ISO 13485:2016 (Medical Devices - Quality Management Systems) Awareness Training

© Operational Excellence Consulting
ISO 13485:2016
Medical Devices –
Quality Management Systems
© Operational Excellence Consulting. All rights reserved.

LEARNING OBJECTIVES
2
Provide background
knowledge of ISO
13485
Describe the audit
approach and learn
useful tips for
handling an audit
session
Gain an overview of
the ISO 13485:2016
structure
Define the ISO
13485:2016
certification process
NOTE: This is a PARTIAL PREVIEW.
To download the complete presentation, please
visit: https://www.oeconsulting.com.sg

CONTENTS
3
OVERVIEW OF
ISO 13485
ISO 13485:2016
STRUCTURE
ISO 13485:2016
CERTIFICATION
PROCESS
AUDIT APPROACH
01 04
03
02
HANDLING AN
AUDIT SESSION
05

“
It is not enough to do your
best; you must know what
to do, then do your best.”
W. EDWARDS DEMING
4

● 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
ABOUT ISO
● Developed more than 22,000
standards for all dimensions of
sustainable development
● ISO’s Technical Committee
ISO/TC 210 was responsible for
the development of ISO 13485*
Quality Management System for
Medical Devices
5
*In this presentation, the reference to ISO 13485
pertains to the third edition published in 2016
unless a different date is included in the reference.

ISO STANDARDS CONTRIBUTE DIRECTLY TO THE U.N. SUSTAINABLE
DEVELOPMENT GOALS (SDGs)
6
ISO 14001:2015
Environmental
Management Systems
ISO/IEC
27001:2013
Information Security
Management Systems
ISO 22000:2018
Food Safety
Management Systems
ISO 26000:2010
Social Responsibility
ISO 9001:2015
Quality Management
Systems
ISO 50001:2018
Energy Management
Systems
ISO 37001:2016
Anti-Bribery
Management Systems
ISO 45001:2018
Occupational Health &
Safety Management
Systems
Some examples of popular ISO standards that are adopted
by various companies and organizations:

● 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
WHAT IS ISO 13485?
● 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
7

● 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
WHO IS ISO 13485 FOR?
8
8

● A medical device is a product,
such as an instrument, machine,
implant or in vitro reagent, that is
intended for use in the diagnosis,
prevention and treatment of
diseases or other medical
conditions
WHAT IS A MEDICAL DEVICE?
9
9

BENEFITS THAT ISO 13485 WILL BRING TO THE ORGANIZATION
10
Improve customer
satisfaction and loyalty
Create a continual
improvement culture
Improve processes and
efficiencies
Demonstrate compliance
with regulatory and legal
requirements
Manage risks effectively
Gain a competitive advantage

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
11
11

KEY IMPROVEMENTS TO ISO 13485:2016
12
More focus on post-market
activities, including
complaint handling and
regulatory reporting
Additional requirements
in the design and
development of medical
devices
Harmonization of validation
requirements for different
software applications
Increased alignment with
regulatory requirements
and documentation
Emphasis on appropriate
infrastructure, e.g.
production of sterile
medical devices
Widen the scope to include
organizations that interact
with the medical devices
manufacturer
Emphasis on risk
management and risk-
based decision making

THE ISO 13485:2016 STRUCTURE
13
1. Scope
2. Normative References
3. Terms & Definitions
4. Quality Management
System
6. Management
Responsibility
7. Resource Management
8. Product Realization
9. Measurement, Analysis
& Improvement

ISO 13485 PROCESS MODEL IS BASED ON THE PDCA CYCLE
14
Source: Based on ISO
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)

ISO 13485:2016 KEY CLAUSE STRUCTURE (4-8)
15
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

DOCUMENTATION REQUIREMENTS
● Documented procedures, records
required by ISO standards
● Organization’s responsibility to decide
when written procedure is required
● Written procedures are not always
necessary!
● Evidence may be seen in consistency
of practices and outputs, e.g. plans,
forms, data, records
● Control of documents and records
16
16

“
Quality has to be caused,
not controlled.”
PHILIP B. CROSBY
17

● 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
BECOMING ISO 13485 CERTIFIED
© Operational Excellence Consulting 18
18

ISO 13485:2016 CERTIFICATION PROCESS
3 5 7
1 4 6
2
Implementation of QMS Selection of a
Certification Body
Stage 2 Audit Continual Improvement
and Surveillance Audits
Conduct Internal Audit
and Review Result by
Top Management Stage 1 Audit
Confirmation of
Certification

WHAT DOES CERTIFICATION ASSURE?
20
Regular assessment to
continually monitor and
improve processes
Credibility that the
system can achieve its
intended outcomes
Reduced risk and
uncertainty and
increase market
opportunities
Consistency in the
outputs designed to
meet stakeholder
expectations

● Systematic, independent and
documented process for obtaining
audit evidence and evaluating it
objectively to determine the extent
to which audit criteria are fulfilled
● Audit criteria
○ Processes or procedures
○ Standards
WHAT IS A QUALITY AUDIT?
21

WHAT ARE AUDITS USED FOR?
22
Auditing conformity
Auditing effectiveness
Looking at the overall process
Approving external service providers
Investigating problems
Way of improving
Assessing for certification
Highlight examples of good practice

AUDIT FOCUS
Effectiveness of the QMS in achieving the
organization’s objectives and in providing
products and services that conform to
requirements of interested parties.

● Focuses on employees’
understanding of the organization’s
processes and verifies that these
processes are:
o complied with
o under control
o achieving the desired results
● Provide evidence, e.g. records,
meeting minutes, reports, data and
emails
AUDIT APPROACH
24

● Document review can be done in
advance of actual site visit
● Documented information refers to
information that must be controlled
and maintained
● You are expected to maintain and
control the medium as well as the
information
● Purpose is to ensure that, in theory,
the documented information meets
the requirements of ISO 13485
or other standards
DOCUMENT REVIEW
25
25

AUDIT FINDINGS
26
MAJOR NONCONFORMITY
§ A major nonconformity
relates to the absence or
total breakdown of a required
process or a number of
minor nonconformities listed
against similar areas
§ A major nonconformity at the
Registration Audit would
defer recommendation for
registration until that major
has been closed
MINOR NONCONFORMITY OBSERVATION
§ A minor nonconformity is an
observed lapse in your
systems ability to meet the
requirements of the standard
or your internal systems,
while the overall process
remains intact
§ An observation or
opportunity for improvement
relates to a matter about
which the Auditor is
concerned but which cannot
be clearly stated as a non-
conformity
§ Observations also indicate
trends which may result in a
future nonconformity

HOW TO HANDLE AN AUDIT SESSION?
27
Ask and clarify
Admit obvious non-conformities
Do not panic
Take note of improvement areas highlighted
by the auditor
Show internal audit report, when necessary
Offer evidence and explain patiently

● Polite
● Professional
● Positive / Receptive
● Sincere
● Commitment
● Formal but not overly serious
AUDITEE’S CONDUCT
28

● 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
INTERACTING WITH AUDITORS – DO’S
● Turn mobile phones to silent mode
● Get the right person in to answer
the question
● Listen carefully and understand
each question before answering –
Be sure responses are complete
and accurate
29

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
ABOUT OPERATIONAL EXCELLENCE CONSULTING

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