Clamason is proud to announce a new milestone, this time in our European operations. Our Slovakian plant has achieved ISO 13485 certification. It’s relatively rare for component manufacturers like Clamason to be awarded this stringent certification and indicates a significant commitment to quality assurance for our medical sector clients. Alongside this new certification, we are also developing a state-of-the-art ‘ISO 8 Clean Room’ to further improve quality control and safety standards for our medical device components.
Understanding ISO 13485
ISO 13485 is a globally recognised Quality Management System (QMS) standard specific to the medical device industry. Building upon the principles of ISO 9001, which we already hold at both our UK and Slovakian facilities, ISO 13485 is tailored to the requirements necessary in medical manufacturing. While ISO 9001 addresses quality across various industries, ISO 13485 is specially crafted for the controlled production and delivery of medical devices and components.
Attaining ISO 13485 demonstrates Clamason’s dedication to quality in medical manufacturing above and beyond industry norms. It reflects Clamason’s proactive steps to align with the high-quality standards essential for the medical sector. Clamason sought this certification not because it was a requirement, but because it differentiates Clamason from other component manufacturers. ISO 13485 sets very high standards of quality that resonates with our customers in the medical device market.
The Certification Process:
To be awarded ISO 13485 certification, Clamason’s Slovakian facility underwent a thorough audit to verify compliance with all aspects of the standard. The scope is defined as the “Production of metal components for medical devices and equipment,” and covers key processes including cold pressing, welding, degreasing, assembly, and packing.
During the documentation audit, our internal records and written procedures were all reviewed to confirm adherence to ISO 13485 standards. These included quality control protocols for stamped parts, risk assessments, and customer quality concern management, along with records of raw material purchases, logistics control, and warehouse management. This rigorous audit means customers can rest assured every component we manufacture meets the highest possible standards for medical use.
What ISO 13485 Certification Means
Clamason’s ISO 13485 certification means every medical component produced in our Slovakian facility is manufactured under strict quality controls that comply with the rigorous requirements of the medical industry. This means customers can rely on consistent and reliable components that meet the highest medical-grade standards. This certification also sets the company apart from other component manufacturers, underscoring Clamason’s commitment to delivering quality beyond what’s expected.
New Clean Room Facility. New Standards of Excellence
In addition to the ISO 13485 certification, Clamason is investing in further enhancing quality by establishing an ISO 8 Clean Room in our Slovakian facility. Clean rooms are specialist environments where air purity, temperature, and humidity are strictly regulated to prevent contamination during the assembly and packing of medical components. Our new clean room, when completed, will align with ISO 8 standards, which limit the number of airborne particulates within the environment to safeguard product integrity.
Once installed, the ISO 8 Clean Room will serve as a dedicated space for packing and assembling medical components, ensuring they remain free from contamination by environmental factors or human contact. Medical device manufacturers understand the importance of technical cleanliness in their components, as even microscopic contaminants can compromise a product’s safety or functionality. When this controlled environment is established, it will reinforce our ability to meet the demanding requirements of the medical industry.
How the Clean Room Adds Value
The Clean Room facility at Clamason’s Slovakian plant once installed, will provide a crucial asset to our medical device clients. Before entering, all workers will have to undergo a strict gowning procedure to minimise contamination risks. Air within the room will be continuously filtered and purified, maintaining stringent ISO 8 particle limits to reduce potential contaminants. Additionally, the clean room will follow strict cleaning procedures, with periodic validation by external laboratories to confirm compliance with ISO 8 standards. In a region where clean room space is in high demand, this new facility will offer an invaluable solution for our clients. It will allow medical device manufacturers to access meticulously prepared components ready for integration, supporting the production of safer, higher-quality devices. This facility will be particularly relevant for manufacturers seeking to improve their supply chain by working with partners who prioritise quality management at every stage. By providing a clean room environment, Clamason will not only helps prevent contamination risks but also support the overall safety and compliance requirements integral to the medical sector. We are delighted that these plans for Clamason Slovakia complement our UK operations and pave the way for greater involvement in the medical sector.
For our customers, our plans reflect Clamason’s unwavering focus on delivering components that align with the highest medical standards in the UK, Europe and beyond. We understand that in the medical sector, quality is king. Therefore, we strive to be more than just a component supplier—we aim to be a trusted partner in our clients’ commitment to safety and quality.
As we continue to invest in our facilities and refine our processes, Clamason remains dedicated to enhancing our offerings and strengthening our position in the medical device market. Our Slovakian operations stand as a testament to our commitment, ensuring that every component we produce upholds the integrity and reliability our customers expect. Through our ISO 13485 certification and the new Clean Room, Clamason is equipped to meet the ever-evolving needs of the medical industry, providing solutions that embody excellence in quality and safety.
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