SIST-TP CWA 17796:2021

Responsibility-by-design - Guidelines to develop long-term strategies (roadmaps) to innovate responsibly

This document provides guidelines to develop long-term strategies (roadmaps) for innovating responsibly, thereby helping organizations to achieve socially desirable outcomes from their innovation processes.
These roadmaps encourage a “responsibility-by-design” approach that integrates considerations of technical, ethical, social, environmental, and economic aspects all along the research, development, and design process leading to an innovation.
The document aims at all organizations and agents involved in planning and performing research and innovation and technological development.
The focus is on innovation enabled by transformative technologies.
This document has been designed to be consistent with, and to support, as much as possible, existing management system standards and management/governance standards (e.g. EN ISO 9001). Particular attention has been given to social responsibility (i.e. EN ISO 26000).
This document has been designed to be consistent with, and to support, as much as possible, existing management system standards and management/governance standards (e.g. EN ISO 9001). Particular attention has been given to social responsibility (i.e. EN ISO 26000).

Odgovornost pri načrtovanju - Smernice za razvoj dolgoročnih strategij (načrtov) za odgovorno inoviranje

General Information

• Status: Published
• Publication Date: 11-Oct-2021
• ICS: 03.100.02 - Governance and ethics
• ICS: 03.100.40 - Research and development
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 06-Oct-2021
• Due Date: 11-Dec-2021
• Completion Date: 12-Oct-2021
• Ref Project: CWA 17796:2021 - Responsibility-by-design - Guidelines to develop long-term strategies (roadmaps) to innovate responsibly

Overview

CWA 17796:2021 - Responsibility-by-design: Guidelines to develop long-term strategies (roadmaps) to innovate responsibly (CEN) provides practical guidance for creating long-term RRI (Responsible Research and Innovation) roadmaps. The document helps organizations integrate technical, ethical, social, environmental and economic considerations throughout the research, development and design lifecycle of innovations - especially those enabled by transformative technologies. It is aligned with mainstream management system standards and puts particular emphasis on social responsibility (EN ISO 26000).

Key Topics

• Scope and principles of RRI: framing responsible innovation versus CSR and risk/quality management, with a focus on early-stage R&I processes and stakeholder involvement.
• Methodological approach: stepwise guidance to plan, implement and monitor an RRI roadmap adapted from innovation policy roadmapping (IPRM).
• Framework elements:
  • Top management commitment and leadership
  • Context analysis (internal and external drivers)
  • Materiality analysis (prioritizing social and ethical issues)
  • Experiment and engage (pilot actions and stakeholder engagement)
  • Validation (impact assessment and feedback)
  • Roadmap design (vision, actions, timeline and KPIs)
• Supporting resources: informative annexes with examples of RRI actions, tools, stakeholder engagement methods, SWOT for industry uptake, impact criteria and example KPIs.
• Normative alignment: designed to support EN ISO 9001 and related management/governance standards.

Applications

• Integrating responsibility-by-design into technology roadmaps for AI, biotech, IoT, and other transformative technologies.
• Guiding R&D and innovation managers to create long-term strategic plans that embed ethical, social and environmental considerations.
• Supporting cross-functional teams (product design, compliance, sustainability, legal, and stakeholder liaison) to prioritize and validate responsible innovation actions.
• Informing consortiums, public-private partnerships and EU-funded projects that require demonstrable RRI practices.
• Helping organizations translate R&I into socially desirable outcomes and measurable KPIs for reporting and decision-making.

Who should use this standard

• Innovation managers, R&D directors, product owners and C-suite leaders
• Sustainability, ethics and compliance officers
• Public sector planners and policymakers involved in research and technology governance
• Standards developers, auditors and consultants supporting responsible innovation adoption

Related Standards

CWA 17796:2021 references and aligns with:

• EN ISO 26000 (social responsibility)
• ISO 31000 (risk management)
• ISO 45001, EN ISO 14001, EN ISO 9001 (management systems)
• EN ISO 56000 / 56002 (innovation management)
• CEN/TS 16555, CWA 17145, IWA 26 and UNI/PdR guidance documents

Keywords: Responsibility-by-design, RRI roadmap, responsible innovation, transformative technologies, CWA 17796:2021, EN ISO 26000, management system standards.

Standards Content (Sample)

SLOVENSKI STANDARD
SIST CWA 17796:2021
01-november-2021
Odgovornost pri načrtovanju - Smernice za razvoj dolgoročnih strategij (načrtov)
za odgovorno inoviranje
Responsibility-by-design - Guidelines to develop long-term strategies (roadmaps) to
innovate responsibly
Ta slovenski standard je istoveten z: CWA 17796:2021
ICS:
03.100.02 Upravljanje in etika Governance and ethics
03.100.40 Raziskave in razvoj Research and development
SIST CWA 17796:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST CWA 17796:2021
SIST CWA 17796:2021
CEN
CWA 17796
WORKSHOP
September 2021
AGREEMENT
ICS 03.100.02; 03.100.40
English version
Responsibility-by-design - Guidelines to develop long-term
strategies (roadmaps) to innovate responsibly
This CEN Workshop Agreement has been drafted and approved by a Workshop of representatives of interested parties, the
constitution of which is indicated in the foreword of this Workshop Agreement.

The formal process followed by the Workshop in the development of this Workshop Agreement has been endorsed by the
National Members of CEN but neither the National Members of CEN nor the CEN-CENELEC Management Centre can be held
accountable for the technical content of this CEN Workshop Agreement or possible conflicts with standards or legislation.

This CEN Workshop Agreement can in no way be held as being an official standard developed by CEN and its Members.

This CEN Workshop Agreement is publicly available as a reference document from the CEN Members National Standard Bodies.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.

Ref. No.:CWA 17796:2021 E
SIST CWA 17796:2021
Contents
Foreword . 3
Introduction. 5
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Principles for implementing RRI . 15
5 Methodological approach . 19
6 Framework for developing an RRI roadmap . 20
6.1 General . 20
6.2 Top management commitment and leadership . 21
6.3 Context analysis . 21
6.4 Materiality analysis . 23
6.5 Experiment and engage . 27
6.6 Validation . 28
6.7 Roadmap design . 29
Annex A (Informative) Examples of RRI actions . 33
Annex B (Informative) Examples of tools . 39
Annex C (Informative) Examples of applying the guidelines . 41
Annex D (Informative) SWOT analysis for RRI implementation in industry . 42
Annex E (Informative) Tools for materiality and stakeholder analysis . 43
Annex F (Informative) Methods for stakeholder engagement . 46
Annex G (Informative) Criteria for impact analysis of RRI actions . 48
Annex H (Informative) Examples of RRI key performance indicators . 50
Annex I (Informative) Informative resources from other initiatives . 53
Bibliography. 55

SIST CWA 17796:2021
Foreword
This CEN Workshop Agreement (CWA 17796:2021) has been developed in accordance with the CEN-
CENELEC Guide 29 “CEN/CENELEC Workshop Agreements – A rapid prototyping to standardization” and
with the relevant provisions of CEN/CENELEC Internal Regulations - Part 2. It was approved by a Workshop
of representatives of interested parties on 2021-04-21, the constitution of which was supported by CEN
following the public call for participation made on 2019-06-27. However, this CEN Workshop Agreement does
not necessarily include all relevant stakeholders.
The final text of this CEN Workshop Agreement was provided to CEN for publication on 2021-08-02.
Results incorporated in this CWA received funding from the European Union’s Horizon 2020 research and
innovation programme under grant agreement No 710059.
The following organizations and individuals developed and approved this CEN Workshop Agreement:
− Andrea Porcari, Airi - Associazione Italiana per la Ricerca Industriale – Chairman
− Ibo van de Poel, Vice chair
− Giovanni Baldi, Colorobbia Consulting
− Francesca Braca, Laboratori ARCHA Srl
− Giulia Bubbolini, CISE – Centro per l’innovazione e lo sviluppo economico
− Mario M. D’Elios, University of Florence
− Donato Di Donato, Agrate & Castelletto Site Labs & Sustainability Quality Manager
− Marc Dreyer, Futopedia Consulting
− Linden Farrer
− Luisa Fracassini Agrate & Castelletto Site Labs & Sustainability Manager
− Jonathan Hankins, Foreign Scientific Correspondent – Fondazione Giannino Bassetti
− Kostas Iatridis, School of Management University of Bath
− Pim Klaassen, Assistant professor
− Zenlin Kwee, Delft University of Technology
− Joost Groot Kormelink, Delft University of Technology
− Agata Gurzawska, TRILATERAL RESEARCH
− Panagiotis Isigonis, Ca Foscari University of Venice
− Maria Maia, Karlsruhe Institute of Technology (KIT) - Institute for Technology Assessment and
Systems Analysis (ITAS)
SIST CWA 17796:2021
− Ineke Malsch, Malsch TechnoValuation
− Elvio Mantovani
− Christopher Nathan, University of Warwick
− Francesco Niglia, CEO - KOYS srls
− Daniela Pimponi, Airi - Associazione Italiana per la Ricerca Industriale
− Tom Sorell, Professor of Politics and Philosophy, University of Warwick
− Rene Von Schomberg
− Bernd Carsten Stahl, De Montfort University, Centre for Computing and Social Responsibility
− Emad Yaghmaei, Delft University of Technology
− Thamar Zijlstra, Consultant Standards Development – NEN, SHERPA project
Attention is drawn to the possibility that some elements of this document may be subject to patent rights. CEN-
CENELEC policy on patent rights is described in CEN-CENELEC Guide 8 “Guidelines for Implementation of
the Common IPR Policy on Patent”. CEN shall not be held responsible for identifying any or all such patent
rights.
Although the Workshop parties have made every effort to ensure the reliability and accuracy of technical and
non-technical descriptions, the Workshop is not able to guarantee, explicitly or implicitly, the correctness of
this document. Anyone who applies this CEN Workshop Agreement shall be aware that neither the Workshop,
nor CEN, can be held liable for damages or losses of any kind whatsoever. The use of this CEN Workshop
Agreement does not relieve users of their responsibility for their own actions, and they apply this document at
their own risk. The CEN Workshop Agreement should not be construed as legal advice authoritatively
endorsed by CEN/CENELEC.
SIST CWA 17796:2021
Introduction
Responsible research and innovation (RRI) addresses the development of products and processes that are
safe, ethically acceptable, and responsive to the needs and expectations of people and society.
The essential difference between RRI and existing practices regarding corporate social responsibility (CSR),
responsible business conduct, risk, and quality management is RRI’s focus on the research and innovation
(R&I) process, from the early stages to prototyping to going to market, and the high degree of societal
involvement RRI requires to assess potential (future) ethical and social impacts of innovation. The goal of RRI
is to design and develop innovations that have socially desirable outcomes, thus addressing specific ethics
and social concerns and providing solutions for acknowledged societal challenges (e.g., sustainable
development goals). Some examples are provided in the Annex III.
The ability to translate technological developments into innovations that generate benefits and value for the
organization and its shareholders and stakeholders and for society is a core aspect of RRI.

Initiatives to put RRI into practice in industry, for instance in the form of action plans, are still limited, with most
being related to cooperative projects within EU framework programmes or national equivalents. Examples
include Horizon 2020’s SwafS (Science with and for Society) projects such as Responsible Industry, Compass,
SMART-map, Liv-In, Orbit, Satori, Sherpa, Sienna, and TechEthos.
However, it’s worth noting that principles and approaches related to RRI have elements in common with
acknowledged business and innovation management methods and practices, such as theory of change,
business model generation, stakeholder management, design-thinking, and agile management.
The guidelines offered here were developed by the PRISMA project, which worked with eight industrial pilot
projects dealing with the application of transformative technologies in different sectors. The pilots were used
to integrate RRI principles in the participating companies’ strategies and actions in order to improve the societal
value and overall performances of their R&D (research and development) outcomes and to develop specific
“pilot RRI roadmaps”.
For an effective RRI uptake, it is essential for companies to identify strategies and practices that fit within the
realities and constraints in which they operate. The roadmap described in these guidelines aims to help them
do just that. The overall goal is to help strengthen aspects of responsibility all along the research, development,
and design process for innovations and thus to support a “responsibility-by-design” approach.
Besides helping to identify a vision, a set of actions, and a timeline (roadmap) for implementing RRI
approaches, this guideline also analyses the potential barriers, opportunities, and benefits in pursuing RRI.
Within this guidance, we understand research and innovation as intertwined: research (besides its role of
creating knowledge) has an applied character and is oriented towards innovation, with the final goal of
generating both economic and societal value.
At the industry level, technology roadmapping is already a quite widely utilized method in strategy planning. A
technology roadmap visualizes an organization’s strategic aims (vision/development plans) and can be utilized
to structure its research, development, and business activities. In recent years, the concept of IPRM
(innovation policy roadmapping methodology) has been developed to connect the development of technologies
and innovations to a wider societal sphere. A main aspect of IPRM is identifying those societal needs that
create a potential demand for new solutions and possibly favour the emergence of new products and markets.

A description of the relevance of these methods for RRI is provided in Dreyer et al., 2017.
The PRISMA project received funding from the EU’s Horizon 2020 research and innovation programme
(grant agreement No. 710059). More information is available on the PRISMA website: www.rri-prisma.eu/
Ahlqvist, T., Valovirta, V., & Loikkanen, T. (2012). Innovation policy roadmapping as a systemic instrument
for forward-looking policy design. Science and Public Policy, 39(2), 178–190
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IPRM integrates a foresight exercise into enabling technologies, applications, products, and markets with
analysis of socio-economical and sectorial drivers and policy and regulatory tools and strategies.
The RRI roadmap proposed in this guideline adapts a generic IPRM architecture to the definition of long-term
visions and action plans for RRI uptake within the innovation strategies of organizations and others agents
(e.g., cooperative projects) active in research and innovation. It provides the methodological and technical
conditions to address RRI principles in the context of rapid (and possibly disruptive) scientific and technological
developments to ensure such developments are relevant to society.

SIST CWA 17796:2021
1 Scope
This document provides guidelines to develop long-term strategies (roadmaps) for innovating responsibly,
thereby helping organizations to achieve socially desirable outcomes from their innovation processes.
These roadmaps encourage a “responsibility-by-design” approach that integrates considerations of technical,
ethical, social, environmental, and economic aspects all along the research, development, and design process
leading to an innovation.
The document aims at all organizations and agents involved in planning and performing research and
innovation and technological development.
The focus is on innovation enabled by transformative technologies.
This document has been designed to be consistent with, and to support, as much as possible, existing
management system standards and management/governance standards (e.g. EN ISO 9001). Particular
attention has been given to social responsibility (i.e. EN ISO 26000).
2 Normative references
The existing management standards and normative references used in this document are listed below. For
dated references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
EN ISO 26000, Guidance on social responsibility
ISO 31000, Risk management – Guidelines
ISO 45001, Occupational health and safety management systems – Requirements with guidance for use
EN ISO 14001, Environmental management
EN ISO 9001, Quality management systems – Requirements
Series CEN/TS 16555, Innovation management
Series CWA 17145, Ethics assessment for research and innovation
IWA 26 Using ISO 26000:2010, in management systems
UNI/PdR 27, Guidelines for management and processes development for responsible innovation
UNI/PdR 18, Social responsibility in organizations – Guidance to the application of UNI ISO 26000

These standards and guidelines (in their scope and contents) refer to and can be used to contribute to the
UN’s Sustainable Development Goals. This document also takes into account the Rome Declaration on
Responsible Research and Innovation in Europe (European Union, 2014). In addition, it recognizes the need
to consider efforts towards responsibility in research and innovation within the broader framework of corporate
sustainability, responsible business, and sustainable finance practices (UN Global Compact:
unglobalcompact.org), though these aspects are not explicitly addressed within the scope of this guidance.
SIST CWA 17796:2021
EN ISO 56000, Innovation management – Fundamentals and vocabulary
EN ISO 56002, Innovation management – Innovation management system – Guidance
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• ISO Online browsing platform: available at https://www.iso.org/obp
• IEC Electropedia: available at https://www.electropedia.org/
3.1
context of the organization
combination of internal and external issues that can have an effect on an organization’s approach to developing
and achieving its objectives.
Note 1 to entry: The organization’s objectives can be related to its products and services, investments and
behaviour towards its interested parties.
Note 2 to entry: The concept of context of the organization is equally applicable to not-for-profit or public
service organizations as it is to those seeking profits.
Note 3 to entry: In English, this concept is often referred to by other terms such as “business environment”,
“organizational environment”, or “ecosystem of an organization”.
Note 4 to entry: Understanding the infrastructure can help to define the context of the organization.
[SOURCE: ISO 9000:2015 Quality management systems -- Fundamentals and vocabulary]
3.2
corporate social responsibility (CSR)
a concept whereby companies integrate social and environmental concerns in their business operations and
in their interaction with their stakeholders on a voluntary basis”, as well as “the responsibility of enterprises for
their impacts on society.
[SOURCE: European Commission, 2011].
3.3
documented information
information required to be controlled and maintained by an organization and the medium on which it is
contained.
Note 1 to entry: Documented information can be in any format and media, and from any source.
Note 2 to entry: Documented information can refer to:
- the management system, including related processes;
- information created in order for the organization to operate (documentation);
- evidence of results achieved (records).
SIST CWA 17796:2021
3.4
engagement
involvement in, and contribution to, activities to achieve shared objectives.
[SOURCE: ISO 9000:2015 Quality management systems -- Fundamentals and vocabulary]
3.5
ethics
systematic reflection on right and wrong conduct according to norms and values that we believe should be
followed. Ethics refers to duties, responsibilities, rights, welfare, justice and the avoidance of harms. Typical
moral values include autonomy, freedom, dignity, privacy, justice, well-being and responsibility.
[SOURCE: Series CWA 17145]
3.6
framework
an outline, or skeleton, of interlinked items and actions that supports a particular approach to a specific
objective and serves as a guide that can be modified as required by adding or deleting items.
3.7
human-centred design (HCD)
characterized by:
- The design is based upon an explicit understanding of users, tasks and environment;
- Users are involved throughout design and development;
- The design is driven and refined by user-centred evaluation;
- The process is iterative;
- The design addresses the whole user experience;
- The design team includes multidisciplinary skills and perspectives.
[SOURCE: ISO 9241-210:2010]
3.8
impact assessment
assessment of research and innovation for its projected or actual societal impacts.
[SOURCE: Series CWA 17145]
3.9
involvement
taking part in an activity, event or situation.
[SOURCE: ISO 9000:2015 Quality management systems -- Fundamentals and vocabulary]
3.10
innovation
new or changed entity, realizing or redistributing value.
Note 1 to entry: Novelty and value are relative to, and determined by the perception of, the organization and
interested parties.
Note 2 to entry: An innovation can be a product, service, process, model, method etc.
SIST CWA 17796:2021
Note 3 to entry: Innovation is an outcome. The word “innovation” sometimes refers to activities or processes
resulting in, or aiming for, innovation. When “innovation” is used in this sense, it should always be used with
some form of qualifier, e.g., “innovation activities”.
Note 4 to entry: For the purpose of statistical measurement, refer to the Oslo Manual (OECD/Eurostat, 2018):
New or changed entity’ corresponds to ‘a new or improved product or process, or combination thereof, that
differs significantly from the unit’s previous products or processes’. Realising or redistributing value’
corresponds to ‘and that has been made available to potential users or brought into use by the unit’.
[SOURCE: EN ISO 56000]
3.11
innovation ecosystem
system of organizations, people and resources, complementing each other and contributing to a common
objective with regards to innovation.
Note 1 to entry: An innovation ecosystem can include private companies, public authorities, universities,
institutes, individual entrepreneurs, investors, researchers as well as funding and infrastructures.
Note 2 to entry: An innovation ecosystem generally includes intangible and qualitative interactions and
relationships necessary for its effectiveness.
[SOURCE: EN ISO 56000]
3.12
management system
set of interrelated or interacting elements of an organization to establish policies and objectives and processes
to achieve those objectives.
Note 1 to entry: A management system can address a single discipline or several disciplines.
Note 2 to entry: The system elements include the organization’s structure, roles and responsibilities, planning,
and operation.
Note 3 to entry: The scope of a management system may include the whole of the organization, specific and
identified functions of the organization, specific and identified sections of the organization, or one or more
functions across a group of organizations.
[SOURCE: ISO/TMB/JTCG Joint technical Coordination Group]
3.13
management standard
management standard designed to be widely applicable across economic sectors, various types and sizes of
organizations and diverse geographical, cultural and social conditions.
[SOURCE: ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2018]
3.14
management system standard (MSS)
MSS designed to be widely applicable across economic sectors, various types and sizes of organizations and
diverse geographical, cultural and social conditions.
[SOURCE: ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2018]

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3.15
materiality
identification and understanding of priorities within the context of social responsibility in which an organization
operates. These priorities reflect the economic, social, and environmental factors that need to be considered.
[SOURCE: UNI/PdR 18 Social responsibility in organizations – Guidance to the application of
UNI EN ISO 26000]
3.16
monitoring
determining the status of a system, a process or an activity.
Note 1 to entry: To determine the status, there may be a need to check, supervise or critically observe.
[SOURCE: ISO/TMB/JTCG Joint technical Coordination Group]
3.17
organization
person or group of people that has its own functions with responsibilities, authorities and relationships to
achieve its objectives.
Note 1 to entry: The concept of organization includes, but is not limited to sole-trader, company, corporation,
firm, enterprise, authority, partnership, charity or institution, or part or combination thereof, whether
incorporated or not, public or private.
[SOURCE: ISO/TMB/JTCG Joint technical Coordination Group]
3.18
participatory design
a “practice of collective creativity” that emphasizes active involvement by the users and all the stakeholders in
design and development of new systems.
[SOURCE: Niemelä et al., 2014].
3.19
process
set of interrelated or interacting activities which transforms inputs into outputs.
[SOURCE: ISO/TMB/JTCG Joint technical Coordination Group]
3.20
performance
measurable result.
Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
Note 2 to entry: Performance can relate to the management of activities, processes, products (including
services), systems or organizations.
[SOURCE: ISO/TMB/JTCG Joint technical Coordination Group]

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3.21
quadruple helix stakeholder
key local actors from public institutions, private organizations, academia and the public.
[SOURCE: Carayannis et al., 2009]
3.22
quality management
management with regard to quality.
Note 1 to entry: Quality management can include establishing quality policies and quality objectives, and
processes to achieve these quality objectives through quality planning, quality assurance, quality control, and
quality improvement.
[SOURCE: ISO 9000:2015 Quality management systems — Fundamentals and vocabulary]
3.23
responsible research and innovation (RRI)
transparent, interactive process by which societal actors and innovators become mutually responsive to each
other with a view to the (ethical) acceptability, sustainability and societal desirability of the innovation process
and its marketable products (in order to allow a proper embedding of scientific and technological advances in
our society).
[SOURCE: Von Schomberg, 2012]
3.24
responsible research and innovation (RRI) maturity level
how RRI is perceived and valued within an organization. Empirical research has identified five different stages:
unaware (the organization is not aware of RRI or its components); exploratory/reactive (the organization reacts
to external pressures concerning aspects of RRI); defined (the organization has definitions for RRI components
and has integrated these components into its practices); proactive (the organization realizes the benefits of
RRI and increasingly integrates RRI into its business); strategic (the organization has adopted RRI as a
component of its strategic framework and aims to ensure that all R&D activities consider most of the RRI
components).
[SOURCE: Stahl et al., 2017]
3.25
roadmap
strategic plan that defines a goal or desired outcomes and includes the major steps or milestones needed to
reach them.
3.26
roadmapping exercise
collaborative learning process and a tool for drawing up strategies, reaching consensus on requirements and
needs, and driving proactive planning and future studies.

SIST CWA 17796:2021
3.27
risk
effect of uncertainty on objectives.
Note 1 to entry: An effect is a deviation from the expected. It can be positive, negative or both, and can
address, create or result in opportunities and threats.
Note 2 to entry: Objectives can have different aspects and categories, and can be applied at different levels.
Note 3 to entry: Risk is usually expressed in terms of risk sources, potential events, their consequences and
their likelihood.
[SOURCE: ISO 31000:2018 Risk management — Guidelines]
3.28
risk assessment
overall process of risk identification, risk analysis and risk evaluation.
3.29
risk identification
process of finding, recognizing and describing risks.
3.30
risk analysis
process to comprehend the nature of risk and to determine the level of risk.
3.31
risk evaluation
process of comparing the results of risk analysis with risk criteria to determine whether the risk and/or its
magnitude is acceptable or tolerable.
[SOURCE: ISO Guide 73:2009 Risk management – Vocabulary]
3.32
RRI product
research and innovation output (e.g., product, service, process, model, method) selected by the organization
as the focus of the RRI roadmap design.
3.33
social responsibility
responsibility of an organization for the impacts of its decisions and activities on society and the environment,
through transparent and ethical behaviour that:
- contributes to sustainable development, including health and the welfare of society;
- takes into account the expectations of stakeholders;
- is in compliance with applicable law and consistent with international norms of behaviour; and
- is integrated throughout the organization and practiced in its relationships.
Note 1 to entry: Activities include products, services and processes.
Note 2 to entry: Relationships refer to an organization's activities within its sphere of influence.
[SOURCE: EN ISO 26000:2020]
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3.34
stakeholder
individual or group that has an interest in any decision or activity of an organization.
[SOURCE: EN ISO 26000:2020 Guidance on social responsibility].
3.35
strategy
plan to achieve a long-term or overall objective.
[SOURCE: EN ISO 9000:2015 Quality management systems – Fundamentals and vocabulary]
3.36
sustained success
organization success over a period of time.
Note 1 to entry: Sustained success emphasizes the need for a balance between economic-financial interests
of an organization and those of the social and ecological environment.
Note 2 to entry: Sustained success relates to the interested parties of an organization, such as customers,
owners, people in an organization, providers, bankers, unions, partners, or society.
[SOURCE: EN ISO 9000:2015 Quality management systems – Fundamentals and vocabulary]
3.37
technology assessment (TA)
scientific, interactive and communicative process which aims to contribute to the formation of public and
political opinion on societal aspects of science and technology.
[SOURCE: Decker/Ladikas, 2014, 14]
3.38
Technology Readiness Level
Technology Readiness Levels (TRLs) are indicators of the maturity level of particular technologies. This
measurement system provides a common understanding of technology status and addresses the entire
innovation chain. There are nine technology readiness levels; TRL 1 being the lowest and TRL 9 the highest.
[SOURCE: European Commission, Horizon 2020 Framework Programme]
3.39
transformative/enabling technologies
knowledge-intensive technologies associated with high R&D intensity, rapid innovation cycles, high capital
expenditure, and high-skilled employment. They enable innovation in processes, goods, and services
throughout the economy. They are systemically relevant and multidisciplinary, cutting across many technology
areas, with a trend towards convergence and integration. These technologies have the capacity to improve
people’s health, safety, and security and they support sustainable development and secure connectivity and
communication among systems and individuals.
[SOURCE: European Commission, High-Level Strategy Group on Industrial Technologies, 2009 and 2018]

SIST CWA 17796:2021
3.40
top management
person or group of people who directs and controls an organization at the highest level.
Note 1 to entry: top management has the power to delegate authority and provide resources within the
organization.
Note 2 to entry: If the scope of the management system covers only part of an organization then top
management refers to those who direct and control that part of the organization.
[SOURCE: ISO 9000:2015]
3.41
usability
extent to which specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a
specified context of use [ISO/IEC 1998] can use a product.
3.42
user-centred design (UCD)
approach to interactive system development that focuses specifically on making systems or applications easy
to use.
[SOURCE: ISO/IEC 13407:1999].
3.43
user committees
method that involves users and other stakeholders in the formal monitoring and steering of the research and
innovation process. Typically, there is a kick-off, a mid-term, and a final workshop.
[SOURCE: Engage2020 Project, 2014].
4 Principles for implementing RRI
Definitions and principles for RRI vary throughout the literature. The definition selected for this guideline – a
transparent, interactive process by which societal actors and innovators become mutually responsive to each
other with a view to the (ethical) acceptability, sustainability, and societal desirability of the innovation process
and its marketable products – focuses on the social value in product development. This definition was
developed considering the EU normative framework, with explicit reference to the Charter of Fundamental
Rights of the European Union.
From this definition, a set of principles has been developed in the literature to support the implementation of
RRI in different kinds of decisional and operative structures and practices. In this guideline, these
“management” principles are connected to specific action lines for RRI implementation along the R&I value
chain (Table 1).
Von Schomberg, R. (2012). Prospects for technology assessment in a framework of responsible research
and innovation. In D. Marc. & B. Richard (Eds.), Technikfolgen abschätzen lehren (pp. 1–19). VS Verlag für
Sozialwissenschaften. https://doi.org/10.1007/978-3-531-93468-6_2.
See https://www.europarl.europa.eu/charter/pdf/text_en.pdf
Lubberink, R., Blok, V., van Ophem, J., & Omta, O. (2017). Lessons for responsible innovation in the
business context: A systematic literature review of responsible, social and sustainable innovation practices.
Sustainability, 9(5), 721. https://doi.org/10.3390/su9050721.
SIST CWA 17796:2021
Table 1 — Set of principles and actions for RRI implementation
Principles for RRI
Action lines
implementation
Integrate analysis of ethical, legal, and social impacts (ELSI)
Reflection & Anticipation from the earliest stages of product conception and product
development
Promote stakeholder engagement and involve stakeholders
from the quadruple helix to inform all phases of product
Inclusion
development and ensure that research and innovation activities
are societally relevant and desirable
Integrate monitoring, learning, and adaptive mechanisms to
Responsiveness address public and social values and normative principles in
product development
These principles are further described in the following :
• Reflection: scrutinize each activity, commitment, and assumption to connect them with a moral value
system and the good practices of science, taking into account the limits of knowledge and that a
particular framing of an issue may not be universally held. Reflexivity in the RRI context does not refer
to the moral responsibility of the single researcher or developer, nor is it a self-critique of the single
professional. Instead, it is intended as an institutional practice. It should therefore be intended as a
public matter, and all parts of the quadruple helix should play a role in the reflexivity actions. Reflexivity
is also important in other phases of the product value chain or other functions (besides R&D) inside
the organization that could be affected by an R&I action or result.

• Anticipation: systematically extrapolate all plausible scenarios for the application of R&I results with
quadruple helix stakeholders; identify in these scenarios the possible risks, opportunities,
uncertainties, and critical issues and consider possible ways to prevent, manage, or exploit them.
Anticipation is intended to not only prevent undesirable events but also shape desirable futures and
organize activities and resources towards those futures. When describing desirable futures,
anticipation should be realistic and avoid overestimating the benefits of the innovation.

• Inclusion: introduce participatory approaches in R&I processes from the very earliest stages in order
to engage people interested in the innovation process or its results. Inclusion refers to the engagement
of both internal and external stakeholders. It considers all potentially impacted groups or users, taking
into account gender and other social attributes and making particular efforts to involve marginalized
or hard-to-reach groups that may be most impacted or excluded by innovations. Inclusion is connected
to the other RRI principles because reflexivity, anticipation, and responsiveness will likely be improved
by a broad participation of different stakeholders.

• Responsiveness: change the direction of the innovation process in response to stakeholder and
public indications, needs, and values or in reaction to changing circumstances. Innovation actions may
also need to be adjusted due to insufficient knowledge and control or in response to new knowledge,

Stilgoe, J., Owen, R., & Macnaghten, P. (2013). Developing a framework for responsible innovation.
Research Policy, 42(9), 1568–1580. https://doi.org/10.1016/j.respol.2013.05.008.
SIST CWA 17796:2021
perspectives, or regulatory requirements. The entire R&I process should be shaped to be as
responsive as possible.
The goal of RRI is to support mutual responsiveness among the different actors in the research and innovation
process in order to jointly shape and direct the innovation towards the generation of value and impact. Mutual
responsiveness is expected to contribute to learning and to the building of relationships, trust, and
trustworthiness. However, given this guideline’s focus on the management practices of an individual
organization, practical implementation of this approach should be done only to the extent possible within the
actions and responsibilities of the organization.
Other important aspects to consider include research integrity and transparency (especially in connection to
the open access of research results). The precautionary principle, the “do no significant harm” principle, and
general corporate social responsibility principles, such as business and human rights should also be
considered.
It is important to note that from an institutional and policy perspective, the principles of RRI can be referred to
as a series of dimensions, including those of multi-actor and public engagement, gender equality, science
education, ethics, open science, and governance.
Box 1 includes a collection of the scopes, principles, and values of some ISO management systems, providing
a useful reference for the implementation of the RRI approach described above.

Note that inclusion and responsiveness have similarities with business concepts such as design-thinking
and agile management.
An analysis of sources of trust and distrust in relation to technology governance is provided by the project
TigTech (www.tigtech.org). The trust drivers identified are intent, public interest, competence, respect,
integrity, inclusion, openness, and fairness.
See the European Code of Conduct for Research Integrity, ALLEA, 2017
R&I activities should not include supporting or carrying out activities that significantly harm any of the six
environmental objectives set in the EU Taxonomy Regulation. See Regulation (EU) 2020/852 (Taxonomy) on
the establishment of a framework to facilitate sustainable investment.
See the UN Guiding Principles on Business and Human Rights.
Responsible research and innovation: Europe's ability to respond to societal challenges, EC DG Research,
2014.
SIST CWA 17796:2021
Box 1: Scopes, principles, and values of ISO standards on social responsibility, risk
management, quality, and innovation management

ISO 56000
EN ISO 26000 ISO 31000 ISO 9001
(Innovation
(Social Responsibility) (Risk Management) (Quality Management)
Management)
Guidance to integrate, Guidance on a common Requirements to Describes the
implement, and promote approach to managing demonstrate fundamental concepts,
socially responsible any type of risk organization’s ability to principles, and vocabulary
behaviour throughout throughout the life of consistently provide of innovation
the organization and, the organization products and services management
through its policies and that meet customer
practices, within its needs (conformity) and
sphere of influence applicable statutory and
regulatory
requirements
 Accountability A risk management  Customer focus  Realization of value
framework: as the ultimate
 Transparency  Ensure leadership
 Integrated in all objective for
in the management
 Ethical behaviour
organizational organizations
system
activities engaging in
 Respect for
 Engagement of innovation activities
stakeholder  Structured and
people
interests comprehensive  Future-focused
 Process approach,
leader, driven by
 Respect of the rule  Customized to the
to operate as an
curiosity and
of law
organization’s
integrated and courage, challenges
external and internal
 Respect for complete system the status quo
context
international norms
 Continuous  Strategic direction
of behaviour  Inclusive,
improvement to for innovation
considering
 Respect for human meet customer
knowledge, views,  Culture of creativity,
rights
requirements and
and perceptions of quality, and
enhance customer
stakeholders innovation
satisfaction
 Dynamic and  Exploiting insights:
 Evidence-based
adaptable using a diverse range
decision-making
of internal and
 Based on best
 Relationship external sources
available information
management
 Managing
 Considering human
uncertainty
and cultural factors
 Adaptability
 Based on continual
improvement  System approach
through learning and
experience
SIST CWA 17796:2021
5 Methodological approach
The methodological approach to the process leading to RRI implementation in industrial practices is
schematically represented in Figure 1 and explained in detail in Clause 6. The final goal is the defining of an
RRI roadmap that sets a strategy and indicates a vision and specific actions for RRI implementation in product
development. The structure and visualization of the roadmap is provided in Figure 2 (Clause 6.7). The roadmap
design includes definitions of the following elements:
• The R&I product(s) the RRI roadmap should focus on
• The vision for RRI implementation in the product’s development
• The timescale for implementing the RRI roadmap
• The drivers and challenges, risks and barriers to achieving the v
...

SLOVENSKI STANDARD
01-november-2021
Odgovornost pri načrtovanju - Smernice za razvoj dolgoročnih strategij (načrtov)
za odgovorno inoviranje
Responsibility-by-design - Guidelines to develop long-term strategies (roadmaps) to
innovate responsibly
Ta slovenski standard je istoveten z: CWA 17796:2021
ICS:
03.100.02 Upravljanje in etika Governance and ethics
03.100.40 Raziskave in razvoj Research and development
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN
CWA 17796
WORKSHOP
September 2021
AGREEMENT
ICS 03.100.02; 03.100.40
English version
Responsibility-by-design - Guidelines to develop long-term
strategies (roadmaps) to innovate responsibly
This CEN Workshop Agreement has been drafted and approved by a Workshop of representatives of interested parties, the
constitution of which is indicated in the foreword of this Workshop Agreement.

The formal process followed by the Workshop in the development of this Workshop Agreement has been endorsed by the
National Members of CEN but neither the National Members of CEN nor the CEN-CENELEC Management Centre can be held
accountable for the technical content of this CEN Workshop Agreement or possible conflicts with standards or legislation.

This CEN Workshop Agreement can in no way be held as being an official standard developed by CEN and its Members.

This CEN Workshop Agreement is publicly available as a reference document from the CEN Members National Standard Bodies.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.

Ref. No.:CWA 17796:2021 E
Contents
Foreword . 3
Introduction. 5
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Principles for implementing RRI . 15
5 Methodological approach . 19
6 Framework for developing an RRI roadmap . 20
6.1 General . 20
6.2 Top management commitment and leadership . 21
6.3 Context analysis . 21
6.4 Materiality analysis . 23
6.5 Experiment and engage . 27
6.6 Validation . 28
6.7 Roadmap design . 29
Annex A (Informative) Examples of RRI actions . 33
Annex B (Informative) Examples of tools . 39
Annex C (Informative) Examples of applying the guidelines . 41
Annex D (Informative) SWOT analysis for RRI implementation in industry . 42
Annex E (Informative) Tools for materiality and stakeholder analysis . 43
Annex F (Informative) Methods for stakeholder engagement . 46
Annex G (Informative) Criteria for impact analysis of RRI actions . 48
Annex H (Informative) Examples of RRI key performance indicators . 50
Annex I (Informative) Informative resources from other initiatives . 53
Bibliography. 55

Foreword
This CEN Workshop Agreement (CWA 17796:2021) has been developed in accordance with the CEN-
CENELEC Guide 29 “CEN/CENELEC Workshop Agreements – A rapid prototyping to standardization” and
with the relevant provisions of CEN/CENELEC Internal Regulations - Part 2. It was approved by a Workshop
of representatives of interested parties on 2021-04-21, the constitution of which was supported by CEN
following the public call for participation made on 2019-06-27. However, this CEN Workshop Agreement does
not necessarily include all relevant stakeholders.
The final text of this CEN Workshop Agreement was provided to CEN for publication on 2021-08-02.
Results incorporated in this CWA received funding from the European Union’s Horizon 2020 research and
innovation programme under grant agreement No 710059.
The following organizations and individuals developed and approved this CEN Workshop Agreement:
− Andrea Porcari, Airi - Associazione Italiana per la Ricerca Industriale – Chairman
− Ibo van de Poel, Vice chair
− Giovanni Baldi, Colorobbia Consulting
− Francesca Braca, Laboratori ARCHA Srl
− Giulia Bubbolini, CISE – Centro per l’innovazione e lo sviluppo economico
− Mario M. D’Elios, University of Florence
− Donato Di Donato, Agrate & Castelletto Site Labs & Sustainability Quality Manager
− Marc Dreyer, Futopedia Consulting
− Linden Farrer
− Luisa Fracassini Agrate & Castelletto Site Labs & Sustainability Manager
− Jonathan Hankins, Foreign Scientific Correspondent – Fondazione Giannino Bassetti
− Kostas Iatridis, School of Management University of Bath
− Pim Klaassen, Assistant professor
− Zenlin Kwee, Delft University of Technology
− Joost Groot Kormelink, Delft University of Technology
− Agata Gurzawska, TRILATERAL RESEARCH
− Panagiotis Isigonis, Ca Foscari University of Venice
− Maria Maia, Karlsruhe Institute of Technology (KIT) - Institute for Technology Assessment and
Systems Analysis (ITAS)
− Ineke Malsch, Malsch TechnoValuation
− Elvio Mantovani
− Christopher Nathan, University of Warwick
− Francesco Niglia, CEO - KOYS srls
− Daniela Pimponi, Airi - Associazione Italiana per la Ricerca Industriale
− Tom Sorell, Professor of Politics and Philosophy, University of Warwick
− Rene Von Schomberg
− Bernd Carsten Stahl, De Montfort University, Centre for Computing and Social Responsibility
− Emad Yaghmaei, Delft University of Technology
− Thamar Zijlstra, Consultant Standards Development – NEN, SHERPA project
Attention is drawn to the possibility that some elements of this document may be subject to patent rights. CEN-
CENELEC policy on patent rights is described in CEN-CENELEC Guide 8 “Guidelines for Implementation of
the Common IPR Policy on Patent”. CEN shall not be held responsible for identifying any or all such patent
rights.
Although the Workshop parties have made every effort to ensure the reliability and accuracy of technical and
non-technical descriptions, the Workshop is not able to guarantee, explicitly or implicitly, the correctness of
this document. Anyone who applies this CEN Workshop Agreement shall be aware that neither the Workshop,
nor CEN, can be held liable for damages or losses of any kind whatsoever. The use of this CEN Workshop
Agreement does not relieve users of their responsibility for their own actions, and they apply this document at
their own risk. The CEN Workshop Agreement should not be construed as legal advice authoritatively
endorsed by CEN/CENELEC.
Introduction
Responsible research and innovation (RRI) addresses the development of products and processes that are
safe, ethically acceptable, and responsive to the needs and expectations of people and society.
The essential difference between RRI and existing practices regarding corporate social responsibility (CSR),
responsible business conduct, risk, and quality management is RRI’s focus on the research and innovation
(R&I) process, from the early stages to prototyping to going to market, and the high degree of societal
involvement RRI requires to assess potential (future) ethical and social impacts of innovation. The goal of RRI
is to design and develop innovations that have socially desirable outcomes, thus addressing specific ethics
and social concerns and providing solutions for acknowledged societal challenges (e.g., sustainable
development goals). Some examples are provided in the Annex III.
The ability to translate technological developments into innovations that generate benefits and value for the
organization and its shareholders and stakeholders and for society is a core aspect of RRI.

Initiatives to put RRI into practice in industry, for instance in the form of action plans, are still limited, with most
being related to cooperative projects within EU framework programmes or national equivalents. Examples
include Horizon 2020’s SwafS (Science with and for Society) projects such as Responsible Industry, Compass,
SMART-map, Liv-In, Orbit, Satori, Sherpa, Sienna, and TechEthos.
However, it’s worth noting that principles and approaches related to RRI have elements in common with
acknowledged business and innovation management methods and practices, such as theory of change,
business model generation, stakeholder management, design-thinking, and agile management.
The guidelines offered here were developed by the PRISMA project, which worked with eight industrial pilot
projects dealing with the application of transformative technologies in different sectors. The pilots were used
to integrate RRI principles in the participating companies’ strategies and actions in order to improve the societal
value and overall performances of their R&D (research and development) outcomes and to develop specific
“pilot RRI roadmaps”.
For an effective RRI uptake, it is essential for companies to identify strategies and practices that fit within the
realities and constraints in which they operate. The roadmap described in these guidelines aims to help them
do just that. The overall goal is to help strengthen aspects of responsibility all along the research, development,
and design process for innovations and thus to support a “responsibility-by-design” approach.
Besides helping to identify a vision, a set of actions, and a timeline (roadmap) for implementing RRI
approaches, this guideline also analyses the potential barriers, opportunities, and benefits in pursuing RRI.
Within this guidance, we understand research and innovation as intertwined: research (besides its role of
creating knowledge) has an applied character and is oriented towards innovation, with the final goal of
generating both economic and societal value.
At the industry level, technology roadmapping is already a quite widely utilized method in strategy planning. A
technology roadmap visualizes an organization’s strategic aims (vision/development plans) and can be utilized
to structure its research, development, and business activities. In recent years, the concept of IPRM
(innovation policy roadmapping methodology) has been developed to connect the development of technologies
and innovations to a wider societal sphere. A main aspect of IPRM is identifying those societal needs that
create a potential demand for new solutions and possibly favour the emergence of new products and markets.

A description of the relevance of these methods for RRI is provided in Dreyer et al., 2017.
The PRISMA project received funding from the EU’s Horizon 2020 research and innovation programme
(grant agreement No. 710059). More information is available on the PRISMA website: www.rri-prisma.eu/
Ahlqvist, T., Valovirta, V., & Loikkanen, T. (2012). Innovation policy roadmapping as a systemic instrument
for forward-looking policy design. Science and Public Policy, 39(2), 178–190
IPRM integrates a foresight exercise into enabling technologies, applications, products, and markets with
analysis of socio-economical and sectorial drivers and policy and regulatory tools and strategies.
The RRI roadmap proposed in this guideline adapts a generic IPRM architecture to the definition of long-term
visions and action plans for RRI uptake within the innovation strategies of organizations and others agents
(e.g., cooperative projects) active in research and innovation. It provides the methodological and technical
conditions to address RRI principles in the context of rapid (and possibly disruptive) scientific and technological
developments to ensure such developments are relevant to society.

1 Scope
This document provides guidelines to develop long-term strategies (roadmaps) for innovating responsibly,
thereby helping organizations to achieve socially desirable outcomes from their innovation processes.
These roadmaps encourage a “responsibility-by-design” approach that integrates considerations of technical,
ethical, social, environmental, and economic aspects all along the research, development, and design process
leading to an innovation.
The document aims at all organizations and agents involved in planning and performing research and
innovation and technological development.
The focus is on innovation enabled by transformative technologies.
This document has been designed to be consistent with, and to support, as much as possible, existing
management system standards and management/governance standards (e.g. EN ISO 9001). Particular
attention has been given to social responsibility (i.e. EN ISO 26000).
2 Normative references
The existing management standards and normative references used in this document are listed below. For
dated references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
EN ISO 26000, Guidance on social responsibility
ISO 31000, Risk management – Guidelines
ISO 45001, Occupational health and safety management systems – Requirements with guidance for use
EN ISO 14001, Environmental management
EN ISO 9001, Quality management systems – Requirements
Series CEN/TS 16555, Innovation management
Series CWA 17145, Ethics assessment for research and innovation
IWA 26 Using ISO 26000:2010, in management systems
UNI/PdR 27, Guidelines for management and processes development for responsible innovation
UNI/PdR 18, Social responsibility in organizations – Guidance to the application of UNI ISO 26000

These standards and guidelines (in their scope and contents) refer to and can be used to contribute to the
UN’s Sustainable Development Goals. This document also takes into account the Rome Declaration on
Responsible Research and Innovation in Europe (European Union, 2014). In addition, it recognizes the need
to consider efforts towards responsibility in research and innovation within the broader framework of corporate
sustainability, responsible business, and sustainable finance practices (UN Global Compact:
unglobalcompact.org), though these aspects are not explicitly addressed within the scope of this guidance.
EN ISO 56000, Innovation management – Fundamentals and vocabulary
EN ISO 56002, Innovation management – Innovation management system – Guidance
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• ISO Online browsing platform: available at https://www.iso.org/obp
• IEC Electropedia: available at https://www.electropedia.org/
3.1
context of the organization
combination of internal and external issues that can have an effect on an organization’s approach to developing
and achieving its objectives.
Note 1 to entry: The organization’s objectives can be related to its products and services, investments and
behaviour towards its interested parties.
Note 2 to entry: The concept of context of the organization is equally applicable to not-for-profit or public
service organizations as it is to those seeking profits.
Note 3 to entry: In English, this concept is often referred to by other terms such as “business environment”,
“organizational environment”, or “ecosystem of an organization”.
Note 4 to entry: Understanding the infrastructure can help to define the context of the organization.
[SOURCE: ISO 9000:2015 Quality management systems -- Fundamentals and vocabulary]
3.2
corporate social responsibility (CSR)
a concept whereby companies integrate social and environmental concerns in their business operations and
in their interaction with their stakeholders on a voluntary basis”, as well as “the responsibility of enterprises for
their impacts on society.
[SOURCE: European Commission, 2011].
3.3
documented information
information required to be controlled and maintained by an organization and the medium on which it is
contained.
Note 1 to entry: Documented information can be in any format and media, and from any source.
Note 2 to entry: Documented information can refer to:
- the management system, including related processes;
- information created in order for the organization to operate (documentation);
- evidence of results achieved (records).
3.4
engagement
involvement in, and contribution to, activities to achieve shared objectives.
[SOURCE: ISO 9000:2015 Quality management systems -- Fundamentals and vocabulary]
3.5
ethics
systematic reflection on right and wrong conduct according to norms and values that we believe should be
followed. Ethics refers to duties, responsibilities, rights, welfare, justice and the avoidance of harms. Typical
moral values include autonomy, freedom, dignity, privacy, justice, well-being and responsibility.
[SOURCE: Series CWA 17145]
3.6
framework
an outline, or skeleton, of interlinked items and actions that supports a particular approach to a specific
objective and serves as a guide that can be modified as required by adding or deleting items.
3.7
human-centred design (HCD)
characterized by:
- The design is based upon an explicit understanding of users, tasks and environment;
- Users are involved throughout design and development;
- The design is driven and refined by user-centred evaluation;
- The process is iterative;
- The design addresses the whole user experience;
- The design team includes multidisciplinary skills and perspectives.
[SOURCE: ISO 9241-210:2010]
3.8
impact assessment
assessment of research and innovation for its projected or actual societal impacts.
[SOURCE: Series CWA 17145]
3.9
involvement
taking part in an activity, event or situation.
[SOURCE: ISO 9000:2015 Quality management systems -- Fundamentals and vocabulary]
3.10
innovation
new or changed entity, realizing or redistributing value.
Note 1 to entry: Novelty and value are relative to, and determined by the perception of, the organization and
interested parties.
Note 2 to entry: An innovation can be a product, service, process, model, method etc.
Note 3 to entry: Innovation is an outcome. The word “innovation” sometimes refers to activities or processes
resulting in, or aiming for, innovation. When “innovation” is used in this sense, it should always be used with
some form of qualifier, e.g., “innovation activities”.
Note 4 to entry: For the purpose of statistical measurement, refer to the Oslo Manual (OECD/Eurostat, 2018):
New or changed entity’ corresponds to ‘a new or improved product or process, or combination thereof, that
differs significantly from the unit’s previous products or processes’. Realising or redistributing value’
corresponds to ‘and that has been made available to potential users or brought into use by the unit’.
[SOURCE: EN ISO 56000]
3.11
innovation ecosystem
system of organizations, people and resources, complementing each other and contributing to a common
objective with regards to innovation.
Note 1 to entry: An innovation ecosystem can include private companies, public authorities, universities,
institutes, individual entrepreneurs, investors, researchers as well as funding and infrastructures.
Note 2 to entry: An innovation ecosystem generally includes intangible and qualitative interactions and
relationships necessary for its effectiveness.
[SOURCE: EN ISO 56000]
3.12
management system
set of interrelated or interacting elements of an organization to establish policies and objectives and processes
to achieve those objectives.
Note 1 to entry: A management system can address a single discipline or several disciplines.
Note 2 to entry: The system elements include the organization’s structure, roles and responsibilities, planning,
and operation.
Note 3 to entry: The scope of a management system may include the whole of the organization, specific and
identified functions of the organization, specific and identified sections of the organization, or one or more
functions across a group of organizations.
[SOURCE: ISO/TMB/JTCG Joint technical Coordination Group]
3.13
management standard
management standard designed to be widely applicable across economic sectors, various types and sizes of
organizations and diverse geographical, cultural and social conditions.
[SOURCE: ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2018]
3.14
management system standard (MSS)
MSS designed to be widely applicable across economic sectors, various types and sizes of organizations and
diverse geographical, cultural and social conditions.
[SOURCE: ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2018]

3.15
materiality
identification and understanding of priorities within the context of social responsibility in which an organization
operates. These priorities reflect the economic, social, and environmental factors that need to be considered.
[SOURCE: UNI/PdR 18 Social responsibility in organizations – Guidance to the application of
UNI EN ISO 26000]
3.16
monitoring
determining the status of a system, a process or an activity.
Note 1 to entry: To determine the status, there may be a need to check, supervise or critically observe.
[SOURCE: ISO/TMB/JTCG Joint technical Coordination Group]
3.17
organization
person or group of people that has its own functions with responsibilities, authorities and relationships to
achieve its objectives.
Note 1 to entry: The concept of organization includes, but is not limited to sole-trader, company, corporation,
firm, enterprise, authority, partnership, charity or institution, or part or combination thereof, whether
incorporated or not, public or private.
[SOURCE: ISO/TMB/JTCG Joint technical Coordination Group]
3.18
participatory design
a “practice of collective creativity” that emphasizes active involvement by the users and all the stakeholders in
design and development of new systems.
[SOURCE: Niemelä et al., 2014].
3.19
process
set of interrelated or interacting activities which transforms inputs into outputs.
[SOURCE: ISO/TMB/JTCG Joint technical Coordination Group]
3.20
performance
measurable result.
Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
Note 2 to entry: Performance can relate to the management of activities, processes, products (including
services), systems or organizations.
[SOURCE: ISO/TMB/JTCG Joint technical Coordination Group]

3.21
quadruple helix stakeholder
key local actors from public institutions, private organizations, academia and the public.
[SOURCE: Carayannis et al., 2009]
3.22
quality management
management with regard to quality.
Note 1 to entry: Quality management can include establishing quality policies and quality objectives, and
processes to achieve these quality objectives through quality planning, quality assurance, quality control, and
quality improvement.
[SOURCE: ISO 9000:2015 Quality management systems — Fundamentals and vocabulary]
3.23
responsible research and innovation (RRI)
transparent, interactive process by which societal actors and innovators become mutually responsive to each
other with a view to the (ethical) acceptability, sustainability and societal desirability of the innovation process
and its marketable products (in order to allow a proper embedding of scientific and technological advances in
our society).
[SOURCE: Von Schomberg, 2012]
3.24
responsible research and innovation (RRI) maturity level
how RRI is perceived and valued within an organization. Empirical research has identified five different stages:
unaware (the organization is not aware of RRI or its components); exploratory/reactive (the organization reacts
to external pressures concerning aspects of RRI); defined (the organization has definitions for RRI components
and has integrated these components into its practices); proactive (the organization realizes the benefits of
RRI and increasingly integrates RRI into its business); strategic (the organization has adopted RRI as a
component of its strategic framework and aims to ensure that all R&D activities consider most of the RRI
components).
[SOURCE: Stahl et al., 2017]
3.25
roadmap
strategic plan that defines a goal or desired outcomes and includes the major steps or milestones needed to
reach them.
3.26
roadmapping exercise
collaborative learning process and a tool for drawing up strategies, reaching consensus on requirements and
needs, and driving proactive planning and future studies.

3.27
risk
effect of uncertainty on objectives.
Note 1 to entry: An effect is a deviation from the expected. It can be positive, negative or both, and can
address, create or result in opportunities and threats.
Note 2 to entry: Objectives can have different aspects and categories, and can be applied at different levels.
Note 3 to entry: Risk is usually expressed in terms of risk sources, potential events, their consequences and
their likelihood.
[SOURCE: ISO 31000:2018 Risk management — Guidelines]
3.28
risk assessment
overall process of risk identification, risk analysis and risk evaluation.
3.29
risk identification
process of finding, recognizing and describing risks.
3.30
risk analysis
process to comprehend the nature of risk and to determine the level of risk.
3.31
risk evaluation
process of comparing the results of risk analysis with risk criteria to determine whether the risk and/or its
magnitude is acceptable or tolerable.
[SOURCE: ISO Guide 73:2009 Risk management – Vocabulary]
3.32
RRI product
research and innovation output (e.g., product, service, process, model, method) selected by the organization
as the focus of the RRI roadmap design.
3.33
social responsibility
responsibility of an organization for the impacts of its decisions and activities on society and the environment,
through transparent and ethical behaviour that:
- contributes to sustainable development, including health and the welfare of society;
- takes into account the expectations of stakeholders;
- is in compliance with applicable law and consistent with international norms of behaviour; and
- is integrated throughout the organization and practiced in its relationships.
Note 1 to entry: Activities include products, services and processes.
Note 2 to entry: Relationships refer to an organization's activities within its sphere of influence.
[SOURCE: EN ISO 26000:2020]
3.34
stakeholder
individual or group that has an interest in any decision or activity of an organization.
[SOURCE: EN ISO 26000:2020 Guidance on social responsibility].
3.35
strategy
plan to achieve a long-term or overall objective.
[SOURCE: EN ISO 9000:2015 Quality management systems – Fundamentals and vocabulary]
3.36
sustained success
organization success over a period of time.
Note 1 to entry: Sustained success emphasizes the need for a balance between economic-financial interests
of an organization and those of the social and ecological environment.
Note 2 to entry: Sustained success relates to the interested parties of an organization, such as customers,
owners, people in an organization, providers, bankers, unions, partners, or society.
[SOURCE: EN ISO 9000:2015 Quality management systems – Fundamentals and vocabulary]
3.37
technology assessment (TA)
scientific, interactive and communicative process which aims to contribute to the formation of public and
political opinion on societal aspects of science and technology.
[SOURCE: Decker/Ladikas, 2014, 14]
3.38
Technology Readiness Level
Technology Readiness Levels (TRLs) are indicators of the maturity level of particular technologies. This
measurement system provides a common understanding of technology status and addresses the entire
innovation chain. There are nine technology readiness levels; TRL 1 being the lowest and TRL 9 the highest.
[SOURCE: European Commission, Horizon 2020 Framework Programme]
3.39
transformative/enabling technologies
knowledge-intensive technologies associated with high R&D intensity, rapid innovation cycles, high capital
expenditure, and high-skilled employment. They enable innovation in processes, goods, and services
throughout the economy. They are systemically relevant and multidisciplinary, cutting across many technology
areas, with a trend towards convergence and integration. These technologies have the capacity to improve
people’s health, safety, and security and they support sustainable development and secure connectivity and
communication among systems and individuals.
[SOURCE: European Commission, High-Level Strategy Group on Industrial Technologies, 2009 and 2018]

3.40
top management
person or group of people who directs and controls an organization at the highest level.
Note 1 to entry: top management has the power to delegate authority and provide resources within the
organization.
Note 2 to entry: If the scope of the management system covers only part of an organization then top
management refers to those who direct and control that part of the organization.
[SOURCE: ISO 9000:2015]
3.41
usability
extent to which specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a
specified context of use [ISO/IEC 1998] can use a product.
3.42
user-centred design (UCD)
approach to interactive system development that focuses specifically on making systems or applications easy
to use.
[SOURCE: ISO/IEC 13407:1999].
3.43
user committees
method that involves users and other stakeholders in the formal monitoring and steering of the research and
innovation process. Typically, there is a kick-off, a mid-term, and a final workshop.
[SOURCE: Engage2020 Project, 2014].
4 Principles for implementing RRI
Definitions and principles for RRI vary throughout the literature. The definition selected for this guideline – a
transparent, interactive process by which societal actors and innovators become mutually responsive to each
other with a view to the (ethical) acceptability, sustainability, and societal desirability of the innovation process
and its marketable products – focuses on the social value in product development. This definition was
developed considering the EU normative framework, with explicit reference to the Charter of Fundamental
Rights of the European Union.
From this definition, a set of principles has been developed in the literature to support the implementation of
RRI in different kinds of decisional and operative structures and practices. In this guideline, these
“management” principles are connected to specific action lines for RRI implementation along the R&I value
chain (Table 1).
Von Schomberg, R. (2012). Prospects for technology assessment in a framework of responsible research
and innovation. In D. Marc. & B. Richard (Eds.), Technikfolgen abschätzen lehren (pp. 1–19). VS Verlag für
Sozialwissenschaften. https://doi.org/10.1007/978-3-531-93468-6_2.
See https://www.europarl.europa.eu/charter/pdf/text_en.pdf
Lubberink, R., Blok, V., van Ophem, J., & Omta, O. (2017). Lessons for responsible innovation in the
business context: A systematic literature review of responsible, social and sustainable innovation practices.
Sustainability, 9(5), 721. https://doi.org/10.3390/su9050721.
Table 1 — Set of principles and actions for RRI implementation
Principles for RRI
Action lines
implementation
Integrate analysis of ethical, legal, and social impacts (ELSI)
Reflection & Anticipation from the earliest stages of product conception and product
development
Promote stakeholder engagement and involve stakeholders
from the quadruple helix to inform all phases of product
Inclusion
development and ensure that research and innovation activities
are societally relevant and desirable
Integrate monitoring, learning, and adaptive mechanisms to
Responsiveness address public and social values and normative principles in
product development
These principles are further described in the following :
• Reflection: scrutinize each activity, commitment, and assumption to connect them with a moral value
system and the good practices of science, taking into account the limits of knowledge and that a
particular framing of an issue may not be universally held. Reflexivity in the RRI context does not refer
to the moral responsibility of the single researcher or developer, nor is it a self-critique of the single
professional. Instead, it is intended as an institutional practice. It should therefore be intended as a
public matter, and all parts of the quadruple helix should play a role in the reflexivity actions. Reflexivity
is also important in other phases of the product value chain or other functions (besides R&D) inside
the organization that could be affected by an R&I action or result.

• Anticipation: systematically extrapolate all plausible scenarios for the application of R&I results with
quadruple helix stakeholders; identify in these scenarios the possible risks, opportunities,
uncertainties, and critical issues and consider possible ways to prevent, manage, or exploit them.
Anticipation is intended to not only prevent undesirable events but also shape desirable futures and
organize activities and resources towards those futures. When describing desirable futures,
anticipation should be realistic and avoid overestimating the benefits of the innovation.

• Inclusion: introduce participatory approaches in R&I processes from the very earliest stages in order
to engage people interested in the innovation process or its results. Inclusion refers to the engagement
of both internal and external stakeholders. It considers all potentially impacted groups or users, taking
into account gender and other social attributes and making particular efforts to involve marginalized
or hard-to-reach groups that may be most impacted or excluded by innovations. Inclusion is connected
to the other RRI principles because reflexivity, anticipation, and responsiveness will likely be improved
by a broad participation of different stakeholders.

• Responsiveness: change the direction of the innovation process in response to stakeholder and
public indications, needs, and values or in reaction to changing circumstances. Innovation actions may
also need to be adjusted due to insufficient knowledge and control or in response to new knowledge,

Stilgoe, J., Owen, R., & Macnaghten, P. (2013). Developing a framework for responsible innovation.
Research Policy, 42(9), 1568–1580. https://doi.org/10.1016/j.respol.2013.05.008.
perspectives, or regulatory requirements. The entire R&I process should be shaped to be as
responsive as possible.
The goal of RRI is to support mutual responsiveness among the different actors in the research and innovation
process in order to jointly shape and direct the innovation towards the generation of value and impact. Mutual
responsiveness is expected to contribute to learning and to the building of relationships, trust, and
trustworthiness. However, given this guideline’s focus on the management practices of an individual
organization, practical implementation of this approach should be done only to the extent possible within the
actions and responsibilities of the organization.
Other important aspects to consider include research integrity and transparency (especially in connection to
the open access of research results). The precautionary principle, the “do no significant harm” principle, and
general corporate social responsibility principles, such as business and human rights should also be
considered.
It is important to note that from an institutional and policy perspective, the principles of RRI can be referred to
as a series of dimensions, including those of multi-actor and public engagement, gender equality, science
education, ethics, open science, and governance.
Box 1 includes a collection of the scopes, principles, and values of some ISO management systems, providing
a useful reference for the implementation of the RRI approach described above.

Note that inclusion and responsiveness have similarities with business concepts such as design-thinking
and agile management.
An analysis of sources of trust and distrust in relation to technology governance is provided by the project
TigTech (www.tigtech.org). The trust drivers identified are intent, public interest, competence, respect,
integrity, inclusion, openness, and fairness.
See the European Code of Conduct for Research Integrity, ALLEA, 2017
R&I activities should not include supporting or carrying out activities that significantly harm any of the six
environmental objectives set in the EU Taxonomy Regulation. See Regulation (EU) 2020/852 (Taxonomy) on
the establishment of a framework to facilitate sustainable investment.
See the UN Guiding Principles on Business and Human Rights.
Responsible research and innovation: Europe's ability to respond to societal challenges, EC DG Research,
2014.
Box 1: Scopes, principles, and values of ISO standards on social responsibility, risk
management, quality, and innovation management

ISO 56000
EN ISO 26000 ISO 31000 ISO 9001
(Innovation
(Social Responsibility) (Risk Management) (Quality Management)
Management)
Guidance to integrate, Guidance on a common Requirements to Describes the
implement, and promote approach to managing demonstrate fundamental concepts,
socially responsible any type of risk organization’s ability to principles, and vocabulary
behaviour throughout throughout the life of consistently provide of innovation
the organization and, the organization products and services management
through its policies and that meet customer
practices, within its needs (conformity) and
sphere of influence applicable statutory and
regulatory
requirements
 Accountability A risk management  Customer focus  Realization of value
framework: as the ultimate
 Transparency  Ensure leadership
 Integrated in all objective for
in the management
 Ethical behaviour
organizational organizations
system
activities engaging in
 Respect for
 Engagement of innovation activities
stakeholder  Structured and
people
interests comprehensive  Future-focused
 Process approach,
leader, driven by
 Respect of the rule  Customized to the
to operate as an
curiosity and
of law
organization’s
integrated and courage, challenges
external and internal
 Respect for complete system the status quo
context
international norms
 Continuous  Strategic direction
of behaviour  Inclusive,
improvement to for innovation
considering
 Respect for human meet customer
knowledge, views,  Culture of creativity,
rights
requirements and
and perceptions of quality, and
enhance customer
stakeholders innovation
satisfaction
 Dynamic and  Exploiting insights:
 Evidence-based
adaptable using a diverse range
decision-making
of internal and
 Based on best
 Relationship external sources
available information
management
 Managing
 Considering human
uncertainty
and cultural factors
 Adaptability
 Based on continual
improvement  System approach
through learning and
experience
5 Methodological approach
The methodological approach to the process leading to RRI implementation in industrial practices is
schematically represented in Figure 1 and explained in detail in Clause 6. The final goal is the defining of an
RRI roadmap that sets a strategy and indicates a vision and specific actions for RRI implementation in product
development. The structure and visualization of the roadmap is provided in Figure 2 (Clause 6.7). The roadmap
design includes definitions of the following elements:
• The R&I product(s) the RRI roadmap should focus on
• The vision for RRI implementation in the product’s development
• The timescale for implementing the RRI roadmap
•
...