Goal: Even better and more cost-effective resources
ISO 9001 certified quality management system and extensive GMP expertise
Kaptas’ quality management system
Kaptas has had its own quality management system since 2014. We apply this system in sales, project management, design, procurement, manufacturing, and machining processes related to the construction of machines and production lines, as well as in after-sales services.
As a significant portion of our customers represent the pharmaceutical industry, which has strict quality requirements for its subcontractors and suppliers, we certified our quality management system with an ISO 9001 certificate in 2015.
We also follow Good Manufacturing Practice (GMP) guidelines required by the pharmaceutical industry.
ISO 9001 certificate for Kaptas’ quality management system
Kaptas’ quality management system was awarded the ISO 9001 certificate in 2015.
ISO 9001 is an international standard that defines the requirements for a quality management system. It helps companies improve operational quality, customer satisfaction, and process efficiency.
The certificate demonstrates that the company adheres to these quality management requirements and is committed to continuous improvement.
The audit of Kaptas’ operations is carried out 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 rules and standards for our customers and meet the strict requirements related to pharmaceutical industry projects.
- Quality and reliability: Our quality management system improves the quality and reliability of the machines and production lines we build. Before delivery, our machines undergo comprehensive testing and inspections to ensure that they meet even our customers’ most stringent requirements. This is especially important for customers in the pharmaceutical industry, where even small errors can lead to serious consequences for the customers of our client companies.
- Process optimization and continuous improvement: Our quality management system requires continuous evaluation and improvement of our processes, which increases efficiency, creates cost savings, and reduces resource usage. These savings are also reflected in more cost-effective solutions for our customers. We continuously gather feedback from our customers and monitor performance according to the quality management system. Developing and updating our processes based on customer feedback ensures even better service levels.
- Risk management: Our quality management system helps us identify and manage risks related to both our operations and machine construction. Our goal is to implement even safer solutions for our customers, where even the smallest risks need to be minimized.
- Documentation and traceability: Our quality management system ensures that our operations are documented and executed consistently. This promotes that the machines and production lines we build meet our customers’ most demanding requirements, and the entire design and construction process is traceable step by step.
- Training and staff commitment: Our quality standards require us to ensure the expertise of our staff and to make sure that all employees work in accordance with the quality management system. This minimizes the chance of errors, which also improves the quality of the machines and production lines we build.
Kaptas follows GMP (Good Manufacturing Practice) guidelines
GMP (Good Manufacturing Practice) is an internationally accepted collection of rules and guidelines aimed at ensuring that products are manufactured and monitored in a manner that guarantees quality and safety.
GMP guidelines cover areas such as:
- Hygiene conditions in factories and production environments
- Monitoring and documentation of production processes
- Maintenance of equipment and facilities
- Staff training
- Product safety monitoring
The goal of GMP guidelines is to ensure that products such as medical devices, pharmaceuticals, and other health-related products meet specific requirements.
For example, products should not contain impurities, must be fit for their intended purpose, and must meet certain quality standards throughout the production process.
GMP is especially applied in the pharmaceutical industry, as well as in the food and cosmetics industries, but is also used in other fields that require high-quality control standards.
Kaptas has carried out numerous projects in compliance with GMP principles, and our staff is highly knowledgeable in these principles.
Our staff’s strong GMP expertise ensures that the machines and production lines we manufacture and deliver to our customers comply with the highest quality and safety standards.
This can reduce the need for extensive inspections or validations by our customers, saving them both time and resources.