Goal: Even better and more cost-effective operations
ISO 9001 certified quality management system and extensive GMP expertise
Kaptas’ quality management system
Kaptas has had its own quality management system since 2014. The system is applied across all core processes: sales, project management, design, procurement, manufacturing, machining, and after-sales services related to the construction of machines and production lines.
As a significant portion of our customers operate in the pharmaceutical industry, which sets strict quality requirements for its suppliers, we certified our quality management system with the ISO 9001 standard in 2015.
In addition, we follow the Good Manufacturing Practice (GMP) guidelines required by the pharmaceutical sector.
ISO 9001 certificate for Kaptas’ quality management system
Kaptas’ quality management system was certified according to the ISO 9001 standard in 2015.
ISO 9001 is an international standard that defines the requirements for a quality management system. It helps companies enhance operational quality, increase customer satisfaction, and improve process efficiency.
The certificate demonstrates that Kaptas meets these quality management requirements and is committed to continuous improvement.
The audit of Kaptas’ operations is conducted by the international inspection and certification company Bureau Veritas.
The benefits of our quality management system for customers:
- Compliance: Our quality management system helps us comply with applicable regulations and standards required by our customers, including the strict requirements of pharmaceutical industry projects.
- Quality and reliability: The system improves the quality and reliability of the machines and production lines we build. Before delivery, each machine undergoes comprehensive testing and inspections to ensure that it meets even the most demanding customer requirements. This is especially critical for pharmaceutical industry clients, where even minor errors can have serious consequences for their end customers.
- Process optimization and continuous improvement: Our quality management system requires ongoing evaluation and development of our processes. This leads to increased efficiency, cost savings, and reduced resource usage — benefits that are also reflected in more cost-effective solutions for our customers. We continuously collect customer feedback and monitor performance in line with our quality system. Developing and updating our processes based on feedback ensures consistently high service levels.
- Risk management: The system helps us identify and manage risks related to both operations and machine construction. Our goal is to deliver increasingly safe solutions where even the smallest risks are minimized.
- Documentation and traceability: Our quality management system ensures that all activities are documented and carried out consistently. This guarantees that the machines and production lines we deliver meet the most demanding requirements, with full traceability throughout the entire design and construction process.
- Training and staff commitment: Our quality standards require that we ensure the expertise of our staff and that all employees work in accordance with the quality management system. This minimizes the risk of errors and improves the overall quality of the machines and production lines we deliver.
Kaptas follows GMP (Good Manufacturing Practice) guidelines
GMP (Good Manufacturing Practice) is an internationally recognized set of rules and guidelines designed to ensure that products are manufactured and monitored in a way that guarantees consistent quality and safety.
GMP covers, for example:
- Hygiene conditions in factories and production environments
- Monitoring and documentation of production processes
- Maintenance of equipment and facilities
- Staff training
- Product safety monitoring
The purpose of GMP is to ensure that products such as medical devices, pharmaceuticals, and other health-related goods are manufactured without contamination, are suitable for their intended use, and meet defined quality standards throughout the production process.
Although GMP is particularly applied in the pharmaceutical, food, and cosmetics industries, it is also used in other sectors where strict quality control is essential.
Kaptas has completed numerous projects in compliance with GMP requirements, and our staff has in-depth knowledge of GMP principles.
This expertise ensures that the machines and production lines we design and deliver meet the highest standards of quality and safety — helping reduce the need for additional inspections or validations on the customer’s side, and saving both time and resources.