In part 1 of the CSR series we introduced what Corporate Social Responsibility was. In this second part we examine both the legal and business requirements behind the EU Law. This presentation also examines how an organization will sustain these efforts

1. Intro to Corporate Social Responsibility © Copyright Willis QS Consulting
01 Jan 2019 STRICTLY CONFIDENTIAL
CORPORATE SOCIAL
RESPONSIBILITY
WHAT DOES COMPLIANCE
MEAN?

2. Intro to Corporate Social Responsibility © Copyright Willis QS Consulting
01 Jan 2019 STRICTLY CONFIDENTIAL
DR. MARK R. WILLIS
Experience
• 15 Years in the Medical Device / Pharmaceutical Industry
• 5 Years in the Financial / Global Communications Industry
• Graduate Level Professor of Project Management & Regulatory Affairs, Northeastern University
• Under Graduate Professor of Health Economics, Massachusetts College of Pharmacy & Health
Sciences
• Project Management Lecturer, Harvard University School of Business
Education
• Notre Dame University - BS Economics
• Northeastern University - MS Regulatory Affairs for Drugs, Biologics, and Medical Devices
• Northeastern University – Doctorate, Law and Policy
Achievements
• Certified: PMP, cSQE, cTFL, cQA, cQM/OE
• ISO 2012 Colleague of Distinction Award Winner
• ISO Standards Board Member – Quality Management Chair (2009 – 2012)
• ISO Standards Board Member – Software Chair (2010 – 2013)
• ISPE Standards Board Member (2013)
• Participant in ISO 9001 update

3. Intro to Corporate Social Responsibility © Copyright Willis QS Consulting
01 Jan 2019 STRICTLY CONFIDENTIAL
CSR PROGRAM
BACKGROUND
November 15, 2014 European Parliament approved Directive
2014/95/EU regarding disclosure of corporate non-financial and
diversity information
Under this new directive, Corporate Social Responsibility (CSR) refers
to organizations taking ownership for their impact on society
The European Commission believes that CSR is important for the
sustainability, competitiveness, and innovation of EU enterprises and
the EU economy
The EU’s CSR directive is broken into six workstreams:
1. Environment
2. Employees
3. Social
4. Human Rights
5. Anti-Corruption
6. Diversity at the Board Level

4. Intro to Corporate Social Responsibility © Copyright Willis QS Consulting
01 Jan 2019 STRICTLY CONFIDENTIAL
THE NEW EU CSR REPORTING
DIRECTIVE
Matters to be reported
Anti-corruption and bribery matters
(e.g. Existing instruments)
Environmental matters
(e.g. Emissions, energy use, protection of
biodiversity, …)
Employee matters
(e.g. gender diversity, working conditions, health &
safety, …)
Social matters
(e.g. Dialogue on municipal and regional level,
protection of local communities, …)
Respect for human rights
(e.g. Prevention of human rights violations)
Per matter:
• Concepts
• Risks
• Material non-financial KPIs
• Context
• Requirement: material information to help:
 understand the course of business,
business performance and economic
position
and
 understand the impact of the company’s
business practices on the above-
mentioned matters
Reporting details per matter
Reporting Requirements:

5. Intro to Corporate Social Responsibility © Copyright Willis QS Consulting
01 Jan 2019 STRICTLY CONFIDENTIAL
• Most important
non-financial key
performance indicators
• Selection of KPIs
depends on business
model
• Disclosure of non-binding
guidelines, including
examples for non-
financial performance
indicators by the
European Commission
CONCEPTS, RISKS, KPI’S AND
CONTEXT
KPIs Context
• Reference to
amounts in
(consolidated) financial
statements
• If necessary for a better
understanding
Risks
• Disclosure of
material risks
• Handling of risks
• Risks resulting from own
business practices
• Supply chain/value
chain risks (from
business relations,
products, services as far
as information is
important and can
reasonably be obtained)
Concepts
• Concepts
 Goals
 Measures
 Processes (including
applied due diligence
processes)
• Results of concepts
Comply-or-explain
principle

6. Intro to Corporate Social Responsibility © Copyright Willis QS Consulting
01 Jan 2019 STRICTLY CONFIDENTIAL
CSR PROGRAM
ENGAGEMENT
Moral obligation means that stakeholders of a growing number of
companies are satisfied only when the company balances the impact of
its business with socially responsible practices.
Sustainability involves meeting the needs of the present without
compromising the capability for future generations. Substantial progress
can be made by investing in solutions that are socially, environmentally,
and financially sustainable (Arena, 2006, p. 9).
Moreover, the very license to operate and crucial contracts themselves,
with governments and other entities, might be conditional upon such
obligation.
Finally, CSR initiatives may be supported due to reputation impact, on
the grounds that they will improve a company's image and even raise the
value of its stock.

7. Intro to Corporate Social Responsibility © Copyright Willis QS Consulting
01 Jan 2019 STRICTLY CONFIDENTIAL
SUSTAINABILITY IN PARTS
Corporate Social Responsibility or Sustainability can be viewed from two
points-of-view
1. Legal Requirement: Filing a Non-Financial Report
2. Business Requirement: Improve beyond Non-Financial Report
What makes the most sense for your company
in 2019 and beyond?

8. Intro to Corporate Social Responsibility © Copyright Willis QS Consulting
01 Jan 2019 STRICTLY CONFIDENTIAL
LEGAL REQUIREMENT:
FILING A NON-FINANCIAL REPORT
For Fiscal Year 2019 and beyond, most companies are legally obligated to
file a Non-Financial Report, i.e. meeting at least the minimal defined
reporting requirements including the assessment by an external auditor
Filing a Non-Financial Report includes:
• Reporting material KPIs for each matter (social, employees, anti-
corruption and bribery, human rights, supply chain and environment)
• Reporting a narrative explaining the management concept including
KPIs and/or why KPIs are not available
• As the 2017 Non-Financial Report was the first of its kind for all companies,
some leniency was applied.
• Therefore, certain improvements are expected in 2018 and beyond

9. Intro to Corporate Social Responsibility © Copyright Willis QS Consulting
01 Jan 2019 STRICTLY CONFIDENTIAL
BUSINESS REQUIREMENT:
IMPROVE BEYOND NON-FINANCIAL REPORT
While the 2017 Non-Financial Report fulfilled minimal legal
requirements, the expectation of the external investor community is
that you do “more than” the minimum
To improve, the companies have launched the sustainability
initiatives such as:
• Sustainable supply chain
• Labor Rights
• Occupational health and safety
• Patient satisfaction
• Human rights
• Data privacy and security

10. Intro to Corporate Social Responsibility © Copyright Willis QS Consulting
01 Jan 2019 STRICTLY CONFIDENTIAL
SUSTAINABILITY IMAGINED
Purpose,
Strategy
Goals Responsibility CoveragePolicy,
Guideline,
Training
Reporting &
Communication
Results,
Progress
EnvironmentEmployeesPatients Human RightsCompliance Supply Chain

11. Intro to Corporate Social Responsibility © Copyright Willis QS Consulting
01 Jan 2019 STRICTLY CONFIDENTIAL
 The European Union Directive for CSR has been in place
since 2014
 While 2017 was the first year corporations were required
to report, this does not mean that the organizations are
done
 The EU Directive requires organizations to continuously
improve their program on a yearly basis
 Corporations need to understand how to build a
sustainable program that allows for growth while meeting
the annual legal compliance
LESSONS LEARNED

12. Intro to Corporate Social Responsibility © Copyright Willis QS Consulting
01 Jan 2019 STRICTLY CONFIDENTIAL
If you would like to know more about Corporate Social
Responsibility, reach out to Willis QS Consulting for more
information.
Willis QS Consulting can help you with all of your CSR
needs.
Dr. Mark R. Willis
WillisQSConsulting@gmail.com
+1 (508) 272-9647
CONTACT