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©2024 American Medical Writers Association. All rights reserved.  
ISSN 2163-5315

AMWAJournal.org     51

There 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 effective 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 efficient 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 This 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 differ-
ent countries. The 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 reflects the most recent research on 
plain language and the experience of plain language experts.

ADVANTAGES OF HAVING A PLAIN LANGUAGE 
STANDARD
We all benefit from the availability of technical standards in 
our everyday lives. They ensure that a plug bought in New 
York will fit a socket in Alaska and San Diego. International 
standards ensure that a product has the same specifica-
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. The 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 definition 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: The 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. The common 
standard allows integration of the various components 
developed in specialized domains.

Clarity and consistency: The standard provides clear 
guidance on how to develop texts in plain language that 
are easily understood by users. This reduces ambiguity 
and enhances the reliability of communication.

Cost efficiency and compliance: The 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 efficiency can be evalu-
ated against compliance with the guidelines, creating a 
useful measure for writers (authors) and readers  
(consumers).

Thomas M. Schindler / Lay & Regulatory Writing, Biberach, and BioNTech SE, Mainz, Germany

The Making of the International Standard for Writing in Plain Language  
ISO 24495-1: Its Usefulness, Content, and How It Came into Existence

TOPICAL FEATURE

“All industries and sectors benefit from improved 
communication. Readers benefit when they can 
understand and use information. And organizations 
gain improved branding, efficiency, and effectiveness 
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 effective.”4

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AMWAJournal.org     52The Making of the International Standard for Writing in Plain Language ISO 24495-1

Collaboration and development: The availability of the 
standard facilitates collaboration among practitioners, 
allowing them to work in a common framework. This will 
accelerate development processes and exchange in the 
community of practitioners across languages.

Portability: The standard will enable the transfer of  
texts across different environments and languages.  
Texts and documents developed in compliance with the 
standard can be more easily translated without major 
modifications.

THE CONTENT OF THE STANDARD
At the center of the standard is the definition of plain lan-
guage. It is characterized as communication in which word-
ing, structure, and design are so clear that intended readers 
can easily

— find what they need,
— understand what they find, 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 find what they  
need (findable)
 Structure the document for readers
 Use information design techniques that enable 

readers to find information
 Use headings to help readers predict what  

comes next
 Keep supplementary information separate

Principle 3: Readers can easily understand what they 
find (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 
definition 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
The standards developed under the auspices of ISO or any 
national standard body are not free. They are therefore not 
freely available on the internet. They 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 afforded by 
most. If the standard is used for professional purposes, this 
expense is usually tax-deductible. The money that is gen-
erated by selling the standards ensures that ISO remains 
independent of economic and political influences 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 difficult to determine who exactly it was 
who came up with the idea for creating a universal definition 
of plain language and a standard across regions, let alone 

Structure of the plain language standard
• Foreword
• Introduction
• Scope
• Normative references
• Terms and definitions
• Governing principles
• Guidelines
• Annex A: Overview of principles and guidelines
• Annex B: Sample checklist

 “Plain language ensures readers can find what 

they need, understand it and use it. Thus, plain 

language focuses on how successfully readers 

can use the document rather than on mechanical 

measures such as readability formulas.”1 

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AMWAJournal.org     53The Making of the International Standard for Writing in Plain Language ISO 24495-1

finding out when and where it happened. However, the initi-
ators and the people who over many years devoted their time 
and efforts to nurture the idea are still around. That 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 definitory and alignment work in 
the field of plain language has been done by volunteers who 
are enthusiastic plain language practitioners and advo-
cates. There 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 official 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 fine-tuning 
text proposals.6-9

 It is difficult enough to develop a definition 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. These groups are organized in 
larger groups called technical committees, or TC for short 
(there are about 250 TCs in ISO). These groups of experts 
negotiate and align on all aspects of the standard.10 
 The strength of the ISO process relies on its global scope, 
its representation of developing countries and consumer 
groups, and the principle of consensus. The 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 first public 
appearances of the idea of a plain language standard in 2007 
to the release of the ISO standard in 2023.11 The first 7 years, 
until 2014, were spent developing and discussing a defini-
tion of plain language. The definition was formally adopted 
by the International Plain Language Federation (IPLF) in 
2014. Then, 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. This 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 effectively 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. This 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. The 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. 
 The 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. The 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 different 
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 different char-
acters, all being experts in the field, each one of them enthu-
siastic about the topic, but each one with a well-formed and 

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AMWAJournal.org     54The Making of the International Standard for Writing 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). The 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 fulfilling conclusion. 
 The 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 finally 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 final vote, all national standard bodies represented in 
TC 37 were given the opportunity to review and comment 
on the final draft. This 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 
final standard was published in June 2023. It is now avail-
able at the ISO website (see above). The 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. The IPLF offers 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. 
 The 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. The standard will help authors to write 
documents in which readers find what they need, under-
stand what they find, and use that information.

Author declaration and disclosures: The author notes no  

commercial associations that may pose a conflict 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/
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2.  Standards. International Organization for Standardization. 
Accessed January 3, 2024. https://www.iso.org/standards.html 

3.  ICH Official web site. International Council for Harmonisation 
of Technical Requirements for Pharmaceuticals for Human Use. 
Accessed January 3, 2024. https://www.ich.org/

4.  The 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 
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questions-faqs/general-faqs.html

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uploads/2020/06/Clarity_79.pdf

7.  Balmford C, Cheek A, Kleimann S, Harris L, Schriver K. 
Plain language standards. A way forward. The Clarity Journal 

Christopher Balmford

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AMWAJournal.org     55The Making of the International Standard for Writing in Plain Language ISO 24495-1

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9.  Balmford C. A language-neutral plain language standard – a tool 
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10. Developing standards: key principles in ISO standard 
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12. Complete list of FAQs. International Plain Language Federation. 
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January 3, 2024. https://www.iso.org/standard/85774.html

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https://www.clarity-international.org/wp-content/uploads/2020/06/Clarity_79.pdf
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https://www.iplfederation.org/an-iso-plain-language-standard/
https://www.iplfederation.org/an-iso-plain-language-standard/
https://plainlanguagenetwork.org/wp-content/uploads/2022/08/pl_2021_e-journal_vol3_no2.pdf
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