The Latvian Medicines Verification Organisation (LZVO) intends to start the ISO certification process for Quality management system (ISO 9001) and Information security management system (ISO 27001) certificates in the first half of 2025. The assessment of the medicines verification system and its supporting processes against international quality and security standards will contribute to the development, stability and reliability of the system.
The International Organization for Standardization (ISO) develops globally recognised standards to improve process safety and efficiency in a wide range of industries. The certification process will offer LZVO a structured approach to assessing process compliance, identifying and systematically implementing necessary improvements.
In the first half of 2025, LZVO will be seeking certification in two categories – quality management and information security management. Certification is a voluntary but important process that benefits all users of the medicines verification system.
ISO 9001: Quality management systems
LZVO plans to obtain the internationally recognised and sought-after ISO 9001 quality management system certification. This certification sets out the requirements for the establishment, maintenance and improvement of a quality management system for the organisation's services. Meeting the requirements of the certificate will include measures such as involving management in quality assurance, developing the organisation’s risk management system, and regular assessments for continuous improvement process. The ISO 9001 standard entails creating a structured yet flexible quality management system, ensuring that employees understand and are satisfied with the organization’s processes and that end users receive quality and relevant services.
ISO 9001 certification will improve LZVO's quality management processes by ensuring a systematic approach to resolving customer complaints, enabling LZVO to resolve uncertainties more quickly and meet customer needs with even greater accuracy. Processes will evolve with the changing requirements of international standards, but this continuous improvement will enhance the usability of the medicines verification system.
ISO 27001: Information security management systems
LZVO is also working towards ISO 27001 certification, the leading standard for information security management systems. The certification will help identify and manage information security risks to ensure the confidentiality, integrity and availability of data in line with the operational objectives of the verification system.
ISO 27001 certification will strengthen data protection in the LZVO. Identifying vulnerabilities in the verification system will help to manage potential risks more effectively and protect customers' sensitive data from cyber threats. Ensuring compliance with global best practices will improve the overall resilience and reliability of the system.
LZVO is choosing to obtain ISO certification because the safety of the medicines supply chain can only be guaranteed through continuous improvement process. Certification to the appropriate standards will help to improve processes and enhance the organisation's ability to meet the needs of all stakeholders, affirming the system’s value and importance.