Quality Management System

TMDA demonstrates its ability to consistently provide quality services that meet customer and regulatory requirements through implementation of Quality Management System principles stipulated in the ISO 9001:2015 Quality management systems - Requirements. Our Quality Management System have been certified to ISO 9001: 2008 in the year 2009 and later recertified to ISO 9001:2015 in the year 2017.

Our Quality Control Laboratory complies with the WHO Good Practices for Pharmaceutical Quality Control Laboratories. It is among the fifty-five (55) quality control laboratories having international recognition as competent laboratory for testing pharmaceutical products after being WHO prequalified in the year 2011.

TMDA’s Quality Management Systems are subjected to regular assessment, audits and management reviews for continuous improvement. Details of TMDA’s Quality Management System are well documented in the Quality Manual which among other things states the Quality Policy Statement, Mission Statement, Vision Statement and Quality Objectives.

To ensure sustainable provision of services TMDA implements risk management in accordance with National and International Guidelines to mitigate risks that may affect achievement of objectives set out in the Strategic Plan. The Authority has developed Risk Management Framework and Business Continuity Plan (BCP) as guiding tools to address risks and respond to disasters that may impede performance and TMDA’s ability to deliver essential business services.

By being certified to ISO 9001:2015 and implementing risk management framework, TMDA has experienced notable achievements. To mention the few they include:-

  • Enhanced customer satisfaction.
  • Increased efficiency, productivity and profit.
  • Improved internal management and decision making.
  • Improved credibility and image.
  • Global recognition as the first African Country to achieve WHO - Maturity Level 3 for its competence in regulation of medicines.
  • Established continual improvement culture.

Quality Statement Policy

Risk Management Policy Statement

Fraud Risks Policy Statement