ISO IEC Guide 17-2016
ISO IEC Guide 17-2016
ISO IEC Guide 17-2016
First edition
2016-03-01
Reference number
ISO/IEC GUIDE 17:2016(E)
© ISO/IEC 2016
ISO/IEC GUIDE 17:2016(E)
Contents Page
Foreword......................................................................................................................................................................................................................................... iv
Introduction...................................................................................................................................................................................................................................v
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references....................................................................................................................................................................................... 1
3 Terms and definitions...................................................................................................................................................................................... 1
4 General considerations................................................................................................................................................................................... 2
5 Issues to consider during the standards development process........................................................................... 2
5.1 General............................................................................................................................................................................................................ 2
5.2 Preparation of a new work item............................................................................................................................................... 2
5.2.1 Market relevance.............................................................................................................................................................. 2
5.2.2 Stakeholders......................................................................................................................................................................... 2
5.3 Issues to be considered during the preparation of a standard....................................................................... 3
5.3.1 Implementation cost-effectiveness of standards for SMEs.......................................................... 3
5.3.2 Availability of elements............................................................................................................................................... 3
5.4 Developing the content of the standard............................................................................................................................. 3
5.4.1 Performance approach................................................................................................................................................ 3
5.4.2 Introduction.......................................................................................................................................................................... 4
5.4.3 Scope........................................................................................................................................................................................... 4
5.4.4 Testing........................................................................................................................................................................................ 4
5.4.5 Verification methods..................................................................................................................................................... 4
5.5 Structure and presentation of the content....................................................................................................................... 5
5.5.1 Length........................................................................................................................................................................................ 5
5.5.2 Structure.................................................................................................................................................................................. 5
5.5.3 Presentation and figures............................................................................................................................................ 5
5.5.4 Clear language..................................................................................................................................................................... 5
5.5.5 References.............................................................................................................................................................................. 6
5.5.6 Revision.................................................................................................................................................................................... 6
5.6 Final review................................................................................................................................................................................................ 7
5.6.1 Transition period.............................................................................................................................................................. 7
5.6.2 Supportive implementation assistance......................................................................................................... 7
6 Checklist......................................................................................................................................................................................................................... 7
Annex A (informative) Definitions of micro, small and medium-sized enterprises............................................. 9
Bibliography.............................................................................................................................................................................................................................. 12
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) are worldwide federations of national standards bodies (ISO member bodies and IEC
national committees). The work of preparing International Standards is normally carried out through
ISO and IEC 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 or IEC, also take part in the
work. ISO collaborates closely with 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 document 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 and IEC 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).
ISO/IEC Guide 17 was prepared jointly by ISO/TMB and IEC/SMB.
ISO/IEC Guide 17 is based on CEN/CENELEC Guide 17, Guidance for writing standards taking into account
micro, small and medium-sized enterprises (SMEs) needs, which can be accessed through http://www.
cencenelec.eu/sme/smenews/Pages/guide17.aspx
Introduction
It is important that the views of micro, small and medium-sized enterprises (SMEs) are sufficiently
considered during the development of standards and that standards aimed at large-scale or mass
production are not too costly and complex for SMEs to implement.
SMEs benefit from standards, however they may have a weaker position in their market because of
their dependency on larger competitors, suppliers or customers or they may have to adapt to existing
solutions on the market.
SMEs are present in the majority of sectors. As do other users, SMEs benefit from the technical expertise
of standards in the elaboration of which they may not have been present. Nevertheless, there are also
sometimes advantages to being small as they can adapt quickly, can be more flexible and can have
smaller overhead.
Furthermore, if standards were to take into consideration the SME perspective, considerable benefits
would accrue to all the stakeholders involved in standardization.
The aim of this Guide is to raise awareness on the issues that may be of importance to SMEs. By
addressing the needs of SMEs, the use of standards may be significantly increased and SMEs will be
able to gain the full benefit of utilizing standards.
This Guide provides guidance, advice and recommendations to standards writers on how to take into
account the needs of SMEs and addresses the issues to be considered during the development process of
ISO or IEC standards.
1 Scope
This Guide provides guidance and recommendations to writers of standards on the needs of micro,
small and medium‐ sized enterprises (SMEs) in order to avoid the exclusion of SMEs from the market
and the distortion of fair competition.
This Guide is relevant to all stakeholders involved in standardization, i.e. standards writers in working
groups (WGs), technical committees (TCs), project committees (PCs), or subcommittees (SCs) as well as
members of national mirror committees. Not all principles presented in this Guide necessarily have to
apply to all standards. Furthermore, sector-specific questions might not be covered. TCs, PCs, SCs and
WGs are best placed to evaluate how to address the specific needs of SMEs in their standards.
This Guide contains:
a) considerations for the development of standards that are best adapted to SMEs’ needs;
b) techniques for identifying and assessing provisions in standards that may especially impact SMEs;
c) ways to reduce negative impacts on SMEs resulting from some provisions in standards;
d) guidelines for writing SME‐friendly standards;
e) a checklist;
f) information on the impact that new standards can have on micro‐enterprises.
NOTE In this Guide, the term “standard” includes all ISO/IEC deliverables.
2 Normative references
There are no normative references.
3.2
standards writer
person(s), group or organization responsible for the drafting of a standard
4 General considerations
Standards writers should ensure that standards are understandable to those who are meant to use
and apply them. The context in which standards users operate within their own organization may be
different depending on the use, sector and type of the standard. Therefore, in drafting standards, care
should be given to the use of terminology and language which is understandable by all qualified users.
SMEs can have similar, but sometimes also very different, business models from other potential target
groups of standards. Given the fact that SMEs are present in almost all sectors, special attention is
required in order to address their interests – and in particular those of micro‐ enterprises – as potential
users of standards. For instance, it should be noted that consultants, certifiers, and testing or research
laboratories may have different interests from enterprises involved in manufacturing or distribution of
specific products or services. Hence, the interests of each of these stakeholders needs to be considered
carefully.
5.1 General
Several aspects of standardization of specific importance to SMEs are presented in 5.2 to 5.6. This is
not exhaustive and may be supported by more general or specific principles relevant to the needs of
standard users as laid down in other documents (e.g. IFAN Guide 3[2]).
Since SMEs, and particularly micro‐enterprises, might find it difficult to contribute directly to the
process, consultations of SME needs and/or interests through their associations and/or sectoral
associations should be undertaken as a priority.
5.2.2 Stakeholders
Consider the costs of investment and training required for the implementation of a standard.
The cost of implementing the standard should be considered before introducing provisions or
requirements that might not be cost‐effective in all situations. Taking into account that SMEs will have
fewer employees, particular attention should be paid to:
— consequences of changes in technology;
— cost of buying new equipment;
— cost of training;
— cost of testing;
— cost of reporting;
— cost of hiring consultants;
— cost of compliance to regulations that refer to the new standard;
— specific competencies of SMEs.
Standards writers should always consider whether the requirements can be followed without putting
disproportionate and/or unnecessary constraints on SMEs. A standard should not hinder the promotion
or innovation of new products, services or processes.
Furthermore, special attention should be paid to situations involving a lesser volume of production
or activities. Standards should not hamper the flexibility and versatility that often characterize SME
business models.
Improve understanding and use of the standard by adding examples and explanations.
According to ISO/IEC Directives, Part 2[5], 4.2, “[w]henever possible, requirements shall be expressed in
terms of performance rather than design or descriptive characteristics. This approach leaves maximum
freedom to technical development. Primarily those characteristics shall be included that are suitable
for worldwide (universal) acceptance. Where necessary, owing to differences in legislation, climate,
environment, economies, social conditions, trade patterns, etc., several options may be indicated.”
The performance approach gives enterprises flexibility and room for innovation. Standards should also
play the role of purveyor of basic know‐how. However, the performance approach sometimes needs to
be accompanied by examples and explanations in order for the standard to be easily understood and
implemented by SMEs.
This can be done in an informative manner, for example through texts, illustrations, graphs or tables
that focus on simple implementation methods.
Such information would facilitate and increase the implementation of standards by SMEs that might
have difficulty transposing pure performance requirements into practical solutions.
5.4.2 Introduction
5.4.3 Scope
5.4.4 Testing
Avoid imposing costly and complex testing regimes and consider the frequency of testing.
The tests required for compliance with standards often present a significant financial burden for SMEs.
This includes the cost of measuring equipment, training staff, and time and resources necessary to
perform the tests. SMEs do not usually produce on a mass scale and their products may have specific
characteristics. Imposing a high number of tests significantly increases the price of their products.
When considering which tests should be included, good regulatory practice should be followed. Prior to
a test being introduced, the principle of proportionality should be followed, taking into account, such
factors as the type of products, services covered, the nature of the risks involved and the economic
impact of the choices made. Ultimately, the choice made should be commensurate with the risk while
minimizing the potential negative impact for all stakeholders, especially SMEs.
Standards should not introduce any unnecessary tests. That is to say, if in doubt about the adequacy
and necessity of a given test method, it should not be added to the existing test regime.
Standards writers should check who can perform a given test and avoid, where possible, favouring a
test that leads to, or reinforces, monopolistic or dominant positions.
Identify simple and cost-effective ways of verifying conformity with the requirements.
In order to allow flexibility when verifying requirements, alternative methods including calculations
and tables should be taken into account in the assessment whenever possible.
In addition, standards writers need to ensure that the results of the tests described in standards are
unambiguous. It is vital for SMEs that standards refer to methods which cannot be undermined by
parties with partial interests.
5.5.1 Length
5.5.2 Structure
Use language simple enough to be understood by all the expected standard users, not only
experts.
Standard users with differing qualifications, knowledge and education should be able to understand
the parts of the standard relevant to them. Even if standards are directed at personnel with knowledge
of specific products, processes or services, they still need to be written in simple, clear language so that
they are comprehensible by standards users who have not been directly involved in their preparation.
Standards should be easy to read. SMEs should be given particular attention as potential users and
the language should be adapted to their way of functioning if they constitute the main target group of
the standard. Attention should be paid to keeping language simple when translating standards into
national languages.
Furthermore, all abbreviations and acronyms should always be explained and, if some wording seems
complicated or ambiguous, it is recommended that it be defined in the Clause on terminology.
TIPS on clear language
The writers should use a style that is clear, direct and unambiguous, for example
— using verbs in the active voice rather than the passive;
— using simple, meaningful and intelligible words;
— being assertive by using commands rather than weaker forms;
— using action verbs rather than abstract nouns;
— speaking directly to users rather than saying what they might do;
— using lists where appropriate;
— defining technical terms and abbreviations;
— using terms consistently throughout the text.
5.5.5 References
5.5.6 Revision
Ensure that clear information about the changes made to a previous version is provided in the
new and revised standard.
According to ISO/IEC Directives, Part 2[5], 6.1.3, “The specific part (…) shall give a statement of
significant technical changes from any previous edition of the document”. This statement appears in
the Foreword.
This is particularly important for the implementation of standards by SMEs as they do not have the
time or the resources to study new editions of standards in detail.
Assess the implications of the changes in new and revised standards in setting the transition
period.
The number and complexity of technical modifications should be reflected in an extension of the
transition period. Any transition period should take into account the implementation needs of all
stakeholders, including SMEs.
In cases where a standard introduces a completely new requirement or solution in some countries, the
coexistence period should be considered. The need to buy new equipment, change the work organization
and train staff should be considered. It is especially difficult and expensive for SMEs to change their
business model, particularly if it was functioning well beforehand. Therefore, they need assistance and
have to assess the profitability of staying on the market. This may, however, require an extended period
of coexistence.
SME associations and/or sectoral associations can help identify SME transition needs and help establish
the correct transition period length.
Investigate whether assistance will be necessary for the implementation of standards that
cannot be simplified.
In some complex areas of standardization, particularly in the application of complex legislation, it might
be difficult to simplify standards. In such cases, standards writers should express their opinion as to
the need for supportive implementation assistance for SMEs, e.g. an implementation manual.
Implementation assistance can also be identified and collaborated on with SME associations and/or
sectoral associations.
Standards writers may participate in the creation of any additional implementation guidance, but their
main role is to ensure that the standards are as easy to apply as possible. The intention to provide
implementation assistance should not be used as a justification for developing complex standards.
6 Checklist
Table 1 presents the recommendations of this Guide in the form of a checklist. Standards writers may
find the table useful in ensuring that the needs of SMEs have been considered during the drafting of a
new standard or the revision of an existing one. Table 1 reads from left to right. The questions in bullet
points have been explained in detail in the corresponding sections of Clause 5 of this Guide.
Annex A
(informative)
A.1 General
There is currently no widely accepted, universal definition of what constitutes a micro, small or
medium‐sized enterprise. Many national and regional institutions, as well as intergovernmental and
non‐governmental organizations, have their own definitions. Criteria such as the number of employees,
total net assets, sales and investment level are all commonly used as part of the definition of an SME,
but the number of employees is perhaps the most common basis.
This annex gives some examples of definitions for SMEs from a variety of sources (updated in May 2014).
These ceilings apply to the figures of individual firms only. A firm which is part of larger grouping may
need to include employee/turnover/balance sheet data from that grouping too.
More information is available in References [1],[6].
field of State aid where SMEs can be granted a higher national and regional aid intensity than large
companies. The new definition raises the financial ceilings: the turnover of medium‐ sized enterprises
(50‐249 employees) should not exceed EUR 50 million; that of small enterprises (10‐49 employees)
should not exceed EUR 10 million while that of micro‐firms (less than 10 employees) should not exceed
EUR 2 million. Alternatively, balance sheets for medium, small and micro‐enterprises should not exceed
EUR 43 million, EUR 10 million and EUR 2 million, respectively.
A.4 World Bank and the International Finance Corporation (World Bank Group)
The World Bank and the International Finance Corporation’s definition of an SME is based on three
indicators: number of employees, total assets and annual sales. To be classified as an SME, enterprises
need to meet two of these three criteria. See Table A.2.
The following group of countries is listed in Table A.4 by each country’s rank in per capita gross national
income (PC‐GNI), and in Table A.5 by their rank relative to the maximum number of employees of an
SME according to the national government.
Bibliography
[1] 2003/361/EC: Commission recommendation of 6 May 2003 concerning the definition of micro,
small and medium‐sized enterprises (Text with EEA relevance) (notified under document
number C(2003) 1422), OJ L 124, 20.5.2003, pp. 36–41, available at: http://eur‐lex.
europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:124:0036:0041:en:PDF
[2] IFAN Guide 3:2008, Guidelines to assist members of standards committees in preparing
user- oriented European Standards, First edition, 2008‐04, available at: http://www.ifan.
org/IFAN_Guide3-2008.pdf
[3] ISO. 10 Good Things for SME, First edition, 2011, available at: http://www.iso.
org/iso/10goodthings.pdf
[4] ISO/IEC Directives, Part 1, 2015, Procedures for the technical work, available at: www.iso.
org/directives
[5] ISO/IEC Directives, Part 2, 2011, Rules for the structure and drafting of International Standards,
available at: www.iso.org/directives
[6] European Commission publication ‘The new SME definition: user guide and model
declaration’, available at: http://ec.europa.eu/DocsRoom/documents/10109/attachments/1/
translations/en/renditions/pdf
[7] OECD Glossary of statistical terms, available at: http://stats.oecd.org/glossary/detail.
asp?ID=3123
[8] Publication: OECD, OECD SME and Entrepreneurship Outlook. OECD Paris, 2005, pp. 17, available
at: http://www.oecd.org/cfe/oecdsmeandentrepreneurshipoutlook-2005edition.htm
[9] Meghana Ayyagari, Thorsten Beck, and Asli Demirgüç‐Kunt (2005), Small and Medium Enterprises
across the Globe. Washington, DC: World Bank, available at: http://siteresources.worldbank.
org/DEC/Resources/84797‐1114437274304/SME_globe.pdf
[10] IFC, Verifying accuracy of IFC’s SME measurement, available at: http://www1.ifc.org/wps/
wcm/connect/635f64804efbe2b18ef5cf3eac88a2f8/IFC_Factsheet_SME_Loan+Size+Proxy_
Brief.pdf?MOD=AJPERES
[11] H. J. van der Vaart and Tom Gibson, Defining SMEs: A Less Imperfect Way of Defining Small
and Medium Enterprises in Developing Countries, The Brookings Institution, 2008, available
at: http://www.brookings.edu/~/media/research/files/papers/2008/9/development%20
gibson/09_development_gibson.pdf
ICS 01.120
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