This two-day course provides an in-depth understanding of ISO 13485:2016. It’s designed specifically for those who are looking to further their knowledge of the management system.
DurationThis two-day course provides an in-depth understanding of ISO 13485:2016. It’s designed specifically for those who are looking to further their knowledge of the management system.
Training will be delivered either live and online or in-person in a classroom setting. You will learn how to explain the scope and structure of ISO 13485:2016 and interpret what’s required for your own organization.
You will finish this stage of your learning journey with deeper knowledge and confidence and have a clear pathway for putting ISO 13485:2016 certification into place for any organization.
How will you benefit?
Full understanding of ISO 13485:2016 requirements
Able to explain and interpret requirements, relevant to your organization
Learn how a quality management system provides a framework for safer medical devices
Comprehensive training notes and 14 CPD points on completion
What will you learn?
Explain the scope and the structure of ISO 13485:2016
Describe the requirements of ISO 13485:2016
Explain how to interpret the requirements of the standard within your organization
Develop your knowledge of how the requirements of ISO 13485:2016 are established and maintained in an organization
Identify the systems that are required to implement an ISO 13485:2016 QMS in order to gain or maintain certification to ISO 13485:2016
Who should attend?
Regulatory, quality, research, design, development, and manufacturing personnel who will be involved in working with ISO 13485:2016 and need to have a greater understanding of the management system
Organizations preparing to put ISO 13485:2016 in place
Personnel who have joined an organization who have ISO 13485:2016 and require in depth knowledge
Delegates attending the Lead Auditor to ISO 13485:2016 course who do not already have a good knowledge of the standard
Why choose BSI?
We are:
A full scope Notified Body
A full scope UK Approved Body
A national Standards Body
An accredited ISO 13485 Certification Body
A recognized Auditing Organization under the Medical Device Single Audit Program
A globally recognized Certification Body
What's included?
You will gain:
14 CPD points on completing the course
Training course notes
BSI is your business improvement partner. We have shaped best practice for over 100 years, helping organizations around the world embed excellence, build competence and capability for sustainable growth.
The ISO 13485 standard is developed to meet the vast requirements for a Quality management system. It provides a foundation for manufacturers to address the requirements pertaining to the EU Directives, regulations, responsibilities as well as the commitment to the safety and quality of related to ...
ISO 13485 quality management systems for medical devices and IVDs provide the framework to consistently produce safe and effective medical devices. The latest version has additions such as regulatory harmonisation and a greater emphasis on risk management. In addition, many countries have committed
The standard is based on the ISO 9001 standards but places a more significant focus on regulatory compliance, requiring risk management to be in place for all stages of product realisation, training and supervision of staff, project site specs, and prevention of contamination.
This 1-day practical course provides a basic background to the structure and requirements of ISO 13485 and how it relates to frameworks such as the Medical Device Regulations (MDR). Students benefit from interactive sessions where they can develop the knowledge they gain.
The aim of this course is to provide delegates with the knowledge and skills required to perform an audit of part of a quality management system based on ISO 13485 and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.
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