Chapter 01

Our Company

ESG focus
areas

2

Initiatives for Patient Safety and Growth

QARA Investments for Patient Safety and
Our Future Growth

QARA Structure
General Meeting of Shareholders
Election/DismissalCompensation
Committee

AuditCommittee evelop a robust organization and supportingD
processes to ensure consistent execution ofQuality System requirements, qualityimprovements, identification and resolution ofcompliance risks
Integrate Quality Engineering and Quality
Leadership organizations globally across all
three regions, manufacturing plants, repair anddistribution centers

CQO’s MessagePierre Boisier
Executive Officer andChief Quality Officer

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Olympus Integrated Report 2023

assurance and regulatory affairs (QARA) organization is being
built to support this effort and to make sure processes are
adopted consistently and globally across manufacturing,
repair and distribution centers.
In addition, we have established the Quality Assuranceand Reguratory Affairs (QA&RA) Committee, which ensures
we live up to our patient safety aspirations and diligently
respond to regulators and fulfill our commitments. We willcontinue to invest in patient safety and our business’ growth,which are fundamental to our organization’s long-termsustainability.
Execute Transformation with the Aim of aSingle Global Quality System andFully Harmonized Processes

Enhance Global Quality andCompliance Functions to Ensure
Consistent Execution

Quality Assurance and Regulatory
Affairs (QA&RA) Committee

Monitoring function
Monitor

Nothing is more important to Olympus than patient safety.
The situation that we are in today is an opportunity for us all
to recognize that we must fundamentally improve our quality
and regulatory systems. We take this challenge extremely
seriously and are working tirelessly on structural and culturalchanges to meet the regulators’ expectations, and thisremains the Company’s highest priority.
We have already started with significant investments andcommitments to transform Olympus’ quality management
processes into a consistent global system for both patient
safety and quality management. A right-sized quality	Establishment of voluntary QA&RA
Committee	Added quality indicators to theevaluation index of executive officers’
compensation

Board of Directors

Nominating
Committee

Commitment to Product Quality and Safety

Efforts in the Monitoring Function

Election/Dismissal

 uild and implement a Single Global Quality SystemBDevelop streamlined digitally-enabled processes tosupport the global execution of the Quality System,
including Complaint Management & MDR, ProcessValidation, Design Controls, Management Review,
Internal Audit, Regulatory Commitment Tracking, etc.

Resolve Compliance Issues andComplete Remediation
 nsure all commitments to regulators are implemented onEtime meeting regulator’s expectations

To strengthen QARA, we have established an independent worldwide quality and regulatory organizational
structure where the Chief Quality Officer (CQO) oversees the activities and reports directly to the CEO. After I
joined Olympus, we analyzed the skill sets and talent of the people in the QARA department. From theresults, we created a QARA organization plan that could implement the functions within a unified global
quality management system.
Based on this new QARA organization plan, we addressed skill set and knowledge needs in quality
and regulatory compliance by continuing to hire MedTech leaders with expertise in areas such ascomplaint handling, regulatory affairs, product quality, and compliance. Keeping up with the latest
regulatory interpretations is also very important for us and it is essential to have the right skilled people
and foster talent. I think we have built a very good foundation with the senior team and we are now readyto move forward to build a globally coherent quality mindset that ensures patient safety as our top priority.
Our design assurance (quality side of R&D) team is set up to make sure that we design products
consistent with applicable regulations and meet the demands of regulators. Our R&D is mostly in Japanand our design assurance team works very closely with these Japanese R&D teams. Their collaborationis getting better and they are designing products within applicable global regulatory guidelines. We arefocusing on bringing the quality management system to a global standard. We are unifying our quality
management system to consolidate requirements for critical processes ensuring that relevant global
regulatory requirements are consistently met.
The entire company is working diligently to remediate the issues identified in the warning letters andtrying to prevent similar incidents from happening again. During this process, we are closely communicatingwith the regulatory authorities. Patient safety is our highest priority. I am confident that these efforts will help
our QARA become globally unified and enable Olympus to transform into a 100% global MedTech company.

Accounting Auditor

ReportExecution function
InternalAudit

Representative Executive Officers
Executive Officers

Group Executive Committee

ReportFunctional Divisions,
Business Units,
Corporate Divisions, andGroup Companies

CTO, CMSO, andall other organizations

CQO

Function for global regulatory affairs, productregistration, and operation management
Function for establishment and management of
global quality organization and QMS
Function for establishment and management of
global QARA compliance and external regulatory
audit & response management
Function for global QARA strategic projects
management, etc.

Audit

Efforts in the Execution Function	Quality Transformation	Remediation

Establishment of QA&RA Committee
We established a QA&RA Committee at
the Board of Directors in April 2023.
This is a voluntary committee composedof outside directors and related
functions such as QARA, R&D, Legal,and Supply Chain will report monthly atthis Committee. The Committee
oversees and provides advice for thedevelopment of global quality
management systems to meet theexpectations of regulators and to ensurecompliance with relevant laws andregulations.

This Committee shall resolve or deliberate on the following matters and reportsuch matters to the Board of Directors as appropriate:Activities

Members1) Oversight and advice on Company plans for the quality management system
as required of a global MedTech company, including the Management Reviewprocess.
2) Oversight and advice on regulatory communication strategy and engagement.
3) Provide recommendations to management for resourcing and areas ofplanning and execution.
4) In addition to the above, monitor any significant resourcing requirements
outside of management plans and/or address any matters that have beenrequested by the Board of Directors with regard to QARA.
Outside Director, Gary John Pruden (Chairperson)
Outside Director, Jimmy C. BeasleyOutside Director, Luann Marie Pendy

Message from Chairperson of the QA&RA Committee

Gary John Pruden
Outside Director

Our Committee oversees the development and execution of Olympus’ QARA strategy to makesure we meet all regulatory standards required for a global MedTech company. Our aim is toenhance our global capabilities to make sure we avoid future regulatory challenges. Thus it isessential to remediate our processes, standards, and capabilities. The Committee will also review
and oversee root cause analysis, support the transformation of the corporate culture, and monitor
the establishment of a robust global quality management system.
I bring over 35 years of experience in global healthcare organizations with extensive knowledgeof the medical device industry, including quality management systems and regulatory affairs. My
fellow committee members, Mr. Beasley and Dr. Pendy, are also very experienced in quality andregulatory and bring a wealth of global medical device knowledge to their roles as outside
directors. We hope to make full use of our expertise to help oversee the transformation at Olympus
and provide advice where necessary. We will support Olympus’ transformation into a global
MedTech company where patient safety is our first priority and the focus of our entire organization.

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