ISO 13485:2016 Awareness Training
in ISO 13485 (Quality Management System)About this course
Course Overview
ISO 13485 – Medical Device – Quality Management Systems –Requirements for regulatory purpose – address the development, implementation and maintenance of quality management system intended for use by medical device manufacturers, developers, and suppliers. The standard details the requirement for quality management systems, to meet customer requirement and allows the incorporation of applicable regulatory requirements within an organization’s quality management system
Covered Topics
§ Basic Introduction to ISO 13485: 2016
§ Relation ISO 9001:2015 / ISO 13485:2016
§ Key issues addressed by ISO 13485:2016
§ Integration of Risk Management ISO 14971 in ISO 13485
Who Should Attend This Course?
§ Medical Device Manufacturers.
§ Quality Professionals
§ Regulatory Professionals
§ Internal and external Auditors
§ Consultants and anyone involved with the implementation of the standard
Study Material
§ Lecture sessions are illustrated with examples based on case studies
§ Practical exercises are based on a case study which includes role playing and discussions
§ Practice tests are similar to the Certification Exam
End Of Course Instruction
After completing the session and passing each session examination, the students can take the final exam. Once the final exam is passed, then it is considered as an end of course.
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