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V39 N1 / 2024
©2024 American Medical Writers Associaon. All rights reserved.
ISSN 2163-5315
AMWAJournal.org 51
ere is ample evidence across many domains that writing in
plain language saves time or money or both for readers and
organizations. Communication in plain language is generally
more eective and produces better outcomes than traditional
writing. In many contexts, readers prefer plain language over
traditional writing styles, and use of plain language fosters the
building of trust. Finally, the process of translating is usually
more ecient for plain language documents.
In July 2023, after many years of development, discus-
sion, and alignment, the International Organization for
Standardization (ISO) published a standard for plain lan-
guage.1 is publication makes an internationally developed
and agreed-upon standard available to all people interested
in the use of plain language. It is an authoritative source
developed by plain language practitioners, linguists, tech-
nical writers, designers, and text creators from many dier-
ent countries. e standard will help all writers (authors) to
make their texts (documents, web pages, etc.) most useful for
the intended audiences (readers, users). It applies to most
written languages and reects the most recent research on
plain language and the experience of plain language experts.
ADVANTAGES OF HAVING A PLAIN LANGUAGE
STANDARD
We all benet from the availability of technical standards in
our everyday lives. ey ensure that a plug bought in New
York will t a socket in Alaska and San Diego. International
standards ensure that a product has the same specica-
tions, regardless of where it is manufactured and used.
Standardization fosters economic activity and growth.
“Standards are the distilled wisdom of people with expertise
in their subject matter and who know the needs of the
organizations they represent – people such as manufactur-
ers, sellers, buyers, customers, trade associations, users
or regulators.”2
Medical writers appreciate the usefulness of standards
in the realm of drug development. e many activities of
the International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH)3
have led to a large set of standards that cover many aspects
of drug development, including the denition of require-
ments on content and format of clinical documents, eg,
structure and content of clinical study reports ICH E3 or
the study protocol and investigator’s brochure in ICH E6 on
Good Clinical Practice. Many of these standards are subse-
quently transferred to company standard operating proce-
dures and associated working instructions and hence have a
direct impact on the work of medical writers. Also, the plain
language standard provides a whole host of advantages:
Interoperability: e standard fosters the mutual
understanding of what constitutes plain language. It pro-
vides a basis for discussion and serves as a basis for the
use of plain language in special domains. e common
standard allows integration of the various components
developed in specialized domains.
Clarity and consistency: e standard provides clear
guidance on how to develop texts in plain language that
are easily understood by users. is reduces ambiguity
and enhances the reliability of communication.
Cost eciency and compliance: e standard will
help streamline the processes of writing in plain lan-
guage and thereby reduce costs. Both the generation of
plain language texts and their eciency can be evalu-
ated against compliance with the guidelines, creating a
useful measure for writers (authors) and readers
(consumers).
Thomas M. Schindler / Lay & Regulatory Wring, Biberach, and BioNTech SE, Mainz, Germany
The Making of the Internaonal Standard for Wring in Plain Language
ISO 24495-1: Its Usefulness, Content, and How It Came into Existence
TOPICAL FEATURE
“All industries and sectors benet from improved
communication. Readers benet when they can
understand and use information. And organizations
gain improved branding, eciency, and eectiveness
of communications products. A plain language
standard provides all sectors, in nearly all languages,
with a set of guidelines and strategies to make
information more accessible and eective.”4
AMWAJournal.org 52
The Making of the Internaonal Standard for Wring in Plain Language ISO 24495-1
Collaboration and development: e availability of the
standard facilitates collaboration among practitioners,
allowing them to work in a common framework. is will
accelerate development processes and exchange in the
community of practitioners across languages.
Portability: e standard will enable the transfer of
texts across dierent environments and languages.
Texts and documents developed in compliance with the
standard can be more easily translated without major
modications.
THE CONTENT OF THE STANDARD
At the center of the standard is the denition of plain lan-
guage. It is characterized as communication in which word-
ing, structure, and design are so clear that intended readers
can easily
— nd what they need,
— understand what they nd, and
— use that information.
Consequently, the standard evolves around 4 principles
that are elaborated on in separate subchapters:
Principle 1: Readers get what they need (relevant)
Identify the readers
Identify the readers’ purpose
Identify the context in which readers will read
the document
Select the document type or types
Select content that readers need
Principle 2: Readers can easily nd what they
need (ndable)
Structure the document for readers
Use information design techniques that enable
readers to nd information
Use headings to help readers predict what
comes next
Keep supplementary information separate
Principle 3: Readers can easily understand what they
nd (understandable)
Choose familiar words
Write clear sentences
Write concise sentences
Write clear and concise paragraphs
Consider including images and multimedia
Project a respectful tone
Ensure that the document is cohesive
Principle 4: Readers can easily use the information
(usable)
Evaluate the document continually as it is developed
Evaluate the document further with readers
Continue to evaluate readers’ use of the document
For each principle, detailed guidelines are presented
each with a small number of examples. Together with the
denition of terms and 2 annexes, the standard provides
comprehensive coverage of the key considerations for writ-
ing plain language texts that are useful for their audiences.
AVAILABILITY OF THE STANDARD
e standards developed under the auspices of ISO or any
national standard body are not free. ey are therefore not
freely available on the internet. ey must be bought from
ISO for a small fee; in the case of the plain language stan-
dard, the fee is 96 Swiss Francs (around $110). Clearly, this
is a comparatively small sum that could be aorded by
most. If the standard is used for professional purposes, this
expense is usually tax-deductible. e money that is gen-
erated by selling the standards ensures that ISO remains
independent of economic and political inuences and
can give full freedom to its communities of volunteers.
Charging for standards allows ISO to “ensure that they are
developed in an impartial environment and therefore
meet the needs of all stakeholders for which the standard
is relevant.”5
THE MAKING OF THE STANDARD
Looking back, it is dicult to determine who exactly it was
who came up with the idea for creating a universal denition
of plain language and a standard across regions, let alone
Structure of the plain language standard
• Foreword
• Introduction
• Scope
• Normative references
• Terms and denitions
• Governing principles
• Guidelines
• Annex A: Overview of principles and guidelines
• Annex B: Sample checklist
“Plain language ensures readers can nd what
they need, understand it and use it. us, plain
language focuses on how successfully readers
can use the document rather than on mechanical
measures such as readability formulas.”1
AMWAJournal.org 53
The Making of the Internaonal Standard for Wring in Plain Language ISO 24495-1
nding out when and where it happened. However, the initi-
ators and the people who over many years devoted their time
and eorts to nurture the idea are still around. at said, they
are usually too modest to brag about their involvement in the
development of the plain language standard.
To fully appreciate this achievement, it is important to
understand that all the denitory and alignment work in
the eld of plain language has been done by volunteers who
are enthusiastic plain language practitioners and advo-
cates. ere was no institutional support from academia
and no monetary support from governments for this initia-
tive. However, some Northern European countries such as
Norway have supported the cause by sending ocial del-
egates. Even so, the international plain language standard
was developed by people who were prepared to spend many
evenings and weekends discussing ideas and ne-tuning
text proposals.6-9
It is dicult enough to develop a denition in a commu-
nity of practitioners and to internationally align it. It is even
more challenging to get a standard developed and adopted
by the International Organization of Standards (ISO). It’s
not ISO that prompts the development of a certain standard.
Rather, someone, usually industry or other groups of practi-
tioners, approaches a national member organization of ISO
which—if they see value in the proposal—brings it into the
ISO system of expert groups. ese groups are organized in
larger groups called technical committees, or TC for short
(there are about 250 TCs in ISO). ese groups of experts
negotiate and align on all aspects of the standard.10
e strength of the ISO process relies on its global scope,
its representation of developing countries and consumer
groups, and the principle of consensus. e latter ensures
that all comments of all stakeholders are considered. Experts
representing national standard development organizations
need to be nominated by their countries’ committee to work
in an ISO working group.
Overall, it has taken some 16 years from the rst public
appearances of the idea of a plain language standard in 2007
to the release of the ISO standard in 2023.11 e rst 7 years,
until 2014, were spent developing and discussing a deni-
tion of plain language. e denition was formally adopted
by the International Plain Language Federation (IPLF) in
2014. en, in 2017, the IPLF set up a committee to develop
a plain language standard.
As is so often the case, it was the initiative of a small
group of people, in this case, from the IPLF, led by
Christopher Balmford, a lawyer by training, to approach
Standards Australia and probe their willingness to take up
the topic. He cold-called the relevant person at Standards
Australia and met with him. Christopher’s enthusiasm
overcame the initially profound skepticism, and he con-
vinced Standard Australia to take up the topic. Apparently,
his cause was greatly helped by the fact that he incidentally
mentioned that he and a friend had paddled a sea kayak
the 150 miles from mainland Australia to Tasmania, island
hopping on a 16-day trip. is demonstrated his tenac-
ity, endurance, and dedication—all very much needed for
bringing an idea to an adopted standard.
Standard Australia quickly realized that a plain lan-
guage standard would be more eectively developed inter-
nationally, rather than nationally, and proposed the project
to ISO. In 2019, ISO Technical Committee 37 (Language
and Terminology) approved Standards Australia’s initia-
tive to develop a plain language standard globally. is was
an enormous success because the standard could now be
developed in alignment with all 35 national standard orga-
nizations that are members of the technical committee.
Subsequently, ISO TC 37 set up a working group
(WG 11) to do the groundwork. e working group
appointed a “drafting committee” of 8 members to do the
initial writing of the many drafts and to discuss the feed-
back from both the national standard committees and
other professional organizations such as Clarity, the Center
for Plain Language, PLAIN (Plain Language Association
International), the International Institute for Information
Design, and the European Parliament.
e proposals of the drafting committee were then dis-
cussed and decided in the wider working group (WG 11),
which comprised the delegates of the national standard
bodies that had decided to become involved. Christopher
Balmford was appointed Convenor and was tasked to lead
the development and to ensure that the principles of ISO
such as fairness, freedom of speech, equality, and consensus
in all decisions were followed. e working group usually had
some 30 delegates from 18 countries—from every continent
except Antarctica—representing about 20 languages.
On a personal level, Christopher, being located in
Australia, had to chair meetings starting at 11 PM and often
continuing until 1 AM so as to accommodate the dierent
time zones of the experts around the globe. Over some 4
years, there were many intense phases, particularly when
revised drafts were due and when comments to drafts
needed to be evaluated. Often, several hundred comments
needed to be read, discussed, and decided upon. Each com-
ment that had been made had to be responded to in writing!
LEADERSHIP, DEDICATION, AND COLLABORATION
Being a global endeavor, both the working group and the
drafting committee comprised a wide range of dierent char-
acters, all being experts in the eld, each one of them enthu-
siastic about the topic, but each one with a well-formed and
AMWAJournal.org 54
The Making of the Internaonal Standard for Wring in Plain Language ISO 24495-1
well-articulated opinion. It was the task of the Convenor to
ensure that everybody was heard, every contribution was dis-
cussed, and, most importantly, a solution was found to which
everybody could agree (in line with ISO’s consensus princi-
ple). e role was also administrative, ie, calling for the meet-
ings and, very often, writing the minutes.
To successfully perform at the helm of such a diverse
and lively group of experts, it takes a well-balanced, patient,
and emphatic character with a detailed understanding of
the topic. Most helpful was Christopher Balmford’s ability to
thoughtfully guide discussions to a fullling conclusion.
e majority of the conceptual work was done by the
drafting committee, which, during the many very intense
phases, often had several meetings a week. Although the
composition of the drafting committee changed over time,
key members who contributed over extended periods of
time were Annetta Cheek (USA), Vera Gergely (Hungary),
Angelika Vaasa, (Belgium), David Lipscomb (USA), Susan
Kleimann (USA), Torunn Reksten (Norway), Machiko Asai
(Japan), Rosa Margarita Galán Vélez (Mexico), and Andreas
Baumert (Germany; also, the author of this article was a
member of this group for several months in 2022, substitut-
ing for Andreas Baumert). Furthermore, editing was han-
dled by Gael Spivak (Canada). Many of them are involved in
one of the plain language organizations.
Although good leadership was of great importance, the
development of the plain language standard was successful
because of the collaborative, inclusive, sharing attitude of
both the members of the drafting committee and the WG 11
over some 4 intense years!
ALL’S WELL THAT ENDS WELL?
Before the standard could be nally published, it had to
undergo various steps of approval and discussion in ISO.
One of them was approval by ISO TC 37. In preparation of
the nal vote, all national standard bodies represented in
TC 37 were given the opportunity to review and comment
on the nal draft. is alone took several months because
the national standard bodies needed to be given enough
time for their review. However, after approval by TC 37, the
nal standard was published in June 2023. It is now avail-
able at the ISO website (see above). e IPLF has also
developed a detailed list of frequently asked questions about
the standard.12
Although the standard is adopted on international level,
national standard bodies with their respective committees
are working on the localization of the standard to their lan-
guage and territory. e IPLF oers a guideline and a check-
list for all those plain language practitioners who want to
engage in the adoption of the standard by their national
standard body.13
Building on ISO plain language standard part 1, there
are 2 initiatives underway that aim to expand the standard
into the realm of
• legal writing and drafting14 and
• science writing (ISO/AWI 24495-3, Plain Language —
Part 3: Science Writing).
Furthermore, because ISO is re-evaluating every stan-
dard in 5-year intervals, the preparations for the next update
have already begun.
Christopher Balmford has meanwhile stepped down
and Angelika Vaasa, from the European Parliament, has
been appointed Convenor.
However, given Christopher’s
enthusiasm for plain lan-
guage, he will continue sup-
porting the cause.
e ISO plain language
standard was initiated and
developed by an interna-
tional group of experts and
enthusiasts over 4 years in
a process that was based on
respect and equality. e standard will help authors to write
documents in which readers nd what they need, under-
stand what they nd, and use that information.
Author declaration and disclosures: e author notes no
commercial associations that may pose a conict of interest in
relation to this article.
Author contact: thomas.schindler@biontech.de
References
1. International Organization for Standardization. Plain Language,
Part 1: Governing Principles and Guidelines, ISO 24495-1:2023;
2023. Accessed September 23, 2023. https://www.iso.org/
standard/78907.html
2. Standards. International Organization for Standardization.
Accessed January 3, 2024. https://www.iso.org/standards.html
3. ICH Ocial web site. International Council for Harmonisation
of Technical Requirements for Pharmaceuticals for Human Use.
Accessed January 3, 2024. https://www.ich.org/
4. e ISO plain language standard. International Plain Language
Federation. Accessed December 20, 2023. https://www.
iplfederation.org/iso-standard/
5. Frequently asked questions: why is there a charge for standards?
International Organization for Standardization. Accessed January
3, 2024. https://www.iso.org/footer-links/frequently-asked-
questions-faqs/general-faqs.html
6. Balmford C. An ISO standard for plain language: the back
story and the next steps. 2018;79:6-10. Accessed January 3,
2024. https://www.clarity-international.org/wp-content/
uploads/2020/06/Clarity_79.pdf
7. Balmford C, Cheek A, Kleimann S, Harris L, Schriver K.
Plain language standards. A way forward. e Clarity Journal
Christopher Balmford
AMWAJournal.org 55
The Making of the Internaonal Standard for Wring in Plain Language ISO 24495-1
2018;79:11-16. Accessed January 3, 2024. https://www.clarity-
international.org/wp-content/uploads/2020/06/Clarity_79.pdf
8. Balmford C. An ISO plain language standard. International Plain
Language Federation. Published September 7, 2020. Accessed
January 3, 2024. https://www.iplfederation.org/an-iso-plain-
language-standard/
9. Balmford C. A language-neutral plain language standard – a tool
for us all. PLAIN eJournal 2021;3(2):6-7. Accessed January 3, 2024.
https://plainlanguagenetwork.org/wp-content/uploads/2022/08/
pl_2021_e-journal_vol3_no2.pdf
10. Developing standards: key principles in ISO standard
development. International Organization for Standardization.
Accessed January 3, 2024. https://www.iso.org/developing-
standards.html
11. International Plain Language Federation. Timeline of developing
the ISO Plain Language Standard. GoogleDocs. Accessed January
3, 2024. https://docs.google.com/document/d/10vfmI55yXnikMC
Jwp9NIDtdOpLcfXX5RyeVf4ZpHzjg/edit
12. Complete list of FAQs. International Plain Language Federation.
Accessed January 3, 2024. https://www.iplfederation.org/1163-2/
13. Adopting and localizing the standard. International Plain
Language Federation. Accessed January 3, 2024. https://www.
iplfederation.org/adopting-and-localizing-the-standard/
14. International Organization for Standardization. Plain Language,
Part 2: Legal Writing and Drafting, ISO/AWI 24495-2. Accessed
January 3, 2024. https://www.iso.org/standard/85774.html
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