Quality Management System

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Quality Management System

Quality

BoMRA is committed to implementing a Quality Management System (QMS) in order to coordinate and direct the organisation’s activities and adequately execute its regulatory mandate. In implementing QMS we expect to continually improve the efficiency and effectiveness of our processes and thereby meet and exceed our customer needs and stakeholder requirements.

Standard

We implement a Quality Management System in accordance with ISO 9001:2015 standard. We employ process approach, which incorporates the Plan-Do-Check-Act cycle and risk-based thinking essential for achieving an effective management system. BoMRA was granted certification against ISO 9001:2015 in April 2021 by British Standards Institute (BSI). Through this, we continually strive to improve and provide quality services that meet and exceed our customer needs and expectations.

Unit

To effectively implement QMS, our Quality Management Unit has thus been mandated to facilitate the implementation of a  management system throughout the organisation in order for BoMRA to attain World Health Organization Maturity Level 3 as well as certification and accreditation against various International Standards. This will assist BoMRA in achieving its Vision of being “The trusted Authority for excellence in medical products and cosmetics regulation”

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Botswana Medicines Regulatory Authority regulates medicines, medical devices and cosmetics to promote human and animal health.