The successful certification of Prime Pharma under the internationally recognized ISO 9001:2015 Quality Management Systems Standard represents a major milestone in strengthening pharmaceutical quality governance and operational accountability in Somalia’s healthcare supply chain.
The certification was the result of a structured institutional process that combined leadership commitment, quality system development, internal auditing, and independent external verification. The initiative was implemented with the technical support of Lexico Inc., working closely with Prime Pharma’s management and operational teams to establish a fully functional Quality Management System (QMS) aligned with international standards.
More than simply achieving certification, the project focused on building a sustainable management system capable of supporting long-term operational excellence, regulatory compliance, and continuous improvement.
Leadership Commitment at Prime Pharma
A critical factor behind the success of the ISO certification journey was the strong leadership of Warsame Mohamud Ibar, who championed the transformation of Prime Pharma’s operational systems.
From the outset, Mr. Warsame emphasized that ISO certification should not be approached as a procedural exercise but rather as a strategic institutional reform designed to strengthen operational governance, improve accountability, and ensure the consistent delivery of high-quality pharmaceutical services.
Under his leadership, Prime Pharma committed to restructuring its operational processes, documenting procedures across departments, strengthening warehouse quality controls, and introducing monitoring systems that support transparency and performance management.
His leadership ensured that the Quality Management System was integrated across the organization, from management decision-making to day-to-day operational procedures.
Facilitating the Development of the Quality Management System
Dr. Farhio Abdi Hassan played an essential role in the implementation process, serving as the primary internal coordinator for quality management within the organization.
Dr. Farhio’s role focused on enabling and facilitating the work of the Lexico implementation team, ensuring that the Quality Management System architecture could be effectively developed and operationalized within Prime Pharma’s operational environment.
Working closely with the consulting specialists from Lexico Inc., she coordinated internal engagement across departments, supported the contextualization of operational procedures, and ensured that staff members understood and adopted the newly developed quality frameworks.
Her contributions included:
Facilitating coordination between Prime Pharma’s departments and the Lexico consulting team
Supporting the development and alignment of Standard Operating Procedures (SOPs)
Assisting with documentation management and quality records
Supporting staff orientation on new quality processes
Coordinating internal preparations for audit and compliance verification
Through this collaborative facilitation role, the Quality Management System was embedded directly into Prime Pharma’s operational structure, ensuring that the system reflects the practical realities of pharmaceutical distribution and management
Quality Management System Development and Internal Audit
The technical design and implementation of the Quality Management System were carried out by a multidisciplinary team from Lexico Inc., working closely with Prime Pharma’s leadership and quality assurance team.
The Lexico implementation team included:
Abasi Ssonko
Abdinor Kamal Mohamed
Amran Ahmed Mohamed
Suzan Abdi Shirwa
Beyond system development and documentation, the Lexico team also conducted a comprehensive internal audit and system readiness assessment prior to the external certification audit.
This internal audit process included:
Staff interviews and management consultations to assess organizational understanding of the Quality Management System
Verification of warehouse and pharmaceutical distribution quality control procedures
Examination of internal monitoring systems and corrective action mechanisms, including CAPA workflows
Review of documentation control systems and operational records
Evaluation of departmental compliance with the established management system
The internal audit played a crucial role in identifying potential gaps and ensuring that Prime Pharma’s operational systems were fully aligned with the requirements of the ISO 9001 standard before undergoing external certification.
External Certification Audit
Following the successful completion of the internal audit phase, the formal certification audit was conducted by Manish Kumar on behalf of B2C Certification Body and QRO Certification.
The external audit involved an independent evaluation of Prime Pharma’s operational systems, documentation, quality controls, and management processes. Through interviews, system verification, and operational observation, the audit confirmed that the organization had successfully implemented a management system that complies with the requirements of ISO 9001:2015.
As a result of this assessment, Prime Pharma was formally awarded ISO certification, confirming that its operational framework meets internationally recognized quality management standards.
Establishing a Sustainable Quality System
A central objective of the project was not simply achieving certification, but ensuring the long-term sustainability of the Quality Management System.
Prime Pharma’s QMS now includes several institutional mechanisms designed to support continuous improvement, including:
Internal audit programs
CAPA (Corrective and Preventive Action) workflows
Warehouse Quality Assurance control procedures
Staff competency and training programs
KPI monitoring and performance evaluation systems
Structured documentation and record management systems
These systems operate within the Plan–Do–Check–Act (PDCA) continuous improvement cycle embedded in ISO standards, ensuring that quality management remains an ongoing operational practice.
Advancing Pharmaceutical Quality Standards
The ISO certification of Prime Pharma demonstrates that Somali pharmaceutical organizations can successfully adopt and implement internationally recognized management systems. The achievement strengthens trust among healthcare providers, regulatory institutions, and patients who rely on safe and reliable pharmaceutical supply chains.
Through strong leadership from CEO Warsame Mohamud Ibar, the facilitative role of QA Lead Farhio Abdi Hassan, and the technical implementation support provided by Lexico Inc., Prime Pharma has established a robust foundation for quality-driven operations.
Continuing the Quality Journey
ISO certification represents a major milestone—but it also marks the beginning of an ongoing process of quality improvement.
Prime Pharma will continue strengthening its management system through periodic internal audits, operational monitoring, staff development, and continuous system enhancement in collaboration with Lexico Inc..
By embedding quality management into its institutional culture, Prime Pharma is well positioned to continue advancing pharmaceutical standards and operational excellence in Somalia’s healthcare sector.
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