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Medical devices training
IRCA Certified Course (A17579)
Medical Devices – Quality Management Systems Auditor/Lead Auditor Course
(ISO 13485 & EN ISO 13485)
7- 11 October 2013 @ Rama Garden Hotel Bangkok
IRCA Certified Course (A17579) Medical Devices – Quality Management
Systems Auditor/Lead Auditor Course (ISO 13485 & EN ISO 13485)

Course Description BSI’s “Medical Devices – Quality Management Systems Auditor/Lead

Auditor (ISO 13485)” course teaches the principles and practices of
effective quality management systems and process audits in accordance
with ISO 13485 and ISO 19011, “Guidelines for auditing management
systems” Experienced instructors guide students through the entire
audit process, from managing an audit programme to reporting on audit
results. Participants will gain necessary auditing skills through a
balance of formal classroom tutorials, practical role-playing, group
workshops, and open forum discussions.

Learning Upon completion of this training, participants will be able to:

Objectives • Interpret the requirements of ISO 13485 in the context of an audit
• Explain the relationship with ISO/TR 14969 and the ISO 9000 series
• Describe the purpose of a quality management system and explain
the 8 principles of quality management
• Explain the role of an auditor to plan, conduct, report and follow up
a quality management system audit in accordance with ISO 19011
• Plan, conduct, report and follow-up on a QMS audit in accordance
with
ISO 19011 and by interpreting ISO 13485
• Manage the duties of a lead auditor in their organization or for a
third-party

Intended Audience • Medical Device quality professionals interested in conducting first-

party, second-party, and/or third-party audits
• Management Representatives
• Quality Directors
• Managers
• Engineers
• Consultants

Course Duration 5 Days

There is a written exam on Day 5.

Prerequisites This course teaches auditing principles using ISO 13485, therefore a
basic knowledge of ISO 13485 and its application within a Medical
Device organization is strongly recommended, together with internal
audit experience.

IRCA Certified Course (A17579)

This course is certified by the International Register of Certificated Auditors (IRCA) and meets the
training requirements for IRCA QMS 2008 auditor certification.

MED04101ENGX v2.0(AD01) Apr 2013 ©The British Standards Institution 2012 1 of 5

Course Details

Day 1
Time Topic

9:00 Welcome and introductions

Overview of course structure and learning objectives
Fundamentals of quality management, ISO 13485 and the relationship
to ISO 9000 series of standards
Use of 13485 in relation to compliance with worldwide regulatory
requirements
Principles and concepts of a risk based approach to quality, quality
management, and quality management systems
The elements of the PDCA cycle and process approach
Apply the PDCA cycle to a simple process
The relationship with ISO/TR 14969
Terminology included in ISO 13485
Structure of ISO 13485 within the process model for management
systems
ISO 13485 – Clause 4 requirements
ISO 13485 – Clause 5 requirements
ISO 13485 – Clause 6 requirements
ISO 13485 – Clause 7 requirements
ISO 13485 – Clause 8 requirements
Organizational benefits of a quality management system
Benefits of 13485 certification in relation to placing medical devices on
6:30 the market worldwide

Two short breaks will be taken at suitably convenient times in the morning and afternoon.
An hour will be given for a lunch break. Additional breaks may be taken as long as agreed by
delegates and tutor, and all learning objectives are met.

MED04101ENGX v2.0(AD01) Apr 2013 ©The British Standards Institution 2012 2 of 5

Day 2
Time Topic
9:00 Review of Day 1
Typical audit activities and Introduction to ISO 19011
Definition of audit terms
Different types of audits
Overview of Process Auditing and ISO 19011
Planning the Audit Programme
Managing an Audit Programme
Audit Activities
Initiating a QMS audit
Attributes, competence, roles, and responsibilities required of QMS
auditors
Documentation Review (Stage 1 audit)
Audit Planning
Prepare work documents
On-site (Stage 2) activities
Close
6:30 Review of Day 2

Two short breaks will be taken at suitably convenient times in the morning and afternoon.
An hour will be given for a lunch break. Additional breaks may be taken as long as agreed by
delegates and tutor, and all learning objectives are met.

MED04101ENGX v2.0(AD01) Apr 2013 ©The British Standards Institution 2012 3 of 5

Day 3
Time Topic

9:00 Review of Day 2

Conduct an opening meeting
Collect and verify audit information
Audit questioning techniques, gathering and verifying information,
taking notes and handling difficult situations
Audit findings and nonconformities
Interview and audit techniques
6:30
Close

Two short breaks will be taken at suitably convenient times in the morning and afternoon.
An hour will be given for a lunch break. Additional breaks may be taken as long as agreed by
delegates and tutor, and all learning objectives are met.

Day 4
Time Topic

9:00 Review of Day 3

Generate audit findings
Prepare audit conclusions
Write an audit report
Conduct a closing meeting
Conduct audit follow up
Sample Exam
6:30
Evaluation and close

Two short breaks will be taken at suitably convenient times in the morning and afternoon.
An hour will be given for a lunch break. Additional breaks may be taken as long as agreed by
delegates and tutor, and all learning objectives are met.

MED04101ENGX v2.0(AD01) Apr 2013 ©The British Standards Institution 2012 4 of 5

Day 5
Time Topic
9:00 Final questions
Introduction to the exam
Exam
12:00 End of course

MED04101ENGX v2.0(AD01) Apr 2013 ©The British Standards Institution 2012 5 of 5

 A leading training academy.

Annually we train in excess of 4000 people. More than 70% of the top
100 medical device companies were trained by us and our technical
trainers have a combined industry and regulatory experience of over
546 years.

l World-leading industry subject matter experts, over 200 BSI l On-line, public or in-house course – its your choice.
Medical Device product and regulation experts. We schedule public courses for you to book onto or if you
prefer to have a group of employees attend a course
together, choose in-house. Courses can be customised
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to your requirements.
ensuring the latest developments are fully understood.

l State of the art courses, representing up-to-date thinking on l Cost efficient – A BSI training course can provide you with the
the current and possible future interpretations of the directives, knowledge to save significant time and money in bringing your
standards and guidance. product to market.

l Accelerated learning philosophy – you don’t just sit and listen, l Make excellence a habit – BSI training will prepare you to take
you experience the subject. You participate in the excellence habit back to your business.
hands-on exercises, case studies, group work, mock real
life situations and learning aids including photos, charts,
games and quizzes.

medicaldevices.bsigroup.com/training

2 BSI Medical Devices Training

 Medical device training courses.

CE marking ISO 13485

Introduction to CE marking Introduction to ISO 13485 Medical Devices
Attend Introduction to CE marking course and start making informed BSI’s Introduction to: ISO 13485 course has been designed to provide
decisions with regards to meeting the requirements of the EU Medical an insight in to the use of ISO 13485 as the basis for a Quality
Devices Directives. On completion , you will be able to identify the Management System implemented by medical device manufacturers.
steps required to reduce the risks and uncertainty in the EU regulatory Time will be spent during the course reviewing requirements of
process and thus bring products to the EU market more quickly. ISO 13485 and making comparisons to ISO 9001 and the FDA’s
Course duration: 1 day Quality System Regulation. In addition to this, participants will also
gain an awareness of the relationship between ISO 13485 and
ISO 14971, Application of Risk Management to Medical Devices.
Medical Devices CE marking
Course duration: 1 day
The medical devices CE marking course is designed to provide
participants with the knowledge to assist their companies in
getting products to market quickly. You will gain knowledge of the Implementing ISO 13485 Medical Devices
requirements of the Medical Device Directive and the CE marking BSI’s Implementing ISO 13485 course has been designed to provide
approach. Participants will be able to provide leadership for their you with the knowledge and process steps to enable them to
organizations when placing medical devices on the market in the effectively implement a Quality Management System in line with the
European Union. requirements for ISO 13485 certification. The course introduces the
Course duration: 3 days concepts needed to understand, develop, and implement a quality
management system.
Introduction to CE marking for the In Vitro Course duration: 2 days
Diagnostics Directive
This BSI course has been designed to introduce the In Vitro Internal Auditor ISO 13485 Medical Devices
Diagnostics Directive (IVDD), the types of product covered by the BSI’s Internal Auditor ISO 13485 course is intended for medical device
Directive and the regulatory framework required for placing IVD quality professionals aiming to build on their current knowledge of
products on the European market. Participants will gain knowledge ISO 13485 and evaluate the effectiveness of the quality management
about the directive and the development of IVD products as well system in their organization. This intensive course teaches the
as their on-going maintenance to achieve continued regulatory principles and practices of effective quality management systems
compliance throughout the lifecycle of the product. process audits in accordance with the ISO 13485 and ISO 19011. An
Course duration: 1 day experienced instructor guides students through the internal audit
process, from planning an audit to reporting on audit results and
Application of the In Vitro Diagnostics Directive following up on corrective actions.
Participants will gain necessary auditing skills through a balance
Application of the In Vitro Diagnostics Directive course has been
of formal classroom tutorials, practical role-playing, and group
designed to enable you to explore the IVD Directive, gain a greater
workshops.
understanding of the requirements and thus enable your IVD devices
to be placed on the European market efficiently. Course duration: 2 days

You will be able to apply the requirements

of the directive to create technical Lead Auditor ISO 13485 Medical Devices
documentation to support BSI’s Lead Auditor ISO 13485 course teaches the principles and
the product throughout “This
course was practices of effective quality management systems and process audits
its lifecycle.
excellent. The tutor in accordance with ISO 13485 and ISO 19011, “Guidelines for Quality
Course duration: 3 day and/or Environmental Management Systems Auditing.” Experienced
delivered the course at instructors guide students through the entire audit process, from
a good pace pitched at managing an audit programme to reporting on audit results.
Participants will gain necessary auditing skills through a balance of
an appropriate level”
formal classroom tutorials, practical role-playing, group workshops,
Michael Dibbens, and open forum discussions.
St Thomas’ Hospital Course duration: 5 days

4 BSI Medical Devices Training Book online at medical.devices.bsigroup.com/training or call +44 (0)845 086 9000
Specialist courses Process Validation for the Medical Device Industry
BSI’s Process Validation for the Medical Device Industry course has
Medical Devices Risk Management ISO 14971 been designed to help manufacturers gain awareness of quality
requirements regarding validation and the nature of “special
This course is designed to provide participants with an understanding processes”. Learn the generally accepted principles of validation, and
of the impact that ISO 14971 has on the decision making process at introduce how-to-do methods of installation, operational, and process
medical device manufacturing firms. This course helps medical device qualification.
professionals gain an understanding of how ISO 14971 can improve
Course duration: 1 day
their business and risk management efforts. Participants will also
understand how ISO 14971 applies to ISO 13485.
The training includes exercises, and participants will have the chance Device-Drug Combinations: Practical Guidance on
to ask questions about how ISO 14971 and risk management apply to Borderline Issues and the Consultation Process
their organizations. This specialized course has been designed to provide manufacturers
Course duration: 1 day with the knowledge and skills to interpret the requirements of the
drug consultation process for devices containing ancillary medicinal
Writing Technical Files for Compliant Devices substances. The course will provide guidance on how to reduce risks
and uncertainty in the EU regulatory process.
BSI’s Writing Technical Files for Compliant Devices course is
The course focuses on determination of the applicable European
designed to support manufactures by confirming current regulatory
legislation for borderline products, and provides insight into further
requirements of technical documentation. The aim of the course is to
information and guidance related to the distinction between medical
speed up the certification process and enable manufacturers to sell
devices and medicinal products. and examines devices incorporating
compliant devices within the European Union.
derivatives of human blood or plasma.
On completion of the training you will be able to identify and locate all
Course duration: 1 day
regulatory requirements and guidance documentation necessary to
write procedures enabling the creation and maintenance of compliant
technical files and design dossiers. CE marking Medical Devices with Software
Course duration: 1 day When it comes to creating, testing, and maintaining software, there
are often grey areas. However, when your software applies to a
Clinical Evaluation for Medical Devices medical device, the steps you take to define, classify, develop, and test
BSI’s Clinical Evaluation for Medical Devices course is designed to your software become critical to both your business and patient
support manufacturers by confirming the information necessary to health. Achieving and maintaining a CE mark for your medical
demonstrate clinical safety and performance of their product in software is essential to keeping your product marketable.
accordance with the requirements of the European Medical Devices For those organizations that are unsure how the medical device
Directive. directives apply to their software, how their software is classified, and
On completion of training, manufacturers will be able to determine if how to develop and maintain it with a CE mark in mind, this course
a clinical trial is required, prepare a clinical evaluation report including will help you evaluate your software and processes so you can know
literature review and determine requirements for post-market clinical what to do during the life-cycle of your software to meet the Medical
follow-up and post-market surveillance to support continuing Device Directives and get on track.
compliance. Course duration: 1 day
Course duration: 1 day
Medical Devices Utilizing Materials of Animal Origin:
Post-Market Surveillance and Vigilance Practical Guidance on the Legislative Approval
Post-market surveillance including clinical follow-up, complaint and Process
vigilance handling, impacts on all aspects of the Quality Management This one day course has been designed to provide manufacturers with
System. Proactive and reactive sources of information are a regulatory the knowledge and skills to interpret the regulatory requirements
requirement to be incorporated in your post-market surveillance relating to materials of animal origin, including those for which a TSE
procedures applicable to all products. Obtaining the right postmarket risk is expected.
information will ensure continued compliance with the directives and
This course will provide guidance on how to reduce risks and
identify consumer needs enabling continued product development.
uncertainty in the EU regulatory process; gain an appreciation of
BSI’s Post-Market Surveillance and Vigilance course is designed to typical hazards associated with animal tissues & derivatives;
help you identify the requirements of the European Medical Device justifications needed to use these materials and awareness of
Directives , standards and guidance documents to enable effective common mistakes to avoid in sourcing, collection and handling to
implementation of a post market surveillance system. ensure delays are minimized.
Course duration: 1 day Course duration: 1 day

Book online at medical.devices.bsigroup.com/training or call +44 (0)845 086 9000 BSI Medical Devices Training 5
 Fast and experienced routes into global
markets.
Be prepared Worldwide access
In the competitive medical device market place, ensuring that Our partnership approach offers a wide range of proven regulatory
product development meets all regulatory requirements is essential. and quality management programmes that work together for full
Understanding and consideration of the complicated clinical and international compliance. Our QMS solutions include: ISO 13485,
regulatory requirements early in the product lifecycle could ensure ISO 9001, ISO 14001 and many more.
your company gains the competitive advantage. Consolidated BSI partner with international regulators to help you get your
clinical and regulatory planning will assist your company to products approved in the USA, Canada, Japan, Australia, Hong Kong,
maximise resources and minimise time to market. Russia and Taiwan.

CE marking: speed-to-market Seamless transfer to BSI

Clients work with us because we understand the challenges medical If you decide to transfer your certification to BSI, we can offer a
device manufacturers face in getting compliant products to market seamless exercise with comprehensive support and the absolute
quickly. minimum level of disruption. With expertise encompassing the full
range of industry sectors and management system standards.
CE-90 Standard: Our standard service, is completed within 90 days
from submission, giving you predictability for accurate planning.
CE- FastTrack: Our FastTrack programmes deliver the speed-
to-market you need to be competitive and move ahead of the Certification support
competition. The aim is review completion in 45 days from
submission with a choice of options: Throughout the certification process and beyond we can continually
help you by providing:
l CE-45 Standard: 45 day service
l Expert training courses:
l CE-Onsite: The review service is conducted at your premises, – In-house for your company
allowing for a faster time-line and dynamic communication. – Public courses, see website for the latest schedule
l CE-Dedicated: Your review will be conducted remotely, your – On-line, we have an increasing number of short courses
Product Expert will be able to arrange flexible schedules running via distance learning
with you. l Regulatory Updates, helping you plan for the future
l Free webinars
l Access to relevant standards.

6 BSI Medical Devices Training

Start your journey to business excellence,
book your course now.
Visit medicaldevices.bsigroup.com/training
or call +44 (0)845 086 9000

T: +44 (0)845 080 9000

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BSI Medical Devices Training 7

Global expertise

Certification services Training courses

ISO 13485 QMS Auditing • CE marking for AIMD, MDD and IVD
CE marking • ISO 13485 QMS
Health Canada CMDCAS
• Medical Devices Risk Management ISO 14971
Japan PAL
FDA 510k Third-Party Review Programme
• CE marking Medical Devices with Software

FDA Accredited Persons Inspections • Compiling and Maintaining Technical Files and
Design Dossiers
Australia EU CAB
Hong Kong CAB • Clinical Evaluation for Medical Devices

Russian Registration Certification • Device - Drug Combinations: Practical Guidance on

Taiwan TCP Borderline Issues and the Consultation Process
• Process Validation for the Medical Device industry
• Post Market Surveillance and Vigilance
• Medical Devices Utilising Material of Animal Origin.

Your partner in worldwide compliance: Call BSI today on +44 (0)845 086 9000
or visit medicaldevices.bsigroup.com – to start your partnership

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