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ISO 13485: 2016 / ISO 9001: 2015
Seta Accredited Programme/ Unit StandardThe industry requires personnel with an understanding of Quality Management Systems (QMS) who can lead their teams to producing quality products or services timeously.
At IBRATSA we meet the industry needs through Skills training by offering:
Our training courses are delivered in 3 ways that offer flexibility to our customers as follows:
These are audio and graphic recorded courses that are accessible on our website.
These courses are delivered by the Trainer via our online live classroom platforms.
These are face to face courses that are delivered from the IBRATSA training facility.
The course is presented by Dr Felistas Mashinya (PhD), a Medical Microbiologist who is trained in Systems thinking. Dr Mashinya received formal training in Project Management as well as a Post Graduate Diploma in Higher Education & Training. She is a BSI Trained Lead Implementor and Auditor for ISO 9001:2015 and Lead Auditor for ISO 13485:2016 Medical Devices Quality Management Systems. She is also trained in the South African Medical Device Legislation and the European Medical Device Regulations.
Dr Mashinya has published 33 peer-reviewed articles in Local and International Journals. She has also presented papers at local and international conferences as well as being a reviewer for local and international journals. Her research output can be found at:
https://scholar.google.com/citations?user=b5O9zPAAAAAJ&hl=en
Dr Mashinya serves as an evaluator and a member of the SAHPRA Medical Device and Biological Medicines Advisory Committees.
She is the founder of IBRATSA (Pty) Ltd, a SANAS Accredited Conformity Assessment Body (CAB) for ISO/IEC 17021-1:2015 for Medical Devices Quality Management Systems Certification.
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