ISO 13485 Medical Devices QMS Awareness Training Conducted by Industry Experts,customized for you & connect with relevance to your Industry & Processes.

1. “If you do not know the subject well enough
You can not explain it simply enough”
Albert Einstein

2. With decades of hands on Industry Experience, and hundreds of
ISO audits, our Principal Trainers help you translate:-

3. In fact, we do not teach you, but involve you and engage you one
Hundred percent. To ideate, to discuss, to brainstorm.
Are you Ready to get involved?

4. www.isocertificationtrainingcourse.org
registrar@isocertificationtrainingcourse.org
ISO 13485 Awareness Training
ISO 13485 Awareness Training Course Features
ISO 13485 Awareness Training gives delegates a broad understanding of the quality
management system requirements outlined in the medical devices standard ISO 13485
requirements. ISO 13485 Awareness Training includes exercises to provide delegates
with the opportunity to practice the information taught in the course. Our instructors
also encourage discussion and debate as part of the learning process.
What you will learn in ISO 13485 Awareness Training
Overview of the ISO 13485 standard and the implications to your company.
The responsibility of senior management.
Why the process approach makes sense.
Setting objectives and defining responsibilities.
Benefits of adopting the standard and regulatory requirements.
Who needs to be involved within the company.
Creating the quality policy manual.
Role of design and development, purchasing, production, record keeping, customer
communications.

5. Continuous improvement, how and why.
Process validation, monitoring and traceability, control of measurement devices and
data analysis.
Who Should Attend ISO 13485 Awareness Training
Quality managers
RA managers
Auditors of medical device manufacturing firms (internal and external)
Those individuals working in an ISO 13485 compliant environment or in the Medical
Devices Industry
Cross functional team members implementing the standard
ISO 13485 Awareness Training Course Assessment
During ISO 13485 Awareness Training the delegate is assessed based on participation
and performancethroughoutthedurationofthe course. Thisincludes all exercises, role
plays, case studiesand all other activitiesduring thecourse. Pleasenote, full attendance
is required during the training course.
ISO 13485 Awareness Training Benefits
Benefits of ISO 13485 Awareness Training includes the knowledge and skills to
effectively understand your management system and legislation applicable.
ISO 13485 Awareness Training Achievement
Upon SUCCESSFUL completion of the course a Certificate of “ISO 13485 Certified
Awareness Training” will be issued.
CPD-8
CEU-0.8
ISO 13485 Awareness Training Duration- 01 day
ISO 13485 Awareness Training Calendar [ Click here ]
Value added ISO 13485 Awareness Training
Accelerate learning with the expert faculty Lead Auditors and Principal Trainers from
the Industry. ISO 13485 Awareness Training from the "Specialist Expert" has many
advantages:-
It will drastically change the way of thinking and basic approach towards the
Management System Standards.
You would cherish & Benchmark our training for a very long time to come.

6. No fictitious case studies you can not connect with.
Real time examples, real time scenarios you can quickly relate to.
Complete Focus on your systems, processes and line of businesses.
100% involvement and engagement of the participants
Learn to make the ISO Standard sweat to:-
A). Improve the profits.
B). Reduce rework, defects, customer rejections, wastage,& cost of operation
C). Enhance customer delight
D). Reduce attrition of customers and employees
E). Enhance confidence of all stakeholders
ISO 13485 Awareness Training