVIATIONS

For the purposes of this guide, the following abbreviations apply.

CASCO ISO Committee for Conformity Assessment

CD Committee Project

DIS International Standard Project

EJ Justification Study

NSG Management System Standards (Type A, B, and C), as described in the

numbers 3.2.1 to 3.2.3.

Family Family of standards of the management system (3.3)

NSG

Project Draft standard of the management system (3.4)

NSG

NWI New work item

PHVA Plan-do-check-act

SC Subcommittee

TC Technical Committee

TMB ISO Technical Management Board

WD Work project

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5. GENERAL PRINCIPLES

The following general principles provide guidance for assessing market relevance.
of the new proposed work (numeral 6) and to the processes of norm development carried out by
the assigned body (number 7), once the work has been accepted.

The questions about justification criteria in Annex A are based on these principles that
provide criteria against which these responses should be evaluated.

The processes described in numeral 7 are based similarly on the principles provided
criteria for the verification and validation of the resulting NSG.

An NSG should be started, developed, and maintained only when all the conditions are observed.
following principles:

Relevance in the market Any NSG should meet the needs of users
primary and other affected parts, and add value.

Compatibility Compatibility between the different NSGs should be maintained and

within a family of NSG.

Ease of use It should be ensured that the user can implement easily.
one or more NSGs.

Coverage of the topic A NSG should have sufficient application coverage for
eliminate or minimize the need for specific variations when
sector.

Flexibility An NSG should be applicable to organizations of any

size, in all relevant sectors and cultures. An NSG does not
should prevent organizations from increasing their
competitiveness or differentiate themselves from others, or improve their systems
management beyond the norm.

Solid technical foundation An NSG should be based on proven management practices, or in

relevant and scientifically validated existing data.

Easy understanding A NSG should be easy to understand, free of ambiguity,

without cultural bias, easily translatable and applicable to business in
general.

Free trade An NSG should allow the free trade of goods and services in
line with the principles included in the WTO Agreement on
Technical Barriers to Trade.

Applicability of the
Assessment of the
Conformity The market need for an evaluation should be assessed.
compliance by first, second, or third party. The NSG
The result should clearly address the convenience of use for the
conformity assessment in its scope. An NSG should
facilitate joint audits.

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Exclusions A NSG should not include related specifications

directly with products (and services), testing methods, levels
of performance (i.e., setting limits) or other forms
normalization of products made by the organization that
make the implementation.

6. PROCESS AND CRITERIA FOR THE JUSTIFICATION STUDY

6.1 GENERALITIES

This numeral describes the process of the justification study (EJ) to justify and evaluate the
relevance of the proposals of an NSG in the market. Annex A presents a group of
questions to address in the justification study.

6.2 JUSTIFICATION STUDY PROCESS

The EJ process applies to any NSG project and consists of:

a) The execution of the EJ by (or on behalf of) the proponent of an NSG project.

b) An independent assessment to consider whether the justification study is sufficient or if it needs

needs additional work.

c) An independent evaluation of the EJ and the preparation of the recommendation report; this
it will include the following information along with the proposal during the subsequent vote:

Recommendations with the summary of its fundamental reason, including the preferred scope and the
type of document.

The conformity assessment methods, if any, against the proposed standard that are
it is considered to fit better for standard users.

The summary of the EJ assessment, including significant factors for and against.

The relevant information about geography, sector, and contacts, prepared and collected during the
evaluation.

The identification of the authors of the report.

The EJ process follows the normal voting procedure of ISO for the approval of a
new area of activity or a new item of work, as appropriate.

The objective of the independent evaluation is to provide objective and impartial information such as the
basis for the recommendation report. It should provide additional objective and useful information in a
report format, so that member organizations can make well-informed decisions in the
approval process.

In the initial phase of any NSG review, a new EJ should be carried out;
The review request should accompany the results and subsequent recommendations. The
The scale of the EJ may vary from lower to higher, depending on the expected changes in the
management practices based on the publication of the NSG in question.

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The evaluation of the EJ should consider the principles of numeral 5 and the questions of Annex A,
and it can be compared against the previous EJ and the design specification. This process should
help identify ongoing market needs related to the standard and the areas for
consider for possible modifications.

The recommendation report from the EJ should indicate one of the following:

Cancellation.

Confirmation, or

Review.

6.3 CRITERIA FOR THE STUDY OF JUSTIFICATION

Based on Annex C of the ISO/IEC Directives, Part 1, 2001, and the general principles
established in numeral 5, Annex A lists a set of questions that should be used
as criteria to justify and evaluate a proposed EJ project.

When preparing the justification study, the proponent of an NSG project should consider
the principles of numeral 5 and take into account the questions from Annex A. This list is not
exhaustive and any additional information relevant to the case should be provided.

The importance and relevance of the different questions in Annex A will vary according to the
nature of the NSG project. The EJ should demonstrate that all have been considered
questions. If it is decided that they are not relevant or appropriate to a particular situation, then
these reasons should be clearly established. A proposal for a new Type C NSG or
a minor revision of an existing standard will require less rigorous responses than a
proposal for a Type A NSG.

The entity responsible for evaluating the EJ should also use these principles and questions.
about the criteria of Annex A, but not limited to them. The unique aspect of a particular EJ can
require the consideration of additional questions in order to objectively assess the
relevance in the market of the proposed NSG project. In the evaluation process of the EJ
you can request the proponent to clarify their answers or provide additional information.

7. GUIDE ON THE DEVELOPMENT PROCESS AND STRUCTURE OF A NSG

7.1 GENERALITIES

The development of an NSG will have related effects on:

The transcendent impact of these regulations on commercial practice.

The importance of global support for standards.

The practical possibility of participation by many, or all, member bodies of ISO, and

The market need for compatible and aligned NSG.

This numeral provides additional guidance to the procedures established in the Directives.
ISO/IEC, in order to take these effects into account.

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The development and review of all NSGs should follow the processes described in the numeral
7.2. When management system requirements or guidelines are developed (3.2), also
the guidance provided in numeral 7.3 should be followed. When it is already available
draft standard that is accepted as the basis for a proposed NSG, should be established the
measure in which the recommendations in sections 7.2 and 7.3 are applied, based on the
document maturity.

All NSGs should use uniform terminology so that they are easy to use and
compatible with each other. When applicable, the NSGs should use common elements that
preferably be arranged in the same sequence (see numeral 7.3).

The architecture of any NSG family should be carefully designed and should
define the function of each document in the family. Any regulations related to the system of
management (Type C) should be fully in line with the system requirements standards
management (Type A). Type B and C standards should not introduce system requirements.
additional management. When NSG family standards on support techniques are developed,
the guidance presented in section 7.2 should be used appropriately. These documents
they are independent and their structure does not need to align with those of Type A or B. Without
embargo, if there are similar documents from another NSG family or from the same one, they should be
properly consider and any effort should be made to achieve its alignment.

When management system guidelines are involved, it is important that their functions are
clearly define along with its relationship to the standard requirements of the management system, by
example:

Guide on the use of the requirement standard.

Guide on the establishment/implementation of the management system.

Guide on improving the management system.

When the guidelines are related to a requirements standard of the management system
Type A should have a structure aligned with that standard.

When the proposed NSG is sector-specific, in addition to the guidance provided in

The numerals 7.2 and 7.3, the following applies:

The specific NSG for a sector should be compatible and aligned with the generic NSG.

The relevant technical committee or subcommittee responsible for the generic NSG may have requirements.
additional requirements to fulfill or procedures that must be followed.

It may be necessary to consult other technical committees or subcommittees, as well as CASCO.

about aspects of conformity assessment.

In the case of specific documents for a sector, their function and relationship with the NSG should be
clearly define (for example: specific additional requirements for a sector; clarification, or
both, depending on the case.

The specific documents for a sector should always clearly show (for example,
through the use of typographic styles), the type of information specific to a sector, which is
supplies.

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7.2 NSG DEVELOPMENT PROCESS

7.2.1 Generalities

Most of the additional guidance provided in this section pertains to the stage
preparatory (stage 2) of the development of standards (ISO/IEC Directives Part 1, 2002, 2.4) that
understand the preparation of a work project.

Note Whenever the following text refers to a technical committee, it can also mean a
technical subcommittee, as appropriate.

7.2.2 Design Specification

To ensure that the intent of the regulation is maintained, as demonstrated by the study of
Justification, it is appropriate to develop and approve a design specification before preparing
the work project.

The responsible technical committee should decide on the format and content of the specification.
of appropriate design for each type of NSG and should establish the necessary organization to
carry out the task.

The design specification should typically take the following into account:

User needs The identification of the standard's users and their needs
associated, along with the costs and benefits for these users.

Scope The scope and purpose of the standard, its title and field of application.

Compatibility How will compatibility be achieved within this NSG family and
with other NSG families, including the identification of the elements
common with similar regulations, and how they will be included in the structure
recommended (see paragraph 7.3).

Consistency Consistency with other documents that will be developed within.

from the NSG family.

Note 1 Most of the information, or all of it, about the users' needs and the scope will be available.
based on the justification study.

In the case of developing a standard of requirements or directives for the management system (3.2), the
The design specification should also take the following into account:

Model The characteristics of the model that will be used for the standard (see numeral
7.3).

The structure should follow the recommendations of numeral 7.3. If there are
reasons for not following the recommended structure should be explained.

The design specification should ensure that:

a) The results of the justification study are correctly translated into requirements for the NSG.

b) Compatibility and alignment issues with other NSG have been identified and addressed.

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c) There is a basis for the verification of the final NSG at appropriate stages during the process of
development.

d) The approval of the design specification provides a foundation for belonging throughout
the project by the members of the TS/SC.

e) Comments received during the NWI voting phase are taken into account, and

f) Any restriction is taken into account.

Note 2 If more than one standard is required for the justification study, it may be necessary to prepare a
design specification for each one.

7.2.3 Development of available products

Project Management

The technical committee should establish a project plan that outlines how it will be organized and
manage the project, its schedule and how key dates will be met.

In the committees that make decisions during this process (generally, TC and SC), all the
member organisms should be invited to participate, to ensure common support. The
technical committees should also strive to ensure that there is adequate representation of
the organizations that expect to implement the proposed NSG. To encourage this support, it can
It is necessary to have additional stages of feedback and decision-making outside of the
established in the ISO/IEC directives.

Experience has shown that due to the nature and application of the NSG, many countries
they want to participate and there can be very large committees. This can be managed by establishing
a difference between operational tasks (for example, writing) and decision making.
Technical committees should find the right balance between the desire for participation from
all stakeholders and the size of the writing groups, to achieve effective work.

[Link] Human resources

The success of any NSG project will largely depend on:

The composition of the editorial teams, which should be made up of experts in both
the thematic field as in the drafting of norms, just like having representation
balanced among the various affected parties, and

The continuity of group membership and therefore the commitment of the members to
relation to the continuity of the assistance.

The TC Secretariat should ensure that the coordinators and secretaries possess the skills.
sufficient for the task. The coordinators should ensure that the people in their group
(for example, SC, WG, drafting group) know what the task is and provide or offer support if needed.
requires.

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[Link] Monitoring of the result

In the writing process, follow-up should be done on the result to determine the
compatibility and ease of use with other NSG, through the coverage of the following
aspects:

Vocabulary and definitions.

The inclusion of agreed common elements.

The use of the agreed structure and topics that must be addressed in each section.

The need for clarity (both in language and presentation), and

Avoid overlaps and contradictions.

[Link] Management of deviations

Any deviation from the program concerning the recommended structure (see item
7.3) The design specification should be agreed upon and documented to allow for ISO and the
The technical committee should take these deviations into account. Procedures should be established.
suitable to apply corrective actions on the deviations. It is the responsibility of the
The technical committee should carry out the work and the secretariats should remind the members of this.
committee.

[Link] Verification and validation

As part of its planning process, the technical committee should establish the stages in the
What are appropriate verification (against the design specification) and validation (against the
intended use), and the methodology to be applied.

Note The definitions of verification and validation are provided in the ISO 9000 standard.

Due to its nature, the verification process cannot begin before the approval of the
design specification, but to benefit from its results, it is important to carry it out
as soon as possible, and at least in the stages of design specification and committee project.

Verification and/or validation can occur at various stages, as follows:

Verification of the design specification against the EJ.

Verification of a 'mature' work project against the design specification.

Verification and/or validation in the CD stage.

Verification and/or validation in the DIS stage.

Validation of the final NSG.

The verification is carried out by the technical committee itself.

Validation techniques may include:

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_______________________________________________________________________________
- Surveys to organizations, to obtain their response on possible benefits, impacts,
problems, etc., of the new NSG.

Pilot programs with selected organizations in member countries, to test the new
NSG and report on its benefits and problems, and

The voting on documents by national standardization bodies.

Where the validation indicates that the project is not meeting expectations.
stakeholders, the NSG project should be reviewed and corrected, or the specification should be corrected
of design, and even review the EJ.

7.2.4 Transparency of the NSG development process

The NSGs have a broader scope than most other types of standards. They cover a
considerable field of human effort and have an impact on a wide range of interests
users.

Consequently, the technical committees that prepare NSG should adopt a broad approach.
transparency for the development of standards, to ensure that:

Clearly identify the possibilities for participation in the development process.

rules, and

All parties understand the development processes that are used.

The technical committees should provide information on progress throughout the cycle of
project life, including:

The status of the project to date (including the items under discussion).

The contact points for additional information.

Press releases and reports on plenary meetings and

Regular listings of frequently asked questions and answers.

In doing this, it is necessary to take into account the distribution facilities available in the
participating countries.

Where it can be expected that users of an NSG can demonstrate compliance (for
by means of self-declarations, second party contracts or certification/registration, it should
pay attention to any guidance provided in the standard on how this can be achieved.

The use of the resources of the Central ISO Secretariat should be maximized to facilitate the
project transparency, and the technical committee should also consider the establishment of
a dedicated open access website.

Technical committees should involve national member bodies in the

building a national awareness about the NSG project, providing projects
as appropriate, to different stakeholders and affected parties, including the bodies of
accreditation, accreditation bodies, companies and the user community, together with the
additional specific information needed.

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The technical committee should ensure that the technical information about the content of the NSG in
development is available to participating members, especially in developing countries
development.

7.2.5 Process of interpreting a norm

The technical committee should establish a process to handle questions of interpretation.

related to their rules, coming from users, and should be made available to others
the resulting interpretations, in a timely manner. This mechanism can effectively handle
possible interpretations at an early stage, and identify aspects that may require a
better drafting of the regulation during the next review cycle.

7.3 MODEL OF STANDARD OF THE MANAGEMENT SYSTEM, STRUCTURE AND ELEMENTS

COMMONS

7.3.1 Generalities

This number applies only to requirements and guidelines of the management system.
as defined in numerals 3.2.1 and 3.2.2.

The compatibility between requirements standards or management system guidelines and ease of
They can be improved by increasing the common features among the standards. They should be.
consider all factors such as the model of the general management system applied, the
structure of the standard and the number of common elements, along with its wording and the
used terminology.

There are several ways to consider these factors when drafting standards for different
topics, ranging from harmonized terminology to a management system standard
fully integrated quality. It is recommended that the requirements and guidelines standards of
management system for different topics applies harmonized terminology and uses a set
identified common elements. In this way, they will provide organizations that are
Implementing the standards, a solid foundation to do this in an integrated way, if so.
they wish.

7.3.2 Model and structure

The general structure of a standard of requirements and guidelines for the management system should be
based on a recognized model and a logical arrangement of the system requirements
management that follows that model.

The chosen model should represent the fundamental principles applied to the standard of
management system for:

a) Help users understand these principles, and assist them in the implementation of systems
management.

b) Help the normalizers establish a consistent and logical structure.

The rules related to the management system (see numeral 3.2.3) may also
they need to be structured in a similar way when there is an obvious benefit in having one
common structure.

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Existing models for NSG will evolve over time and new models will emerge.
Therefore, it is not appropriate to favor any particular NSG model. In international standards
Currently, two models are recognized: the PHVA model and the process model. The committees
ISO technicians who develop management system standards and aim to adopt a model
different, they should ensure compatibility with the NSGs developed by other committees
technicians.

Note In the ISO 9001, ISO 9004, and ISO 14001 standards, examples of the use of these models can be found.

7.3.3 Common elements

The experience with the NSGs developed by ISO shows that there are many elements
common. These common elements can be categorized under the following main themes:

a) Politics.
b) Planning.
c) Implementation and operation.
d) Performance evaluation.
Improvement.
f) Management review

Table B.1 of Annex B shows the common elements in the requirement standards and
management system guidelines listed according to this structure. It is recommended
follow this arrangement of the elements, to facilitate the use of the standard and also the
joint implementation of a NSG. It is acknowledged that the common arrangement of elements
it can only be practical at the levels of main elements, that is, that of the main number and
the first level.

The technical committees of ISO that develop requirements and guidelines for the system of
management, and those who seek to adopt a different sequence of elements should demonstrate
how can ease of use and joint implementation with developed NSG be achieved
by other technical committees. For communication with the TMB and other technical committees as needed.
Appropriate, the technical committee should provide a table presenting references.
between the arrangement of its own system management regulation and Table B.1.

If a technical committee selects a sequence of elements that differs significantly from the
From Table B.1, cross-reference tables with others should be included in your document.
NSG, to help facilitate its use.

When drafting a text for common elements of system requirements standards

quality, the same wording should be used when expressing the same meaning.

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Annex A
(Informative)

Questions about justification criteria

A.1 GENERALITIES

The following list of questions, which must be taken into account in the justification study, is not
exhaustive. Additional information not covered by these questions should be provided, if it is
relevant.

The answers to the questions listed from A.2.3 to A.2.8 should be differentiated accordingly.
with the parts that may be affected by the proposed NSG if the responses differ
significantly.

A.2 QUESTIONS

A.2.1 Basic information about the NSG proposal

a) What are the proposed purpose and scope of the NSG?

b) Would the proposed work item of the NSG result in an international standard (IS),
an ISO (IEC) guide, a technical specification (TS), a technical report (TR), a specification
publicly available (PAS) or an International Workshop Agreement (IWA)?

c) Do the proposed purpose or scope include product (service) specifications, methods

of product testing, product performance levels, or other forms of guidance or
requirements directly related to the products manufactured or supplied by the
implementing organization?

d) Are there one or more existing ISO technical committees, or an organization different from ISO that
Could it logically have responsibility for the proposed NSG? If so, identify it.

Have relevant reference materials been identified, such as guidelines or practices?

established?

f) Are there technical experts available to support the standardization work? The
Technical experts are direct representatives of the affected parties from different regions.
geographical?

g) What efforts are expected as necessary to develop the document in terms of the
necessary experts and the number/duration of the meetings?

h) What is the expected completion date?

A.2.2 Affected parties

a) Have all the affected parties been identified? For example:

1) Organizations (of different types and sizes): the decision-makers

within an organization, that approve the work of implementing and achieving compliance with the
NSG.

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2) The customers/end users, that is, individuals or parties that pay for a product (including
the service) or for its use, of an organization.

3) Supplier organizations, such as: producers, distributors, wholesalers

minor of a product, or suppliers of a service or information.

4) Service provider with an NSG, for example: certification bodies based on

NSG, accreditation bodies or consultants.

Regulatory organisms.

6) Non-governmental organizations.

b) Is the NSG intended to be a guiding document, a contractual specification, or a

regulatory specification of an organization.

A.2.3 Need for an NSG

a) What is the need? Does this need exist at a local, regional, or global level? Does it apply to
developing countries? Does it apply to developed countries? What is the added value of
having an ISO document (for example: facilitating communication between organizations
different countries)?

b) Does this need exist for many sectors, and is it therefore generic? If so, which ones?
son? Does this need exist for small, medium, or large organizations?

c) Is this need important? Will it continue? If so, the deadline for

Will the proposed NSG termination meet this need? Are there identified alternatives?
viable?

d) Describe how the need was determined and its importance. List the affected parties.
consulted and the main geographical or economic regions in which they are located
located.

e) Is there known or expected support for this NSG? List the organizations that have
manifested their support. Is there known or expected opposition to the proposed NSG? List the
organizations that have indicated their opposition.

A.2.4 Specific NSG proposals for the sector.

a) Is the NSG specific to a single sector?

b) Will the NSG reference or incorporate an existing non-industry specific ISO NSG?
(for example: from the ISO 9000 series of management system standards)? If so, the
the development of the NSG will comply with the ISO/IEC Policy on Sectors (see numeral 6.8.2 of
the ISO/IEC Directives, Part 2, 2001) and any other relevant policies and procedures of
orientation (for example: those that can be obtained with a relevant ISO technical committee)?

c) What steps have been taken to eliminate or minimize the need for deviations in a sector?
specific particular regarding a generic NSG?

A.2.5 Value of an NSG

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A.2.5.1 Value for an organization that implements the NSG

a) What are the expected benefits and costs for organizations, differentiated for
small, medium, and large organizations, if applicable?

b) Describe how the benefits and costs were determined. Provide available information.
about geographical or economic focuses, industrial sector, and size of the organization.
Provide information about the consulted sources and their basis (for example: practices
verified), preliminary observations, hypotheses, and conditions (for example: speculative or
theoretical), and other relevant information.

c) Will the NSG allow an organization to competitively increase, differentiate, or stimulate the
innovation of your management system beyond the standard?

d) If the intended use is for contractual or regulatory purposes, what are the methods
potentials to demonstrate conformity (for example: first, second, or third party)? The NSG
allows organizations flexibility in selecting the method to demonstrate compliance and
to adapt to changes in their operations, management, physical facilities, and equipment?

e) If third-party certification/registration is a potential option, what are the benefits and

Expected costs for the organization? Will the NSG facilitate joint audits with other NSGs?
Will it promote parallel evaluations?

A.2.5.2 Value for other affected parties

a) What are the expected benefits and costs for the other affected parties (including the
developing countries?)

b) Describe how the benefits and costs were determined. Provide information.
regarding the affected parties indicated.

c) What will the expected value be for society?

A.2.6 Risk of trade barriers

a) How will the NSG facilitate or affect global trade? Could the NSG create or hinder a
technical barrier to trade?

b) Could the NSG create or prevent a technical barrier to trade for organizations
small, medium or large?

c) Could the NSG create or prevent a technical barrier to trade for developed or developing countries?
development route?

d) If the proposed NSG is intended for use in government regulations, is it possible that
add, duplicate, replace, improve or support existing government regulations?

A.2.7 Risk of incompatibility, redundancy, and proliferation

a) Does it partially coincide or potentially conflict with other international ISO standards or
from another organization, existing or planned, or with national or regional standards? Do they exist?
other public or private actions, guidance, requirements, and regulations that seek to address the

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identified need, such as technical documents, proven practices, studies

academics or professionals, or any other body of knowledge?

b) Does the NSG or the related conformity assessment activities (for example:
audits, certifications) may add, replace, harmonize, and simplify,
duplicate or repeat, engage in conflict or deviate from existing activities already
identified? What steps are being considered to ensure compatibility, resolve
conflicts or avoid duplication?

c) Is it possible that the proposed NSG promotes or gives rise to the proliferation of NSG at the level
national or regional, or by industrial sectors?

A.2.8 Other risk factors

Have other risks been identified (for example: opportunity or unforeseen consequences for
a specific business)?

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Annex B
(Information)

Table B.1 Common elements of the ISO NSG

Themes Common elements Typical aspects to cover

main ones that
are common to
all the NSG
B.1 Policy B.1 Policy and principles B.1 Policy to demonstrate the commitment of a
organization with compliance of requirements
related to the NSG and establish a sense of
direction and general action principles. The policy
should provide a structure for the establishment
of objectives and goals.
B.2 B.2.1 Identification of needs, B.2.1 Identification of the aspects that should be
Planning requirements and analysis of critical aspects. to control and/or improve in order to provide satisfaction to
the interested party/parties. The term "requirements"
includes the legal requirements.

B.2.2 Selection of significant aspects B.2.2 Prioritization of the aspects identified as

that should be dealt with result of B.2.1.

B.2.3 Establishment of objectives and goals B.2.3 Identification of clear goals and objectives
(including schedules) based on the results of
B.2.2, the organization's policy and the results of
the review by management (B.6).

B.2.4 Identification of resources B.2.4 Identification of the necessary resources and the
availability of human resources, infrastructure
and adequate financial resources.

B.2.5 Identification of the structure B.2.5 Identification of the functions, responsibilities,

organizational, functions, responsibilities, authority, and interrelationships within the organization,
authority to the necessary extent to ensure operations
effective and efficient.

B.2.6 Planning of processes B.2.6 The provisions for planning of the

operational operational processes that may include actions
that affect how objectives and goals are achieved
defined in B.2.3.

B.2.7 Preparation for contingencies, for B.2.7 The measures that need to be taken to manage
predictable events the foreseeable emergencies.

B.3 B.3.1 Operational control B.3.1 The necessary operational control measures
Implementation to implement the plan(s) and maintain control
and operation of activities against defined goals.

B.3.2 Human Resource Management B.3.2 The management of employees, contractors, staff
temporary, etc., including qualifications and activities
such as the construction of awareness and
training).

B.3.3 Management of other resources B.3.3 Operational management and maintenance of the
infrastructure, the plant, the facilities, the finances,
etc., that have an impact on performance of the
organization.

B.3.4 Management and its control B.3.4 The management of the elements that are essential
for the successful implementation and operation of the
management system.

B.3.5 Communication B.3.5 The provisions for communications both

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within the organization how towards/from sources

external.

B.3.6 Relationshipwith suppliers y B.3.6 The formalization of provisions for those who
contractors. they provide
y hire their services for the
organization, that have an impact on performance of
this.

B.4 Evaluation B.4.1 Monitoring and measurement B.4.1 The mechanisms by which the
of the performance organization evaluates its current performance.

B.4.2 Analysis and management of non-conformities B.4.2 The determination of non-conformities and the
way of facing them.

B.4.3 System Audits B.4.3 The audit of the management system.

B.5.1 Corrective Action B.5.1 The mechanism to eliminate the causes of the no
compliances detected both in the system of
management as in operational processes.

B.5.2 Preventive action B.5.2 The mechanism to promote action towards the
elimination of causes of non-conformities
detected, both in the management system and in the
operational processes.

B.5.3 Continuous improvement B.5.3 The measures taken for improvement

continuity of the management system.
B.6 Review B.6 Review by management B.6 The review of the management system by the
by the address address, to determine your current performance,
ensure their convenience, sufficiency, and effectiveness
continued, and instruct about improvements and new ones
directions, when necessary.

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BIBLIOGRAPHY

[1] Guide 7:1994 ISO/IEC: Guidelines for the drafting of standards suitable for use in
conformity assessment.

[2] ISO 9001:2000, Quality Management Systems - Requirements.

[3] ISO 9004:2000, Quality Management Systems – Requirements.

[4] ISO 14001:1996, Environmental Management Systems – Specification with Guidance for Use

[5] ISO 14004:1996, Environmental Management Systems – General Guidelines on the

Principles, Systems, and Support Techniques

ISO/TAG 12 report to TMB ISO on compatibility ISO 9000/ISO 14000.

REFERENCE DOCUMENT

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. Guidelines for the Justification

and Development of Management System Standards. ISO: Geneva, 2001. 17 p. (ISO Guide 72)

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