Quality of products and services and continuous improvement of key processes are important elements of Krka’s strategy. Krka has developed a systematic approach aiming to exceed customer requirements and achieve business objectives.

Integrated management system (IMS)

Since its beginning, Krka's strategy has been to manufacture high-quality, safe and effective medicines. Krka uses innovative approaches to manufacturing and follows good practices improved and perfected through development of the industry. In 1974, Krka was audited by FDA (Food and Drug Administration) for the first time and passed successfully. Krka has kept upgrading its good manufacturing practice (GMP) and other good practices (GXP) to improve further its quality management system, which has eventually evolved into the integrated management system (IMS). ISO 9001, Responsible Care (RC), ISO 14001, HACCP, ISO 45001, ISO/IEC 27001, ISO 22301 and Regulation (EU) 2017/745 (Medical Device Regulation, MDR) have been gradually included in the system. Excellent performance of IMS has been made possible by the continuously improving centralised system of document management introduced by Krka in 1993. Credibility of each system and IMS as a whole is confirmed by certificates issued by an external independent institution. Thanks to this approach Krka has been gaining the partners’ extended trust.

Our commitment to standards, guidelines and the PDCA (Plan-Do-Check-Act) approach result in constant improvements. They are the driving force of progress and permanent improvements in all areas of the Company's operations. The process management system covers every step from customer requirements via marketing, research and development, product supply and sales to the monitoring of customer satisfaction.

Quality system

GMP is the oldest quality system in Krka and forms the basis for development of all other management systems. Compliance with GMP is required by law, and without it the manufacture and sales of medicinal products would not be possible. Functioning of the quality management system is controlled internally and externally. Krka controls functioning of the quality management system periodically also at its suppliers and contractors.

Internal audits are carried out by an experienced team of Krka's auditors. The compliance of Krka's management system is examined and approved by regular inspections carried out by domestic and foreign government agencies and inspectorates, certification organisations and partner audits.

Our Quality Committee and Management Board periodically review all processes most important for quality and propose measures and strategic guidelines for implementation of Krka's development strategy.

Quality policy

Krka's Management Board has adopted the quality policy in compliance with strategic objectives. All Krka employees have been informed about the policy and it is also available to all interest groups. It is regularly reviewed and updated during reviews.

The quality policy involves the commitment to:

  • Improving and continuously upgrading the quality management system;
  • Monitoring quality of processes, products and services, setting measurable periodic targets aimed at constant improvement;
  • Improving products and services in accordance with the expectations and requirements of the clients and in compliance with the legal requirements that apply to the pharmaceutical production;
  • Providing for resources that will enable implementation of this policy;
  • Raising awareness and informing employees, suppliers, partners and clients (with regard to the requirements of individual interest groups) about changes and new developments in quality system management, and about products and services;
  • Engaging employees in training programmes and upgrading knowledge by motivating them for good work performance;
  • Providing for occupational health and safety, and healthy working environment;
  • Providing responsible data management (data integrity);
  • Implementing Krka's quality policy in subsidiaries and representative offices in compliance with the Krka Group’s Quality Policy.

Business excellence

One of Krka's key objectives is to reach excellence in all its fields of operations, so IMS has been upgraded according to the EFQM excellence model, which was prepared by European Foundation for Quality Management.