Lead Auditor Training Course

ISO 13485:2016 – Medical Device- Quality

Management System

This course provides delegates with fundamental knowledge of assessment skills that will add value to
organiza ons. This course complies with PR 369 criteria. Successful comple on of the course fulfils the
formal training requirement for individuals seeking Third Party Assessments.

By the end of this course, you are expected to be able to get the:

Knowledge
Explain the purpose of a medical device quality management
system (MD-QMS), interac on with appropriate medical device
regulatory authority requirements, quality management systems
standards, third- party cer fica on, and the business benefits of the
quality management system.
Explain the role and responsibili es of an auditor to plan,
conduct, report, and follow- up a quality management system audit in
accordance with ISO 19011 and ISO/IEC 17021.

Skills
Plan, conduct, report, and follow-up an audit of a medical device
quality management system to establish conformity (or otherwise) with
ISO 13485 and applicable medical device regulatory requirement
documents in accordance with ISO 19011, ISO/IEC 17021.

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 Who is or Aspires to be:
• A Third-Party Assessor or Lead Assessor of ISO
13485:2016
• Responsible for undertaking audits of
suppliers/subcontractors as per ISO 13485:2016
• Responsible for implemen ng internal audits and audit
programs as per ISO 13485:2016
• Responsible for implemen ng the ISO 13485 series of
standards

Course Outline:
Course starts at 07:00 PM and ends approximately at
11:00 PM. Maximum a endance 10 delegates per tutor.

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 Timings for the course:

Day 1 to Day 9 07: 00 PM - 11:00 PM UAE Time

Including Breaks.

Pre-course informa on is sent to delegates approximately a week prior to the beginning of the course
(subject to the fee paid). Pre-Ques onnaire to be successfully passed by 70% prior to the training
course in order to a end the training.

The course is highly par cipa ve and will enable delegates to build on exis ng skills. Emphasis is based
on prac cal applica on of assessment knowledge and skills. Realis c case studies allow delegates to
apply skills and knowledge to all stages of the assessment process.

Eligibility Criteria:-

Some specific Medical Device knowledge and Min. 4 years working experience is required. This is an
intensive course.

Before star ng this course, students are expected to have the following prior knowledge:

Management Systems:

Knowledge of the requirements of ISO 13485, which may be gained bycomple ng a CQI and
IRCA Cer fied
MD-QMS ISO 13485:2016, Founda on (FD132) course or equivalent.

Medical Device Management Systems Audit:

Knowledge of the following quality management principles and concepts:
• The Plan, Do, Check, Act (PDCA) cycle.

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 • The rela onship between ISO 13485 and applicable
interna onal regulatory requirements for medical devices.
• Commonly used quality mana gement terms and defini ons
within ISO 13485 and ISO 9000.

•The process approach used in MD-QMS .

• A working knowledge of medical device regulatory process
applicable to countries the course is designed to cover, including
device regula ons, regulatory audi ng standards and their
rela onship with ISO 13485.
This knowledge may be gained by successfully comple ng a CQI
and IRCA course rela ng to individual regulatory authority
standards, which will be available subject to demand (e.g., MD-
QMS Comprehensive EU Medical Device Regula on 2017/745
(EU MDR) Prac oner – PT219)
• A working knowledge of risk-management principles related
to the design of a medical device, for example ISO 14971

Course Facilitator:

All course facilitators are highly qualified and experienced

both in training and assessment of Medical Device Quality
Management System. We strongly believe that the experience
in Medical Device Quality Management System Assessment
and Training skills is a right combina on to deliver a prac cal
training course. They are selected on their ability to make BSCIC
courses both prac cal and enjoyable.

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