[Note: This is a partial preview. To download this presentation, visit: https://www.oeconsulting.com.sg/training-presentations] ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle. This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry. It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016. LEARNING OBJECTIVES 1. Provide background knowledge on ISO 13485:2016 2. Gain an overview of ISO 13485:2016 structure and the certification process 3. Understand the audit approach 4. Gather useful tips on handling an audit session CONTENTS 1. Overview of ISO 13485 About ISO What are Standards? Why are Standards Important? What is ISO 13485? Who is ISO 13485 For? What is a Medical Device? What is a Quality Management System? How Does ISO 13485 Work? Benefits that ISO 13485 Will Bring to the Organization Advantages of Certification Development of ISO 13485 Why Was ISO 13485 Revised? Key Improvements to ISO 13485:2016 Relationship of ISO 13485 with ISO 9001 2. ISO 13485:2016 Structure The ISO 13485:2016 Structure The Plan-Do-Check-Act (PDCA) Process Model ISO 13485:2016 Approach is Based on the PDCA Cycle Documentation Requirements ISO 13485:2016 Key Clause Structure (4-8) Clause 4: Quality Management System Clause 5: Management Responsibility Clause 6: Resource Management Clause 7: Product Realization Clause 8: Measurement, Analysis & Improvement 3. ISO 13485:2016 Certification Becoming ISO 13485:2016 Certified ISO 13485:2016 Certification Process 4. Audit Approach What is a Quality Audit? What Are Audits Used For? Types of Quality Audits Internal Quality Audit Principles of Auditing Audit Focus Audit Approach Audit Emphasis Document Review Audit Findings 5. Handling an Audit Session Rights of Auditee Rights of Auditor How to Handle an Audit Session? Auditee's Conduct Interacting with Auditors: Do's Interacting with Auditors: Don'ts

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ISO 13485:2016
Medical Devices – Quality Management System

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Learning Objectives
Provide
background
knowledge of
ISO 13485
Gain an
overview of the
ISO 13485:2016
structure
Understand the
ISO 13485:2016
certification
process
Describe the
audit approach
and learn useful
tips on handling
an audit session

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Contents
2
3
4
ISO 13485:2016 Structure
ISO 13485:2016 Certification
Audit Approach
1 Overview of ISO 13485:2016
5 Handling an Audit Session

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“It is not enough to do
your best; you must
know what to do, then
do your best.”
W. Edwards Deming

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About ISO
§ Non-governmental organization (NGO) established in 1947, based
in Geneva, Switzerland
§ Has a membership of over 160 national standards institutes from
countries in all regions of the world
§ The world’s largest developer of voluntary International Standards,
based on global and market relevance

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Why are Standards Important?
Facilitates
business
interaction
Communication
Enables
companies to
comply with
relevants laws and
regulations
Compliance
Speeds up the
introduction of
innovative
products and
services to the
market
Innovation
Provides
interoperability
between new and
existing prodcucts,
services and
processes
Interoperability

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What is ISO 13485?
§ ISO 13485 is an international standard that sets out the
requirements for a quality management system (QMS) specific to
the medical devices industry
§ Focuses on meeting customer and applicable regulatory
requirements
§ ISO 13485 is intended for any organization partially or fully involved
in the medical device life-cycle
§ Covers any organization – whatever the size or type
§ A certification model

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Who is ISO 13485 for?
§ ISO 13485 is designed to be used
by organizations involved in the
design, production, installation and
servicing of medical devices and
related services
§ It can also be used by internal and
external parties, such as
certification bodies, to help them
with their auditing processes
§ It helps an organization design a
QMS that establishes and
maintains the effectiveness of its
processes

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Benefits that ISO 13485 Will Bring to the
Organization
§ Demonstrate compliance with regulatory and legal requirements
§ Ensure the establishment of QMS practices that consistently yield
safe and effective medical devices
§ Manage risk effectively
§ Improve processes and efficiencies as necessary
§ Gain a competitive advantage

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Advantages of Certification
§ Certification to ISO 13485 is
voluntary
§ Independent check of
conformity by a third party
§ Indicates an effective Quality
Management System
§ National/International
recognition
§ Provides competitive advantage
§ Improves company image

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Development of ISO 13485
ISO 13485:1996 (1st issue)
ISO 13485:2003 (2nd issue)
ISO 13485:2016 (3rd issue)
2003
2016
1996

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Why Was ISO 13485 Revised?
§ All ISO standards are reviewed and revised regularly to make sure
they remain relevant to the marketplace
§ ISO 13485:2016 responds to the latest QMS practices, reflecting the
evolution in medical device technology and changes in regulatory
requirements and expectations
§ To ensure that the standard remains compatible with other
management system standards, including ISO 9001

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The ISO 13485:2016 Structure
1. Scope
2. Normative References
3. Terms & Definitions
4. Quality Management System
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis &
Improvement

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The ISO 13485 Process Model is Based on the
PDCA Cycle
Value-adding activities
Information flow
Input Output
Product
Maintain Effectiveness of the
Quality Management System
Regulators &
Customers
Requirements
Regulators &
Customers
Feedback
Management
Responsibility
(Clause 5)
Resource
Management
(Clause 6)
Measurement,
analysis &
Improvement
(Clause 8)
Product
Realization
(Clause 7)
Quality
Management
System
(Clause 4)

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ISO 13485:2016 Key Clause Structure (4-8)
4. Quality
Management
System
5. Management
Responsibility
6. Resource
Management
7. Product
Realization
8. Measurement,
Analysis &
Improvement
4.1 General Requirements 5.1 Management
Commitment
6.1 Provision of
Resources
7.1 Planning of Product
Realization
8.1 General
4.2 Documentation
Requirements
5.2 Customer Focus 6.2 Human Resources 7.2 Customer-related
Processes
8.2 Monitoring &
Measurement
5.3 Quality Policy 6.3 Infrastructure 7.3 Design & Development 8.3 Control of
Nonconforming Product
5.4 Planning 6.4 Work Environment &
Contamination Control
7.4 Purchasing 8.4 Analysis of Data
5.5 Responsibility,
Authority &
Communication
7.5 Production & Service
Provision
8.5 Improvement
5.6 Management Review 7.6 Control of Monitoring &
Measuring Equipment

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Becoming ISO 13485 Certified
§ The certification body examines
the QMS for conformity to the
ISO 13485 standard
§ The QMS audit is a compliance
audit
§ Certification means the
organization has a documented
QMS that is fully implemented
and meets ISO 13485
requirements

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ISO 13485 Certification Process
Implementation of
QMS
Conduct Internal
Audit and Review
Result by Top
Management
Selection of a
Certification Body
Stage 1 AuditStage 2 Audit
Confirmation of
Registration
Continual
Improvement and
Surveillance Audits

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What Are Audits Used For?
§ Looking at the overall process
§ Auditing conformity
§ Auditing effectiveness
§ Approving external service providers
§ Assessing for certification
§ Investigating problems
§ Way of improving

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Internal Quality Audit
§ To ensure the whole Quality System is
audited to check:
• The system is being followed
• The system meets ISO 13485
requirements
• The system is effectively implemented and
maintained

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Audit Focus
Effectiveness of QMS
in achieving the organization’s objectives
and in providing products and services that
conform to customer and applicable
regulatory requirements.

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Audit Emphasis
§ Measurement and results are of greater importance than mere
presence of written procedures or documents

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Audit Findings
Minor Non-conformity
Observation
Major Non-conformity

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How to Handle the Audit Session?
§ Do not panic
§ Ask and clarify
§ Admit obvious non-conformities
§ Offer evidence and explain
patiently
§ Take note of improvement
areas highlighted by the auditor
§ Show internal audit report,
when necessary

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Auditee’s Conduct
§ Polite
§ Professional
§ Positive / Receptive
§ Sincere
§ Commitment
§ Formal but not overly serious

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Interacting with Auditors
§ Be honest and open
§ Recognize they may be experts
§ Realize they may not be subject matter
experts
§ Understand the purpose of the meeting and
review related records prior to interviews
§ Turn mobile phones to silent mode

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Interacting with Auditors
§ Assume auditors are familiar with your
organization’s QMS
§ Challenge auditors
§ Show more competence in ISO 13485
§ Argue internally
§ Express unfairness
§ Ask for solution
§ Fix non-conformities on the spot

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“In the race for
quality, there is no
finish line.”
David Kearns,
former CEO of Xerox

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Operational Excellence Consulting is a management training and consulting
firm that assists organizations in improving business performance and
effectiveness. Based in Singapore, the firm’s mission is to create business
value for organizations through innovative design and operational excellence
management training and consulting solutions. For more information, please
visit www.oeconsulting.com.sg