Quality has always been the cornerstone of our operations. While our long-standing ISO 9001, 14001, and 45001 certifications have demonstrated our commitment to excellence, we are proud to announce a significant new milestone: Skar is now ISO 13485:2016 certified.
This certification is specifically tailored to the Medical Device industry. It signifies our management system meets the rigorous regulatory requirements necessary to support the design, manufacture, and distribution of plastic injection moulded parts for medical applications.
While ISO 9001 focuses on general quality management and customer satisfaction, ISO 13485 is a more stringent standard. It is designed to ensure manufacturers can consistently meet both customer and (most importantly) regulatory requirements for medical devices.
In the medical sector, the stakes are high. A component used in a medical device must be safe, reliable, and perfectly traceable. Our achievement of this standard means Skar has implemented a comprehensive quality management system that prioritises:
Risk management: Every stage of the manufacturing process is evaluated for potential risks to ensure the safety of the end-user.
Total traceability: We have established a “full-circle” traceability system, ensuring every batch of material and every manufactured part can be tracked back through the production chain.
Strict process validation: Our moulding processes are rigorously validated to ensure every part we produce meets the precise specifications required by medical OEMs.
Sterile environment controls: Where necessary, our systems now support the heightened cleanliness and contamination controls required for medical grade production.
The certification, awarded by NQA, covers “the sales, control of design, manufacture and distribution of injection moulded parts for use in the further manufacture of medical devices”.
This scope shows we are an integrated partner capable of assisting in the control of design and the complex logistics of distribution, within a framework that satisfies international medical regulators.
For our existing clients, this certification is further proof of the maturity and robustness of our quality systems. For manufacturers in the medical and life sciences sectors, it makes Skar a premier partner for your next project.
Whether you are developing a new surgical instrument, a diagnostic housing, or a complex drug delivery component, you can be confident Skar understands the regulatory landscape you operate in. We speak the language of ISO 13485, and we are ready to help bring safe, compliant, and high-precision medical products to market.
This certification marks a new chapter for Skar Precision Mouldings. As we expand our capabilities in the medical sector, we remain committed to the same values that have defined us for decades: engineering expertise, transparency, and precision.
For further enquiries or more detailed information please call us on 01473 828000 or email us at sales@skar.co.uk