Quality Management
At A. Hopf GmbH, we prioritise product quality and customer service, offering cost-saving maintenance services, technical advice, shipping support, and mould customisation.
This reflects our holistic approach to quality. Our Quality Management System is certified to EN ISO 13485:2016 for medical production, including production in Class 8 (100,000) clean rooms.
We use tested and certified raw materials, such as granulate or steel from established suppliers, and conduct in-process control with short testing intervals to ensure quality in the medical sector.
High standards are also applied to the raw materials and injection-moulded parts used in our technical precision parts. Our expertise allows us to meet demanding requirements for unscrewing tools, injection moulds in the in-mould process, and technical parts with flame retardant properties.
Quality as Competitive Advantage
Producing high-quality precision components is essential for customer satisfaction and is our standard. This competitive advantage is maintained through a synchronized quality management system across all processes. In the medical field, unrestricted traceability of products along the process chain back to the raw material and batch is crucial.
We ensure additional traceability and process security through cleanroom processing and assembly, regular in-process controls, and bag number labelling. Our production of medical devices in Class 8 cleanrooms includes monitoring with internal measurements and external partners, as well as microbiological counts by accredited laboratories, as part of our regular certification.
Quality Standards
Our use of computer-aided manufacturing based on the latest technology ensures a high standard of precision. Cleanroom production of medical devices adheres to the strictest quality criteria of DIN EN ISO 13485:2016, achieved through consistent recording, monitoring, and evaluation of work and control process data. Our quality management program and quality assurance form the basis for regular certification of our QM system. To guarantee the highest quality and traceability, we select raw materials according to strict quality criteria and conduct regular in-process controls during production.
Years of experience combined with consistent quality management ensure the safety and reliability of our products. Continuous dialogue with our customers drives innovation and practical solutions for our product range.
REACH Declaration
A. Hopf GmbH does not produce materials but processes them through thermoplastic injection moulding. In compliance with the REACH Regulation, we collect and provide all available information and certificates from our suppliers to customers upon request.