ISO QMS Certification Services
Idependent & Impartial
Dr Felistas Mashinya (PhD)
Managing Director
Dr. Felistas Mashinya is the Managing Director and founder of IBRATSA. A Medical Microbiologist with extensive expertise in QMS and project management, Dr. Mashinya is registered on SAATCA as a Provisional Auditor for Quality Management Systems (ISO 13485 and ISO 9001). Her leadership has been pivotal in securing SANAS accreditation and establishing IBRATSA’s reputation for excellence.
Leading ISO QMS Certification Body
Committed to Excellence in Quality Management
IBRATSA (Institute of Bio-Research Auditing and Training in Southern Africa) is a SANAS accredited certification body (Accreditation No: C109) and a SAATCA registered training course provider. We specialize in ISO 13485 and ISO 9001 Quality Management Systems certification, offering independent and impartial auditing and certification services to manufacturers, distributors, and wholesalers in the medical devices industry.
Our mission is to empower organizations to meet regulatory and compliance requirements through our comprehensive certification and training services. We are recognized by SAHPRA as a conformity assessment body for medical devices, ensuring that our clients are aligned with the highest standards in quality management.
ISO Certification Experts
Our TeamAccredited Auditing & Certification Services
We provide expert ISO certification auditing services to ensure your organization meets the latest standards for ISO 13485 and ISO 9001. Our audits focus on compliance, effectiveness, and continual improvement of your QMS.
How can we help you?
Introduction to ISO Certification Services
IBRATSA provides certification against the international standard ISO 13485:2016 for Medical Devices and ISO 9001:2015 General Quality Management System. This certification is crucial for businesses aiming to demonstrate best practices and gain international recognition for their quality management systems.
Knowledge Sharing and Awareness Programs
IBRATSA is committed to raising awareness on Quality Management Systems through:
- Workshops and Awareness Sessions on ISO 13485:2016 and ISO 9001:2015 standards.
- General Information Sessions on Compliance and Best Practices.
Our sessions are designed to inform and empower organizations about quality standards, promoting a culture of compliance and continual improvement.
Research Services
IBRATSA has a specialized division dedicated to Bio Medical research services, providing expert support in the following areas:
- Statistical Analysis and Report Writing
- Editing and Proofreading of Scientific Reports and Postgraduate Theses
- Research Project Management
- Development of Training Material
