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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.

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 performance throughout the duration of the course. This includes all exercises, role plays, case studies and all other activities during the course. Please note, 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

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.

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