Quality management
KKS customers operate in demanding sectors such as the medical technology industry, where fulfilling various customer-specific and regulatory requirements and standards represents a key success factor. Qualified equipment and high process reliability thanks to validated processes, procedures and methods are important prerequisites for meeting the quality requirements expected of medical products.
As a supplier and service provider, KKS is aware of the strict requirements and high expectations of customers. We meet customer demands thanks to our many years of experience, industry expertise, highly qualified employees and our quality management system.
For us, quality means meeting the customer’s requirements and exceeding their expectations in every order or project.
Our quality management services for medical products…
Comprehensive quality management for medical products through constant innovation
The procedures and technologies offered by KKS are the result of our in-house R&D and underline our company’s enormous innovative strength. We aim to inspire, not just to satisfy!
Thanks to our history of dealing with industry-specific requirements – for example equipment qualifications and process validations – we have a wealth of experience to draw on and can provide you with the relevant support. When it comes to quality management, seamless traceability and process documentation are also a matter of course, as is the continuous training of our employees.
Quality management in equipment construction and the manufacturing of KKS ultrasonic components
Our equipment construction and ultrasonic technology teams work in accordance with our certified quality management system as per ISO 9001. The systems and installations are developed, manufactured and commissioned on site at the customer’s premises according to customer specifications.
At the customer’s request, the KKS systems engineering team will also take care of equipment qualification (DQ/IQ/OQ) as well as the computer system validation of equipment (CSV). Our comprehensive expertise in systems engineering, manufacturing, commissioning and equipment qualification is supplemented by our wealth of experience in the medical technology industry and other regulated sectors. We know the industry requirements and ensure we meet them. We are on hand to support our customers with process validations.
Certified quality management system in the KKS Medical Surface Center
In the Medical Surface Center, we work in accordance with our certified quality management system as per EN ISO 13485. Qualified and passionate employees in production planning, production, quality assurance and packaging guarantee that our customers always benefit from the impeccable quality of our services in the field of surface treatment and ultrasonic cleaning for medical products. In the Medical Surface Center, we work with state-of-the-art systems that have been developed and implemented in-house. It goes without saying that all the equipment that we use are qualified!
Our R&D team develops processes while taking into account all the requirements (customer requirements, regulatory requirements and standards). Robust and reliable processes are the result and the basic prerequisite for our joint success with our customers. We validate processes requiring validation using worst-case parts / reference products. We of course carry out customer-specific validations too.
Quality assurance in the Medical Surface Center
Since our processes and services relate to surface treatment, it is primarily visual characteristics that are checked during the final inspection. Where necessary or agreed with our customers, we carry out further measurements and inspections. A state-of-the-art analysis laboratory complete with scanning electron microscope for surface analyses is available in the Medical Surface Center.
Medical product cleanliness – the result of stringent quality management
After ultrasonic final cleaning, the medical products are transferred to qualified cleanrooms of cleanroom class ISO 8 or ISO 7 (as per ISO 14644-1), where they undergo final inspection and packaging. Medical products are packaged in accordance with the respective customer requirements and in a manner that ensures they are protected against damage and contamination.
To prevent the highly active surface of etched and rinsed dental implants from becoming contaminated, the implants can be contactlessly transferred from the etching machine to the packaging specified by the customer.
Our certified quality management system
In order to guarantee the highest quality at all times, we continuously hone and improve the quality management systems that govern everything we do. We are certified to ISO 9001:2015, EN ISO 13485:2016 and the Federal Water Act (WHG).
