At RKT, quality is more than just a promise, it’s our unwavering commitment. We meticulously design every aspect of our processes to ensure they are valid, stable, and reliable.
Interested in learning more about our high quality standards? Explore our wide range of quality systems and controls, advanced analysis techniques, validations, qualifications, comprehensive process and test documentation, and certifications below.
Our quality management system certifications exemplify the foundation of our quality systems. During process development, statistical methods (DoE, ProOp) are used to develop optimum, process-safe, and stable parameter settings. The entire process is then validated, including the qualification of tools and equipment. Defined parameters are recorded during each injection process, and critical quality metrics are checked at defined intervals to detect deviations and trends early. Online sensors monitor equipment and environmental conditions, while regular calibration and maintenance ensure validated conditions are maintained. Automated camera vision inspection is incorporated directly on production lines, and cleanrooms underdo regular air particle measurements and contact sampling to manage particulate and microbial contamination. All of this is an example of our commitment to your product quality.
We recognize that each product has specific quality requirements and we implement custom control mechanisms to meet those needs. Our quality department supports early stages of design engineering utilizing advance quality planning, drafts the measurement strategy for needed for volume production, and preforms design Failure Mode and Effects Analysis (FMEA) to recognize and control risk.
In 2024, we implemented an Information Security Management System (ISMS) aligned with the international standard ISO/IEC 27001.
Our goal is to systematically improve the protection of sensitive data, maintain business continuity, and adhere to the highest security standards. The confidentiality, integrity, and availability of information are at the core of this effort.
The standard allows us to analyze risks in a structured manner, make them measurable, and reduce them in a targeted way to foster systematic improvement. Particularly in the era of increasing digitalization, technical measures are crucial to ensure we do not jeopardize our own supply chains or those of our customers. To this end, for example, we have housed our servers in separate buildings and established a system availability target of 99.98% for production-critical systems. The medical industry, in particular, places very high demands on data archiving—requirements that we fully meet through our ISMS.
Introducing this system is a clear commitment that we take the protection of our customers’, partners’, and employees’ data very seriously and act proactively. To continuously review and enhance the effectiveness of our ISMS, it is regularly audited by an external service provider.
ISO 45001 is an international standard for occupational health and safety that provides a framework for the continuous improvement of management systems. Over a period of 15 years, RKT has progressively developed and established an Occupational Health and Safety Management System (OHSMS) aligned with this standard. We have been consistently implementing this system for a decade now, with our most recent audit conducted by an external service provider in 2025.
For us, implementing this management system is a genuine win-win situation: our employees benefit from consistent adherence to high safety standards and a healthy working environment. At the same time, we record fewer absences due to workplace accidents. In terms of the statistical average over the last 10 years, our figures have consistently remained below the industry average reported by our trade association—a result that validates our approach.
Introducing this system represents our clear commitment to the highest standards of occupational safety. It boosts employee satisfaction, reduces costs through effective accident prevention, and ensures compliance with all legal requirements. In doing so, we not only solidify our market position but also foster a corporate culture of continuous improvement in all areas of health and safety.
RKT’s commitment to quality is exemplified by our extensive certifications, with regular recertifications ensuring we continue to live up to the strict requirements. Click on a certificate below to download a copy.
Sustainability is integral to high quality and a principle long embraced at RKT. We demonstrated our commitment as early as 2011 by obtaining ISO 14001 certification for environmental management. ISO 50001 certification for energy management soon followed, making us one of the first companies in Germany to receive both credentials.
We constantly explore methods of optimizing energy and resource consumption across our company and processes, regularly launching new initiatives. We are proud to have already implemented more than 100 projects, including heat recovery, converting to LEDs, optimizing our cooling tower, using energy-efficient technology, replacing circulation pumps, and optimizing compressed air consumption.
Learn more about our sustainability efforts and projects here.
There is no room for errors in medical product manufacturing. Our production tolerances and processes are tightly controlled to ensure product function and safety. We perform 100% inspections along our production lines for particularly sensitive products and per client request to ensure processes remain reliable. Depending on product requirement and the process design, quality inspection can be carried out manually during production ramp-up and automatically using cameras at higher volumes.
In addition to final product inspection, we conduct inspect raw materials and incoming material, and conduct in-process audits throughout the production process to maintain consistent quality levels.
