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Quality management

Quality management

Quality
management

Amsler & Frey AG operates on the basis of a quality management system that has been certified to ISO 9001 standard since 1996 and achieved ISO 13485 certification in 2006. Our validated processes and machinery ensure consistent quality. State-of-the-art measuring equipment ensures that the tightest dimensional tolerances are observed and recorded. As specialists in dry machining, we can reliably avoid any contamination of or damage to the plastic parts. Full traceability of the materials used can be guaranteed upon request.


SN EN ISO 9001:2015

ISO 9001 certification is an internationally recognised standard for quality management systems. It helps to ensure that consistent, high-quality products are offered and is based on continuous improvement of internal processes. This certification is an effective tool for managing quality processes within the company and can be applied across all industries.


SN EN ISO 13485:2016

ISO 13485 certification is an international quality management standard that regulates the requirements for medical products. This standard particularly takes into account aspects such as traceability, compliance with regulatory requirements, risk management and control and proficiency in handling specific processes. This certification lays the foundations for ensuring conformity with the essential European directives and ordinances.


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